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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Ace Medical Autofuser Elastomeric Infusion Pump System (K090300) and its performance criteria and study details:

Summary of Acceptance Criteria and Device Performance (Based on available information):

Acceptance Criteria	Reported Device Performance
Predetermined Performance Specifications for Modified System	"Test results demonstrate that the modified Autofuser system met its predetermined performance specifications."
Safety and Effectiveness (compared to predicate)	"The modified Autofuser system is as safe and effective as the previously-cleared Autofuser system."
Technological Characteristics (compared to predicate)	"The modified device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device."
New Issues of Safety or Effectiveness	"The minor technological differences between the modified device and its predicate device raise no new issues of safety or effectiveness."

Detailed Study Information:

A table of acceptance criteria and the reported device performance:
- See the table above. The document broadly states that the modified device "met its predetermined performance specifications" and is "as safe and effective" as the predicate device. Specific numerical acceptance criteria or detailed individual performance metrics are not provided in this summary.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the sample size used for the test set.
- The document does not specify the data provenance (e.g., country of origin) or whether it was retrospective or prospective. It only mentions "Performance testing was performed to verify/validate the modifications to the system."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable as the device is an infusion pump, not an AI/diagnostic device that typically relies on expert-established ground truth for a test set. The performance testing would likely involve engineering and functional tests rather than expert opinion on output.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable for this type of device and study. Adjudication methods are typically used in studies involving human interpretation (e.g., medical image reading) where multiple experts or readers are involved.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices involving human readers. This device is an elastomeric infusion pump.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable in the AI sense. This device is a physical medical device (an infusion pump), not a software algorithm being tested for standalone performance. The "performance data" refers to the physical pump's functional integrity.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a device like an elastomeric infusion pump, the "ground truth" would be established by engineering standards, predetermined specifications, and validated measurement techniques (e.g., flow rate accuracy, pressure limits, material compatibility, duration of infusion). The document broadly states that the device "met its predetermined performance specifications," implying these engineering benchmarks were used.
The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- This is not applicable for the same reason as point 8.

Conclusion:

The 510(k) summary for the Ace Medical Autofuser Elastomeric Infusion Pump System (K090300) indicates that the device met its predetermined performance specifications and was found to be as safe and effective as its predicate device (K060258) after modifications. However, the summary provides very high-level information about the "Performance Data." It does not include specific numerical acceptance criteria, detailed test methodologies, sample sizes for testing, or the specific types of "predetermined performance specifications" that were met. The document uses general statements to affirm substantial equivalence, rather than detailed quantitative results commonly found in AI/diagnostic device studies. Due to the nature of the device (an infusion pump), many of the questions related to AI studies (experts, ground truth for training/test sets, MRMC studies) are not relevant.

Summary

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

K090300

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

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

Technological Characteristics

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

{4}------------------------------------------------

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

Page of of

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).