(44 days)
KR84307, K884307
Not Found
No
The 510(k) summary describes a replacement battery for an infusion controller and contains no mention of AI or ML technology.
No
Explanation: This device is a replacement battery for an Infusion Controller, not a therapeutic device itself.
No
The device is described as a "replacement battery" for an infusion controller, not a device used to diagnose medical conditions.
No
The device is a replacement battery, 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: The intended use is clearly stated as a "Replacement battery for IVAC Corp. 123233, 41B905KD10-1 230 Infusion Controller". This is a component for a medical device (an infusion controller), not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: While "Not Found" is listed, the context of a replacement battery for an infusion controller strongly suggests it's an electrical component.
- Mentions image processing, AI, DNN, ML: These are all "Not Found," which are often associated with more complex diagnostic devices.
- Input Imaging Modality, Anatomical Site, Indicated Patient Age Range: These are all "Not Applicable," further indicating it's not a device directly interacting with the patient or biological samples for diagnostic purposes.
- Intended User: The intended user is a "biomedical equipment technician," who would be responsible for maintaining and repairing medical equipment, not performing diagnostic tests.
In summary, the device is a replacement part for a medical device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Replacement battery for IVAC Corp. 123233, 41B905KD10-1 230 Infusion Controller, 510(k) Number KR84307 K884307. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitions only contrience with the replacement battley of to pancellar device of to intended use is a replacement hattery. The biomedical equipment technician t intended use is as a replacement battery.
Product codes
LDR
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KR84307 K884307
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Ken Heimendinger Alexander Manufacturing Company 1511 South Garfield Place Mason City, Iowa 50401
JAN 1 0 2017
Re: K971865
Trade/Device Name: Alexander Manufacturing Company Rechargeable Battery Part Number M12/500-3P Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump
Regulatory Class: Class II Product Code: LDR Dated: May 16, 1997 Received: May 20, 1997
Dear Mr. Heimendinger:
This letter corrects our substantially equivalent letter of July 3, 1997.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
Page 2 - Mr. Ken Heimendinger
as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: KG41865
Device Name:- .M12/500-3P ... .. ..................................................
Indications for Use:
Replacement battery for IVAC Corp. 123233, 41B905KD10-1 230 Infusion Controller, 510(k) Number
KR84307 K884307.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitions only contrience with the replacement battley of to pancellar device of to
intended use is a replacement hattery. The biomedical equipment technician t intended use is as a replacement battery.
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | 6971865 |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ||
|---|---|---|
| OR | OVER-THE-COUNTER USE | |
| (optional Form 1-2-96) | ||
| 3-3 |
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