(29 days)
No
The device is a replacement battery and the summary contains no mention of AI or ML.
No
This device is a replacement battery for a medical device (K945964 Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324), not the therapeutic device itself.
No
The device is a replacement battery for a feeding pump, not a diagnostic device.
No
The device description clearly states it is a "Rechargeable Battery Part Number MS06224," which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is a replacement battery for a feeding pump. Its function is to power the feeding pump, which is a medical device used to deliver nutrition to a patient. It does not perform any tests on samples from the human body.
- Intended Use: The intended use is clearly stated as a replacement battery for a specific feeding pump model. This is a functional component of a medical device, not a diagnostic test.
Therefore, based on the provided information, this replacement battery for a feeding pump does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Replacement battery for Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324, 510(k) Number K945964.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Product codes
MRZ
Device Description
Not Found
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 technician
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 seal for the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ken Heimendinger 'Alexander Manufacturing Company 1511 South Garfield Place Mason City, Iowa 50401
JUL - 3 1997
K972089 Re : Alexander Manufacturing Company Rechargeable Trade Name: Battery Part Number MS06224 Regulatory Class: II Product Code: MRZ Dated: May 30, 1997 Received: June 4, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Heimendinger
through 542 of the Act for devices under the Electronic enrough Sadiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your deyice as Into issue in your 510 (k) premarket notification. The FDA acberroom in formalence of your device to a legally rinang or edicate 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 che 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.fdaa.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo 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: K972089
Device Name: MS06224 ···· ....
Indications for Use:
Replacement battery for Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324, 510(k) Number K945964.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
(Division Sign-Off) Patricia Caconté
Division of Dental, Infection Control,
And General Hospital Devices
Number K172087
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use