OLYMPUS SUCTION PUMP, MODEL KV-5

K011725 · Keymed (Medical & Industrial Equipment), Ltd. · JCX · Aug 31, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011725
• Device Name: OLYMPUS SUCTION PUMP, MODEL KV-5
• Applicant: Keymed (Medical & Industrial Equipment), Ltd.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Aug 31, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2

Intended 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.

Device Story

Olympus Suction Pump Model KV-5 is a medical suction device designed for aspiration during flexible endoscopy and general surgical procedures. Operated by healthcare professionals within clinical environments, the device provides vacuum suction to remove fluids or debris. It is not intended for thoracic surgery or use in home, field, or transport settings. The device functions as a standard suction pump to assist in maintaining clear surgical or endoscopic fields, thereby facilitating procedural visibility and patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrically powered suction pump for medical aspiration. Designed for use in healthcare establishments. Form factor is a standalone unit. No software or complex algorithms described.

Indications for Use

Indicated for aspiration during flexible endoscopy and general or surgical suction in healthcare facilities. Not for thoracic, home, field, or transport use.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

AUG 3 1 2001

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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 [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" (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 [phone] or [phone] 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