INSORB ABSORBABLE STAPLE, MODEL SP-B20

K033602 · Incisive Surgical, Inc. · GDW · Dec 16, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033602
• Device Name: INSORB ABSORBABLE STAPLE, MODEL SP-B20
• Applicant: Incisive Surgical, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

INSORB™ Absorbable Staples are synthetic, absorbable tissue fasteners used for subcuticular skin closure. Staples measure 5 mm in length, 0.8 mm in thickness, 3.5 mm in width, and feature barb tips spaced 0.7 mm apart. Device is deployed using a manual surgical stapler (Class I exempt). Used in clinical settings by surgeons for temporary tissue approximation across various surgical specialties including abdominal, thoracic, gynecologic, orthopedic, and plastic/reconstructive procedures. Benefit includes providing secure closure that is absorbable, eliminating need for staple removal.

Clinical Evidence

No clinical data provided; substantial equivalence based on design identity and sterilization validation.

Technological Characteristics

Synthetic absorbable material; dimensions: 5 mm length, 0.8 mm thickness, 3.5 mm width, 0.7 mm barb tip spacing. Mechanical implantable staple. Sterilization method: Gamma Radiation.

Indications for Use

Indicated for subcuticular skin closure in abdominal, thoracic, gynecologic, orthopedic, plastic, and reconstructive surgery requiring temporary tissue approximation via absorbable fasteners.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• INSORB™ Absorbable Staple (K024117)

Submission Summary (Full Text)

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DEC 1 6 2003

K033602

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## Exhibit E

## 510(k) Summary

| Submitter: | Incisive Surgical<br>14405 21st Avenue North, Suite 130<br>Plymouth, MN 55447-2000 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jim Peterson<br>Vice President<br>Ph: (952) 591- 2543 ext 14 |
| Date Prepared: | November 13, 2003 |
| Trade Name: | INSORB™ Absorbable Staple |
| Classification Name<br>and Number: | Class II, 21 CFR 8787.4750, Staple, Implantable |
| Product Code: | GDW |
| Predicate Device<br>Name and 510(k)<br>Number | INSORB™ Absorbable Staple<br>K024117 |
| Device Description: | INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm<br>thick, 3.5 mm wide overall, and have barb tips that are 0.7 mm<br>apart. They are used in conjunction with a manual surgical<br>stapler from Incisive (Note: Incisive's manual surgical stapler is<br>a Class I exempt device pursuant to 21 CFR 878.4800 and is not<br>the subject of this submission). |
| Intended Use: | Synthetic absorbable INSORB™ staples are intended for use in<br>abdominal, thoracic, gynecologic, orthopedic, plastic and<br>reconstructive surgery for the subcuticular closure of skin where<br>an absorbable tissue fastener is desired for temporary tissue<br>approximation. INSORB™ Absorbable Staples are 5 mm in<br>length, 0.8 mm thick, 3.5 mm wide overall, and have barb tips<br>that are 0.7 mm apart. They are used in conjunction with a<br>manual surgical stapler from Incisive (Note: Incisive's manual<br>surgical stapler is a Class I exempt device pursuant to 21 CFR<br>878.4800 and is not the subject of this submission). |
| Statement of<br>Technological<br>Comparison | The subject device and the predicate device are identical except<br>for the method of sterilization. The subject device is sterilized<br>by Gamma Radiation. |
| Conclusion: | The modified INSORB Absorbable Staple described in this<br>submission is substantially equivalent to the predicate device. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.

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 [phone]. 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 [phone] or [phone] 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;

Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skip where an absorbable tissue fastener is desired for temporary tissue approximation.

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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