KELLER VITAL SIGNS MONITOR, KMS 890+

K990648 · Keller Medical Specialties Products, Inc. · DXN · Aug 10, 1999 · Cardiovascular

Device Facts

• Record ID: K990648
• Device Name: KELLER VITAL SIGNS MONITOR, KMS 890+
• Applicant: Keller Medical Specialties Products, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Keller Medical Specialties Model KMS-890+ Combined Pulse Oximeter and Non-invasive Blood Pressure Monitor is intended to monitor the arterial oxygen saturation (SaO2), pulse rate and measure the blood pressure parameters. All values are obtained by non-invasive methods. The blood pressure parameters measured are systolic, diastolic and mean arterial pressure. This device can be operated by the internal rechargeable battery. Alarm settings for the displayed parameters can be adjusted as required.

Device Story

The KMS 890+ is a portable, battery-operated, non-invasive vital signs monitor. It integrates pulse oximetry and blood pressure measurement functions into a single unit. The device measures arterial oxygen saturation (SaO2), pulse rate, and blood pressure (systolic, diastolic, mean arterial pressure). It features adjustable alarm settings for displayed parameters. The device is intended for clinical use to assist healthcare providers in patient monitoring. It provides real-time physiological data to support clinical decision-making and patient assessment.

Clinical Evidence

Bench testing only. The device was tested using commercially available simulators to verify the reliability of readings against predicate models. No clinical tests were performed.

Technological Characteristics

Portable, battery-operated, non-invasive physiological monitor. Combines pulse oximetry and blood pressure measurement functions. No new technological characteristics introduced compared to predicate devices.

Indications for Use

Indicated for monitoring arterial oxygen saturation (SaO2), pulse rate, and non-invasive blood pressure (systolic, diastolic, mean arterial pressure) in patients. Contraindicated for use on neonates.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Vital Signs Monitor Model KMS-890 (K910262)
• Pulse Oximeter Model KMS-850+ (K982331)
• Model 507O (K910852)

Submission Summary (Full Text)

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Image /page/0/Figure/0 description: This image shows the logo for Keller Medical Specialties. The logo includes the company name in bold, along with the address 42609 Crawford Road, Antioch, Illinois 60002. The image also includes the phone number 847/395-3547 and the toll-free number 800/843-6226. The date AUG 10 1999 and the number K990648 are also present.

• FAX [phone]

# 510(k) Summary of Safety and Effectiveness

| Date of Preparation: | February 15, 1999 |
|--------------------------------------|----------------------------|
| Company / Institution name: | Keller Medical Specialties |
| FDA establishment regulation number: | 14 21498 |
| Division name (if applicable): | N.A. |
| Phone number (include area code): | [phone] |
| Street address: | 42609 Crawford Road |
| FAX number (include area code): | [phone] |
| City: | Antioch |
| State/Province: | Illinois |
| Country: | USA |
| ZIP/Postal Code: | 60002 |
| Contact name: | Ms Jean Wagner |
| Contact title: | President |

Product Information:

| Trade name: | Combined Pulse Oximeter/BP Monitor |
|----------------------|------------------------------------|
| Model number: | KMS 890+ |
| Common name: | Vital Signs Monitor |
| Classification Name: | Physiological Monitor |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---------------|------------------------------------|----------------------------|
| K910262 | Vital Signs Monitor Model KMS-890 | Keller Medical Specialties |
| K982331 | Pulse Oximeter Model KMS-850+ | Keller Medical Specialties |
| K910852 | Model 507O | Criticare |
| | | |

### Description 1.0

The Model KMS-890+ is a portable, battery operated, non-invasive monitor used to measure a patient's blood pressure and/or oxygen saturation level with the pulse rate

### 2.0 Intended Use

The Keller Medical Specialties Model KMS-890+ Combined Pulse Oximeter and Non-invasive Blood Pressure Monitor is intended to monitor the arterial oxygen saturation (SaO2), pulse rate and measure the blood pressure parameters. All

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#### 2.0 Intended Use (cont.)

values are obtained by non-invasive methods. The blood pressure parameters measured are systolic, diastolic and mean arterial pressure.

This device can be operated by the internal rechargeable battery. Alarm settings for the displayed parameters can be adjusted as required.

### Contraindications:

This device is not intended for use on neonates.

#### 3.0 Technological Characteristics

No new technological characteristics are introduced with this unit. The device is designed from incorporating the functions of the two existing Keller Medical Specialties devices into one single device.

#### 4.0 Substantial Equivalence

The Model KMS 890+ is substantially equivalent to the two Keller Medical Specialties predecessor models currently on the market, as well as numerous vital signs monitors sold by competitors; including the Criticare Model 5070.

#### 5.0 Performance Data

The Model KMS 890+ was bench tested using commercially available simulators to assure the reliability of the readings. The reliability is substantially equivalent to the reliability of the Keller Medical Specialties predecessor models.

#### 6.0 Clinical Tests

No clinical tests performed.

#### 7.0 Conclusions Drawn

The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals.

By: Jean Keller Wagner
Jean Keller
President

Date: 2- 26-99

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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of stylized lines and curves.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 1999

Ms. Jean Wagner Keller Medical Specialties 42609 Crawford Road Antioch, IL 60002

Re: K990648 Model KMS 890+ Requlatory Class: II (two) Product Code: 74 DXN and DQA June 25, 1999 Dated: Received: June 28, 1999

Dear Ms. Wagner:

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 leqally 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 Failure to comply with the GMP requlation may result in assumptions. 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 Wagner

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 [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):

K990648

Device Name:

Model-KMS890+ Combination Monitor

### Intended Use:

The Keller Medical Specialties Model-KMS890+ Combined Pulse Oximeter and Non-invasive Blood Pressure Monitor is intended to monitor the arterial oxygen saturation (SaO2), pulse rate and measure the blood pressure parameters. All values are obtained by non-invasive methods. The blood pressure parameters measured are systolic and mean arterial pressure.

This device can be operated by the internal rechargeable battery. Alarm settings for the displayed parameters can be adjusted as required.

## Contraindications:

This device is not intended for use on neonates.

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Concurrence of CDRH Office of Device Evaluation (ODE)

Joanne HWe Arshausen

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

OR

Over-The Counter

Prescription Use
Per 21 CFR 801.109