KELLER PULSE OXIMETER, MODEL 850+

K982331 · Keller Medical Specialties Products, Inc. · DQA · Sep 11, 1998 · Cardiovascular

Device Facts

• Record ID: K982331
• Device Name: KELLER PULSE OXIMETER, MODEL 850+
• Applicant: Keller Medical Specialties Products, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Portable, battery-operated pulse oximeter; measures arterial oxygen saturation (SaO2) and pulse rate via infrared sensor attached to finger or ear. Uses dual wavelength pulse oximetry and variable averaging methods. Provides patient alarm limit settings. Used in clinical settings to assist healthcare providers in monitoring patient status. Output allows for clinical decision-making regarding patient oxygenation and heart rate. Benefits include portable, continuous monitoring of vital signs.

Clinical Evidence

Clinical study conducted on 30 patients comparing Model 850+ readings to the predicate Model 850. Results indicated no significant deviation between devices. Bench testing verified alarm accuracy.

Technological Characteristics

Dual wavelength pulse oximetry; variable averaging methods; portable, battery-operated form factor; infrared sensor interface.

Indications for Use

Indicated for monitoring arterial oxygen saturation (SaO2) and pulse rate in patients. Contraindicated for use on neonates.

Regulatory Classification

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.

Predicate Devices

• Keller Model 850 (k895987)

Reference Devices

• Biochem device

Submission Summary (Full Text)

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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 [phone]

## SEP 1 1 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Company: | Keller Medical Specialties<br>42609 Crawford Road<br>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<br>President |
| DESCRIPTION: | The Keller Model 850+ Pulse Oximeter is a portable, battery operated,<br>patient pulse oximeter. It measures oxygen saturation and the pulse rate of<br>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<br>monitors arterial oxygen saturation (SaO2) and pulse rate using standard<br>dual wavelength pulse oximetry techniques.<br><br>This unit is portable with battery operation. The oximeter allows complete<br>control of patient alarm limit settings.<br><br>The unit is <b>not</b> intended for use on neonates. |
| TECHNOLOGICAL CHARACTERISTICS: | This device incorporates dual wavelength technology and<br>uses variable averaging methods to allow the user to incorporate<br>the method best suited to the situation. |
| PERFORMANCE DATA: | Bench data showed that the Model 850+ is equivalent to the Model<br>850 and a Biochem device. Alarms were tested and verified as<br>accurate. |

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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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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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