(88 days)
For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the Olympus Suction Pump Model KV-5, confirming its substantial equivalence to a legally marketed predicate device.
It details:
- The device name and model.
- The regulation number and regulatory class.
- The date of the letter and previous correspondence dates.
- The contact information for the recipient.
- General information about FDA regulations and responsibilities.
- The intended use of the device: "For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not not intended for thoracic, domiciliary, field or transport use."
It does not provide:
- A table of acceptance criteria or reported device performance.
- Sample sizes or data provenance for any test set.
- Information on experts, ground truth establishment, or adjudication methods for a test set.
- Details of any MRMC comparative effectiveness study or standalone algorithm performance.
- Sample sizes or ground truth establishment methods for a training set.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
AUG 3 1 2001
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle or other bird-like figure with three wing-like shapes extending from its body. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger Gray Head of Quality Assurance and Regulatory Affairs KeyMed (Medical & Industrial Equipment) Ltd. KeyMed House Stock Road, Southend-on-Sea Essex SS2 5OH United Kingdom
Re: K011725
Trade/Device Name: Olympus Suction Pump Model KV-5 Regulation Number: 878.4780 Regulatory Class: II Product Code: JCX Dated: May 21, 2001 Received: June 4, 2001
Dear Mr. Gray:
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 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). 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 (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. Roger Gray
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 (301) 594-4659. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Lisa Wlmefr
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): צוגרונס או א Unknown
Olympus Suction Pump model KV-5 Device Name:
Indications For Use:
For aspiration during flexible endoscopy and general or surgical suction within a health care establishment. It is not intended for thoracic, domiciliary, field or transport use.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
SR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011725
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.