MODULAR TROCAR SYSTEM

K060096 · Applied Medical Resources Corp. · GCJ · Jan 24, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060096
• Device Name: MODULAR TROCAR SYSTEM
• Applicant: Applied Medical Resources Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Applied Medical Modular Trocar System is a sterile single use device, or may be used with a reusable stainless steel or reusable DuraGold® cannula and is intended for use in coniunction 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. If utilizing the Applied Medical Optical Separator Obturator with the Modular Trocar System it may be used with or without visualization for primary and secondary insertions.

Device Story

Modular Trocar System; sterile single-use device; establishes entry path for endoscopic instruments; used in general, abdominal, gynecological, and thoracic minimally invasive procedures. Components include obturator, seal, and cannula system; available in 5mm, 11mm, 12mm, and 15mm diameters; lengths 55mm to 150mm. May be used with Optical Separator for visualization during primary/secondary insertions. Operated by surgeons in clinical/OR settings. Provides physical access channel; facilitates minimally invasive surgery; reduces trauma compared to open procedures.

Clinical Evidence

Bench testing only. Performance and functional testing verified inflation and leakage characteristics against predicate devices.

Technological Characteristics

Modular trocar assembly consisting of obturator, seal, and cannula. Sizes: 5mm, 11mm, 12mm, 15mm; lengths: 55mm-150mm. Sterile, single-use. Compatible with reusable stainless steel or DuraGold® cannulas. Mechanical device; no energy source or software.

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 (K932995)
• Applied Medical Optical Separator (K032889)

Submission Summary (Full Text)

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JAN 2 4 2006

K 060096

## 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] |
| CONTACT PERSON: | Cheryl Blake<br>Vice President, Regulatory Affairs and Quality<br>Systems |
| DATE OF PREPARATION: | December 21, 2005 |
| NAME OF DEVICE: | Modular Trocar System |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery (21CFR<br>876.1500) |
| TRADE NAME: | Modular Trocar System |
| PREDICATE DEVICE: | Applied Medical Modular Trocar (K932995)<br>Applied Medical Optical Separator (K032889)<br>Applied Medical, Rancho Santa Margarita, CA |

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 qain access through tissue planes and/or potential spaces for endoscopic instruments. The Modular System may be used with an Optical Separator and may be used with or without visualization for primary and secondary insertions.

DEVICE DESCRIPTION: The Modular Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system.

The Modular Trocar System will be available in sizes of 5mm, 11mm, 12 mm and 15mm diameter in lengths ranging from 55mm to 150mm.

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PERFORMANCE DATA SUMMARY: The performance and functional testing of the Modular Trocar System included tests to verify the inflation and leakage as compared to its predicate devices. The performance and functional testing demonstrated that the Modular Trocar System is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed.

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## Third Party Review Quality Assessment

| Section 1 – Submission Information |
|------------------------------------|
|------------------------------------|

| 510(k) No.: | K060096 | Third Party Organization: | UL |
|------------------------------------|--------------------|---------------------------|------|
| Third Party's Primary Reviewer(s): | Morten Christensen | | |
| ODE/OIVD Division: | DGRND | Branch/Team: | GSDB |

| Section 2 – 510(k) Decision |
|-----------------------------|
|-----------------------------|

| Third party recommendation: | SE <span style="text-decoration: underline;">✓</span> NSE <td>Other (specify):</td> <td></td> | Other (specify): | |
|-----------------------------|-----------------------------------------------------------------------------------------------|------------------|--|
| ODE/OIVD final decision: | SE <span style="text-decoration: underline;">✓</span> NSE <td>Other (specify):</td> <td></td> | Other (specify): | |

| Section 3 – Assessment of Third Party Review |
|----------------------------------------------|
|----------------------------------------------|

| Review Element | Rating (check one) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------|----------------|
| | Adequate | Minor Issue(s) | Major Issue(s) |
| a. Determination of device eligibility for third party review | <span style="text-decoration: underline;">✓</span> | | |
| b. Extent of pre-submission consultation with ODE/OIVD division | <span style="text-decoration: underline;">✓</span> | | |
| c. Organization and format of review documentation | <span style="text-decoration: underline;">✓</span> | | |
| d. Determination of 510(k) administrative completeness (screening review) | <span style="text-decoration: underline;">✓</span> | | |
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | <span style="text-decoration: underline;">✓</span> | | |
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | <span style="text-decoration: underline;">✓</span> | | |
| g. Rationale for conclusions and recommendation | <span style="text-decoration: underline;">✓</span> | | |
| h. Use of guidance documents and standards | <span style="text-decoration: underline;">✓</span> | | |
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | <span style="text-decoration: underline;">✓</span> | | |

Comments (explanation of ratings/issues):

k. Other (specify):

j. Scope of reviewer expertise and use of consulting reviewers

Section 4 – ODE/OIVD Assessor/Information

| Labels | Values |
|--------------|--------------------|
| Assessed by: | <em>illegible</em> |
| Date: | 1/23/06 |
| Tel. No.: | 4-130.7. ×192 |

سمل

Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k). DMC--Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes emanating from its head, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2006

Applied Medical Resources c/o Mr. Morten Simon Christensen Staff Engineer and FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road San Jose, California 95131-1230

Re: K060096

Trade/Device Name: Modular Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 12, 2006 Received: January 13, 2006

Dear Mr. Christensen:

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. Iisting 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 cquivalence determination does not mcan 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

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## Page 2 - Mr. Christensen

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.

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" (21 CFR 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,

Barbara Buckner

Mark N. Melk 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): K 060096

Device Name:

Indications for Use:

The Applied Medical Modular Trocar System is a sterile single use device, or may be used with a reusable stainless steel or reusable DuraGold® cannula and is intended for use in coniunction 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. If utilizing the Applied Medical Optical Separator Obturator with the Modular Trocar System it may be used with or without visualization for primary and secondary insertions.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Obarbare Bucknum An MPA Page 1 of 1
Division Sign off

Division of Genera'. Restorative, and Neurological Devices

**510(k) Number** K060096

510(k) - ODE/FDA Modular Trocar System December 2005