(55 days)
Not Found
No
The 510(k) summary describes a replacement battery and does not mention any AI or ML capabilities.
No
The device is a replacement battery for an enteral pump, not a therapeutic device itself.
No
The description explicitly states this device is a "Replacement battery" for an enteral pump. Batteries are components that power devices, not diagnostic devices themselves.
No
The device description explicitly states it is a "Rechargeable Battery Part Number GL4018," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "Replacement battery for Abbott Medical Electronics 0810-0077, 140050-080 Enteral Pump Model #076 FlexiFlow II". This indicates the device is a component for a medical device (an enteral pump), not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is described as a "Rechargeable Battery". Batteries are power sources, not diagnostic tools.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The device is a replacement part for a medical device, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Replacement battery for Abbott Medical Electronics 0810-0077, 140050-080 Enteral Pump Model #076 FlexiFlow II, 510(k) Number K821661. This battery is shipped only to customers who request a replacement battery for a particular device or This battery is shipped only to ouslomers with Teques a replacemician therefore knows the intended use is as a replacement battery.
Product codes
MRZ
Device Description
Rechargeable Battery Part Number GL4018
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
.. -
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1997
Mr. Ken Heimendinger 510 (k) Department Alexander Manufacturing Company 1511 South Garfield Place Mason City, Iowa 50401
Re : K971212 Alexander Manufacturing Company Rechargeable Trade Name: Battery Part Number GL4018 Requlatory Class: II Product Code: MRZ Dated: March 19, 1997 Received: April 2, 1997
Dear Mr. Heimendinger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requiations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Heimendinger
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gof/cdrh/dsmamain.html".
Sincerely Yours
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
510(k) Number: 971717
Device Name: GL4018
and av 6,201 - 17, a.s. ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
00 10 01 16 12 1411
Indications for Use:
Replacement battery for Abbott Medical Electronics 0810-0077, 140050-080 Enteral Pump Model #076 FlexiFlow II, 510(k) Number K821661.
This battery is shipped only to customers who request a replacement battery for a particular device or This battery is shipped only to ouslomers with Teques a replacemician therefore knows the intended use is as a replacement battery.
PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Brenda Batten |
|---|---|
| --------------------- | --------------- |
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K971212 |
|---|---|
| --------------- | --------- |