MODIFICATION TO VASCULAR CLOSURE DEVICE

K012362 · Std Mfg., Inc. · GDW · Aug 23, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012362
• Device Name: MODIFICATION TO VASCULAR CLOSURE DEVICE
• Applicant: Std Mfg., Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Aug 23, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vascular Closure Device indications for use are to approximate vascular, small tubular structures, and general tissue for achieving hemostatic closure of wound or puncture site to aid healing in minimally invasive or open procedures for full body applications.

Device Story

Vascular Closure Device (VCD) functions as a mechanical stapler/clip applier for tissue approximation. Used in clinical settings (minimally invasive or open procedures) by physicians to achieve hemostatic closure of vascular puncture sites or small tubular structures. Device delivers implantable staples to secure tissue, facilitating healing. Clinical benefit includes rapid hemostasis at wound sites.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to the predicate device.

Technological Characteristics

Implantable stapler/clip applier for tissue approximation. Class II device (21 CFR 878.4750). Mechanical operation for staple delivery.

Indications for Use

Indicated for patients requiring hemostatic closure of vascular, small tubular structures, or general tissue wounds/punctures during minimally invasive or open surgical procedures.

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

• Vascular Closure Device (K003169)

Submission Summary (Full Text)

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### AUG 2 3 2001

### STD Manufacturing, Inc., Confidential - Trade Secret

# Special 510(k) Pre-Market Notification

| 510(k) Summary | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92 | |
| The assigned 510(k) number is: | K012362 |
| Submitted by: | Stephen M. Palumbo<br>Director of Regulatory Affairs<br>STD Manufacturing, Inc.<br>1063 Turnpike Street<br>Stoughton, MA 02072<br>Telephone #:[phone] Facsimile #:[phone] |
| Date Prepared: | 17 July 2001 |
| Establishment Registration Number: | STD Manufacturing, Inc. is located at 1063 Turnpike Street, Box 420, Stoughton, MA 02072. We are registered with the Food and Drug Administration as Establishment Number 1222928. |
| Classification Name: | Staple, Implantable (GDW)<br>General and Plastic Surgery<br>21 CFR § 878.4750 (1999) |
| Common/Usual Name: | Stapler/ Clip Applier, with Implantable Staple |
| Proprietary Name: | Vascular Closure Device |
| Indication for Use: | The Vascular Closure Device indications for use are to approximate vascular, small tubular structures, and general tissue for achieving hemostatic closure of wound or puncture site to aid healing in minimally invasive or open procedures for full body applications. |
| Device Description: | See Product Description Section on pages 17 and 18. |

"Special 510(K)" Submission

24

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012362 (p.2 or a)

#### STD Manufacturing, Inc., Confidential - Trade Secret

#### Special 510(k) Pre-Market Notification

#### 510(k) Summary (Cont.)

Substantial Equivalence Claim:

The Vascular Closure Device is substantially equivalent to the Vascular Closure Device cleared under K#003169

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, human services, and the pursuit of well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is presented in black and white.

AUG 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen M. Palumbo Director, Regulatory Affairs STD Manufacturing, Inc. 1063 Turnpike Street P.O. Box 420 Stoughton, Massachusets 02072

Re: K012362

Trade/Device Name: Vascular Closure Device Regulation Number: 878.4750 Regulatory Class: II Product Code: GDW Dated: July 17, 2001 Received: July 25, 2001

Dear Mr. Palumbo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to nopoly with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Stephen M. Palumbo

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Mark N Millman

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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## STD Manufacturing, Inc. Confidential - Trade Secret

### Special 510(k) Pre-Market Notification

510(k) Number (if known):

Device Name: Vascular Closure Device

Indications for Use:

The Vascular Closure Device (VCD) Indications for use is to approximate vascular, The Vascular Closure Device (VOD) Intersue for achieving hemostatic closure of small tubular Structures, and general treasive or open procedures for full body applications.

(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Mark N Mulkerson

vision of General, Restorative and Neurological Devices

510(k) Number K012362

"Special 510(K)" Submission