(64 days)
No
The 510(k) summary describes a replacement battery for a pulse oximeter and does not mention any AI or ML components or functionalities.
No.
The device is described as a replacement battery for a pulse oximeter, not a therapeutic device itself. Its intended use is to power a medical device, not to provide therapy.
No
This device is a replacement battery for a pulse oximeter, not the diagnostic pulse oximeter itself. Its intended use is to power the diagnostic device, not to perform diagnosis.
No
The device description explicitly states it 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 Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter". This is a component intended to power a medical device, not to perform a diagnostic test on a sample taken from the human body.
- Device Description: The description reinforces that it is a "Replacement battery".
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a replacement part for a medical device (a pulse oximeter), which is used to measure physiological parameters (oxygen saturation and pulse rate) in vivo (on the living body), not in vitro (in a test tube or laboratory setting).
N/A
Intended Use / Indications for Use
Replacement battery for Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter with Factory Replacement Block, 510(k) Number K863784.
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
74 DQA
Device Description
GL625-W
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
customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The 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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(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 the department's name arranged in a circular fashion around a stylized graphic. The graphic is a symbol that represents human concern and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 1997
Mr. Ken Heimendinger Alexander Manufacturing Company P.O. Box 1508 ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 1511 South Garfield Place Mason City, Iowa 50401
Re: « K971235 Replacement Battery Part Number GL625-W Requlatory Class: II (two) Product Code: 74 DQA 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 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Ken Heimendinger
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) 594-4646. 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" (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.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number: | 17 / 12 3 ﻛ
Device Name: GL625-W ... . . .
Indications for Use:
Replacement battery for Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter with Factory Replacement Block, 510(k) Number K863784.
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.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chari Aldo
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971235
Prescription Use _
OVER-THE-COUNTER US loptional Form 1-2-96
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