SMARTMONITOR 2, MODEL 4000

K011597 · Respironics Georgia, Inc. · FLS · Jan 11, 2002 · Anesthesiology

Device Facts

• Record ID: K011597
• Device Name: SMARTMONITOR 2, MODEL 4000
• Applicant: Respironics Georgia, Inc.
• Product Code: FLS · Anesthesiology
• Decision Date: Jan 11, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.2377
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SmartMonitor® 2 Infant Apnea Monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

Device Story

SmartMonitor 2 monitors infant respiration and heart rate; inputs electrical heart activity via 2 or 3-lead electrode configuration; electrodes also measure transthoracic impedance for respiration signal. Software algorithms analyze ECG and respiration signals to detect heart beats and breaths; calculates apnea intervals, average heart rates, and average breath rates. Device compares calculated rates against preset thresholds; triggers visual and audible alarms upon detection of abnormal events. Logs tabular data and waveforms in nonvolatile memory for clinical review. Used in home or hospital environments; operated by caregivers or clinicians. Provides feedback via Heart and Respiration LEDs. Benefits include continuous monitoring and automated detection of central apnea and heart rate abnormalities, facilitating timely clinical intervention.

Clinical Evidence

Clinical protocol compared SmartMonitor 2 performance against hand-scored 'gold standard' data compiled from multiple sites. Data analyzed per FDA Guidance for Apnea Monitor 510(k) submissions to demonstrate substantial equivalence to predicate in detection of central apnea.

Technological Characteristics

Class II device; 2 or 3-lead ECG/impedance sensing; internal modem; PCMCIA memory card slot; 2 Mbyte nonvolatile memory. ECG detection: 25-300 BPM, 0.2-5 mV range. Respiration detection: 1-120 BrPM, 0.1-5 Ohm range. CMRR >75 dB at 60 Hz. Input impedance >75 kOhms. Software-based detection algorithms.

Indications for Use

Indicated for continuous monitoring of respiration and heart rate in infant patients in home or hospital settings; detects and alarms for central apnea and abnormal heart rates.

Regulatory Classification

Identification

An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”

Predicate Devices

• Healthdyne Technologies SmartMonitor (K892006)

Submission Summary (Full Text)

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![Image of Respironics logo]

RESPIRONICS™

www.respironics.com

# JAN 1 1 2002

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS SMARTMONITOR 2 INFANT APNEA MONITOR / SYNERGY-E SOFTWARE

| Establishment | |
|---------------|----------------------|
| | Registration Number: |

Official Contact:

1040777

Betsy Cortelloni Respironics Georgia, Inc. 175 Chastain Meadows Court Kennesaw, GA 30144 Phone: [phone] Fax: [phone]

Name of Contact:

Device Model Number:

Classification Name:

Device Classification:

Predicate Devices:

Device Description:

Device Name:

SmartMonitor 2 / Synergy-E

4000 Series

Apnea Monitor, 21 CFR 868.2377

Betsy Cortelloni, Regulatory Affairs Manager

Class II (Special Controls)

Healthdyne Technologies SmartMonitor. Originally cleared under K892006 (5/23/89).

KO11597

The SmartMonitor 2 is a monitoring device designed to monitor respiration and heart rate. Upon detection of abnormal events, SmartMonitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review.

SmartMonitor 2 acquires the electrical activity of the heart via a two or three-lead electrode configuration. The same set of electrodes is used to measure transthoracic impedance and to subsequently develop a respiration signal. Detection of heart beats and respiration breaths is accomplished via softwarebased algorithms, which analyze the ECG and respiration signals. When beats or breaths are detected, SmartMonitor 2 provides feedback by blinking the Heart and Respiration LED's and calculates apnea intervals, average heart rates, and average breath rates for the purpose for identifying ECG and respiration rates that violate preset threshold values. In addition to the alarms, when abnormal ECG and respiration rates are detected, both tabular data and associated waveforms are logged in nonvolatile memory for subsequent review by a Health Care Professional.

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Image /page/1/Picture/0 description: The image shows the logo for Respironics. The logo consists of a stylized human figure inside a triangle, with the word "RESPIRONICS" written below it in a sans-serif font. Below the company name is the website address, "www.respironics.com", also in a sans-serif font. The logo is white against a black background.

