VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES

K043594 · Vanguard Medical Concepts, Inc. · NLM · Mar 31, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043594
• Device Name: VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLM · Gastroenterology, Urology
• Decision Date: Mar 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.

Device Story

Vanguard reprocesses previously used OEM trocars (US Surgical/AutoSuture series) for reuse in minimally invasive surgery. Process involves cleaning, inspection, testing, packaging, and sterilization of used devices. Trocars consist of cannulae (5-15mm diameter, 70-100mm length) with pressure seals for pneumoperitoneum maintenance, optional luer stopcock ports for insufflation/desufflation, and stability anchors. Obturators include bladed (with safety shield to reduce injury risk) and non-bladed (blunt or dilator tips) configurations. Used in clinical settings by surgeons to create access pathways for endoscopic instruments. Reprocessing restores device functionality to OEM specifications, providing a cost-effective alternative for healthcare facilities while maintaining clinical performance and patient safety.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including cleaning, sterilization, packaging validation, and performance/biocompatibility testing to demonstrate that reprocessed devices meet OEM specifications and safety requirements.

Technological Characteristics

Mechanical trocar system; materials identical to OEM. Features include cannulae with pressure seals, luer stopcock ports, and stability anchors. Obturators available in bladed (with safety shield) and non-bladed (blunt/dilator) configurations. Sizes 5-15mm diameter, 70-100mm length. No electronic components or software.

Indications for Use

Indicated for patients undergoing minimally invasive abdominal, gynecological, urological, or thoracic surgery requiring instrument access. Contraindicated for patients for whom endoscopic procedures are contraindicated.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• US Surgical (AutoSuture) VersaPort™ V2 (5-12mm) Trocar System (K012539)
• US Surgical (AutoSuture) VersaPort™ RPF (5-12mm) Trocar System (K954108)
• US Surgical (AutoSuture) VersaPort™ RT (5-12mm) Trocar System (K954108)
• US Surgical (AutoSuture) BluntPort™ (5-12mm) Trocar System (K945457)
• US Surgical (AutoSuture) VersaStep™ (5-12mm) Trocar System (K012539)
• US Surgical (AutoSuture) SpringGrip Anchoring Accessory (K931337)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary of Safety & Effectiveness MAR 3 1 2005

| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC<br>Director of Regulatory Affairs<br>863-683-8680, ext. 249 [voice]<br>863-683-8703 [facsimile]<br>[e-mail] [email] |
| Date | December 28, 2004 |
| Device | Trade Name: Vanguard Reprocessed Bladed and Non-Bladed Trocars<br>(US Surgical/AutoSuture Series)<br>Common Name: Bladed and Non-Bladed Trocar<br>Classification Number: 21 CFR 876.1500<br>Classification Name: Endoscope and accessories<br>Product Code: NLM - Laparoscope, General & Plastic Surgery,<br>Reprocessed - Class II |
| Predicate<br>Devices | Original equipment manufacturer (OEM) Bladed and Non-Bladed Trocars are<br>currently marketed under a variety of trade names. Trade names of current<br>legally marketed predicate devices are:<br>US Surgical (AutoSuture) VersaPort™ V2 (5-12mm) Trocar System US Surgical (AutoSuture) VersaPort™ RPF (5-12mm) Trocar System US Surgical (AutoSuture) VersaPort™ RT (5-12mm) Trocar System US Surgical (AutoSuture) BluntPort™ (5-12mm) Trocar System US Surgical (AutoSuture) VersaStep™ (5-12mm) Trocar System US Surgical (AutoSuture) SpringGrip Anchoring Accessory The 510(k) Premarket Notification numbers for these devices are: K012539: VersaStep K963115: Trocar Cannula K954108: Modified VersaPort K945457: Trocar (Accessory) K931337: AutoSuture Dilating Cannula |
| Indications<br>for Use | Reprocessed trocars are intended to provide a pathway for entry of<br>instruments during minimally invasive surgery, with particular applications in<br>abdominal, gynecological, urological, and thoracic procedures. |
| Contra-<br>indications | Reprocessed trocars should not be used in patients for whom endoscopic<br>procedure is contraindicated. |
| Device<br>Description | A Vanguard Reprocessed Trocar is a previously used device that has been<br>cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts,<br>Inc. |
| | Trocar Cannulae are available in sizes 5-15mm inner diameter and 70-<br>100mm length. Cannulae are equipped with a pressure seal for maintenance<br>of pneumopertineum during insertion and withdrawal of instruments. Some<br>models are equipped with a luer stopcock port for insufflation and<br>desufflation of the operative cavity. Some models are provided with stability<br>anchors inserted over the cannula sleeve to help seal the incision site and<br>maintain cavity pressure. |
| | Trocar Obturator is available in bladed and non-bladed configurations sized<br>5-15mm. Bladed models are equipped with a safety shield designed to<br>expose the blade during insertion but to retract over the tip once the operative<br>cavity has been penetrated so as to reduce the risk for vascular or visceral<br>injury. |
| | Non-Bladed obturators have either a rounded (blunt) tip or sharply tapered<br>(dilator) tip to allow trocar insertion following a cut down and minimize the<br>risk for internal injury. |
| | Vanguard receives previously used trocars from healthcare facilities; cleans,<br>inspects, tests, packages, labels, and sterilizes the devices; and returns them to<br>a healthcare facility for subsequent use. |
| Technological<br>Characteristics | Vanguard Reprocessed Bladed and Non-Bladed Trocars are essentially<br>identical to the Original Equipment Manufacturer (i.e., AutoSuture®)<br>devices. No changes are made to the device materials or specifications and<br>the reprocessed trocars possess identical technological characteristics. |
| | Continued on next page |

Continued on next page

KO435

BluntPort™, VersaPort™, VersaStep™ and AutoSuture® are registered trademarks of United States Surgical, a division of Tyco Healthcarc

{1}------------------------------------------------

510(k) Summary of Safety & Effectiveness, Continued

2/3

94

{2}------------------------------------------------

KO43534 510(k) Summary of Safety & Effectiveness, Continued

sterilization, packaging validations, and performance and Cleaning, Test Data biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective. Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed Bladed and Non-Bladed Trocars are substantially equivalent to their legally marketed predicate devices under the Federal Food, Drug and Cosmetic Act.

BluntPort™, VersaPort™, VersaStep™ and AutoSuture® are registered trademarks of United States Surgical, a division of Tyco Healthcare

র বি

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human profiles facing to the right.

NOV 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Ascent Healthcare Solutions % Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044

Re: K043594 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CRF 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: March 7, 2005 Received: March 9, 2005

Dear Ms. Barton:

This letter corrects our substantially equivalent letter of March 31, 2005. The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 31, 2005. We have received your supplemental validation data as required for reprocessed singleuse 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.

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

{4}------------------------------------------------

Page 2 - Ms. Moira Barton

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 wours,

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

Enclosure

{5}------------------------------------------------

Page 3 - Ms. Moira Barton

## Indications for Use

510 (k) Number (if known) : K043594

Vanguard Reprocessed Bladed and Non-Bladed Trocars Device Name:

Indications For Use:

Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.

Prescription Use (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 )

evice Evaluation (ODE) Concurrence of CDRH, Offic

> estoral e and Neurological

510(k) Nr

{6}------------------------------------------------

Page 4 – Ms. Moira Barton

## List of Models:

US Surgical (AutoSuture)VersaPort™ V2 (5-12 mm) Trocar System US Surgical (AutoSuture)VersaPort™ RPF (5-12 mm) Trocar System US Surgical (AutoSuture)VersaPort™ RT (5-12 mm) Trocar System US Surgical (AutoSuture)BluntPort™ (5-12 mm) Trocar System US Surgical (AutoSuture)VersaStep™ (5-12 mm) Trocar System US Surgical (AutoSuture) SpringGrip Anchoring Accessory