MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

K062095 · Spacelabs Medical, Inc. · MHX · Sep 29, 2006 · Cardiovascular

Device Facts

• Record ID: K062095
• Device Name: MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
• Applicant: Spacelabs Medical, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Device Story

Portable patient monitor for clinical environments; used by healthcare professionals to track physiological parameters including ECG, respiration, blood pressure (invasive/noninvasive), temperature, SpO2, and EtCO2. Device processes physiological signals to provide real-time monitoring and arrhythmia detection. Output displayed to clinicians to support patient assessment and clinical decision-making. Benefits include continuous patient surveillance across hospital settings.

Clinical Evidence

Bench testing only. Device validated through rigorous testing to demonstrate conformance to established standards and Class II Special Controls for arrhythmia detection and alarms. Software was fully specified and validated.

Technological Characteristics

Portable vital signs monitor. Parameters: ECG, respiration, NIBP, IBP, temperature, SpO2, EtCO2. Includes arrhythmia detection and alarm functionality. Complies with Class II Special Controls for Arrhythmia Detector and Alarm.

Indications for Use

Indicated for adult, pediatric, and neonate patients requiring monitoring of ECG, respiration, invasive/noninvasive blood pressure, body temperature, SpO2, or EtCO2. Prescription use only.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Spacelabs Medical COSMOS SYSTEM, model 95000 (K013046)
• Welch-Allyn MS53000 (K031740)
• Nellcor N-595 (K012740)
• Respironics Capnostat 5 (042601)
• Respironics Lo Flo C5 (K053174)

Submission Summary (Full Text)

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# 510(k) Premarket Notification Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220 Summary of Safety and Effectiveness

SEP 2 9 2006

July 17, 2006

The 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.

| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Spacelabs<br>Medical mCARE 300 Vital Signs Monitor, Model 91220. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Medical, Inc.<br>PO Box 7018<br>Issaquah, WA 98029<br><br>David J. Geraghty<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Proprietary<br>Name: | Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220 |
| Common<br>Name and<br>Classification: | Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms)<br>(74 MHX, 21CFR 870.1025, Class II)<br>Special Controls - The guidance document entitled "Class II Special Controls<br>Guidance Document: Arrhythmia Detector and Alarm" will serve as the special<br>control. |
| Device<br>Description: | The Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220, is<br>a portable patient monitoring device intended to be used by clinicians and<br>medically qualified personnel for monitoring physiological parameters; ECG,<br>respiration, noninvasive and invasive blood pressure, body temperature, Sp02,<br>or End tidal C02 or ETC02; in neonatal, of pediatric and adult patients.<br><br>This device is designed to be used in all general hospital and alternate care<br>environments. This device is available for sale only upon the order of a<br>physician or licensed health care professional. |
| Intended Use: | The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is<br>indicated for use in adult, pediatric and neonate patient populations wherever<br>there is a need for the monitoring of ECG, respiration, invasive or noninvasive<br>blood pressures, body temperature, functional arterial oxygen saturation, or<br>expired or minimum inspire CO2.<br><br>The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is<br>a prescription device intended to be used by healthcare professionals in all<br>areas of a healthcare facility. |
| Test<br>Discussion: | The mCARE 300, Model 91220, Vital Signs Monitor and is substantially<br>equivalent in design concepts, technologies and materials the Spacelabs<br>Medical COSMOS SYSTEM, model 95000, patient monitor (K013046) with<br>respect to ECG, respiration, IBP and arrhythmia processing; to the<br>Welch-Allyn MS53000 (K031740) with respect to NIBP, the to Nellcor N-595<br>(K012740) with respect to SpO2 and to the Respironics Capnostat 5 (042601)<br>and Lo Flo C5 (K053174) with respect to EtCO2.<br>The mCARE 3000 Vital Signs Monitor successfully underwent testing to<br>demonstrate conformance to the Special Controls established for<br>21CFR 807.1025, "Class II Special Controls Guidance Document: Arrhythmia<br>Detector and Alarm".<br>The mCARE 300 Vital Signs Monitor was validated through rigorous<br>testing that, in part, support the compliance of the mCARE 300 Vital Signs<br>Monitor to the Standards mentioned in Section 9.0 of this submission.<br>Additionally, the software for the mCARE 300 Vital Signs Monitor was<br>developed following a robust software development process and was fully<br>specified and validated. |
| Test<br>Conclusion: | The mCARE 300, Model 91220, Vital Signs Monitor is substantially<br>equivalent to its predicate devices in design concepts, technologies and<br>materials. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2006

Spacelabs Medical Inc. c/o Mr. David J. Geraghty Manager, Regulatory and Quality 5150 220th Ave. SE PO Box 7018 Issaquah, WA 98027

Re: K062095

Trade Name: mCARE 300 Vital Signs Monitor, Model 91220 Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: July 19, 2006 Received: July 24, 2006

Dear Mr. Geraghty:

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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 -- Mr. David J. Geraghty

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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) premarket notification. The FDATinding of substantial equivaleneerof-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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Bhimiman for

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

Enclosure

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## Indications for Use

| 510(k) Number (if known): | K062095 |
|---------------------------|---------|
|---------------------------|---------|

Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor Device Name:

Indications for Use:

The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2.

The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH Office of Device Evaluation (ODE)

Rhumma
ision Sign-Off

invision of Cardiovascular Devices 5 : J(k) Number

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