INSORB ABSORBABLE STAPLE, MODEL SP-B20 by INCISIVE SURGICAL, INC.

Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation. INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have barb tips that are 0.7 mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).

Device Description

INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have barb tips that are 0.7 mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).

AI/ML Overview

The provided K033602 510(k) summary does not contain the acceptance criteria or a study demonstrating that the device meets such criteria in the traditional sense of performance metrics against predefined thresholds.

This 510(k) submission is for a modified version of an already cleared device (K024117). The modification is solely related to the method of sterilization (Gamma Radiation). Therefore, the focus of this submission is on demonstrating that the new sterilization method does not alter the fundamental characteristics or safety and effectiveness of the device, rather than proving a new set of performance criteria for the device itself.

Based on the provided text, here's what can be inferred or stated about the study and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics. The underlying acceptance criterion for a 510(k) of this nature is substantial equivalence to the predicate device. This means demonstrating that the change in sterilization method does not introduce new questions of safety or effectiveness and that the device remains as safe and effective as the predicate.
Reported Device Performance: Not reported in terms of specific numerical performance data (e.g., tensile strength, absorption rates) in this document. The "performance" demonstrated is that the device, with the new sterilization method, is deemed substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable / Not Provided: The summary does not describe a clinical or performance study with a "test set" as would be used for a new device's primary efficacy or safety claims. The focus is on the sterilization process. Information on the testing done for the sterilization validation itself (e.g., sterility testing, biocompatibility after sterilization) is not detailed in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable / Not Provided: There is no indication of experts establishing a "ground truth" for a test set. This type of evaluation is not relevant for a sterilization change submission.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided: No adjudication method is mentioned as there is no described test set requiring expert review or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No: An MRMC study is typically used for diagnostic devices involving human interpretation of results. This device is a surgical staple, and such a study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No: This is not an AI/algorithm-based device.

7. Type of Ground Truth Used:

Not Applicable: For a sterilization change, the "ground truth" would relate to the validation of the sterilization process itself (e.g., demonstrating sterility assurance level, material compatibility post-sterilization), rather than expert consensus on clinical outcomes or pathology. This information is not detailed in the summary.

8. Sample Size for the Training Set:

Not Applicable / Not Provided: There is no "training set" as this is not a machine learning or diagnostic device that requires such data.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable / Not Provided: Not relevant for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to its predicate device (K024117). The single key difference, as stated, is the method of sterilization (Gamma Radiation).

The implication is that Incisive Surgical provided data to the FDA to demonstrate:

Effectiveness of Gamma Sterilization: That the chosen Gamma radiation dose achieves the required sterility assurance level (SAL). This typically involves bioburden testing, dose mapping, and validation studies according to standards like ANSI/AAMI/ISO 11137.
Material Compatibility/Integrity: That the Gamma sterilization process does not adversely affect the physical properties, chemical composition, biocompatibility, or performance (e.g., strength, absorption profile) of the INSORB™ Absorbable Staple material. This would involve comparing pre- and post-sterilization testing of critical device characteristics.
Packaging Integrity: That the packaging maintains its integrity and barrier properties after exposure to Gamma radiation.

The acceptance criteria for this submission, though not explicitly listed as numerical targets, would have been that:

The device, post-Gamma sterilization, remains sterile (meeting SAL requirements).
The device's functional performance and safety characteristics remain unchanged compared to the predicate device.
The device continues to meet its intended use for subcuticular closure of skin.

The conclusion of the 510(k) summary explicitly states: "The modified INSORB Absorbable Staple described in this submission is substantially equivalent to the predicate device." This statement, along with the FDA's clearance letter ("We have reviewed your Section 510(k) premarket notification... and have determined that this device is substantially equivalent..."), confirms that Incisive Surgical successfully demonstrated these points to the FDA's satisfaction for the change in sterilization method.

Summary

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DEC 1 6 2003

K033602

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Exhibit E

510(k) Summary

Submitter:	Incisive Surgical14405 21st Avenue North, Suite 130Plymouth, MN 55447-2000
Contact Person:	Jim PetersonVice PresidentPh: (952) 591- 2543 ext 14
Date Prepared:	November 13, 2003
Trade Name:	INSORB™ Absorbable Staple
Classification Nameand Number:	Class II, 21 CFR 8787.4750, Staple, Implantable
Product Code:	GDW
Predicate DeviceName and 510(k)Number	INSORB™ Absorbable StapleK024117
Device Description:	INSORB™ Absorbable Staples are 5 mm in length, 0.8 mmthick, 3.5 mm wide overall, and have barb tips that are 0.7 mmapart. They are used in conjunction with a manual surgicalstapler from Incisive (Note: Incisive's manual surgical stapler isa Class I exempt device pursuant to 21 CFR 878.4800 and is notthe subject of this submission).
Intended Use:	Synthetic absorbable INSORB™ staples are intended for use inabdominal, thoracic, gynecologic, orthopedic, plastic andreconstructive surgery for the subcuticular closure of skin wherean absorbable tissue fastener is desired for temporary tissueapproximation. INSORB™ Absorbable Staples are 5 mm inlength, 0.8 mm thick, 3.5 mm wide overall, and have barb tipsthat are 0.7 mm apart. They are used in conjunction with amanual surgical stapler from Incisive (Note: Incisive's manualsurgical stapler is a Class I exempt device pursuant to 21 CFR878.4800 and is not the subject of this submission).
Statement ofTechnologicalComparison	The subject device and the predicate device are identical exceptfor the method of sterilization. The subject device is sterilizedby Gamma Radiation.
Conclusion:	The modified INSORB Absorbable Staple described in thissubmission is substantially equivalent to the predicate device.

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Public Health Service

DEC 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Peterson Vice President Incisive Surgical, Inc. 14405 21st Avenue North Plymouth, Minnesota 55447

Re: K033602

Trade/Device Name: INSORBTM Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: November 13, 2003 Received: November 18, 2003

Dear Mr. Peterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass mated in the enactment date of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de necs that have been rouire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 70dr abless to such additional controls. Existing major regulations affecting your device can he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. James Peterson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation enuitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K033602

Indications for Use

510(k) Number (if known): K033602

Device Name: INSORB™ Absorbable Staple

Indications For Use;

Yes Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

No Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Division of Genc Restorative and Neurological L . . . ces

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Number K633602

Regulation Number and Section

§ 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.