INSORB ABSORBABLE STAPLE, MODEL 1020

K061784 · Incisive Surgical, Inc. · GDW · Jul 26, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061784
• Device Name: INSORB ABSORBABLE STAPLE, MODEL 1020
• Applicant: Incisive Surgical, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jul 26, 2006
• 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.

Device Story

INSORB™ Absorbable Staples are implantable fasteners used for subcuticular skin closure; deployed via manual surgical stapler (not part of this submission). Staples measure 5mm length, 0.8mm thickness, 3.5mm width, with 0.7mm cleat tip spacing. Used in clinical settings by surgeons across various specialties (abdominal, thoracic, gynecologic, orthopedic, plastic, reconstructive). Device provides temporary tissue approximation; absorbable material eliminates need for staple removal. Modifications include updated sterilization (Method 1 gamma), addition of desiccant to packaging, and increased strength specifications following 7 and 21-day saline exposure due to improved micromolding processes. Shelf life extended to 2 years.

Clinical Evidence

Bench testing only. Testing included strength specifications after exposure to 37°C buffered saline for 7 and 21 days to verify performance improvements resulting from refined micromolding and sterilization processes.

Technological Characteristics

Synthetic absorbable implantable staple. Dimensions: 5mm length, 0.8mm thickness, 3.5mm width, 0.7mm cleat tip spacing. Sterilization: Gamma radiation (Method 1). Packaging includes desiccant. Shelf life: 2 years.

Indications for Use

Indicated for patients undergoing abdominal, thoracic, gynecologic, orthopedic, plastic, or reconstructive surgery requiring subcuticular skin closure where temporary tissue approximation via absorbable fastener is desired.

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 (K033602)

Submission Summary (Full Text)

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K061784

## Exhibit I

## JUL 26 2006

## 510(k) Summary

| Submitter: | Incisive Surgical<br>14405 21st Avenue North, Suite 130, Plymouth, MN 55447-2000 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Peterson, Vice President, Ph: [phone] ext 14 |
| Date Prepared: | June 22, 2006 |
| Trade Name: | INSORB™ Absorbable Staple |
| Classification | Class II, 21 CFR 8787.4750, Staple, Implantable |
| Product Code: | GDW |
| Predicate Device<br>and 510(k) No. | INSORB™ Absorbable Staple<br>K033602 |
| Device<br>Description: | INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have cleat tips that are 0.7 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). |
| 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. |
| Statement of<br>Technological<br>Comparison | The subject device and the predicate device are identical except for:<br>1) Sterilization Validation changed from VDmax to Method 1 to allow implementation of a 10-6 SAL validated gamma dose at less than 25kGy.<br>2) Packaging includes a desiccant.<br>3) Strength specifications for the staple following exposure to 37°C buffered saline for 7 days and 21 days have been increased 50% to accommodate the STRONGER staple fabricated by the refinements in the micromolding process, the lower gamma dose possible under a Method 1 validation, and the storage benefits of including a desiccant within the packaging.<br>4) Shelf Life extended to 2 years. |
| Conclusion: | The modified INSORB Absorbable Staple described in this submission is substantially equivalent to the predicate device. |

Incisive Surgical, Inc.

.

Special 510(k)

June 22, 2006

CONFIDENTIAL

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2006

Incisive Surgical, Inc. % Mr. James Peterson Vice President 14405 21st Avenue North, Suite 130 Plymouth, Minnesota 55447-2000

Re: K061784

> Trade/Device Name: INSORB™ Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 22, 2006 Received: June 29, 2006

Dear Mr. Peterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, 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, and Cosmetic Act (Act) that do not require 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 may be subject to such additional controls. Existing major regulations affecting your device can be 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 does 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 contacthe regulation entitled, "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/industry/support/index.html.

Sincerely yours,

hulul Lunes us

/ Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

K061784

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 skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ _______________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huler Lemen

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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Kob 1784 510(k) Number_