## 510(k) Summary, continued:

The SmartMonitor 2 Infant Apnea Monitor is intended for use in the Intended Use: continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

### Comparison of Technological

Characteristics:

The SmartMonitor 2 is functionally equivalent to the original SmartMonitor. Many of the differences that exist are not readily visible to the user. Primary differences are:

- SmartMonitor 2 is available with an internal modem and/or a removable . PCMCIA memory card;
- . Enhanced menu options;
- SmartMonitor 2 powers down in less than 1 second; and .
- SmartMonitor 2 can download memory (2 Mbytes) in approximately three . minutes.

The performance specifications of SmartMonitor and SmartMonitor 2 for Respiration monitoring are:

- Resp. Detection Rate .
- . Sensitivity

1 to 120 BrPM @ 1Ohm, peak to peak

0.1 to 5 Ohms, peak to peak

- Output Amplitude Accuracy .
- CMRR .

.

.

- Input Impedance .
- >75 dB at 60 Hz > 75 KOhms
- 0.2 to 5 Ohms, peak to peak Detection amplitude range

The performance specifications of SmartMonitor and SmartMonitor 2 for ECG monitoring are:

+1-5%

- . ECG Detection Rate
- Sensitivity .
- Output Amplitude Accuracy .
- .
- > 75 dB at 60 Hz > 75 KOhms
- Input Impedance Detection Amplitude Range

0.2 mV to 5 mV, baseline to peak

- @ 2000 Respironics, Inc.
- 25 to 300 BPM @ 1mV, baseline to peak +/- 0.1 to +/- 5.0 mV
- +1-2%
- ECG CMRR

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Image /page/2/Picture/0 description: The image shows the logo for Respironics. The logo consists of a stylized human figure inside a triangle, with the word "RESPIRONICS" written below it in a sans-serif font. Below the company name is the website address, "www.respironics.com".

# 510(k) Summary, continued:

## Testing:

#### Performance

System qualification testing of the SmartMonitor 2 was conducted in accordance System qualification tooting of the en as well as applicable standards and with internal Rooplionies pro timited to, the draft apnea monitor performance guidances including, but not linked to the Part 896, ANSI/AAMI EC13, and IEC 601-1.

The results of these tests support that the SmartMonitor 2 meets the requirements specified in the Product Specification and that it conforms to the required standards.

### Software

Testing for the firmware and host software consisted of system level testing, resting for the firmware and module/integration level testing. Test results confirmed that all requirements were met.

### Clinical

The clinical protocol was designed to compare the performance of SmartMonitor The cillinoarprotoon was accigned Data were compiled from multiple sites on at 2 to the prodiouts orified via the "gold standard" of hand scoring.

Data were analyzed as specified in the Guidance for Apnea Monitor 510(K) Data were analyzou do opeomou ille substantial equivalence Oubmissions, folouos to the predicate SmartMonitor in detection of central apnea.

Conclusion:

The results of the performance and clinical testing demonstrated the functionality, rne results of the portent the SmartMonitor 2 Infant Apnea Monitor, as well as its substantial equivalence to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings of the symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2002

Ms. Betsy Cortelloni Regulatory Affairs Manager Respironics Georgia, Inc. 175 Chastain Meadows Court Kennesaw, GA 30144

Re: K011597

SmartMonitor® 2, Model 4000 Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II (two) Product Code: FLS Dated: October 12, 2001 Received: October 15, 2001

Dear Ms. Cortelloni:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to cash was a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Betsy Cortelloni

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase of adrisou that I Dr. over device complies with other requirements of the Act that I Dr has intaintes and regulations administered by other Federal agencies. You must or any I edital statutes and registents, including, but not limited to: registration and listing (21 Comply with an the 110- 370quirements) 01); good manufacturing practice requirements as set CI K Part 607); facomig (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your le FDA finding of substantial equivalence of your device to a legally premated notineted wice 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 01 1 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Center of Devices and Radiological Health

510(k) Number (if known):__________K011597

Page 1 of 1

Device Name: SMARTMONITOR 2

Indications for Use:

The SmartMonitor® 2 Infant Apnea Monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

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

Image /page/5/Picture/7 description: The image shows the phrase "Concurrence of CDRH, Office of Device Evaluation (ODE)" at the top. Below that is a signature. The number KO11597 is at the bottom of the image.

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