SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2

K012266 · National Custom Ent., Inc. · MRZ · Sep 12, 2001 · General Hospital

Device Facts

• Record ID: K012266
• Device Name: SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
• Applicant: National Custom Ent., Inc.
• Product Code: MRZ · General Hospital
• Decision Date: Sep 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Device Story

Replacement battery pack for Sherwood 224/324 feeding pumps and K524 Intri-Flush; provides electrical power to maintain device operation during clinical use; distributed to biomedical technicians or end-users for maintenance/repair; ensures continued functionality of enteral feeding pumps.

Clinical Evidence

Bench testing only.

Technological Characteristics

Replacement battery pack; electrical power storage; designed for compatibility with Sherwood 224, 324, and K524 feeding pump systems.

Indications for Use

Indicated for use as a replacement battery pack for Sherwood 224 and 324 feeding pumps and the Sherwood K524 Intri-Flush device. Intended for biomedical equipment technicians or customers requiring battery replacement.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2001

Mr. Don Pelletier President National Custom Enterprises, Incorporated 1133 East Cliff Road Burnsville, Minnesota 55337

Re: K012266

Trade/Device Name: Sherwood 224, 324 Feeding Pump & K524 Intri-Flush, Model N Regulation Number: 880.5725 Regulation Name: Pump, Infusion, Eternal; Accessory-Replacement Battery Pack Regulatory Class: II Product Code: MRZ and MOQ Dated: July 11, 2001 Received: July 18, 2001

Dear Mr. Pelletier:

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.

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

{1}------------------------------------------------

## Page 2 - Mr. Pelletier

of the Act or any Federal statutes and regulations administered by other Federal agencies. or are recordly with all the Act's requirements, including, but not limited to: registration 1 od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifoung (22 early in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

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 premilated 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,

La Cluturat

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

Enclosure

{2}------------------------------------------------

Applicant: National Custom Enterprises, Inc. [phone]

510(k) Number: 仏のアプレビ

N7213IWC2 Device Name:

Indications For Use: Replacement battery pack for

SHERWOOD 224, 324 FEEDING PUMP &

SHERWOOD K524 INTRI-FLUSH

This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1 (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Vittorio Lucente

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

OR