(83 days)
Not Found
No
The summary describes a mechanical, disposable infusion pump system with no mention of AI or ML capabilities.
Yes
The device is described as an "ambulatory infusion pump" intended for "general infusion use" for administering substances like "local anesthetic near a nerve for regional anesthesia and pain management." This indicates it is used for delivering treatments to patients, which is characteristic of a therapeutic device.
No
The intended use describes the device as an infusion pump for administering medication, not for diagnosing medical conditions.
No
The device description clearly states it is a family of disposable infusion pumps and associated procedure kits, which are physical 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 device as an "ambulatory infusion pump" for delivering medications via various routes (intravenous, subcutaneous, etc.) for general infusion and pain management. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a pump with a medication reservoir and administration set. This aligns with a device used to deliver substances into the body, not to analyze samples from 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is designed to deliver medication.
N/A
Intended Use / Indications for Use
The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into 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 regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Product codes
MEB
Device Description
The Autofuser system consists of a family of disposable infusion pumps and associated procedure kits. The pump is comprised of a balloon-style medication reservoir and an integrated flowrate-controlling administration set. When the Autofuser pump is packaged in a procedure kit, the kit includes legally marketed components such as filling syringe, catheter, catheter introducer, and pump carrying pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Near a nerve for regional anesthesia and pain management; intra-operative (soft tissue/body cavity) sites.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing was performed to verify/validate the modifications to the system. Test results demonstrate that the modified Autofuser system met its predetermined performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ace Medical Autofuser Elastomeric Infusion Pump System (K060258)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 30 2009
510(k) SUMMARY
Ace Medical Autofuser Elastomeric Infusion Pump System
Submitted by:
Ace Medical US, LLC 9102 Turfway Bend Drive, Powell, OH 43065-8497 Contact Person: Phil Marsh Phone: (614) 733-3601 Fax: (614) 733-3602 Establishment Registration: 3005627389 Date Prepared: January 31, 2009
Device Information:
Name of Device: Autofuser Elastomeric Infusion Pump System Common Name: Elastomeric Infusion Pump & Procedure Kit Classification Name: Elastomeric Infusion Pump Product code: MEB - Elastomeric Infusion Pump Device Classification: Class II Regulation Number: 880.5725 Classification Panel: 80, General Hospital and Personal Use Device
Predicate Device
Ace Medical Autofuser Elastomeric Infusion Pump System (K060258)
Intended Use / Indications for Use
The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into 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 regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
1
Technological Characteristics
The Autofuser system consists of a family of disposable infusion pumps and associated procedure kits. The pump is comprised of a balloon-style medication reservoir and an integrated flowrate-controlling administration set. When the Autofuser pump is packaged in a procedure kit, the kit includes legally marketed components such as filling syringe, catheter, catheter introducer, and pump carrying pouch.
Performance Data
Performance testing was performed to verify/validate the modifications to the system. Test results demonstrate that the modified Autofuser system met its predetermined performance specifications.
Substantial Equivalence
The modified Autofuser system is as safe and effective as the previously-cleared Autofuser system. The modified device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the modified device and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the modified Autofuser is as safe and effective as the predicate device. Thus, the modified Autofuser system is substantially equivalent to the previously-cleared predicate Autofuser system.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2009
Mr. Andrew N. Lamborne Ace Medical US, LLC 9102 Turfway Bend Drive Powell, Ohio 43065
Re: K090300
Trade/Device Name: Autofuser Elastomeric Infusion Pump System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: March 24, 2009 Received: March 31, 2009
Dear Mr. Lamborne:
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 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.
3
Page 2- Mr. Lamborne
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Antan O. hum for
Susan Runner, D.D.S., MA Acting 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 Statement
510(k) Number (if known): K090300
Device Name: Autofuser Elastomeric Infusion Pump System
Indications for Use:
The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, intra-arterial and epidural, and into 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 regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093000
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