(234 days)
The MinFlex Washer-Disinfector is intended for washing and high-level disinfecting one or two submersible flexible endoscopes that do not contact normally sterile areas of the body and that feature either no internal channel (i.e., a probe) or one internal channel. The types of flexible endoscopes for which the MinFlex Washer-Disinfector is labeled include those that are used to examine, diagnose, and treat diseases of the pulmonary tract, urinary tract, uterine cavity, and ear, nose, and throat (ENT) cavities.
System 83 Plus MiniFlex Washer -- Disinfector
This document is a 510(k) clearance letter from the FDA for a medical device called the "System 83 Plus MiniFlex Washer-Disinfector." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The provided text describes the FDA's decision to clear the device for marketing based on its substantial equivalence to a legally marketed predicate device. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, ground truth establishment) is typically found in a clinical study report or a risk management document for an AI/ML device, which this document is not.
Therefore, I cannot fulfill the request using the provided input.
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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Lawrence F. Muscarella Director, Research & Development Custom Ultrasonics, Incorporated l 44 Railroad Drive Ivyland, Pennsylvania 18974
JAN 1 2 2007
Re: K061430
Trade/Device Name: System 83 Plus MiniFlex Washer -- Disinfector Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: January 4, 2007 Received: January 5, 2007
Dear Dr. Muscarella:
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.
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Page 2 - Dr. Muscarella
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 set 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Cherls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K061430
Device Name: System 83 Plus MiniFlex Washer-Disinfector
Indications For Use: The MinFlex Washer-Disinfector is intended for washing and high-level disinfecting one or two submersible flexible endoscopes that do not contact normally sterile areas of the body and that feature either no internal channel (i.e., a probe) or one internal channel. The types of flexible endoscopes for which the MinFlex Washer-Disinfector is labeled include those that are used to examine, diagnose, and treat diseases of the pulmonary tract, urinary tract, uterine cavity, and ear, nose, and throat (ENT) cavities.
Prescription Use NA AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use YES (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheila A. Murphy, MD
A. Division of Damages
Page 1 of
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.