INTUITIVE SURGICAL SEAL

K060534 · Applied Medical Resources Corp. · GCJ · Mar 13, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060534
• Device Name: INTUITIVE SURGICAL SEAL
• Applicant: Applied Medical Resources Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Intuitive Surgical Seal 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

Device Story

Intuitive Surgical Seal is a trocar component used in minimally invasive surgery. Device is assembled with an Intuitive Surgical cannula and used with a previously approved obturator. Assembly is placed over a skin incision; advanced through tissue layers to create an access path. Obturator is removed, leaving the seal and cannula in place to maintain pneumoperitoneum while allowing endoscopic instrument passage. Used in OR settings by surgeons. Device facilitates access to surgical sites; maintains abdominal pressure for visualization and instrumentation; benefits patient by enabling minimally invasive surgical techniques.

Clinical Evidence

Bench testing only. Performance and functional testing, including inflation and leakage verification, were conducted to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Trocar seal assembly; used with cannula and obturator. Maintains pneumoperitoneum during endoscopic procedures. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing general, abdominal, gynecological, or thoracic minimally invasive surgical procedures requiring endoscopic instrument access.

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)

Submission Summary (Full Text)

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# MAR 1 3 2006

#### 510(k) SUMMARY

510(k) NUMBER: PENDING

SUBMITTED BY: Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 [phone]

- CONTACT PERSON: Cheryl Blake Vice President, Regulatory Affairs and Quality Systems
DATE OF PREPARATION: January 20, 2006

NAME OF DEVICE: Intuitive Surgical Seal

CLASSIFICATION NAME:Laparoscope, General & Plastic Surgery (21CFR 876.1500)

| TRADE NAME: | Intuitve Surgical Seal |
|-------------------|-----------------------------------------------------------------------------------------|
| PREDICATE DEVICE: | Applied Medical Modular Trocar (K932995)<br>Applied Medical, Rancho Santa Margarita, CA |

## INTENDED USE: DESCRIPTION/INDICATIONS:

The Intuitive Surgical Seal 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

DEVICE DESCRIPTION: The Intuitive Surgical Seal is assembled with an Intuitive Surgical cannula and used with a previously approved obturator. The assembly is placed over an incision made through the skin, large enough to accept the tip of the trocar. The trocar assembly is then advanced through the remaining layers of tissue. The obturator is then removed leaving the Intuitive Surgical Seal and Intuitive Cannula in place to allow access to the surgical site for endoscopic instruments while maintaining pneumopertoneum.

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

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MAR 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060534

Trade/Device Name: Intuitive Surgical Seal Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 27, 2006 Received: February 28, 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, 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 sct

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### Page 2 - Mr. Morten Simon Christenscn

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" (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 yours,

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Intuitive Surgical Seal

Indications for Use:

The Intuitive Surgical Seal 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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

el.moll

Division of General, Restorative. and Neurological Devices

KOGOE34 510(k) Number_