VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS

K011800 · Vanguard Medical Concepts, Inc. · NLU · Sep 27, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011800
• Device Name: VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLU · Gastroenterology, Urology
• Decision Date: Sep 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.

Device Story

Vanguard Reprocessed Electric Biopsy Forceps are reprocessed versions of OEM devices (Boston Scientific Microvasive Radial Jaw 3 and C.R. Bard Precisor). Device consists of flexible, electrically isolated sheath with distal grasping cups controlled by proximal handle. Used via endoscope operating channel (min 2.8 mm) to collect tissue samples or remove polyps. Electrocautery function requires connection to compatible electrosurgical unit and patient grounding pad. Operated by physicians in clinical settings. Vanguard collects used devices, cleans, inspects, tests, repackages, and sterilizes them for return to healthcare facilities. Reprocessing restores device to original OEM specifications, allowing for safe clinical use in tissue removal.

Clinical Evidence

No clinical data. Bench testing only. Validation included decontamination and cleaning efficacy, packaging integrity, sterilization validation, functional/performance testing, shelf-life testing, and biocompatibility testing.

Technological Characteristics

Flexible, electrically isolated sheath with distal grasping cups and proximal handle. Monopolar electrocautery capability. Dimensions and materials are identical to OEM predicate devices. Sterilization performed as part of the reprocessing cycle.

Indications for Use

Indicated for patients requiring electrocautery and removal of polyps or tissue within the gastrointestinal tract via endoscopy. Prescription use only.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Boston Scientific Microvasive Radial Jaw 3 Electric Biopsy Forceps (K860366)
• C.R. Bard Precisor Hot Biopsy Forceps (K912601)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2004 NOV

Heather Crawford, RAC Director of Regulatory Affairs Vanguard Medical Concepts, Inc 5307 Great Oak Drive LAKELAND FL 33815

K011800 - Supplemental Validation Submission Re: Trade/Device Name: See Enclosed List Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLU Dated: September 7, 2001 Received: September 10, 2001

Dear Ms. Crawford:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on September 10, 2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

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#### Page 2 - Ms. Heather Crawford

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at 240-276-0115. 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 vours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ·Attachment 1

The following list is the models used in this submission.

### K011800: Vanguard Reprocessed Electric Biopsy Forceps

Microvasive® Radial Jaw 3, Model 1550 Bard Precisor, Model 852 Bard Precisor, Model 853 Bard Precisor, Model 854 Bard Precisor, Model 856

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### Indications for Use

4011800 510(k) Number:

Device Name: Vanguard Reprocessed Electric Biopsy Forceps

Indications for Use:

When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Nancy C. Brogdon

f Reproductive, Abdor rical Device

iv

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SEP 2 7 2001

K011800
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## 510(k) Summary of Safety & Effectiveness

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| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mike Sammon, Ph.D.<br>Director, Research & Development<br>[phone], extension 228<br>[e-mail] |
| Date | May 31, 2001 |
| Devices | Trade Names: Vanguard Reprocessed Electric Biopsy Forceps<br>⇒ Boston Scientific Microvasive® Radial Jaw® 3, and<br>⇒ C.R. Bard Precisor® Electric Biopsy Forceps Common Name: Electric biopsy forceps Classification: 21 CFR 876.4300 - Endoscopic Electrosurgical Unit and<br>Accessories - Class II Product Code KGE |
| Predicate<br>Devices | Boston Scientific Microvasive® Radial Jaw® 3 Electric Biopsy Forceps<br>believed to be legally marketed under 510(k) premarket notification<br>K860366 C.R. Bard Precisor® Hot Biopsy Forceps believed to be legally marketed<br>under 510(k) premarket notification K912601 |
| Indications for<br>Use | When used with a compatible electrosurgical unit, endoscope and patient<br>grounding pad, electric biopsy forceps are intended for electrocautery and<br>removal of polyps and/or tissue within the gastrointestinal tract. The forceps<br>are prescription devices intended for a single patient use only. |
| Device<br>Description | Biopsy forceps are devices used to collect tissue samples and/or remove<br>polyps within the gastrointestinal tract via the operating channel of<br>endoscopic instruments.<br><br>Electric biopsy forceps include an electrocautery function when used with a<br>compatible electrosurgical unit.<br><br>The devices consist of flexible, electrically isolated sheaths with distal<br>grasping cups that are controlled by a proximal handle. The forceps are<br>guided by endoscopy through a biopsy channel with a minimum dimension of<br>2.8 mm. Monopolar electrocautery requires electrical connection of the<br>forceps to a compatible electrosurgical unit and use of an appropriate patient<br>grounding pad.<br><br>Vanguard receives previously used electric biopsy forceps from healthcare<br>facilities; cleans, inspects, tests, repackages and sterilizes the forceps; and<br>returns them to the healthcare facility. |
| Technological<br>Characteristics | The technological characteristics of the Vanguard reprocessed electric biopsy<br>forceps are the same as the predicate devices, the original equipment<br>manufacturer (OEM) electric biopsy forceps. The materials and dimensions<br>are unchanged and the physical characteristics, performance specifications,<br>and all other characteristics are essentially identical. |
| Test Data | Decontamination and cleaning, packaging and sterilization validations and<br>functional/performance, shelf life and biocompatibility testing demonstrates<br>that the reprocessed devices perform as intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that the Vanguard<br>reprocessed electric biopsy forceps are substantially equivalent to the<br>predicate device, the respective OEM biopsy forceps under the Federal Food,<br>Drug and Cosmetic Act. |

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