(56 days)
Not Found
Not Found
No
The summary describes a replacement battery pack and does not mention any AI or ML capabilities.
No
The device is described as a "Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP". A battery pack itself is not a therapeutic device; it powers a therapeutic device (the infusion pump).
No
This device is a replacement battery pack for an infusion pump, which is a therapeutic device, not a diagnostic one. Its purpose is to power the pump, not to diagnose medical conditions.
No
The device description explicitly states it is a "Replacement battery pack," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is a "Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP". This clearly indicates the device is a component for an infusion pump, which is a medical device used for delivering fluids to a patient.
- Device Description: The description confirms it's a "Replacement battery pack".
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or diagnostic purposes.
Therefore, this device is a replacement part for a medical device, not an IVD.
N/A
Intended Use / Indications for Use
Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP
Product codes
MRZ, MOQ
Device Description
This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
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
biomedical equipment technicians and or customers who request a replacement battery
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)
Not Found
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
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.
1
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
2
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
나
Patrua Lucente
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _