HEPATOSTAT SET

K073493 · Vygon Corp. · GAM · May 6, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073493
• Device Name: HEPATOSTAT SET
• Applicant: Vygon Corp.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.

Device Story

Hepatostat Set is an absorbable compression system for achieving hemostasis during hepatic, splenic, and nephric resections or trauma. The device consists of four pre-perforated absorbable strips connected by twenty Safil polyfilament ligatures. Each ligature features a stainless steel dart and is pre-inserted into a stainless steel tubular needle holder. During surgery, the clinician uses the needle holder to pass ligatures through the tissue; two clamps are then used to bring the strips together, creating a tourniquet effect on the target organ. The device provides compressive hemostasis to the wound site and is designed to resorb naturally over time. It is intended for use by surgeons in an operating room setting.

Clinical Evidence

No human clinical data provided. Safety and efficacy for the expanded indications (splenic and nephric resection) were demonstrated via animal testing.

Technological Characteristics

Absorbable compression system; components include four pre-perforated absorbable strips, twenty Safil polyfilament ligatures, stainless steel darts, and stainless steel tubular needle holders. Operates via mechanical compression (tourniquet effect).

Indications for Use

Indicated for patients undergoing hepatic, splenic, or nephric resections or those with traumatic liver, kidney, or spleen injuries requiring compressive hemostasis.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Hepatostat (K061796)

Submission Summary (Full Text)

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MAY - 6 2008

K073493

VYGON CORPORA 2495 General Armistead Avenue Norristown, PA 19403-3685

> (800) 544-490 [phone] Fax [phone] http://www.vygonusa.com

## PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)

Date of Preparation: November 29, 2007

Courtney Smith, Regulatory Affairs Manager

Applicant:

Vygon Corporation 2495 General Armistead Ave. Norristown, PA 19403

Contact Individual:

Trade Name: Hepatostat

Common Name: Synthetic Absorbable Surgical Suture & Surgical Clamp

610-539-9300 Ext. 110

Regulation Number: 878.4493 & 878.4493

Product Code: GAM & GDJ

Classification Name: Synthetic Absorbable Surgical Suture & Surgical Clamp

Classification: Class II

Predicate Device Name: Hepatostat (K061796)

Device Description:

The Hepatostat Set® is an absorbable compression device which allows to perform any type of hepatic resection, large or small, without any significant bleeding. It is made of four pre-perforated absorbable strips. These strips are connected together by twenty Safil® polyfilament ligatures introduced through the liver by a special tubular needle holder. Each suture is terminated by a stainless steel dart and already inserted into a stainless steel tubular needle holder, fitted to the liver thickness. Two clamps enable to bring together two strips.

Image /page/0/Picture/18 description: The image shows the word "VYGON" in white letters against a black background. The word is in all capital letters and has a bold, sans-serif font. There is a small triangle above the "V" in "VYGON". The background is a rounded rectangle shape.

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Intended Use: Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen It is designed to provide compressive injuries. hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.

- Technology Characteristics: The Hepatostat in this submission is identical to the Hepatostat (K061796). Vygon is resubmitting of premarket notification due to an expanded indication.
Summary of Design Control Activities: Animal testing has been conducted to demonstrate the safety and efficacy for use in splenic and nephric resection.

Conclusion: Performance testing demonstrates that the Hepatostat is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use.

Courtney Smith May 5, 2008.

Courtney Smith Regulatory Affairs Manager

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 6 2008

Vygon Corporation % Ms. Courtney Smith 2495 General Armistead Avenue Norristown, Pennsylvania 19403-3685

Re: K073493

Trade/Device Name: Hepatostat Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM, GDJ Dated: April 11, 2008 Received: April 14, 2008

Dear Ms. Smith:

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 - Ms. Courtney Smith

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 N. Millerson

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): K073493

Device Name: Hepatostat

Indications for Use:

Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

*Division Sign-Off*

Division of General Restorative, and Neurological Devices

| 510(k) Number | K073493 |
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