INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES

K090159 · Incisive Surgical, Inc. · GDW · Feb 6, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090159
• Device Name: INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
• Applicant: Incisive Surgical, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Feb 6, 2009
• 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. Staples are 5 mm long, 0.8 mm thick, 3.5 mm wide, with cleat tips spaced 0.8 mm apart. Device is used in conjunction with a manual surgical stapler (Class I exempt) operated by surgeons in clinical settings. Optimization of staple shape provides increased peak load pull strength compared to the predicate. Staples provide temporary tissue approximation during healing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing of mechanical pull strength specifications.

Technological Characteristics

Implantable synthetic absorbable staple. Dimensions: 5 mm length, 0.8 mm thickness, 3.5 mm width, 0.8 mm cleat tip spacing. Mechanical performance characterized by peak load pull strength specifications (1.500-lbs dry; 0.750-lbs at 1-day; 0.375-lbs at 7-days in 37°C saline).

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 (K061784)

Submission Summary (Full Text)

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and the comments of the country of the country

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KOGOIS9 FEB -6 2008

BB-62009

| 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: | January 21, 2009 |
| 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 K061784 |
| 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 0.8 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 an optimization in the staple shape that allows the following specification changes:<br>• Minimum "peak load" pull strength specification for the staple in its "dry" as packaged state is increased 25% to 1.500-lbs.<br>• Minimum "peak load" pull strength specification for the staple following exposure to 37°C buffered saline for 1-day is increased 25% to 0.750-lbs<br>• Minimum "peak load" pull strength specification for the staple following exposure to 37°C buffered saline for 7-days is increased 25% to 0.375-lbs. |
| Conclusion: | The modified INSORB Absorbable Staple described in this submission is substantially equivalent to the predicate device. |

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and the comments of the comments of

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle, with its wings spread, symbolizing protection and service.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 2009

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

Re: K090159

Trade/Device Name: INSORB Absorbable Staples Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: January 21, 2009 Received: January 22, 2009

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. 1

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket.notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark M. Mulkerson

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 Statement

## 510(k) Number (if known)

### K090159

Device Name

INSORB™ Absorbable Staples

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.

Stapler is designed to aid in the prevention of accidental needle stick injuries.

Prescription Use Yes (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (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)

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

**510(k) Number** K090155