REPROCESSED TROCARS

K070059 · Ascent Healthcare Solutions · NLM · Oct 2, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070059
• Device Name: REPROCESSED TROCARS
• Applicant: Ascent Healthcare Solutions
• Product Code: NLM · Gastroenterology, Urology
• Decision Date: Oct 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

Device Story

Reprocessed endoscopic trocars and cannulae; used to establish port of entry for endoscopic instruments during minimally invasive surgery. Cannulae feature sealing system for pneumoperitoneum maintenance and luer stopcock for insufflation/desufflation. Obturators include bladed configuration with safety shield to reduce vascular/visceral injury risk. Used in OR by surgeons. Device is reprocessed version of OEM trocars; involves cleaning, decontamination, and sterilization. Provides same mechanical function as predicate.

Clinical Evidence

No clinical data. Bench and laboratory testing conducted, including biocompatibility, validation of reprocessing, sterilization validation, function tests, and packaging validation.

Technological Characteristics

Mechanical trocar system; 5-12mm diameter, 75-100mm length. Features include sealing system, luer stopcock, and safety shield for bladed obturators. Materials and design identical to predicate. Sterilization via validated reprocessing method.

Indications for Use

Indicated for patients requiring minimally invasive surgical procedures, including thoracic, gynecologic laparoscopy, and other abdominal 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.

Predicate Devices

• ENDOPATH III Bladeless Trocars, ENDOPATH III Blunt Tip Trocars, ENDOPATH III Dilating Tip Trocars (K032676)

Submission Summary (Full Text)

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K070059 pg 1 of 2

### SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | OCT 2 2007 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Contact: | Moira Barton<br>Regulatory Affairs Manager<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | |
| Date of preparation: | October 16, 2006 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Trocar<br>Classification Name: Laparoscope, General and Plastic Surgery | |
| Predicate Device<br>K032676 | 510(k) Title<br>ENDOPATH III Bladeless Trocars<br>ENDOPATH III Blunt Tip Trocars<br>ENDOPATH III Dilating Tip Trocars | Manufacturer<br>Ethicon Endo-Surgery |

*Applicable Trade Name/devices within K032676 to K070059 underlined.

#### Device description:

Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery.

Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-12mm inner diameter and 75- 100mm length. Cannulae are equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity.

Trocar Obturator is available in bladed configuration, sized 5-12 mm. Bladed obturators are equipped with a safety shield designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated, so as to reduce the risk for vascular or visceral injury.

#### Indications for Use:

Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

#### Technological characteristics:

The design, materials, and intended use of Reprocessed Trocars are identical to the predicate devices. The mechanism of Reprocessed Trocars is identical to the predicate devices

> Ascent Healthcare Solutions Reprocessed Trocars Traditional 510(k)

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070059 pg 2 of 2

in that the same standard mechanical design, materials, and sizes are utilized. There are no in that the same standard moonance. Ilinical applications, patient population, performance changes to the blaims, internetalism Ascent Healthcare Solutions reprocessing of Specifications, or method of operation "nible soil and decontamination. Each individual Trocar Trocals Includes removal of admorent nombroents prior to packaging and labeling operations.

#### Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Trocars. This included the following tests:

- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- Function test(s) .
- Packaging Validation .

Performance testing demonstrates that Reprocessed Trocars perform as originally intended.

Ascent Healthcare Solutions concludes that the modified Conclusion: devices (Reprocessed Trocars) are safe, effective, and substantially equivalent to the predicate devices as described herein.

> Ascent Healthcare Solutions Reprocessed Trocars Traditional 510(k)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ascent Healthcare Solutions % Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, Arizona 85044

OCT 2 2007

Re: K070059

Trade/Device Name: Reprocessed Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: August 27, 2007 Received: August 29, 2007

Dear Ms. Bray:

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. Katie Bray

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,

Daniel Kraene

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

Enclosure

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070059 pg 1 of 1

## List of Devices:

:

| OEM | Model<br>Number | Device | Diameter | Length | Cannula |
|---------|-----------------|--------------------------------------------------------------------|----------|--------|-----------|
| Ethicon | D5LT | Bladed Trocar, 5mm<br>diameter, 100mm length,<br>Stability sleeve | 5mm | 100mm | Stability |
| | D5ST | Bladed Trocar, 5mm<br>diameter, 75mm length,<br>Stability sleeve | 5mm | 75mm | |
| | D11LT | Bladed Trocar, 11mm<br>diameter, 100mm length,<br>Stability sleeve | 11mm | 100mm | |
| | D12LT | Bladed Trocar, 12mm<br>diameter, 100mm length,<br>Stability sleeve | 12mm | 100mm | |

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Ascent Healthcare Solutions Reprocessed Trocars Traditional 510(k)

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K070059 pg 1 of 1

# SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Reprocessed Trocars

Indications For Use: Reprocessed Endoscopic Trocars are indicated for use to Indications For USE. Treprocessor Endoscopic in stimations requiring minimally
establish a port of entry for endoscopic instruments in patients requirement ond other establish a port of entry for endoooople incruments as a consider laparoscopy and other abdominal procedures.

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)

Daniel Krame

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

510(k) Number K070059

Ascent Healthcare Solutions Reprocessed Trocars Traditional 510(k)