DR180-R/OXY

K983576 · North East Monitoring, Inc. · FLL · Mar 23, 1999 · General Hospital

Device Facts

• Record ID: K983576
• Device Name: DR180-R/OXY
• Applicant: North East Monitoring, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Mar 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Indications for Use

Detection of Arrhythmias: The NorthEast Monitoring DR180-R/Oxy is indicated for 1.) use for long-term monitoring of cardiac rhythm when intermittent arrhythmias are suspected due to patient symptoms such as palpitations, transient attacks (TIA's), syncope (fainting), or other such symptoms as determined by the physician. 2.) Efficacy of Treatment: The NorthEast Monitoring DR180-R/Oxy is indicated for use to determine if current pharmacological treatment of known arrhythmias is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment. Pacemaker Evaluation: The NorthEast Monitoring DR180-R/Oxy is indicated for use to 3.) evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. 4.) Trending of oxygen saturation (SpO2) in the blood for periods of up to 24 hours. If the device is to be used for home monitoring, periods of activity or excessive movement are to be omitted due to the artifact that would be generated. 5.) . The NorthEast Monitoring DR180-R/Oxy is to be used only on the order of a physician.

Device Story

DR180-R/Oxy combines Holter ECG monitoring with Nonin Xpod pulse oximetry. Device records ECG and SpO2 data simultaneously onto PCMCIA Flashdisk memory cards. Used in clinical or home settings; operated by patients under physician order. Post-recording, memory card is removed and inserted into an analysis system for data download. Oximetry data is presented to the operator without manipulation or editing. Enables physicians to correlate cardiac rhythm events with oxygen saturation trends to assist in clinical decision-making regarding arrhythmia management and pacemaker function.

Clinical Evidence

No clinical trials performed on the integrated system. Nonin Xpod probe was clinically tested by its manufacturer (human subjects) with <2% error. NorthEast Monitoring performed bench testing using a pulse oximetry simulator to verify accuracy of the integrated DR180-R/Oxy system.

Technological Characteristics

System integrates a Holter recorder with a Nonin Xpod pulse oximetry probe. Data storage via PCMCIA Flashdisk. Connectivity involves physical removal of memory card for transfer to an external analysis system. No internal signal processing or editing of oximetry data; data is presented raw to the operator.

Indications for Use

Indicated for patients requiring long-term cardiac rhythm monitoring for suspected intermittent arrhythmias (palpitations, TIA, syncope), evaluation of pharmacological treatment efficacy for known arrhythmias, pacemaker function assessment, and 24-hour SpO2 trending. Use restricted to physician order.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• DR180 Holter recorder (K960925)

Submission Summary (Full Text)

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3/23/99

K983576

## 510(k) Summary

The DR180-R/Oxy Holter and Pulse Oximetry Recorder is the predicate device (DR180 Holter recorder, 510(k) K960925) with the addition of a Nonin Xpod pulse oximetry probe. The probe cable is attached to the DR180 with the electrode lead wires. ECG and pulse oximetry are recorded simultaneously for periods up to the hours. This data is recorded onto PCMCIA Flashdisk memory storage cards. When recording is complete, the card is removed from the DR180-R/Oxy, inserted into a slot in the analysis system, and the data is downloaded and analyzed as previously. The oximetry data is simply presented to the operator; no manipulation or editing is allowed.

The Xpod was clinically tested (human subjects) by its manufacturer, Nonin, and found to have <2% error. NorthEast Monitoring tested the DR180-R/Oxy using a pulse oximetry simulator, resulting in even greater accuracy.

The DR180-R/Oxy Operator's Manual is identical to the previous DR180 Operator's Manual with the addition of oximetry capability. The Holter for Windows Operators Manual is identical to the previous with the addition of the oximetry option.

To the best of our knowledge, no other manufacturer has added oximetry capabilities to a Holter recorder at this date.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with their arms raised, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Mr. Rodney L. Cambre Director of Regulatory Affairs and Quality Assurance Northeast Monitoring, Inc. 730 Boston Post Road Suite 22 Sudbury, MA 01776

Re : K983576 DR180-R/Oxy Regulatory Class: II (two) Product Code: FLL Dated: January 26, 1999 Received: January 28, 1999

Dear Mr. Cambre:

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 Requlations, 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

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Page 2 - Mr. Edward F. Waddell

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.

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, 2 Misbranding by reference to premarket notification² (21CFR 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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. **Page** **_ of _**

| 510(k) Number (if known): | K983576 |
|---------------------------|-------------|
| Device Name: | DR180-R/Oxy |
| Indications For Use: | |

## NORTHEAST MONITORING DR180-R/Oxy

Detection of Arrhythmias: The NorthEast Monitoring DR180-R/Oxy is indicated for 1.) use for long-term monitoring of cardiac rhythm when intermittent arrhythmias are suspected due to patient symptoms such as palpitations, transient attacks (TIA's), syncope (fainting), or other such symptoms as determined by the physician.

2.) Efficacy of Treatment: The NorthEast Monitoring DR180-R/Oxy is indicated for use to determine if current pharmacological treatment of known arrhythmias is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.

Pacemaker Evaluation: The NorthEast Monitoring DR180-R/Oxy is indicated for use to 3.) evaluate the function of implanted pacemakers to insure that the pacemaker is functioning . within prescribed limits.

4.) Trending of oxygen saturation (SpO2) in the blood for periods of up to 24 hours. If the device is to be used for home monitoring, periods of activity or excessive movement are to be omitted due to the artifact that would be generated.

5.) . The NorthEast Monitoring DR180-R/Oxy is to be used only on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

[signature]

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 310(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)