KODAK HOME HEALTH MONITORING SYSTEM

K983928 · Eastman Kodak Company · MWI · Feb 11, 2000 · Cardiovascular

Device Facts

• Record ID: K983928
• Device Name: KODAK HOME HEALTH MONITORING SYSTEM
• Applicant: Eastman Kodak Company
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The Home Health Monitoring System is intended for use as a monitoring device, whereby a health care professional can view and communicate with the patient between offices visits to collect readings of patient blood pressure, the manage, pulse, temperature, and listen to sounds emanating from the bowel, heart and lungs.

Device Story

Kodak LifeView Telemonitoring System consists of Model 110 Patient Station and Model 1000 Nurse Station. System facilitates remote patient monitoring between office visits. Patient station collects physiological data including blood pressure, pulse, temperature, and auscultatory sounds (bowel, heart, lungs). Data transmitted to nurse station for clinician review. Enables communication between healthcare professional and patient. Used in home setting by patient/caregiver; operated by clinician at nurse station. Output allows clinicians to monitor patient status remotely, supporting clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises Model 110 Patient Station and Model 1000 Nurse Station. Functions as a telemonitoring system for physiological data collection (BP, pulse, temperature) and remote auscultation. Connectivity between patient and nurse stations. Regulatory class II.

Indications for Use

Indicated for patients requiring remote monitoring of blood pressure, pulse, temperature, and auscultation of bowel, heart, and lung sounds. Contraindicated for patients/caregivers physically unable to use the device or those with cognitive/language impairments precluding effective communication or device operation. Not for continuous monitoring.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2000

Mr. Donald R. Ellis Eastman Kodak Company 901 Elmgrove Road Rochester, NY 14653

Re: K983928 Kodak LifeView Telemonitoring System (Model 110 Patient Station and Model 1000 Nurse Station) Requlatory Class: II (two) 74 MWI, DRG, and DXN Product Code: Dated: December 22, 1999 Received: December 23, 1999

Dear Mr. Ellis:

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 - Mr. Donald R. Ellis

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 Also, please note the regulation entitled, [phone]. "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,

fe arnold Wietstockus fon

elia M. Witten, Ph.D., M.D. Acting 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: K983928

Device Name: KODAK LifeView

Indication of use: The Home Health Monitoring System is intended for use as a monitoring device, whereby a health care professional can view and communicate with the patient between offices visits to collect readings of patient blood pressure, the manage, pulse, temperature, and listen to sounds emanating from the bowel, heart and lungs.

The system is contraindicated for two populations. Patient's and/or caregivers that are physically unable to use this device. Patients' and/or caregivers who's cognitive and or language skills are impaired to such an extent as to preclude communication with medical personnel or effectively operate the device

This device should not be used for continuos monitoring.

Concurrence of CDRH, Office of Device Evaluation

| Prescription Use | | OR | | Over-The-Counter | |
|------------------|--|----|--|------------------|--|
|------------------|--|----|--|------------------|--|

| | 2/4/00 |
|--|-----------------|
| | <i>B. Clary</i> |

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

35