INSORB ABSORBALBE STAPLE

K120373 · Incisive Surgical, Inc. · GDW · Mar 16, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120373
• Device Name: INSORB ABSORBALBE STAPLE
• Applicant: Incisive Surgical, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Mar 16, 2012
• 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 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 measure 5 mm in length, 0.8 mm thick, and 3.5 mm wide with 0.8 mm cleat tips. Device is used in conjunction with a manual surgical stapler (Class I exempt) to approximate tissue. Intended for use by clinicians in surgical settings. Device provides temporary tissue approximation via absorbable material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic absorbable material; 5 mm length, 0.8 mm thickness, 3.5 mm width; cleat tip design. Mechanical implantable staple.

Indications for Use

Indicated for subcuticular skin closure requiring temporary tissue approximation using an absorbable fastener.

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 (K090159)

Submission Summary (Full Text)

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# Exhibit F: 510(k) K120373 Summary

## MAR 1 6 2012

| Submitter: | Incisive Surgical<br>14405 21st Avenue North, Suite 130,<br>Plymouth, MN 55447-2000 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David B. Herridge, Vice President, Ph: [phone] ext. 19 |
| Date Prepared: | February 3, 2012 |
| 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 K090159 |
| Device<br>Description: | INSORB Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide<br>overall, and have cleat tips that are 0.8 mm apart. They are used in<br>conjunction with a manual surgical stapler from Incisive Surgical Inc. (Note:<br>manual surgical stapler is a Class I exempt device pursuant to 21 CFR<br>878.4800 and is not the primary subject of this submission). |
| Intended Use: | Synthetic absorbable INSORB staples are intended for the subcuticular<br>closure of skin where an absorbable tissue fastener is desired for temporary<br>tissue approximation. |
| Statement of<br>Technological<br>Comparison | The subject device and the predicate device are identical. This Special<br>510(k) seeks only to more clearly communicate the device's intended use<br>for the subcuticular closure of skin. |
| Conclusion: | The modified INSORB Absorbable Staple described in this submission is<br>substantially equivalent to the predicate device. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 1 6 2012

Incisive Surgical % Mr. David B. Herridge Vice President 14405 21st Avenue North, Suite 130 Plymouth, Minnesota 55447-2000

Re: K120373

Trade/Device Name: INSORB® Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: March 01, 2012 Received: March 05, 2012

Dear Mr. Herridge:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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#### Page 2 - Mr. David B. Herridge

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Exhibit D: Indications for Use

| 510(k) Number (if known): | K120373 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | INSORB® Staple |
| Indications for Use | Synthetic absorbable INSORB staples are intended<br>for the subcuticular closure of skin where an<br>absorbable tissue fastener is desired for temporary<br>tissue approximation. |

Prescription Use_ (Per 21 CFR 801. 109)

OR

Over-The-Counter Use_

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 Surgical, Orthopedic, and Restorative Devices

510(k) Number K120373

Incisive Surgical, Inc.