REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS

K024015 · Alliance Medical Corp. · NLM · Mar 4, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K024015
• Device Name: REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
• Applicant: Alliance Medical Corp.
• Product Code: NLM · Gastroenterology, Urology
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

Reprocessed Endoscopic Trocars and Cannulas are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Device Story

Alliance Medical Corporation reprocesses single-use endoscopic trocars and cannulas originally manufactured by US Surgical (Auto Suture) and Ethicon. These devices are used in minimally invasive surgery to create a port of entry for endoscopic instruments. The reprocessing workflow restores the devices to a functional state equivalent to the original single-use devices, allowing for reuse in clinical settings. The devices are mechanical instruments; they do not involve electronic inputs, software, or automated algorithms. They are operated by surgeons or trained clinical staff in an operating room environment. The benefit is the provision of functional surgical access tools through a validated reprocessing cycle.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical endoscopic trocars and cannulas. Materials are consistent with original OEM specifications for surgical access devices. No electronic components, software, or energy sources. Sterilization is performed as part of the validated reprocessing cycle.

Indications for Use

Indicated for patients requiring minimally invasive surgical procedures to establish a port of entry for endoscopic instruments.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

MAR - 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Eric Varty Research and Development Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

Re: K024015 -- Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: December 3, 2002 Received: December 4, 2002

Dear Mr. Varty:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 4, 2003. 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 as 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. Ilsting 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 vour 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

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Page 2 - Mr. Varty

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 [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 yo

Mark N. Me

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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## Indications for Use

510(k) Number (if known): K024015

Device Name: Alliance Medical Corporation Reprocessed Endoscopic Trocars and Cannulas

Indications For Use: Reprocessed Endoscopic Trocars and Cannulas are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2gN2l

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

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KC240i5 510(k) Number_

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The following list represents the specific Endoscopic Trocars and Cannulas to be
reprocessed by Alliance Medical Corporation under this submission.

| Manufacturer | Description | Model |
|--------------------------|-----------------------------------------------------------|---------------|
| US Surgical, Auto Suture | Surgiport Trocar w/ radiolucent (bladed) | 171040 |
| US Surgical, Auto Suture | Spring Grip Non-Conductive Spring Grip Non-Conductive | 174102 |
| US Surgical, Auto Suture | Conductive | 174103 |
| US Surgical, Auto Suture | Spring Grip Non-Conductive | 174104 |
| US Surgical, Auto Suture | Spring Grip Non-Conductive | 174110 |
| US Surgical, Auto Suture | Thoracoport Trocar | 179301 |
| US Surgical, Auto Suture | Thoracoport Trocar | 179303 |
| US Surgical. Auto Suture | Thoracoport Trocar | 179305 179307 |
| US Surgical, Auto Suture | Thoracoport Trocar | 179315 |
| Ethicon | ENDOPATH adjustable cannula | T355 |
| Ethicon | ENDOPATH adjustable cannula | T511 |
| Ethicon | ENDOPATH adjustable cannula | T512 |
| Ethicon | Bladeless Trocar with Stability Sleeve, Non-handled | 35NST |
| Ethicon | Bladeless Trocar with Smooth Sleeve, non-handled | 35OS |
| Ethicon | Bladeless Trocar with Smooth Sleeve, handled | 35HL |
| Ethicon | Bladeless Trocar with Smooth Sleeve, Non-handled | 35OL |
| Ethicon | Bladeless Trocar with Stability Sleeve, Non-handled | 35NLT |
| Ethicon | Bladeless Trocar with Smooth Sleeve, Handled | 511H |
| Ethicon | Bladeless Trocar with Smooth Sleeve, Non-handled | 511O |
| Ethicon | Bladeless Trocar with Stability Sleeve, Handled | 511 HT |
| Ethicon | Bladeless Trocar with Stability Sleeve, Non-handled | 511NT |
| Ethicon | Bladeless Trocar with Smooth Sleeve, Handled | 512HN |
| Ethicon | Bladeless Trocar with Smooth Sleeve, Non- | 512ON |
| Ethicon | Bladeless Trocar with Stability Sleeve, Handled | 512HT |
| Ethicon | Bladeless Trocar with Stability Sleeve, Non-handled | 512NT |
| Ethicon | Bladeless Trocar with Smooth Sleeve | 5128 |
| Ethicon | ENDOPATH Dilating Tip Trocar with Stability Sleeve | 355SD |
| Ethicon | ENDOPATH Dilating Tip Trocar with Smooth Sleeve | 355SM |
| Ethicon | ENDOPATH Dilating lip Trocar with Stability Sleeve | 578SD |
| Ethicon | ENDOPATH Dilating Tip Trocar with Smooth Sleeve | 511SM |
| Ethicon | ENDOPATH Dilating Tip Trocar with Stability Sleeve | 511SD |
| Ethicon | ENDOPATH Dilating Tip Trocar with Stability Sleeve | 512SD |
| Ethicon | ENDOPATH Dilating Tip Trocar with Smooth Sleeve | 512SM |
| Ethicon | ENDOPATH Dilating Tip Trocar with Smooth Sleeve | 512XD |
| Ethicon | ENDOPATH TRISTAR Trocar with Smooth Sleeve | 355S |
| Ethicon | ENDOPATH TRISTAR Trocar with Integrated Stability Threads | 355T |
| Ethicon | ENDOPATH TRISTAR Trocar with Smooth Sleeve | 355L |
| Ethicon | ENDOPATH TRISTAR Trocar with Smooth Sleeve | 511S |

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