DILATING TIP OBTURATOR

K012884 · Applied Medical Resources Corp. · GCJ · Jan 17, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K012884
• Device Name: DILATING TIP OBTURATOR
• Applicant: Applied Medical Resources Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Dilating Tip Obturator 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.

Device Story

Dilating Tip Obturator is a sterile, single-use surgical instrument used with trocar assemblies; replaces traditional bladed obturators. Principle of operation involves dilating and separating tissue along natural fiber lines rather than cutting. Used in general, abdominal, gynecological, and thoracic minimally invasive procedures. Operated by surgeons to establish entry paths for endoscopic instruments. Benefits include reduced trauma to vessels and abdominal wall, minimized risk of organ puncture, and improved tissue reapproximation post-removal, resulting in smaller, linear defects.

Clinical Evidence

Bench testing only. Performance and functional testing verified insertion force and device reliability during use.

Technological Characteristics

Sterile, single-use obturator. Available in 5mm, 11mm, and 12mm diameters; lengths 55mm to 150mm. Mechanical design utilizes a dilating tip to separate tissue fibers. No electronic, software, or energy-based components.

Indications for Use

Indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces 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 Optiview Optical Surgical Obturator, Ethicon-Endo-Surgery, Inc.

Submission Summary (Full Text)

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K012884

## JAN 1 7 2002

## 510(k) SUMMAR Y

| 510(k) NUMBER: | PENDING |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA-92688<br>[phone] |
| CONTACT PERSON: | Anil Bhalani<br>Vice President of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | August 27, 2001 |
| NAME OF DEVICE: | Dilating Tip Obturator |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery (21CFR 876.1500) |
| TRADE NAME: | Dilating Tip Obturator |
| PREDICATE DEVICE: | EndoPath Optiview Optical Surgical Obturator, Ethicon-<br>Endo-Surgery, Inc. Cincinnati, OH. |

INTENDED USE: The Dilating Tip Obturator 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.

DEVICE DESCRIPTION: The Dilating Tip Obturator 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. Traditional obturators use a blade for cutting to establish a path of entry through the several layers of tissue. The Dilating Tip Trocar dilates and separates tissue along its natural fiber lines in its path of entry.

The Dilating Tip Obturator will be available in sizes of 5mm, 11mm and 12mm diameter in lengths ranging from 55mm to 150mm.

The use of the Dilating Tip Obturator, which separates tissue along its natural fibers versus cutting of tissue by traditional bladed trocars is expected to reduce trauma to vessels and the abdominal wall and minimize the risk of organ puncture. Upon removal of the trocar at the end of the procedure the separated tissue is expected to reapproximate, leaving a smaller, linear defect.

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K012884

PERFORMANCE DATA SUMMARY: The performance and functional testing of the Dilating Tip Obturator included tests to verify the insertion force and tests to verify its reliability during use. The performance and functional testing demonstrated that the Dilating Tip Obturator is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Anil Bhalani Vice-President of Regulatory Affairs and Clinical Programs Applied Medical 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K012884 Trade Name: Dilating Tip Obturator Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 26, 2001 Received: November 28, 2001

Dear Mr. Bhalani:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Anil Bhalani

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter notification. The FDA finding of substantial equivalence of your device to a legally prematics notification " 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compinatee at (301) 594-461 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oinor goneral 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 yours,

Mark n Milkman

Celia M. Witten, Ph.D., M.D. 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

Applied Medical Resources is providing this separate cover page for the Dilating Tip Obturator "Indications for Use" as required.

510(k) Number: Not assigned

Dilating Tip Obturator Device Name:

Indications for Use: The Dilating Tip Obturator is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Signature:

Title: *Vice President of RA/Clinical Programs* Date: *8-27-01*

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <span style="text-decoration: overline;">✓</span> </div> | OR | Over-The -Counter Use | <div> <span style="text-decoration: overline;"></span> </div> |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----|-----------------------|---------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">Mark N. Melker</span> </div> (Division Sign-Off) | | | | (Optional Format 1-2-96) |
| Division of General, Restorative<br>and Neurological Devices | | | | |
| 510(k) Number | K012884 | | | |

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