AUTOFUSER AMBULATORY INFUSION PUMP

K041585 · Algos, LC · MEB · Aug 26, 2004 · General Hospital

Device Facts

• Record ID: K041585
• Device Name: AUTOFUSER AMBULATORY INFUSION PUMP
• Applicant: Algos, LC
• Product Code: MEB · General Hospital
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AutoFuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, and its predicate devices are indicated for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. Members of the AutoFuser family and the predicate devices are also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

Device Story

AutoFuser is a disposable, ambulatory elastomeric infusion pump; utilizes silicone balloon as both fluid reservoir and pressure/energy source; provides continuous fluid delivery via fixed-rate administration set. Family includes standard models and Patient Medication Control Module (PCM) models allowing patient-administered bolus with fixed lockout time. Used in hospital, home, or alternative care sites; operated by clinicians or patients. Flow rate controlled by glass orifice or PVC tubing. Device provides continuous infusion of local anesthetics or general fluids; bolus feature allows patient-controlled pain management. Benefits include ambulatory delivery of medication for regional anesthesia and post-surgical pain management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, materials, and intended use to legally marketed predicate devices.

Technological Characteristics

Elastomeric infusion pump; silicone balloon reservoir/energy source; glass orifice or PVC tubing flow control; integrated administration set. Fluid path materials conform to ISO 10993 Part 1. Disposable, single-patient use. Ambulatory form factor.

Indications for Use

Indicated for general infusion use in patients requiring intravenous, percutaneous, subcutaneous, intra-arterial, epidural, or intra-operative (soft tissue/body cavity) delivery of fluids or medications, including local anesthetics for regional anesthesia and pain management (pre-operative, perioperative, postoperative). Includes patient-controlled bolus delivery.

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

• I-Flow Homepump (Eclipse) C-Series
• Baxter Infusor
• Baxter Intermate
• McKinley Accufuser
• B Braun spring pump (used in Sgarlato pain kit)

Reference Devices

• I-Flow PainBuster kit
• On-Q pain management kit
• Sgarlato PCIP

Submission Summary (Full Text)

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AUG 2 6 2004

K041585

## SUMMARY OF SAFETY AND EFFECTIVENESS

June 1, 2004

Trade Name: AutoFuser Elastomeric Infusion Pump

Common Name: Elastomeric Infusion Pump

Classification Name: Pump, Infusion, Elastomeric

Classification Panel: General Hospital and Personal Use Device

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq. Managing Director

HealthCare Technologies Consultants 150 Lake Village Dr Suite 203 Telephone: [phone] Fax: [phone]

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#### DESCRIPTION OF THE AUTOFUSER PRODUCT 1.0

- The AutoFuser pump (Continuous type Silicone Balloon) 1.1
- 1.1.1 The pump provides continuous fluid delivery with attached, fixed rate administration set.
- The pumps are supplied as fixed flow rates. 1.1.2
- 1.1.3 A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.
- The AutoFuser pump family includes models of the standard 1.2 AutoFuser with the addition of a Patient Medication Control Module (PCM)
- Patient Medication Control Module allows the patient to 1.2.1 administer a bolus of fixed volume with a fixed lockout (re-fill) time.
- 1.2.2 The pump is a disposable device intended for single patient use.
- 1.2.3 The pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
- 1.2.4 The AutoFuser and the AutoFuser PCM pumps are substantially similar to the I-Flow Homepump (Eclipse) C-Series (included in the I-Flow PainBuster kit and the On-Q pain management kit), the Baxter Infuser and Intermate, the McKinley Accufuser, and the B Braun spring pump (used in the Sgarlato pain kit).

### THE AUTOFUSER/AUTOFUSER PCM PUMP AND ITS PREDICATE 2.0 DEVICES ARE INTENDED:

- For general infusion use. Routes of infusion include intravenous, 2.1 percutaneous, subcutaneous, intra-arterial and epidural and into the intra-operative (soft tissue / body cavity) site.
- 2.2 General infusion use Includes pain management for pre-operative, perioperative and postoperative surgery.
- The predicate pumps (and the pumps included with the I-2.2.1 Flow PainBuster and ON-Q Infusion Kit and the Sgarlato Pain Control Infusion Pump (PCIP)) have the same intended use as the device under review:

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- 2.2.2 The AutoFuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, and its predicate devices are indicated for general infusion use. Routes of infusion include intravenous. percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites.
Members of the AutoFuser family and the predicate devices are also intended for patient-controlled infusion using the integrated bolus button.

General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

- 2.3 Device Descriptions
- 2.3.1 Specifications
- 2.3.1.1 The AutoFuser and the AutoFuser PCM pumps have fill volumes and flow rates substantially similar to the pumps of the McKinley Medical Accufuser, the I-Flow PainBuster (Homepump Eclipse C-Series), the B Braun spring pump included in the Sgarlato PCIP, and the Baxter Infusor and Intermate pumps.
- 2.3.2 Flow Control
- The AutoFuser and AutoFuser PCM pumps and 2.3.2.1 the identified predicate device use either a glass orifice or PVC tubing to control the flow rate.
- 2.3.3 Materials
- 2.3.3.1 All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 2 6 2004

ALGOS, LC C/O Mr. Robert J. Bard Managing Director Healthcare Technologies Consultants 150 Lake Village Drive, Suite 203 Ann Arbor, Michigan 48103

Re: K041585

Trade/Device Name: AutoFuser Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: June 1, 2004 Received: June 14, 2004

Dear Mr. Bard:

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 - Mr. Bard

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 nfour that or any Federal statutes and regulations administered by other Federal agencies. or not ret of any ly 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 and fishing (21 CF CF th 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), 11 yea 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,

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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# Indications for Use

510(k) Number (if known): K041585

AutoFuser infusion pump Device Name:

Indications For Use:

The AutoFuser family of ambulatory infusion pumps with integrated administration set, The AutoFuser family of ambulatory intrason paniped for general infusion use.
either separately or as part of a convenience subentageous inter-arterial an either separately of as part of a convenience in the rubert of the readers, inter-arterial and
Routes of infusion include intravenous, percutaneous, subout announces in the Routes of infusion intra-operative (soft tissue / body cavity) sites.

Within the AutoFuser family are pump models intended for patient-controlled infusion using the integrated bolus button.

General infusion uses include continuous infusion of a local anesthetic near a nerve for
e General music uses infolude contined of the pre-operative, perioperative and postoperative surgery.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFF 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cluif

nesthesiology, General Hospitali Infection Cor trol, Dental

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510(k) Number: K041595