The AutoMed 3300 and 3400 ambulatory infusion pumps and dedicated administration sets and accessories are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intraoperative (soft tissue / body cavity) sites. The AutoMed systems 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 Description

The AutoMed Systems presented in this product notification include the AM 3300 and AM 3400 rotary peristaltic pumps and associated dedicated administration sets (AM 320, AM 330 and AM 340) and accessories. The systems are suitable for use as ambulatory devices and that are intended for use in the hospital, home environment or alternative care sites.

AI/ML Overview

This looks like a 510(k) submission for infusion pumps (AutoMed 3300 and 3400). It focuses on the device description, intended use, and substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance claims or AI integration.

Therefore, the requested information about acceptance criteria, study design, expert involvement, and AI performance cannot be extracted from the provided text because these elements are not present. The document is primarily a regulatory submission demonstrating substantial equivalence, not a clinical performance study.

Here's why the requested information cannot be found in the provided text:

Acceptance Criteria and Reported Device Performance: This document describes the device and its intended use but does not present specific performance metrics or acceptance criteria that a study would aim to meet.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are all aspects of a clinical or performance study designed to evaluate a device against specific metrics. This document does not describe such a study.
Type of Ground Truth: This is relevant for studies where a device's output is compared against a definitive standard. This document does not describe such a comparison.
Training Set Sample Size and Ground Truth Establishment (Relevant for AI): This document does not mention any artificial intelligence (AI) component in the infusion pumps. Therefore, information about training sets or how ground truth for training was established is not applicable.

In summary, the provided text is a 510(k) premarket notification for infusion pumps, establishing substantial equivalence, and does not contain the details of a performance or clinical study with the elements you've requested.

Summary

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K 023491

SUMMARY OF SAFETY AND EFFECTIVENESS

September 20, 2002

Trade Name: AutoMed 3300 and AutoMed 3400 infusion pumps

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: 949.235.0545 Fax: 949.240.3460

1.0 DEVICE DESCRIPTIONS

INTENDED USE 2.0

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

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

PREDICATE PRODUCTS 3.0

The AutoMed 330 and 3400 are 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.

0116

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

ood and Drug Administratio 9200 Corporate Boulevard Rockville . MD 20850

. DEC 13 2002

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

Re: K023491

Trade/Device Name: AutoMed 3300 and 3400 Pump systems Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN and MEA Dated: September 20, 2002 Received: October 17, 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.

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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 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Timukula A. Ulatowski

Timblay A. Ulatowski 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): Device Name: AutoMed 3300 and 3400 pump systems Indications for Use:

Lucio Curcenti

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-!

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).