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K Number
K120373
Device Name
INSORB ABSORBALBE STAPLE
Manufacturer
INCISIVE SURGICAL, INC.
Date Cleared
2012-03-16

(39 days)

Product Code
GDW
Regulation Number
878.4750
Type
Special
Panel
SU
Reference & Predicate Devices
K090159
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Synthetic absorbable INSORB staples are intended for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Device Description

INSORB Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have cleat tips that are 0.8 mm apart. They are used in conjunction with a manual surgical stapler from Incisive Surgical Inc. (Note: manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the primary subject of this submission).

AI/ML Overview

This document is a 510(k) K120373 summary for the Incisive Surgical INSORB® Absorbable Staple. It is a Special 510(k) that seeks to clarify the intended use of the device, stating that the subject device and the predicate device (INSORB Absorbable Staple K090159) are identical. Therefore, this submission does not contain information on new acceptance criteria or a new study.

Here's a breakdown of why the requested information cannot be found in this document:

  1. Acceptance Criteria and Reported Device Performance: Not applicable. The document explicitly states, "The subject device and the predicate device are identical. This Special 510(k) seeks only to more clearly communicate the device's intended use for the subcuticular closure of skin." There are no new performance tests or acceptance criteria because the device is identical to an already cleared predicate.

  2. Sample Size for Test Set and Data Provenance: Not applicable. No new test set or study was conducted for this Special 510(k). The basis of clearance is substantial equivalence to a predicate device.

  3. Number of Experts and Qualifications: Not applicable. No new clinical or performance data requiring expert review was generated for this submission.

  4. Adjudication Method: Not applicable. As no new data requiring adjudication was generated, there is no mention of an adjudication method.

  5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is not relevant to a device like an absorbable staple, which is typically evaluated for its physical properties and clinical performance through non-AI-assisted methods.

  6. Standalone (Algorithm Only) Performance: Not applicable. This device is an absorbable surgical staple, not an AI or algorithm-based device.

  7. Type of Ground Truth Used: Not applicable. No new Bdata requiring ground truth establishment was used in this Special 510(k).

  8. Sample Size for the Training Set: Not applicable. This device is not an AI/ML product and does not have a "training set."

  9. How Ground Truth for Training Set was Established: Not applicable. See point 8.

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.