(292 days)
SPM is indicated for monitoring heart rate, invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric and neonatal populations.
SPM is indicated for monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatic populations only (not intended for use on neonatal populations).
SPM will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits at which point timed or alarm recordings will be produced. SPM connects to an R50 Bedside recorder, or via the Saad Patient Monitoring network (SPMS).
SPM does NOT perform ST Segment analysis and it is not intended to be used in transport or ambulatory environments.
MR Environment Compatibility Statement:
The Saad Patient Monitors are not compatible for use in an MR Environment (MR Unsafe).
Not Found
This FDA clearance letter for the Saad Patient Monitor (SPM) does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance. The letter is a 510(k) clearance, which designates that the device is substantially equivalent to a predicate device.
Here's why the requested information is absent from this document and what is typically found in such a clearance:
- Acceptance Criteria and Device Performance Table: This type of detail would be in the 510(k) submission document, specifically within the performance testing sections. The clearance letter itself only summarizes the FDA's decision based on that submission.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: All of these details are part of the device's validation and verification studies, which are contained within the full 510(k) submission. The FDA clearance letter only affirms that the submitted information was sufficient for clearance.
What the provided document does tell us:
- Trade/Device Name: Saad Patient Monitor (SPM)
- Regulation Number/Name: 21 CFR 870.1025, Patient Monitor
- Regulatory Class: Class II
- Product Code: MHX
- Indications for Use:
- Monitoring heart rate, invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric, and neonatal populations.
- Monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatric populations only (not for neonatal).
- Produces visual and audible alarms for out-of-preset-limit physiological parameters, leading to timed or alarm recordings.
- Connects to an R50 Bedside recorder or via the Saad Patient Monitoring network (SPMS).
- Limitations: DOES NOT perform ST Segment analysis, not intended for transport or ambulatory environments, and not compatible for use in an MR Environment (MR Unsafe).
- Type of Use: Prescription Use (Part 21 CFR 801 Subpart D)
- 510(k) Number: K133222
To obtain the detailed information you are requesting, you would need to access the full 510(k) submission for K133222, which is typically available through an FDA Freedom of Information Act (FOIA) request, though portions may be redacted for proprietary reasons.
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Auqust 6, 2014
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
Hanin Medical Services Co. Ltd Raymond Kelly 57 Lazy Brook Road Monroe, CT 06468 US
Re: K133222
Trade/Device Name: Saad Patient Monitor (SPM) Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Monitor Regulatory Class: Class II Product Code: MHX Dated: July 23, 2014 Received: July 24, 2014
Dear Mr. Kelly,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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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. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133222
Device Name
Saad Patient Monitor (SPM)
Indications for Use (Describe)
SPM is indicated for monitoring heart rate, invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric and neonatal populations.
SPM is indicated for monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatic populations only (not intended for use on neonatal populations).
SPM will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits at which point timed or alarm recordings will be produced. SPM connects to an R50 Bedside recorder, or via the Saad Patient Monitoring network (SPMS).
SPM does NOT perform ST Segment analysis and it is not intended to be used in transport or ambulatory environments.
MR Environment Compatibility Statement:
The Saad Patient Monitors are not compatible for use in an MR Environment (MR Unsafe).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) ( Signature ) |
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Ken Skodacek for
Bram Zuckerman
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§ 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.