Cleared Traditional

K230551 - Visual-ICE Cryoablation System

K230551 is the FDA 510(k) clearance for Visual-ICE Cryoablation System by Boston Scientific Corporation. It is a Class 2 Orthopedic device (product code GEH) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K230551 · Boston Scientific Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
161d
Days
Class 2
Risk

K230551 is an FDA 510(k) clearance for the Visual-ICE Cryoablation System. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on August 8, 2023 after a review of 161 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4350 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K230551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2023
Decision Date August 08, 2023
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
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: 122d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
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 Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02511678 Completed Interventional Industry-sponsored

Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

73
Patients (actual)
11
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pain; Neoplasm Metastasis; Bone Metastasis of Diverse Origins
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jack Jennings, MD
Sponsor Boston Scientific Corporation (industry)
Started 2016-02-15 → Primary completion 2018-03-12
Primary outcome
Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8
View full study on ClinicalTrials.gov

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 80
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