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.

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.

AI/ML Overview

This 510(k) summary does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria for the Masimo Patient Safety Net. This submission focuses on establishing substantial equivalence to a predicate device rather than detailing performance testing against pre-defined acceptance criteria.

Here's a breakdown of why the requested information is absent:

Type of Device: The Masimo Patient Safety Net is described as a "supplemental alarm system" and "system, network and communication, physiological monitors." It's essentially a system for relaying data and alarms from existing physiological monitors. It's not a diagnostic device that performs calculations or makes medical determinations based on physiological data itself.
Regulatory Pathway: The 510(k) pathway for "substantial equivalence" often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This typically involves showing similar technological characteristics and performance, rather than extensive clinical studies to prove accuracy against a ground truth.

However, based on the provided text, I can infer some general information provided and what is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred)	Reported Device Performance	Comments
Functional Equivalence to Predicate Device: The PSN should communicate with multiple patient monitoring devices and distribute physiological monitoring information remotely, including alarm information and physiological parameters, similarly to the predicate device.	"The PSN functions and transmits data similarly to the predicate device. The PSN and the predicate device use similar data transmission and communication technologies."	This is a general statement of similarity, not a quantitative measure against specific criteria. No specific performance metrics (e.g., latency, data integrity, alarm reliability) are provided.
Compliance with Voluntary Standards: (Detailed in Section 9 of the submission - not provided in the excerpt).	"The Masimo Patient Safety Net (PSN) complies with the voluntary standards as detailed in Section 9 of this submission."	The actual standards and compliance details are not in the excerpt.
Quality Assurance Measures: Device developed under established quality processes.	". Risk Analysis.. Design Reviews.. Component Level Testing.. System Level TestingPerformance Testing .Safety Testing ... Environmental Testing"	These are types of testing performed during development, not specific performance criteria or results.

2. Sample size used for the test set and the data provenance:

Not provided. The submission mentions "Component Level Testing," "System Level Testing," and "Performance Testing," but it does not specify the sample size, duration, or provenance of any data used for these tests. This is a technical product, so "test set" would likely refer to system-level integration and functionality testing rather than a patient-data-based test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. As this is a system for relaying data, "ground truth" in the diagnostic sense (e.g., expert consensus on an image or pathology result) is not relevant here. Ground truth would be about whether the system accurately transmits the data and alarms generated by the primary physiological monitors. No information on how this was verified by experts is given.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. Adjudication methods are typically used in clinical studies where there's subjectivity in interpreting data (e.g., reviewing medical images). For a system that transmits data, the "ground truth" is typically the source data itself (i.e., the data from the connected physiological monitor). Verification would involve checking for fidelity of transmission, not an interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, this was not done. An MRMC study is relevant for diagnostic devices where human readers interpret medical data, and the device might assist in that interpretation (e.g., CAD systems for radiology). The Masimo Patient Safety Net is a data transmission and alarm relay system, not an interpretive or diagnostic AI. Therefore, an MRMC study is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The "Performance Testing" and "System Level Testing" mentioned would have evaluated the system's functions (data transmission, alarm relay) independently of a human user making a clinical decision. However, no results from such testing are provided. The "system" (algorithm and hardware) is the device, and its standalone performance in transmitting data is its core function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated, but inferred to be the output of the connected physiological monitors. For this type of device, the "ground truth" for its performance would be the accuracy and timeliness with which it relays the data and alarms generated by the primary, connected physiological monitoring devices. If a primary monitor shows SpO2 at 98% and generates an alarm for a low heart rate, the PSN's "ground truth" challenge is to accurately reflect that 98% and relay that alarm.

8. The sample size for the training set:

Not applicable/Not provided. This device is described as using "application software" developed by Masimo, which suggests it might involve traditional software engineering rather than machine learning or AI that would require a "training set" of data in the common sense. If it does use machine learning (which is not indicated), no information about a training set is provided.

9. How the ground truth for the training set was established:

Not applicable/Not provided. See the explanation for point 8.

Summary

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Section 5: 510(k) Summary

K071047

JUN - 8 2007

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618PHONE (949) 297-7000FAX (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 System510(k) Number – K061932

Description of Masimo Patient Safety Net

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

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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.

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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.

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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

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Section 4 - Indications for Use .

510(k) Number (if known): K071047

Device Name: Masimo Patient Safety Net

Indications For Use:

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

Regulation Number and Section

§ 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).