(79 days)
Not Found
Not Found
No
The document describes a rotary peristaltic infusion pump and its intended uses, without mentioning any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an "ambulatory infusion pump" intended for "general infusion use, including continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery." These uses directly involve the delivery of substances for medical treatment and pain management, which falls under the definition of a therapeutic device.
No
The device is described as an "ambulatory infusion pump" for "general infusion use," specifically for delivering substances like local anesthetics. Its primary function is to administer, not to diagnose conditions or analyze physiological data.
No
The device description explicitly states it is a "rotary peristaltic pump" with an "integrated administration set and drug reservoir," indicating it is a hardware device.
Based on the provided information, the AutoMed 3000 ambulatory infusion pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an infusion pump for delivering substances into the body (intravenous, subcutaneous, etc.). This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a pump and administration set, which are components for delivering fluids, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. The AutoMed 3000 is designed to deliver substances into the body for treatment or pain management.
N/A
Intended Use / Indications for 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.
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.
The AutoMed 3000 ambulatory infusion pump with integrated administration set/drug reservoir 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The AutoMed 3000 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 ambulatory devices and is intended for use in the hospital, home environment or alternative care sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, home environment or alternative care sites.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
SUMMARY OF SAFETY AND EFFECTIVENESS
September 20, 2002
FEB 0 7 2003
Trade Name: AutoMed 3000 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: 949.235.0545 Fax: 949.240.3460
1.0 DEVICE DESCRIPTIONS
The AutoMed 3000 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 ambulatory devices and is intended for use in the hospital, home environment or alternative care sites.
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 3000 infusion pump 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 seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2003
Mr. Robert J. Bard, Esq. Managing Director HELP Technologies 24312 Armada Drive Dana Point, California 92629
Re: K023863
Trade/Device Name: AutoMed 3000 Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 20, 2002 Received: November 20, 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.
2
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 (OS) 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. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runner
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): 1 023863 Device Name: AutoMed 3000 infusion pump
Indications for Use:
The AutoMed 3000 ambulatory infusion pump with integrated administration set/drug reservoir 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. 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 √ OR Over-The-Counter Use __
(Per 21 CFR 801.109)
talucia cente
Division Sian-Off) ion of Anesthesiology, General Hospital.
(Optional Format 1-2-96)
510(k) Number K023863