(56 days)
Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Medfusion 2001 & 2010 replacement battery pack:
Based on the provided FDA 510(k) letter (K012259), the primary "study" performed is a demonstration of substantial equivalence to a legally marketed predicate device. This is a regulatory pathway for low-to-moderate risk medical devices and does not typically involve the detailed performance studies common for novel devices or AI/ML-driven software.
Therefore, many of the requested categories (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training sets) are not applicable in the context of this 510(k) submission for a replacement battery pack, as it is a component demonstrating substantial equivalence rather than a novel diagnostic or therapeutic device.
The "acceptance criteria" here are largely implicit in the FDA's decision about substantial equivalence, meaning the new device performs as safely and effectively as a predicate device without raising new questions of safety or effectiveness. For a battery pack, this mainly revolves around physical specifications, electrical compatibility, and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Submission) |
|---|---|
| Functional Equivalence: Compatible with Medfusion 2001 & 2010 Infusion Pumps. | "Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP." |
| Safety: Does not introduce new safety concerns compared to the original battery. | (Implicit in 510(k) clearance) |
| Performance: Provides equivalent power and duration as the original battery. | (Implicit in 510(k) clearance) |
| Material/Design Equivalence: Similar materials and design to the original battery. | (Implicit in 510(k) clearance) |
Note: The letter explicitly states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the core "acceptance criteria" and "performance" in this context. The detailed technical specifications that support this substantial equivalence are not contained within this letter.
2. Sample size used for the test set and the data provenance
- Not Applicable. The provided document is an FDA clearance letter for a 510(k) submission based on substantial equivalence for a replacement battery pack. This pathway typically does not involve clinical "test sets" in the way a diagnostic AI/ML device would. The "tests" performed would be engineering bench tests for compatibility, electrical performance, and safety, comparing the new battery to the original or predicate battery. The details of these tests (sample sizes, specific data provenance) are not included in this summary letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, the concept of "ground truth" and expert adjudication for a battery pack's performance is not relevant in the way it is for diagnostic algorithms. Engineering and safety testing typically relies on validated measurement instruments and standards.
4. Adjudication method for the test set
- Not Applicable. See points 2 and 3.
5. 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
- Not Applicable. This is a replacement battery pack, not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used
- Not Applicable. For a battery pack, "ground truth" would be established by objective physical and electrical measurements against predefined specifications and existing predicate device performance, not expert consensus or pathology.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2001
Mr. Don Pelletier President National Custom Enterprises, Incorporated 1133 East Cliff Road Burnsville, Minnesota 55337
Re: K012259
Trade/Device Name: Medfusion 2001 & 2010, Model N7215IWC Regulation Number: 880.5725 Regulation Name: Pump, Infusion-Accessory; Replacement Battery Pack FRN Regulatory Class: II Product Code: MRZ and MOQ Dated: July 18, 2001 Received: July 18, 2001
Dear Mr. Pelletier:
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.
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.
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Page 2 - Mr. Pelletier
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with and and manufacturing (21 CFR Part 801); good manufacturing practice and instills (21 CF 21 regulation (QS) regulation (21 CFR Part 820); and if requirence as ecoronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) Trans reter wification. The FDA finding of substantial equivalence of your device to a promative nouried aredicate 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 and additionally 809.10 for in vitro diagnostic devices), 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 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,
L. Chilton
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Applicant: National Custom Enterprises, Inc. (800) 328-3773
510(k) Number: 长の12スタタ
N7215IWC Device Name:
Indications For Use: Replacement battery pack for_
MEDFUSION, INC. 2001 & 2010 INFUSION PUMP
This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 801.109)
Over-The-Counter Use
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Patrua Lucente
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
§ 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).