(71 days)
Not Found
No
The description focuses on standard pulse oximetry techniques and does not mention AI or ML.
No
The device is a pulse oximeter used for monitoring vital signs (SaO2 and pulse rate), not for treating a condition.
Yes
The device measures and monitors arterial oxygen saturation (SaO2) and pulse rate, which are physiological parameters used to assess a patient's health status. While it doesn't provide a diagnosis itself, the measurements it provides are used by healthcare professionals for diagnostic purposes.
No
The device description explicitly states it is a portable, battery-operated device that measures oxygen saturation and pulse rate using an infrared sensor attached to the finger or ear. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Keller Medical Specialties Pulse Oximeter Model 850+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Pulse Oximeter Function: The description clearly states that the pulse oximeter measures arterial oxygen saturation and pulse rate using a sensor attached to the finger or ear. This is a non-invasive measurement taken on the living body (in vivo).
- No Sample Analysis: There is no mention of the device analyzing any biological samples.
Therefore, the function and method of operation of the Keller Medical Specialties Pulse Oximeter Model 850+ fall outside the scope of In Vitro Diagnostics. It is a medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The Keller Medical Specialties Pulse Oximeter Model 850+ measures and monitors arterial oxygen saturation (SaO2) and pulse rate using standard dual wavelength pulse oximetry techniques.
This unit is portable with battery operation. The oximeter allows complete control of patient alarm limit settings.
This unit is not intended for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA
Device Description
The Keller Model 850+ Pulse Oximeter is a portable, battery operated, patient pulse oximeter. It measures oxygen saturation and the pulse rate of the patient by means of an infrared sensor attached to the finger or ear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger or ear
Indicated Patient Age Range
The unit is not intended for use on neonates.
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)
Bench data showed that the Model 850+ is equivalent to the Model 850 and a Biochem device. Alarms were tested and verified as accurate.
The Model 850+ was tested on 30 patients and compared to readings obtained by predicated Model 850. The date results indicated no significant deviation between the two devices.
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.
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
§ 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/0 description: The image shows the logo for Keller Medical Specialties. The logo includes the text "KELLER MEDICAL SPECIALTIES" in bold, black letters. Below the text is the address "42609 Crawford Road • Antioch, Illinois 60002".
Toll Free 800/843-6226 •
847/395-3547 • FAX 847/395-6918
SEP 1 1 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
| Company: | Keller Medical Specialties
42609 Crawford Road
Antioch Road, Illinois 60002 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration: | 1421498 |
| Device: | Model 850+ Pulse Oximeter |
| Substantially Equivalent: | Keller Model 850 (K895987) and numerous competitor's models |
| Contact: | Jean Keller
President |
| DESCRIPTION: | The Keller Model 850+ Pulse Oximeter is a portable, battery operated,
patient pulse oximeter. It measures oxygen saturation and the pulse rate of
the patient by means of an infrared sensor attached to the finger or ear. |
| INTENDED USE: | The Keller Medical Specialties Pulse Oximeter Model 850+ measures and
monitors arterial oxygen saturation (SaO2) and pulse rate using standard
dual wavelength pulse oximetry techniques.
This unit is portable with battery operation. The oximeter allows complete
control of patient alarm limit settings.
The unit is not intended for use on neonates. |
| TECHNOLOGICAL CHARACTERISTICS: | This device incorporates dual wavelength technology and
uses variable averaging methods to allow the user to incorporate
the method best suited to the situation. |
| PERFORMANCE DATA: | Bench data showed that the Model 850+ is equivalent to the Model
850 and a Biochem device. Alarms were tested and verified as
accurate. |
1
The Model 850+ was tested on 30 patients and compared to readings CLINICAL DATA: obtained by predicated Model 850. The date results indicated no significant deviation between the two devices.
Comparison of all hardware and software changes, risk analysis, and the CONCLUSIONS: data obtained from performance and clinical testing proves that the Keller Model 850+ is substantially equivalent to predicate device in addition to being safe and effective on it's own merits.
Signed: Jean Keller
Date: 6-29-98
Jean Keller President
2
Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with three flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ia
SEP | | 1998
Ms. Jean Keller Keller Medical Specialties 42609 Crawford Road Antioch, IL 60002
Re: K982331 Model 850+ Pulse Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: June 29, 1998 Received: July 2, 1998
Dear Ms. Keller:
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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 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.
3
Page 2 - Ms. Jean Keller
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Device Name:
982331
Keller Medical Specialties Model 850+ Pulse Oximeter
Intended Use:
The Keller Medical Specialties Pulse Oximeter Model 850+ measures and monitors arterial oxygen saturation (SaO2) and pulse rate using standard dual wavelength pulse oximetry techniques.
This unit is portable with battery operation. The oximeter allows complete control of patient alarm limit settings.
This unit is not intended for use on neonates.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Mark Kramer
510k) N
Image /page/4/Picture/12 description: The image shows the text "Prescription Use" and "Per 21 CFR 801.109". There is a check mark to the right of the text. The text is likely part of a form or document related to medical prescriptions and regulations.
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Over-The Counter___