UNISURGE INTERFACE P

K972178 · Unisurge Holding, Inc. · GCJ · Sep 5, 1997 · Gastroenterology, Urology

Device Facts

Record IDK972178
Device NameUNISURGE INTERFACE P
ApplicantUnisurge Holding, Inc.
Product CodeGCJ · Gastroenterology, Urology
Decision DateSep 5, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2

Intended Use

The UNISURGE Interface Controller - P is indicated for use in procedures (endo in which the UNIGRIP is used... The Interface Controller with pump is not designed to deliver any type of blood, blood products, or analgesics. It is designed for the administration of sterile irrigation fluid via sterile deposable tubing

Device Story

The Unisurge Interface Controller - P is a pump-based device used in endoscopic procedures. It functions by delivering sterile irrigation fluid through sterile disposable tubing to the surgical site. The device is operated by clinical staff in a surgical or clinical setting. It does not deliver blood, blood products, or analgesics. The primary benefit is the controlled administration of irrigation fluid to support endoscopic visualization and procedural requirements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pump-based irrigation controller; utilizes sterile disposable tubing; designed for sterile irrigation fluid delivery; non-blood/non-analgesic delivery system.

Indications for Use

Indicated for use in endoscopic procedures requiring the UNIGRIP device. Not for delivery of blood, blood products, or analgesics. Designed for administration of sterile irrigation fluid via sterile disposable tubing.

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.

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a person embracing another person, with three figures in total. Food and Drug Administration .. 9200 Corporate Boulevard Rockville MD 20850 Ms. Stacie Buttorff Director, Regulatory Affairs & Quality Assurance Unisurge, Inc. . . . . . . . . . 6107 Oakbrook Parkway, Suite A Norcross, Georgia 30093-1716 SEP = 5 1997 Re: K972178 Trade Name: Unisurge Interface P Regulatory Class: II Product Code: GCJ Dated: June 5, 1997 Received: June 10, 1997 Dear Ms. Buttorff: 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 requirements , as set forth in the Quality System Regulation (OS) 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. {1}------------------------------------------------ ## Page 2 - Ms. Stacie Buttorff 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 vour 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Sincerely yours, [signature] 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 {2}------------------------------------------------ Kangins/ Page 1 of 1 ``` 510(k) Number (if known): 972178. Device Name: Interface - P Indications For Use: The UNISURGE Interface Controller - P is indicated for use in procedures (endo in which the UNIGRIP is used... The Interface Controller with pump is not designed to deliver any type of blood, blood products, or analgesics. It is designed for the administration of sterile irrigation fluid via sterile deposable tubing X rescription Use (Per 21 CFR 801.109) {FDA/CDRH/COE/D} 3 SEP 97 15 05 (Division Sign-Off) Division of General Restorative Devices 510(k) Number K972178 SK 30
Innolitics
510(k) Summary
Decision Summary
Classification Order
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