K Number
K062095
Device Name
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
Date Cleared
2006-09-29

(67 days)

Product Code
Regulation Number
870.1025
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220, is a portable patient monitoring device intended to be used by clinicians and medically qualified personnel for monitoring physiological parameters; ECG, respiration, noninvasive and invasive blood pressure, body temperature, Sp02, or End tidal C02 or ETC02; in neonatal, of pediatric and adult patients. This device is designed to be used in all general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.
More Information

Not Found

No
The document describes a standard vital signs monitor and does not mention AI or ML capabilities.

No
The device is described as a "Vital Signs Monitor" and its intended use is for "monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2." This indicates it is a diagnostic or monitoring device, not one that treats or cures a condition.

No

The device is a vital signs monitor used for monitoring physiological parameters, not for diagnosing conditions.

No

The device description explicitly states it is a "portable patient monitoring device" and a "Vital Signs Monitor," which are hardware devices that measure physiological parameters. The testing section also mentions validation of the "mCARE 300 Vital Signs Monitor," further indicating a hardware component. While software is mentioned as being developed and validated, it is part of a larger hardware system.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The Spacelabs Medical mCARE 300 is a vital signs monitor. It measures physiological parameters directly from the patient's body (ECG, respiration, blood pressure, temperature, SpO2, CO2). It does not analyze samples taken from the body.
  • Intended Use: The intended use describes monitoring physiological parameters in patients, not analyzing samples from patients.

Therefore, the device falls under the category of a patient monitoring device, not an in vitro diagnostic device.

N/A

Intended Use / 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.

Product codes

MHX

Device Description

The Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220, is a portable patient monitoring device intended to be used by clinicians and medically qualified personnel for monitoring physiological parameters; ECG, respiration, noninvasive and invasive blood pressure, body temperature, Sp02, or End tidal C02 or ETC02; in neonatal, of pediatric and adult patients.

This device is designed to be used in all general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult, pediatric and neonate patient populations

Intended User / Care Setting

clinicians and medically qualified personnel; all general hospital and alternate care environments. Prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The mCARE 300, Model 91220, Vital Signs Monitor successfully underwent testing to demonstrate conformance to the Special Controls established for 21CFR 807.1025, "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm".
The mCARE 300 Vital Signs Monitor was validated through rigorous testing that, in part, support the compliance of the mCARE 300 Vital Signs Monitor to the Standards mentioned in Section 9.0 of this submission.
Additionally, the software for the mCARE 300 Vital Signs Monitor was developed following a robust software development process and was fully specified and validated.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K013046, K031740, K012740, K042601, K053174

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.

0

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
Medical mCARE 300 Vital Signs Monitor, Model 91220. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Medical, Inc.
PO Box 7018
Issaquah, WA 98029

David J. Geraghty
Phone: 1 425 657 7200
Fax: 1 425 657 7207
david.geraghty@slmd.com |
| Proprietary
Name: | Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220 |
| Common
Name and
Classification: | Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms)
(74 MHX, 21CFR 870.1025, Class II)
Special Controls - The guidance document entitled "Class II Special Controls
Guidance Document: Arrhythmia Detector and Alarm" will serve as the special
control. |
| Device
Description: | The Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220, is
a portable patient monitoring device intended to be used by clinicians and
medically qualified personnel for monitoring physiological parameters; ECG,
respiration, noninvasive and invasive blood pressure, body temperature, Sp02,
or End tidal C02 or ETC02; in neonatal, of pediatric and adult patients.

This device is designed to be used in all general hospital and alternate care
environments. This device is available for sale only upon the order of a
physician or licensed health care professional. |
| 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. |
| Test
Discussion: | The mCARE 300, Model 91220, Vital Signs Monitor and is substantially
equivalent in design concepts, technologies and materials the Spacelabs
Medical COSMOS SYSTEM, model 95000, patient monitor (K013046) with
respect to ECG, respiration, IBP and arrhythmia processing; to the
Welch-Allyn MS53000 (K031740) with respect to NIBP, the to Nellcor N-595
(K012740) with respect to SpO2 and to the Respironics Capnostat 5 (042601)
and Lo Flo C5 (K053174) with respect to EtCO2.
The mCARE 3000 Vital Signs Monitor successfully underwent testing to
demonstrate conformance to the Special Controls established for
21CFR 807.1025, "Class II Special Controls Guidance Document: Arrhythmia
Detector and Alarm".
The mCARE 300 Vital Signs Monitor was validated through rigorous
testing that, in part, support the compliance of the mCARE 300 Vital Signs
Monitor to the Standards mentioned in Section 9.0 of this submission.
Additionally, the software for the mCARE 300 Vital Signs Monitor was
developed following a robust software development process and was fully
specified and validated. |
| Test
Conclusion: | The mCARE 300, Model 91220, Vital Signs Monitor is substantially
equivalent to its predicate devices in design concepts, technologies and
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.

3

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

4

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)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Rhumma
ision Sign-Off

invision of Cardiovascular Devices 5 : J(k) Number

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