(57 days)
Not Found
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard pump technology.
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," and also for "patient-controlled infusion." These uses directly involve treating or managing medical conditions, which aligns with the definition of a therapeutic device.
No
The device description indicates it is a pump used for general infusion and patient-controlled infusion of substances like local anesthetics, not for diagnosing conditions.
No
The device description explicitly states it includes "rotary peristaltic pumps and associated dedicated administration sets and accessories," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the infusion of substances directly into the body (intravenous, subcutaneous, etc.) for therapeutic purposes like pain management and anesthesia. This is a direct interaction with the patient's body, not the examination of samples taken from the body.
- Device Description: The device is described as an ambulatory infusion pump and associated administration sets. This aligns with a device used for delivering substances to a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver substances into the body, which is a therapeutic or supportive function, not a diagnostic one.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
FRN, MEA
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.
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.
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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
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
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.
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
1
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.
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 (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
3
510(k) Number (if known): Device Name: AutoMed 3300 and 3400 pump systems Indications for Use:
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.
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)
OR
Over-The-Counter Use
(Optional Format 1-2-!