REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS

K032973 · Vanguard Medical Concepts, Inc. · GDW · Dec 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032973
• Device Name: REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Cutters, Staplers and Appliers are indicated for resection, transection or ligation of tissue in abdominal, gynecological, pediatric and thoracic applications.

Device Story

Vanguard Medical reprocesses used, single-use surgical instruments, specifically linear cutters, staplers, and appliers. The process involves cleaning and sterilizing the handheld instrument body; all original reloads are removed and discarded by the hospital prior to reprocessing. The reprocessed device is intended for use by surgeons in clinical settings for tissue resection, transection, or ligation. The device functions mechanically to deliver staggered rows of staples or to ligate vessels. By restoring the device to a safe and effective state, the reprocessor provides a reusable alternative to single-use instruments, potentially reducing medical waste and costs for healthcare facilities.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the device's ability to withstand validated cleaning and sterilization protocols.

Technological Characteristics

Manual surgical instruments. Materials and design are identical to the original single-use predicate devices. Sterilization is performed via validated processes to ensure safety for reuse. No electronic components, software, or energy sources.

Indications for Use

Indicated for resection, transection, or ligation of tissue in abdominal, gynecological, pediatric, and thoracic surgical applications.

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

• Ethicon Linear Cutter (K843034)
• Ethicon Linear Cutter (K892927)
• Ethicon Linear Stapler (K821994)
• Ethicon Appliers (K830503)

Submission Summary (Full Text)

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DEC 1 8 2003

K\$\phi\$32973

**Vanguard Medical**

1207 Crest Oak Drive Tel: [phone]

Page 1 of

307 Great Oak . akeland, FL

Fax: (413) 21

## 510(k) SUMMARY

| Reference: | Vanguard Medical Concepts, Inc.<br>Section 510(k) Notification<br>Reprocessed Used, Disposable Cutters, Staplers and Appliers |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name: | Manual Surgical Instruments<br>LSR Disposable Linear Stapler |
| Common/Usual Name: | Disposable Surgical Instruments |
| Proprietary Name: | Reprocessed Used, Disposable Cutters, Staplers and<br>Appliers |
| Establishment Reg. No.: | 1649663 |
| Classification: | The FDA has classified Manual, General Surgical<br>Instruments as Class I devices under the General and<br>Plastic Surgery Panel (21 CFR 878.4800) Class II |

Vanguard intends to market Reprocessed Disposable Cutters and Staplers, that have Vanguard intends to market Reprocesses only the hand held instrument. All reloads are
removable reloads. Vanguard reprocesses only the hand held instrument. Steplers and removed and discarded before being reprocessed. Reprocessing Cutters, Staplers and removed and usearded octore oching . Vanguard protocol Number 40018.

"Reprocessed," means all operations performed to render a contaminated single-use Reprocessed, "means an operation Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). Vanguard is a "third party reprocessor" and reprocesses used single-used medical devices.

Vanguard does NOT reprocess the re-loads. Reloads must be supplied by the hospital

Vanguard believes that single-use Cutters, Staplers and Appliers can be considered "reusable" - by Vanguard " as defined in the Food and Drug Administration Compliance Policy Guide #7124.16; they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use,

Linear staplers deliver staggered rows of staples in order to approximate internal tissues. Linear Cutters are hand held surgical devices used to deliver staggered rows of staples while simultaneously dividing the tissue. Appliers are hand beld surgical instruments that litigate tubular structures and vessels.

Vanguard reprocessed devices are substantially equivalent to Ethicon Linear Cutter: 510(k) Number K843034 and K892927, Ethicon Linear Stapler 510(k) Number K821994 and Ethicon Appliers 510(k) Number K830503

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Image /page/1/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird, with three wing-like shapes stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2003

Vanguard Medical Concepts, Inc. c/o Mr. Mark W. Aldana Adven Medical, Inc. 3706 76" Street Lubbock, Texas 79423

Re: K032973

Trade/Device Name: Reprocessed Disposable Cutters, Staplers and Appliers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: September 22, 2003 Received: October 3, 2003

Dear Mr. Aldana:

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 10 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. Mark W. Aldana

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 note the 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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## Indications for Use

032973 510(k) Number (if known): #032978

Device Name: Reprocessed Disposable Cutters, Staplers and Appliers

Indications For Use:

Cutters, Staplers and Appliers are indicated for resection, transection or ligation of tissue in abdominal, gynecological, pediatric and thoracic applications.

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)

Muriam C. Provost

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

510(k) Number K032973