ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP

K081905 · Westmed, Inc. · MEB · Jul 15, 2008 · General Hospital

Device Facts

• Record ID: K081905
• Device Name: ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
• Applicant: Westmed, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Jul 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

AccuFlo & AccuFlux devices are intended for patients requiring intravenous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Device Story

AccuFlo & AccuFlux are disposable, non-electric elastomeric infusion pumps. Devices deliver precise medication volumes at predetermined hourly flow rates. Used for IV, subcutaneous, intra-operative, or epidural administration; specifically for pain management and antibiotic delivery. Operated by clinicians in intraoperative or postoperative settings. Principle of operation relies on elastomeric pressure to drive fluid flow. No electronic components or software involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable, non-electric elastomeric infusion pump. Complies with IEC 60601-2-24, IEC 60601-1-1, IEC 60601-1-6, ISO 10993 (biocompatibility), ISO 11607 (packaging), and ISO 14971 (risk management). Sterilized via Ethylene Oxide.

Indications for Use

Indicated for patients requiring intravenous, subcutaneous, intra-operative, or epidural medication administration, including local anesthetics for regional anesthesia and pain management, or antibiotics. Routes include intraoperative, percutaneous, intramuscular, or subcutaneous.

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.

Predicate Devices

• McKinley Accufuser (K050770)
• Baxer Infuser (K062457)
• MPS MedFlo (K052451)
• I-Flow (K052117)

Submission Summary (Full Text)

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K\$\phi\$81945 JUL 1 5 2008

Westmed, Incorporated 510(k) Premarket Notification

## 510(k) Summary

| Submitted by: | Westmed, Inc.<br>5580 Nogales Highway<br>Tucson, AZ 85706 USA<br>Telephone: [phone]<br>Facsimile: 520.294.6580<br>Website: www.Westmedinc.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle Wates<br>Regulatory Affairs Manager<br>Westmed, Inc.<br>Telephone: [phone] ext. 1233<br>Facsimile: 520.294.6580<br>Email: [e-mail] |
| Date Prepared: | June 30, 2008 |
| Proprietary Name: | AccuFlo & AccuFlux |
| Common Name: | Non-electrically Powered Disposable Infusion Pump |
| Classification Name: | Elastomeric External Infusion Pump (21 CFR 880.5725) 80 MEB |
| Predicate Device: | McKinley Accufuser K050770 cleared April 14, 2005<br>Baxer Infuser K062457 cleared September 21, 2006<br>MPS MedFlo K052451 cleared December 8, 2005<br>I-Flow K052117 cleared September 9, 2005 |

Device Description: The AccuFlo & AccuFlux models are both disposable, non-electric infusion pumps that deliver precise volume of medication at predetermined flow rate for IV therapy.

Intended Use of Device: AccuFlo & AccuFlux devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert.

The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes

The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Technological Characteristics: The proposed device is equivalent to the identified predicate devices with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of International Electrotechnical Commission Standards for Medical Devices, IEC 60601-2-24, IEC 60601-1-1, IEC 60601-1-6, plus International Standards Organization Standards for Biocompatibility ISO 10993, Packaging ISO 11607, Ethylene Oxide Sterilization and Risk Management ISO 14971.

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Image /page/1/Picture/10 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Westmed, Incorporated C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K081905

Trade/Device Name: Accuflow&AccuFlux Elastomeric Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: July 1, 2008 Received: July 3, 2008

JUL 1 5 2008

Dear Mr. Lehtonen:

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 ffor 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 - Lehtonen

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-[See Below For Phone Numbers]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Morre

G

Chiu Lin, Ph.D. 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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510(k) Number (if known): K481995

Device Name: Accuflow& AccuFLux Elastomeric Infusion Pump

Indications for Use:

AccuFlo & AccuFlux devices are intended for patients requiring intravenous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes.

The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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