(14 days)
Not Found
No
The document describes a standard vital signs monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a vital signs monitor which is used for diagnosis and monitoring, not for therapeutic treatment.
No
Explanation: The device is described as a "Vital Signs Monitor" that measures physiological parameters. While it provides data that can be used for diagnosis, its primary purpose, as stated, is "monitoring physiological parameters" and not to independently diagnose a condition.
No
The device description explicitly states it is a "portable patient monitoring device" and mentions hardware components like an "NIBP module," indicating it is a physical device with integrated software, not a software-only device.
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 description clearly states the device is a "Vital Signs Monitor" that monitors physiological parameters directly from the patient (ECG, respiration, blood pressure, temperature, SpO2, ETCO2). It does not mention analyzing samples taken from the body.
- Intended Use: The intended use is for monitoring patients in a healthcare setting, not for performing laboratory tests on samples.
Therefore, the Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spacclabs 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 (mCare 300), 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, SpO2, or End tidal CO2 or ETCO2; 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.
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 NIBP module revision to the mCare 300 was validated through rigorous testing that, in part, supports the compliance of the mCare 300 to the various standards identified in this submission. Additionally, the software revision, to accommodate the new NIBP module 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)
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
AUG - 1 2008
July 11, 2008
.
510(K) Summary of Safety and Effectiveness
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. |
| 5150 220th Avenue SE | |
| Issaquah, WA 98029 | |
| David J. Geraghty | |
| Phone: 425-657-7200 | |
| Fax: 425-657-7210 | |
| Email: 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, §870.1025, Class II) | |
| Device Description: | The Spacelabs Medical mCare 300 Vital Signs Monitor Model 91220 (mCare 300), 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, SpO2, or End tidal CO2 or ETCO2; 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. |
1
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 Spacclabs Mcdical 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 The revised mCare 300 is substantially equivalent in design concepts, Discussion: technologies and materials to the mCare 300 that was originally cleared under 510(k) number K062095 and the Press-Mate BX-10 Vital Signs Monitor (BX-10) by Colin (now Omron) that was cleared under 510(k) number K032857.
The mCare 300 originally incorporated a Welch Allyn NIBP module, the revised mCare 300 and the basis for this submission, uses the Omron (formally Colin) M3200 NIBP module. The M3200 NIBP module was an integral part of the BX-10 cleared under 510(k) number K032857. With the exception of the NIBP feature, this change has no significant impact on the other features or functions (respiration, ECG, invasive blood pressure, body temperature, Sp02, or End Tidal CO2 or ETCO2) of the originally cleared mCare 300. The change in NIBP modules was made for supply reasons.
The NIBP module revision to the mCare 300 was validated through rigorous testing that, in part, supports the compliance of the mCare 300 to the various standards identified in this submission. Additionally, the software revision, to accommodate the new NIBP module was developed following a robust software development process and was fully specified and validated.
Test The mCare 300 with the new NIBP module is substantially equivalent to Conclusion: its predicate devices in design concepts, technologies and materials.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spacelabs Medical, Inc. c/o Mr. David J. Geraghty Manager, Regulatory & Quality 5150 2200 Avenue, SE P.O. Box 7018 Issaquah. WA 98029
AUG - 1 2008
Re: K082045
Trade/Device Namc: Spacelabs Medical, mCare 300, Vital Signs Monitor, Model 91220 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: June 22, 2008 Received: June 24, 2008
Dear Mr. David J. 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 not me 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 FDA finding of substantial equivalence of your device to a logally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
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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K082045
Indications for Use
| 510(k) Number (if known): | K |
|---|---|
| Device Name: | Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor |
| Indications For Use: | The Spacclabs 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 (Part21 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oma
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K082045
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