KII TROCAR SYSTEM

K072674 · Applied Medical Resources Corp. · GCJ · Oct 5, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072674
• Device Name: KII TROCAR SYSTEM
• Applicant: Applied Medical Resources Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Modular Trocar System is a sterile, single-use device, intended for use in conjunction with APPLIED's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal. gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The Modular Trocar System may be used with an optical separator or a bladed obturator, and may be used with or without visualization for primary and secondary insertions.

Device Story

Modular Trocar System provides access for endoscopic instruments during minimally invasive surgery. Device consists of seal, cannula, and obturator. Subject device introduces optional bladed obturator with retractable shield; shield de-activated via handle switch. Used in OR by surgeons; facilitates entry into abdominal/thoracic cavities. Input is manual force applied by clinician to advance trocar through tissue; output is established access channel for endoscopes. Benefits include reliable tissue penetration and instrument port creation. Performance verified via insertion force, shield reliability, and structural strength testing.

Clinical Evidence

Bench testing only. Testing included insertion force, shield mechanism reliability, shield deployment time, and locking mechanism structural strength. Results demonstrated functional equivalence to predicate devices.

Technological Characteristics

Materials: polymers and stainless steel. Components: seal, cannula, obturator. Dimensions: 5mm to 12mm diameter; 55mm to 150mm length. Mechanism: manual insertion with retractable blade shield. Sterilization: sterile, single-use.

Indications for Use

Indicated for patients undergoing general, abdominal, gynecological, or thoracic minimally invasive procedures requiring endoscopic instrument access through tissue planes or potential spaces.

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

• Applied Medical Modular Trocar System (K060096)
• Applied Medical Disposable Surgical Trocar (K943489)
• Ethicon Bladed Shielded System (K971475)

Submission Summary (Full Text)

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OCT 5 2007

K072674

## 510(k) SUMMARY

| 510(k) NUMBER: | PENDING | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA-92688<br>[phone]<br>[phone] (FAX) | |
| CONTACT PERSON: | Frans VandenBroek<br>Vice President, Regulatory Affairs<br>[e-mail] | |
| DATE OF PREPARATION: | August 24, 2007 | |
| NAME OF DEVICE: | Modular Trocar System | |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery (21CFR<br>876.1500) | |
| TRADE NAME: | Kii Shielded Access System | |
| PREDICATE DEVICE: | Applied Medical Modular Trocar System (K060096)<br>Applied Medical Disposable Surgical Trocar (K943489)<br>Ethicon Bladed Shielded System (K971475) | |

INTENDED USE: The Modular Trocar System is a sterile, single-use device, intended for use in conjunction with APPLIED's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal. gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The Modular Trocar System may be used with an optical separator or a bladed obturator, and may be used with or without visualization for primary and secondary insertions.

DEVICE DESCRIPTION: A typical trocar access system consists of a seal, a cannula and an obturator. This filing applies to a change to the access system approved in K060096. The change involves offering the option of a second obturator design. The optional obturator has a cutting blade covered by a retractable shield. De-activation of the shield is accomplished by moving a switch on the obturator handle. The design concept and materials of the optional obturator are similar to those approved in APPLIED's Disposable Surgical Trocar 510(k) K943489. The method of de-activation of the shield is similar to the method used in the Ethicon Bladed Shielded system approved in K971475.

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Differences between the subject device and the device approved in K943489 are Differences between the basysurator cutting blades. The subject device has a flat primanly in the shape of the obtarate of one aither flat or tri-pointed blades.

The blade design and its sharpness affects insertion forces needed to advance the The blade design and to onalphoos answer in Appendix III, insertion forces trocal through tissue. As accembed in the 100 receicate device of K943489 compastrated substantially equivalence.

The materials used in the subject device are polymers and stainless steels, as is the case with the predicate devices.

The Modular Trocar System will be available in sizes ranging from 5mm to 12mm The Modular 1100ar System ing from 55mm to 150mm. These dimensions match the trocars approved in K060096.

PERFORMANCE DATA SUMMARY: The performance and functional testing of the PERT ORMANOE Drem, as modified for this filing, included tests to verify:

- Insertion Force .
- Shield Mechanism Reliability .
- Shield Deployment Time .
- Locking Mechanism Structural Strength Test. .

These tests were performed on the subject device as well as predicate devices. The These tests were portemal testing demonstrated that the Modular Trocar System with performance and fancifically equivalent to its predicate devices and introduces no new safety and effectiveness issues when used as instructed.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Applied Medical Resources Corp. % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle, NC 27709

Re: K072674

OCT 5 * 2007

Trade/Device Name: Kii Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: September 18, 2007 Received: September 21, 2007

Dear Mr. Rongero:

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 - Mr. Jeff D. Rongero

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 vours.

Mark N Millikan

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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## INDICATIONS FOR USE

510(k) Number (if known): _K072674

Device Name: Modular Trocar System

Indications for Use:

Indications for USC.
The Applied Medical Modular Trocar System is a sterile, single-use device consisting of The Applied Medical Modular Trood. The obturator and seal may also be a bladed, Shiciaed Obtarder, I stannulas that may be made of stainless steel or used with reusable APP E.E.B cannais is intended for use in conjunction with APPLIED'S DuraGold® polymer: The Sadnats to establish a path of entry for endoscopic currently marketed trocal produce labdominal, gynecological and thoracic minimally instituments for use daing general, as a mind, 97
invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|--------|
| | AND/OR |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark N. Milliman

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

510(k) Number