(118 days)
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.
The modification to the existing device is the addition of new flow rates, new reservoir size and procedure kit components.
Here's an analysis of the provided text regarding the Ace Medical Autofuser System (K060258), broken down by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific numerical acceptance criteria for the device's performance (e.g., "flow rate must be within X% of target"). Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Risk Control Measures | Verified and/or validated as appropriate. |
| Design Verification (General) | Results demonstrate that the predetermined acceptance criteria were met. |
| Design Validation (General) | Results demonstrate that the predetermined acceptance criteria were met. |
| Substantial Equivalence (Overall) | The modified device is substantially equivalent to the cleared original device (K041585). |
| Safety and Efficacy Concerns | The modified Autofuser system does not raise any new safety and efficacy concerns when compared to the original Autofuser device. |
| Kit Components | Legally marketed (pre-amendment, exempt, or substantially equivalent through PN process). Substantially equivalent to components in predicate pain management kits. |
From the text, "The design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met," implies that internal criteria were established and achieved, but the specific metrics are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The submission focuses on modifications to an existing device and demonstrating substantial equivalence through design verification and validation, rather than a clinical study with a patient-based test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The evaluation appears to be based on engineering verification and validation of the device's performance against internal specifications and comparison to predicate devices, not on expert consensus regarding clinical outcomes.
4. Adjudication Method for the Test Set
As no test set involving human assessment or expert review is described, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe an MRMC comparative effectiveness study. This submission is for modifications to an elastomeric infusion pump, which typically does not involve this type of study design. The focus is on the device's mechanical and functional performance, not on human interpretive tasks that would benefit from MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an elastomeric infusion pump. There is no "algorithm only" or "standalone" performance described in the context of AI or software. The performance assessed would be the physical pumping mechanism and its ability to deliver fluids at specific rates.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is implicit in its design specifications and functional requirements. For example, a target flow rate, reservoir size, and bolus delivery mechanism. The document states that "design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met." This implies the ground truth was based on engineering specifications and established performance benchmarks for infusion pumps, not on pathology, outcomes data, or expert consensus in a clinical sense.
8. Sample Size for the Training Set
As this is a submission for a medical device (an elastomeric infusion pump) and not an AI/ML algorithm that requires a training set, the concept of a "training set" does not apply to this document.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an AI/ML algorithm for this device, information on how its "ground truth" was established is not applicable.
{0}------------------------------------------------
Modifications to the Ace Medical Autofuser System
19 January 2006
Submitted by: Ace Medical US, LLC, 9102 Turfway Bend Drive, Powell, OH 43065-8497 Contact for Questions: Andy Lamborne, 303-443-7500 x.228, alamborne.co@netzero.net Trade Name: Autofuser Common Name: Elastomeric Infusion Pump & Procedure Kit Classification Name: Elastomeric Infusion Pump Device Classification: Class II Regulation Number: 880.5725 Classification Panel: 80, General Hospital and Personal Use Device Product code: MEB - Elastomeric Infusion Pump Original cleared 510(k): K041585 Establishment Registration: pending assignment from FDA Owner/Operator Number: 9082449
Summary of Safety and Effectiveness of the Autofuser System 5.
- This premarket notification submission is intended to notify the Food and Drug 5.1 Administration that Ace Medical US, LLC intends to market a modification to an existing device (K041585), the Autofuser system.
- The cleared indications for use for the Autofuser system are: 5.2
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.
- 5.3 Summary of the Modification
- 5.3.1 The modification to the existing device is the addition of new flow rates, new reservoir size and procedure kit components.
- 5.3.2 A risk analysis for the modified Autofuser device has been performed. incorporating risk analysis, risk evaluation and risk control in accordance with ISO 14971.
510(k) Ace Medical Autofuser System
510(k) Summary p. 1 of 2
{1}------------------------------------------------
- The risk control measures are verified and/or validated, as ಡಿ. appropriate.
- b. The design verification and validation activities have been performed and the results demonstrate that the predetermined acceptance criteria were met. These results demonstrate that the modified device is substantially equivalent to the cleared original device.
1060258
- 5.3.3 The kit components are legally marketed-either pre-amendment devices. devices exempt from premarket notification, or devices found to be substantially equivalent through the premarket notification process for the intended use of the kit. The kit components are substantially equivalent to the components included in pain management kits for the original Autofuser, the Accufuser and the OnQ/Painbuster predicate devices.
- 5.4 Conclusion: The modified Autofuser system does not raise any new safety and efficacy concerns when compared to the original Autofuser device that is already legally marketed. The modified Autofuser system is substantially equivalent to the original cleared Autofuser (K041585). The modified Autofuser system also demonstrates substantial equivalence to the Woo Young/McKinley Medical Accufuser System (K033039), and to the I-Flow Homepump/Eclipse/OnQ Painbuster system (K980558, K982946, K944692, K896546).
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
Public Health Service
MAY 30 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Andrew N. Lamborne Technical Advisor Ace Medical US, LLC 9102 Turfway Bend Drive Powell, Ohio 43065-8497
Re: K060258
Trade/Device Name: Autofuser Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: March 20, 2006 Received: March 28, 2006
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 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.
{3}------------------------------------------------
Page 2 - Mr. Lamborne
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
510(k) Number (if known): K060258
Device Name: Autofuser
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.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anting D, ma
ology, General Hospita
on Centre, Lental Devices
501 4258
§ 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).