CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES

K990724 · Conway Stuart Medical, Inc. · GCJ · Aug 13, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990724
• Device Name: CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
• Applicant: Conway Stuart Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Conway Stuart Medical Model 100 Irrigation Pump and Accessories is indicated for irrigation of tissue.

Device Story

Model 100 Irrigation Pump and Accessories provides controlled fluid delivery for tissue irrigation. Device operates as an electromechanical pump system; delivers irrigation fluid to surgical or clinical sites. Used by medical practitioners in clinical settings to facilitate tissue cleaning or visualization. System consists of pump unit and associated accessories. Output is controlled fluid flow; assists clinicians in maintaining clear surgical fields or treating tissue. Benefits include improved procedural visibility and effective site irrigation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electromechanical irrigation pump system. Includes pump unit and accessories. Operates via electrical power source. Designed for clinical use in tissue irrigation.

Indications for Use

Indicated for irrigation of tissue in patients where irrigation is clinically appropriate. Contraindicated when, in the judgment of a medical practitioner, irrigation is contrary to the patient's best interest.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 1999

Thomas C. Wehman, Ph.D. Regulatory and Quality Assurance Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086

Re: K990724

> Trade Name: Model 100 Irrigation Pump and Accessories Regulatory Class: II Product Code: GCJ and FPA Dated: June 4, 1999 Received: June 22, 1999

Dear Dr. Wehman:

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 - Thomas C. Wehman, Ph.D.

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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Conway Stuart Medical, Inc. Sunnyvale, California

K9907224

510(k) Premarket Notification Model 100 Irrigation Pump and Accessories

## Indications for Use

TBD

510(k) Number (if known):

Device Name:

Indications for Use:

Contraindications for Use:

Model 100 Irrigation Pump and Accessories

The Conway Stuart Medical Model 100 Irrigation Pump and Accessories is indicated for irrigation of tissue.

The use of the CSM Model 100 Irrigation Pump and Accessories is contraindicated when, in the judgment of a medical practitioner, the use of irrigation would be contrary to the best interest of the patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (per 21 CFR 801.109) | <div> <span></span> </div> |
|---------------------------------------|----------------------------|
| | OR |
| | Over-the-Counter Use |
| | (Optional format 1-2-06) |

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990724
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Conway Stuart Medical, Inc.