BARIATRIC LAPAROSCOPE, MODEL 367

K993045 · Stryker Endoscopy · GCJ · Oct 27, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993045
• Device Name: BARIATRIC LAPAROSCOPE, MODEL 367
• Applicant: Stryker Endoscopy
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Laparoscopes are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, gastric bypass, laparoscopic Nissen and examination of the abdominal cavity, appendix, gallbladder and liver. Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of their patient population.

Device Story

Stryker Bariatric Laparoscope is a reusable, rigid endoscope designed for minimally invasive abdominal surgery. It serves as a modified version of a predicate device, featuring an increased length to accommodate the anatomy of morbidly obese patients. The device is inserted through small skin punctures to provide visualization of the abdominal cavity, including organs such as the gallbladder, appendix, and liver, and to facilitate procedures like hernia repair and gastric bypass. It is intended for use by surgeons in clinical settings. The device is supplied non-sterile and must be cleaned and sterilized by the user via steam autoclave, Sterrad, or Steris prior to each use. It conforms to electrical safety standards for type BF or CF applied parts.

Clinical Evidence

Bench testing only. Evaluation included optical performance testing and mechanical strength/rigidity testing under surgical loads. Biocompatibility testing was performed per ISO 10993 and CDRH G95-1 guidance.

Technological Characteristics

Reusable rigid endoscope; materials tested for biocompatibility per ISO 10993 and CDRH G95-1; electrical safety per IEC 601-2-18 (Type BF or CF applied part); sterilization via steam autoclave, Sterrad, or Steris.

Indications for Use

Indicated for surgeons performing diagnostic and therapeutic laparoscopic procedures in the abdominal cavity, including morbidly obese patients.

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

• Laparoscope (K910132)

Submission Summary (Full Text)

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2590 Walsh Avenue Santa Clara, CA 95051

OCT 27 1999

(408) 567-9 1-800-435-0111

K993045

## Attachment 6

## 510 (k) Summary Safety and Efficacy

· Device Name

Current Classification Name(s): Endoscope 21 CFR 876.1500 Class II Common and Usual Name: Laparoscope Proprietary Name: Stryker Bariatric Laparoscope

Device Sponsor:

Stryker Endoscopy 2590 Walsh Ave. Santa Clara, CA 95051

This summary of 510(k) safety and effectiveness is submitted in accordance with requirements of SMDA:1990.

equirements of SMDATI990.
The Stryker Bariatric Laparoscope is a design modification been Laparoscope, K910132 of 2/21/91. The useful length of the device has been Laparoscope, R910132 Of 2721731. The aborar 2019.
increased to a length appropriate for laparoscopic surgery on morbidly obese patients.

The Stryker Bariatric Laparoscope is a reusable rigid endoscopc, packaged in the not-sterile state.

The Stryker Bariatric Laparoscope is cleaned and sterilized by the user prior of the Scryker Darlations and our demonstrated to be sterilizable with a prior to arr uses. The doviets) of 10-6 under a variety of recommended sterility assurance rever (brid) or io health care facilities, including: steritation mosteam autoclave, Sterrad and Steris.

me oxide, Sceam adcociate, Scear is constructed of materials which are tested for biocompatibility per ISO 10993 and CDRH G95-1 guidance; these cested for broomparative and durable for their intended purposes.

The Stryker Bariatric Laparoscope conforms to the electrical safety requirements of IEC 601-2-18 as a type BF or type CF applied part of medical electrical equipment.

rcar equipment.
The Stryker Bariatric Laparoscope has been evaluated to ensure equivalent optical performance to the predicate device.

The Stryker Bariatric Laparoscope has been evaluated to ensure equivalent mechanical strength and rigidity under loads normally expected in laparoscopic surgery.

The Stryker Bariatric Laparoscope does not introduce new issues when compared to its predicate device or uses. Therefore the Stryker Bariatric Laparoscope is considered to be substantially equivalent to its predicate device and uses.

summr

R. H. Dahla Associate Project Engineer Stryker Endoscopy

9-7-99

Date

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DEPARTMENT OF HEALTH & HUMAN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1999

Mr. Robert H. Dahla Associate Project Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051

K993045 Re: Trade Name: Stryker Bariatric Laparoscope Regulatory Class: II Product Code: GCJ Dated: September 10, 1999 Received: September 10, 1999

Dear Mr. Dahla:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Robert H. Dahla

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

K993045

Indications for Use Statement

510(k) Number:

Stryker Bariatric Laparoscope Device Name:

Indications for Use:

Laparoscopes are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, gastric bypass, laparoscopic Nissen and examination of the abdominal cavity, appendix, gallbladder and liver.

Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of their patient population.

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) | <span style="text-decoration: overline;">✓</span> | OR | Over-the-Counter Use <span style="text-decoration: overline;"></span> |
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| (Division Sign-Off) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K993045 |