CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT

K972867 · Rocket Medical Plc · ICX · Oct 24, 1997 · Hematology

Device Facts

• Record ID: K972867
• Device Name: CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
• Applicant: Rocket Medical Plc
• Product Code: ICX · Hematology
• Decision Date: Oct 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Provide Low flow regulated negative pressure for general suction and aspiration.

Device Story

Craft Suction Pump and Craft Duo-Vac Suction Pump provide regulated negative pressure for general suction and aspiration. Device utilizes a quiet diaphragm pump powered by mains voltage (110V 60Hz). Surgeon controls vacuum activation via a foot-operated switch; foot control uses an air-operated solenoid with no electrical connections to the switch. Vacuum range is 0-450mmHg, adjustable via pre-set control. An overflow bottle acts as a reservoir and safety mechanism to prevent aspirated fluids from entering the pump. Device is intended for clinical use by healthcare professionals.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by 12 years of incident-free use in the UK and bench testing of pump performance.

Technological Characteristics

Diaphragm pump; mains voltage (110V 60Hz) power source; air-operated solenoid foot switch; 0-450mmHg vacuum range; overflow bottle reservoir. Mechanical operation; no software or electronic control circuitry in the foot switch.

Indications for Use

Indicated for general suction and aspiration requiring low flow regulated negative pressure in clinical settings.

Regulatory Classification

Identification

Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Predicate Devices

• Pionext Pro-Pump (K914220)
• Pioneer Pro-Punus Dual Control (K914224)

Submission Summary (Full Text)

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P-02
K972867

### Rocket Medical plc - 510(k) Notification Craft™ Suction Units

OCT 2 4 1997

## Summary of Safety and Effectiveness

Craft™ Suction Pump Craft™ Duo-Vac Suction Pump

In the Code of Foderil Regulations, relative to the medical devices reviewed by the General and Plastic Surgery devices classification panel, FDA identified Powered suction pumps as a Class II device (878,4780).

These devices, registerval by Rocket Medical plc (Establishment number: 8010022/9610632) are substantially equivalent to devices which are currently in commerce and have been submitted to the FDA and found to be substantially oquivalent. One such device is the Pionext Pro-Pump (K# 914220) and the Pioneer Pro-Punus Dual Control (K# 91424), both found substantially cquivalent 920304, produced by Pionecr Medical Inc., 34 Laurelcrest Road, Madison, CT 06443, USA.

The device is indicated for use to provide low flow regulated negative pressure for general suction and aspiration. These devices are safe and effective for the above application and have been tested to confirm there safety and effectivencss in this format for over 12 years, without incident in the UK.

The Craft™ Suction Pumps have been developed to provide a smooth low volume vacuum at variable negative pressure. The device has the same technological characteristics as the predicate device. vacuum being activated by a foot operatual switch controlled by the surgeon. The range of vacuyum being variable from 0-4.50mmHg and adjustable over this range by a pre-set control. Vacuum is provided by a quiet diaphringm pump, working from a mains voltage supply (USA I IOV 60Hz). An overflow bottle provides a mensure of safety to prevent aspirated fluids being drawn into the vacuum power unit. The tran also acting us a reservoir to provide an even vacuum pressure during procedures, The foot control has an air-operated solennid, switching the main purnp unit. No electrical connections are made to the sealed foot operated control.

Rocket Medical plc continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

#### CERTIFICATION

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated devices.

Z.G. Zill

Signed by Leslic Todd Quality Assurance and Regulatory Affairs Manager Rocket Modical plc Wear Industrial Estate, Washington Tyne & Wear. England. NE37 INE Tel: [phone]

21st October 1997

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 2 4 1997

Mr. L. Todd Mr. D. Todd
Quality Assurance & Regulatory Affairs Manager Rocket Medical PLC Wear Industries Estate Washington Tyne & Wear NE37 1NE United Kingdom

K972867 Re : Craft Duo-Vac Suction Unit, Craft Suction Trade Name: Unit Requlatory Class: II Product Code: ICX Dated: July 11, 1997 August 4, 1997 Received:

Dear Mr. Todd:

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 current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Todd

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 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 requlation (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,

Timothy A. Ulatowski

Timothy A Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Rocket Medical plc - 510(k) Notification Craft™ Suction Units

Page 1 of 1

Device Name: Craft™ Suction Pump and Craft™ Duo-Vac Suction Pumps

# Indications for Use:

A vacuum powered body fluid suction apparatus could be used in a variety of clinical conditions, however , these particular units have been developed to:

Provide Low flow regulated negative pressure for general suction and aspiration.

Signature

Signed L. Todd QA and Regulatory Affairs Manager Rocket Medical Plc

11th July 1997

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

Patricia Crescenti

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972847

6 Prescription use_

OR

Over-The -Counter Use ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)