Cleared Traditional

K140305 - CAYA CONTOURED DIAPHRAGM

K140305 is an FDA 510(k) clearance for CAYA CONTOURED DIAPHRAGM, manufactured by Kessel Medintim GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HDW cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K140305 · Kessel Medintim GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
200d
Days
Class 2
Risk

K140305 is an FDA 510(k) clearance for the CAYA CONTOURED DIAPHRAGM. Classified as Diaphragm, Contraceptive (and Accessories) (product code HDW), Class II - Special Controls.

Submitted by Kessel Medintim GmbH (Frankfurt, DE). The FDA issued a Cleared decision on August 26, 2014 after a review of 200 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5350 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K140305

510(k) Number K140305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2014
Decision Date August 26, 2014
Days to Decision 200 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 161d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

HDW Device Classification - Class 2, Special Controls

Product Code HDW Diaphragm, Contraceptive (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00561613 Completed Interventional

Postcoital Testing of the SILCS Diaphragm

A Phase I Postcoital Testing and Safety Study of the SILCS Diaphragm, Prototype VI

40
Patients (actual)
2
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Contraceptive Device
Study design Crossover
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Jill Schwartz, MD
Sponsor CONRAD
Started 2003-08-01 → Completed 2004-10-01
Primary outcome
Percentage of women with any sperm in the cervical mucus, with ≥ 5 progressively motile sperm per high power field (HPF), and the average number of progressively motile sperm per HPF.
Secondary outcome
Symptoms and signs of irritation of the external genitalia, cervix, and vagina before and after intercourse and by gel product. The handling, fit, and general acceptability of the SILCS diaphragm was assessed.
Study completed - no results published. This trial concluded in 2004 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov
K140305 · CAYA CONTOURED DIAPHRAGM
Download PDF FDA Summary Kessel Medintim GmbH