(56 days)
Not Found
No
The description focuses on communication, remote display, and alarm transmission, with no mention of AI/ML terms or functions like learning, prediction, or complex data analysis beyond simple parameter display and alarm forwarding.
No
The device is a supplemental alarm and monitoring system, not directly involved in treating or diagnosing medical conditions. It transmits physiological data and alarms but does not apply therapy.
No
The device is described as a "supplemental alarm system" that provides "secondary display of physiological monitoring parameters" and enables "viewing and monitoring of patient physiological conditions." It communicates with existing patient monitoring devices to relay information, primarily for remote monitoring and alarm transmission to clinicians. It is explicitly stated that it is "not intended to replace any part of the patient monitoring procedures." This functionality suggests a role in information dissemination and alarm management rather than directly identifying disease or health conditions, which is the primary function of a diagnostic device.
Unknown
The description focuses on the system's function and communication, but doesn't explicitly state whether the PSN itself is purely software or includes dedicated hardware components beyond the communication interfaces. The mention of "communicating with multiple patient monitoring devices" and "wireless transmission" suggests potential hardware involvement, but it's not definitive.
Based on the provided information, the Masimo Patient Safety Net (PSN) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health.
- PSN Function: The PSN's intended use and description clearly state that it is a supplemental alarm system that communicates with patient monitoring devices and displays physiological monitoring parameters. It receives information from these devices, not by analyzing biological specimens.
The PSN is a system for managing and relaying data from other medical devices that are monitoring the patient's physiological state. It does not perform any diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Masimo Patient Safety Net (PSN) is intended to be used as a supplemental alarm system, communicating with multiple patient monitoring devices. The PSN provides secondary display of physiological monitoring parameters. It enables the viewing and monitoring of patient physiological conditions. The PSN is used in hospitals or hospitals or hospital type environments.
Product codes
MSX
Device Description
The Masimo Patient Safety Net (PSN) is a supplemental alarm system for physiological monitoring devices. It is not intended to replace any part of the patient monitoring procedures already existing for the patient monitoring devices.
The PSN communicates with multiple patient monitoring devices and distributes physiological monitoring information remotely. Skilled clinicians remotely receive wireless transmission of patient physiological monitoring information, from patient monitoring device(s) to their pagers. The transmitted information includes alarm information and physiological parameters.
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
Not Found
Intended User / Care Setting
Skilled clinicians / hospitals or hospital-type environments
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
The Masimo Patient Safety Net (PSN) complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the PSN:
- . Risk Analysis
- . Design Reviews
- . Component Level Testing
- . System Level Testing
- Performance Testing .
- Safety Testing .
- . Environmental Testing
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Section 5: 510(k) Summary
K071047
JUN - 8 2007
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
PHONE (949) 297-7000
FAX (949) 297-7001 |
|--------------------------------------|---------------------------------------------------------------------------------------------------|
| Official Correspondent: | James Cronin, Vice President, Regulatory Affairs |
| Company Contact for this Submission: | Marguerite Thomlinson, Manager, Regulatory Affairs |
| Date Summary Prepared: | April 12, 2007 |
| Trade Name: | Masimo Patient Safety Net |
| Common Name: | System, Network and Communication, Physiological Monitors |
| Device Class: | Class II |
| Product Code: | MSX |
| Classification Name: | System, Network and Communication, Physiological Monitors |
| Substantially Equivalent Devices: | Bernoulli Management System
510(k) Number – K061932 |
Description of Masimo Patient Safety Net
The Masimo Patient Safety Net (PSN) is a supplemental alarm system for physiological monitoring devices. It is not intended to replace any part of the patient monitoring procedures already existing for the patient monitoring devices.
The PSN communicates with multiple patient monitoring devices and distributes physiological monitoring information remotely. Skilled clinicians remotely receive wireless transmission of patient physiological monitoring information, from patient monitoring device(s) to their pagers. The transmitted information includes alarm information and physiological parameters.
Intended use/ Indications for Use
The Masimo Patient Safety Net (PSN) is intended to be used as a supplemental alarm system, communicating with multiple patient monitoring devices. The PSN provides secondary display of physiological monitoring parameters. It enables the viewing and monitoring of patient physiological conditions. The PSN is used in hospitals or hospitals or hospital type environments.
1
Section 5: 510(k) Summary רK071047
Technology
The Masimo Patient Safety Net (PSN) includes standard telecommunication and IT hardware. Masimo develops the application software which is used on the system server and PC computer (central monitoring station).
The PSN functions and transmits data similarly to the predicate device. The PSN and the predicate device use similar data transmission and communication technologies.
Test Summary
The Masimo Patient Safety Net (PSN) complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the PSN:
- . Risk Analysis
- . Design Reviews
- . Component Level Testing
- . System Level Testing
- Performance Testing .
- Safety Testing .
- . Environmental Testing
Conclusions
The information in this 510(k) submission demonstrates that the Masimo Patient Safety Net is substantially equivalent to the predicate device as a supplementary alarm system, with respect to safety, effectiveness, and performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three heads, representing the department's focus on health, human services, and the well-being of the population. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IN - 8 2007
Masimo Corporation c/o Marguerite Thomlinson Manager, Regulatory Affairs 40 Parker Irvine, California 92618
Re: K071047
Masimo Patient Safety Net Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MSX Dated: April 12, 2007 Received: April 13, 2007
Dear Ms. Thomlinson:
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 - Ms. Marguerite Thomlinson
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 FDA finding of substantial equivalence of 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,
В.Кратта
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use .
510(k) Number (if known): K071047
Device Name: Masimo Patient Safety Net
Indications For Use:
The Masimo Patient Safety Net (PSN) is intended to be used as a supplemental alarm system, communicating with multiple patient monitoring devices. The PSN provides secondary display of physiological monitoring parameters. It enables the viewing and monitoring of patient physiological conditions. The PSN is used in hospitals or hospital-type environments.
Prescription Use __X
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 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)
Bhummo
cular Devices 510(k) 1