KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II

K031432 · Hk Surgical, Inc. · FRN · Aug 7, 2003 · General Hospital

Device Facts

• Record ID: K031432
• Device Name: KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
• Applicant: Hk Surgical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.

Device Story

Klein Surgical Infiltration Pump (Model KIP-II/KIP-02) is a fluid delivery device; operates by pumping fluid from an IV bag into a patient. Controlled manually by healthcare professional; not intended for IV infusion pump applications. Device facilitates infiltration procedures; provides controlled flow rates; assists in clinical fluid management. Used in clinical settings by trained personnel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion pump; manual flow control mechanism; intended for infiltration fluid delivery; Class II device (21 CFR 880.5725).

Indications for Use

Indicated for the controlled manual delivery of fluid from an IV bag into a patient by a healthcare professional. Not intended for use as an IV infusion pump.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2003

Ms. Sally M. Bowdon General Manager HK Surgical, Incorporated 1271 Puerta Del Sol San Clemente, California 92673

Re: K031432

Trade/Device Name: Klein Surgical Infiltration Pump, Model KIP-II Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 5, 2003 Received: May 6, 2003

Dear Ms. Bowdon:

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 -- Ms. Bowdon

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Ruances

Susan Runner, DDDS, MA Interim 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 Statement

510K number:

Device Name: Klein Surgical Infiltration Pump, Model KIP-02

Indications For Use. This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.

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

Patrícia Cucente

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031432