MODIFICATION TO SYSTEM 83 PLUS

K983017 · Custom Ultrasonics · NVE · Sep 22, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K983017
• Device Name: MODIFICATION TO SYSTEM 83 PLUS
• Applicant: Custom Ultrasonics
• Product Code: NVE · Gastroenterology, Urology
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The System 83 Plus is designed for the simultaneous reprocessing of up to two flexible endoscopes. These endoscopes may be high level disinfected when the washing/disinfection cycle of the System 83 Plus is used with the labeled contact conditions for the germicide as in the predicated device.

Device Story

System 83 Plus is an automated endoscope washer/disinfector; designed for simultaneous reprocessing of up to two flexible endoscopes. Device performs washing and high-level disinfection cycles using chemical germicides. Operated by clinical staff in healthcare settings. Output consists of reprocessed, disinfected endoscopes ready for subsequent patient use. Benefit includes standardized, automated cleaning and disinfection to reduce risk of cross-contamination between procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison to predicate device specifications for reprocessing and disinfection efficacy.

Technological Characteristics

Automated endoscope washer/disinfector; dual-channel capacity for simultaneous processing. Utilizes chemical germicide-based disinfection. System operates via programmed wash/disinfection cycles. No specific materials or software architecture details provided.

Indications for Use

Indicated for the simultaneous reprocessing and high-level disinfection of up to two flexible endoscopes used in gastrointestinal and/or pulmonary procedures.

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

SEP 2 2 1998

Mr. Frank J. Weber President Custom Ultrasonics, Incorporated 144 Railroad Drive Ivyland, Pennsylvania 18974

Re : K983017 Trade Name: Modification to System 83 Plus Requlatory Class: II Product Code: KOG Dated: August 25, 1998 Received: August 28, 1998

Dear Mr. Weber:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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

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Page 2 - Mr. Weber

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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,

Susan Runner

)Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Custom Ultrasonics, Inc.

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| 510(k) Number (if known): | K983017 |
|---------------------------|----------------|
| Device Name: | System 83 Plus |

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Indications For Use:

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## INDICATIONS FOR USE STATEMENT

I certify that, in my capacity as President of Custom Ultrasonics, Inc., that the System 83 recently that, in my capacity as reor is designed for the simultaneous reprocessing of up I Tus Endoscope WashorDishmobiler is actor and in the gastrointestinal and/or to two trextone submorsions on account and then exposed to then exposed to the punthonal y these Frexton soopes there 83 Plus may be high level disinfected when the wasning/dismitection vyolo of the Uplabeled contact conditions for the germicide as in the predicated device.

Frank Joseph

Frank J. Weber

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------|
| | <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> | |
| 510(k) Number | KC982617 | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |

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