(71 days)
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.
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.
The provided text describes the Keller Medical Specialties Model 850+ Pulse Oximeter, which measures and monitors arterial oxygen saturation (SaO2) and pulse rate. The information necessary to fully answer all parts of your request is limited, as the document focuses on regulatory submission (510(k)) and establishing substantial equivalence rather than detailing a comprehensive clinical study report with extensive statistical analysis.
However, based on the available text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with numerical thresholds in the modern sense (e.g., "accuracy must be within ±X%"). Instead, the main "acceptance criterion" was demonstrating substantial equivalence to a predicate device and showing that there was no significant deviation in readings.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Keller Model 850) | "substantially equivalent to predicate device" |
| No significant deviation in readings compared to predicate device | "no significant deviation between the two devices" |
| Alarms tested and verified as accurate | "Alarms were tested and verified as accurate." |
| Equivalence to predicate device and a Biochem device (bench data) | "Bench data showed that the Model 850+ is equivalent to the Model 850 and a Biochem device." |
| Safe and effective on its own merits | "safe and effective on it's own merits" |
2. Sample size used for the test set and the data provenance
- Sample Size: 30 patients.
- Data Provenance: The study was a clinical comparison conducted on patients, comparing the Model 850+ to the predicate Model 850. The text does not specify the country of origin, but given the company location (Antioch, Illinois) and FDA submission, it's highly likely to be US-based. The study appears to be prospective in nature, as it involved actively "testing" the device on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth. The comparison was made against readings from a predicate device rather than an independent "ground truth" established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for a test set. This type of detail is usually associated with studies involving human interpretation (e.g., radiologists reading images), which is not the primary focus here. The comparison was device-to-device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted human reading, which is not applicable to a pulse oximeter. The device measures physiological data directly.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The performance described refers to the standalone (device-only) performance of the Model 850+ compared to the predicate Model 850. The pulse oximeter is a diagnostic device that provides readings directly, without a human-in-the-loop component for interpretation in the same way an AI algorithm might augment a radiologist.
7. The type of ground truth used
The "ground truth" in this context was the readings obtained by the predicate device (Keller Model 850). The study aimed to show that the new device's readings were equivalent to or not significantly different from an already legally marketed and accepted device. There is no mention of pathology, outcomes data, or expert consensus being used as an independent ground truth for SaO2 or pulse rate measurements.
8. The sample size for the training set
The document does not mention a "training set" as this device is not an AI/ML algorithm. It's a hardware device measuring physiological parameters.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 Specialties42609 Crawford RoadAntioch Road, Illinois 60002 |
|---|---|
| Registration: | 1421498 |
| Device: | Model 850+ Pulse Oximeter |
| Substantially Equivalent: | Keller Model 850 (K895987) and numerous competitor's models |
| Contact: | Jean KellerPresident |
| DESCRIPTION: | The Keller Model 850+ Pulse Oximeter is a portable, battery operated,patient pulse oximeter. It measures oxygen saturation and the pulse rate ofthe patient by means of an infrared sensor attached to the finger or ear. |
| INTENDED USE: | The Keller Medical Specialties Pulse Oximeter Model 850+ measures andmonitors arterial oxygen saturation (SaO2) and pulse rate using standarddual wavelength pulse oximetry techniques.This unit is portable with battery operation. The oximeter allows completecontrol of patient alarm limit settings.The unit is not intended for use on neonates. |
| TECHNOLOGICAL CHARACTERISTICS: | This device incorporates dual wavelength technology anduses variable averaging methods to allow the user to incorporatethe method best suited to the situation. |
| PERFORMANCE DATA: | Bench data showed that the Model 850+ is equivalent to the Model850 and a Biochem device. Alarms were tested and verified asaccurate. |
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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
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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.
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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
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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___
§ 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).