AUTOMED 3200 INFUSION PUMP

K023973 · Help Technologies · FRN · Feb 27, 2003 · General Hospital

Device Facts

• Record ID: K023973
• Device Name: AUTOMED 3200 INFUSION PUMP
• Applicant: Help Technologies
• Product Code: FRN · General Hospital
• Decision Date: Feb 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AutoMed 3200 ambulatory infusion pump with integrated administration set is intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. The AutoMed 3200 infusion pump is 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

AutoMed 3200 is a rotary peristaltic infusion pump designed for ambulatory use in hospitals, homes, or alternative care sites. System includes integrated administration set (AM 330) and drug reservoir. Device delivers continuous infusions and supports patient-controlled bolus dosing via an integrated button. Operated by clinicians or patients for regional anesthesia and pain management. Output provides controlled medication delivery to specific anatomical sites; assists healthcare providers in managing patient pain; enables ambulatory treatment, potentially improving patient mobility and recovery outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rotary peristaltic infusion pump; includes integrated administration set (AM 330) and drug reservoir. Designed for ambulatory use. No specific materials, software architecture, or connectivity standards disclosed.

Indications for Use

Indicated for patients requiring general infusion therapy, including intravenous, percutaneous, subcutaneous, inter-arterial, epidural, or intra-operative (soft tissue/body cavity) administration. Also indicated for patient-controlled infusion for regional anesthesia and pain management (pre-operative, perioperative, postoperative).

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 WalkMed® 300, 350, PCA and IC
• Sorenson Medical, Inc, MicroJect® Model 30 pump
• Model 200 Pump
• Model PCA Pump
• Model PCEA Pump
• Stryker Instruments Pain Pump II
• I-Flow PainBuster Infusion Kit

Submission Summary (Full Text)

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

FEB 2 7 2003

Image /page/0/Picture/1 description: The image shows a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the numbers '023973'. The characters are written in a handwritten style, with varying stroke thicknesses.

# SUMMARY OF SAFETY AND EFFECTIVENESS

September 20, 2002

Trade Name: AutoMed 3200 infusion pump

Common Name: Infusion Pump

Classification Name: Pump, Infusion,

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

HELP Technologies 24312 Armada Dr. Dana Point, CA 92629 Telephone: [phone] Fax: [phone]

#### 1.0 DEVICE DESCRIPTIONS

The AutoMed 3200 infusion pump with integrated administration set and drug reservoir is a rotary peristaltic pump. Associated dedicated administration set, AM 330, and accessories are part of the overall system. The system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

#### 2.0 INTENDED USE

For general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural and into the intraoperative (soft tissue / body cavity) site.

The AutoMed 3200 infusion pump is intended for patient-controlled infusion using the integrated bolus button.

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

### PREDICATE PRODUCTS 3.0

The AutoMed 3200 is substantially similar to the following devices: McKinley WalkMed® 300, 350, PCA and IC; Sorenson Medical, Inc, MicroJect® Model 30 pump, Model 200 Pump, Model PCA Pump, Model PCEA Pump; Stryker Instruments Pain Pump II; and the I-Flow PainBuster Infusion Kit.

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES - USA" are written in a circular pattern around the top of the symbol, and the word "DEPARTMENT" is written along the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2003

Mr. Robert J. Bard Managing Director HELP Technologies 24312 Armada Drive Dana Point, California 92629

Re: K023973

Trade/Device Name: AutoMed 3200 Infusion Pump Regulation Number: 880.5725, 880.5440 Regulation Name: Infusion Pump, Intravascular Administration Set Regulatory Class: II Product Code: FRN, FPA Dated: September 20, 2002 Received: December 2, 2002

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.

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

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

Page 2 - Mr. Bard

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 Puoser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): K 023973 Device Name: AutoMed 3200 infusion pump

## Indications for Use:

The AutoMed 3200 ambulatory infusion pump with integrated administration set is intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. The AutoMed 3200 infusion pump is 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:flex; align-items:center;"><img alt="Tick" src="tick.png" style="height:1em; margin-right:0.5em;"/></div> | OR | Over-The-Counter Use |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----|--------------------------|
| (Division Sign-Off) | | | |
| | Von NH2ymm Fou PXC | | (Optional Format 1-2-96) |
| | Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | | |
| 510(k) Number: | K023973 | | |

Page ii