VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS

K012700 · Vanguard Medical Concepts, Inc. · GEI · Nov 7, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012700
• Device Name: VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dissector instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for grasping, mobilization, dissection and/or cauterization of tissue. Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.

Device Story

Reprocessed electrosurgical instruments (dissectors/scissors) for minimally invasive surgery; used with trocar and electrosurgical unit. Device features ring loop handles for jaw operation; insulated shaft with 360° rotation; cautery pin for monopolar electrocautery (requires patient grounding pad). Vanguard collects used OEM instruments; cleans, inspects, tests, repackages, and sterilizes; returns to healthcare facilities. Physician operates device during surgery to grasp, mobilize, dissect, or cauterize tissue. Output is mechanical tissue manipulation and electrical cauterization. Benefits include reuse of surgical instruments.

Clinical Evidence

Bench testing only. Validation included cleaning, sterilization, and packaging integrity testing, alongside performance and biocompatibility testing to ensure reprocessed devices meet original OEM specifications.

Technological Characteristics

Electrosurgical instruments with ring loop handles, insulated shafts, and 360° rotation. Monopolar cautery capability via cautery pin. Materials and specifications identical to OEM predicates. Sterilization performed as part of the reprocessing cycle.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring grasping, mobilization, dissection, transection, and/or cauterization of tissue. Contraindicated for contraceptive coagulation of fallopian tissue or applications where minimally invasive surgery is contraindicated.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Ethicon Endo-Surgery ENDOPATH endoscopic instruments
• AutoSuture endoscopic instruments

Submission Summary (Full Text)

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K012 700

JUL 2 9 2005

## 510(k) Summary of Safety & Effectiveness

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC<br>Director, Regulatory Affairs<br>[phone] (voice)<br>[phone] (facsimile)<br>[e-mail] |
| Date | June 08, 2005 |
| Device | <ul><li>Trade Names: Vanguard Reprocessed Electrosurgical Instruments</li><li>Common Name: Endoscopic surgical instruments, laparoscopic surgical instruments</li><li>Classification: 21 CFR 876.1500 - Endoscope and accessories – Class II</li><li>Product Code: GCJ</li></ul> |
| Predicate Devices | Respective Ethicon Endo-Surgery ENDOPATH® and AutoSuture® endoscopic instruments legally marketed under various 510(k) premarket notifications. |
| Indications for Use | Dissector instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for grasping, mobilization, dissection and/or cauterization of tissue. |
| | Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue. |
| Contra-indications | This device is not intended for contraceptive coagulation of fallopian tissue or applications where minimally invasive surgery is contraindicated. |
| | Continued on next page |

ENDOPATH is a registered trademark of Ethicon Endo-Surgery, Inc. , a Johnson & Johnson company AutoSuture is a registered trademark of United States Surgical, a division of Tyco Healthgroup LP

.

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K012700

## 510(k) Summary of Safety & Effectiveness, Continued

| Device Description | The electrosurgical instrument is used for grasping, dissection and cauterization in endoscopic general surgery. The distal instrument scissors or jaws are opened and closed using ring loop handles. The instrument shaft is insulated and designed for use with an appropriately sized trocar cannula; the shaft can be rotated 360° in either direction using a handle knob. Devices with electrocautery capability are supplied with a pin for connection to a compatible electrosurgical unit; use of the device for monopolar electrocautery requires use of a patient grounding pad. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.<br>Vanguard receives previously used electrosurgical instruments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to a healthcare facility. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics | Vanguard reprocessed electrosurgical instruments are essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices. Device materials, specifications, and technological characteristics are equivalent. |
| Test Data | Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial Equivalence" Decision Making Process Chart, we conclude that the Vanguard reprocessed electrosurgical instruments are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2005

Ms. Heather Crawford, RAC Director, Regulatory Affairs Vanguard Medical Concepts Inc. 5307 Great Oak Drivce Lakeland, Florida 33815-3113

Re: K012700

Trade/Device Name: Vanguard Reprocessed Electrosurgical Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: April 21, 2005 Received: April 22, 2005

Dear Ms. Crawford:

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. Heather Crawford, RAC

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/industry/support/index.html.

Sincerely yours,

Hyph Rlurdu

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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The Original Equipment Manufacturers (OEMs) and device models in this SVS application K012700 are:

| OEM | Model# | Diameter | Length | Description |
|---------------------------------------------|--------|----------|--------|-------------------------------|
| Ethicon<br>w/unipolar cautery | 5DCD | 5mm | 32cm | Curved Dissector |
| Ethicon<br>w/unipolar cautery | 5DCS | 5mm | 32cm | Curved Scissors |
| US Surgical<br>Mini-Shears<br>cautery | 174301 | 5mm | 32.5cm | AutoSuture Endo<br>w/unipolar |
| US Surgical<br>Shears<br>w/unipolar cautery | 176643 | 5mm | 33cm | AutoSuture Endo |
| US Surgical<br>Dissector Shears<br>cautery | 176645 | 5mm | 33cm | AutoSuture Endo<br>w/unipolar |

Stupt Rurda

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

**510(k) Number** K012700

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## Indications for Use

K012700 510(k) Number (if known):

Device Name: Vanguard Reprocessed Electrosurgical Instruments

Indications for Use:

Dissector instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for grasping, mobilization, dissection and/or cauterization of tissue.

Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (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)

Hupt Church
(Division Sign-Off)

Division of General, Restorative and in- ological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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