MASIMO PATIENT SAFETY NET

K071047 · Masimo Corporation · MSX · Jun 8, 2007 · Cardiovascular

Device Facts

• Record ID: K071047
• Device Name: MASIMO PATIENT SAFETY NET
• Applicant: Masimo Corporation
• Product Code: MSX · Cardiovascular
• Decision Date: Jun 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Masimo Patient Safety Net (PSN) acts as supplemental alarm system for existing physiological monitors; communicates with multiple devices to distribute data remotely. System inputs include physiological parameters and alarm signals from bedside monitors; transforms these into wireless transmissions sent to clinician pagers. Used in hospital environments by skilled clinicians. Provides secondary display of patient conditions; enables remote viewing of alarms/parameters. Benefits patient by facilitating timely clinician response to physiological events. Operates via standard IT/telecommunication hardware and proprietary application software on system server and central monitoring station PC.

Clinical Evidence

Bench testing only. No clinical data provided. Quality assurance measures included risk analysis, design reviews, component-level testing, system-level testing, performance testing, safety testing, and environmental testing.

Technological Characteristics

System utilizes standard telecommunication and IT hardware. Software runs on system server and central monitoring station PC. Connectivity is networked for data transmission to pagers. No specific materials or proprietary sensing hardware described; device functions as a communication layer for existing monitors.

Indications for Use

Indicated for use in hospital or hospital-type environments as a supplemental alarm system for secondary display and remote monitoring of physiological parameters from multiple patient monitoring devices.

Regulatory Classification

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.

Predicate Devices

• Bernoulli Management System (K061932)

Submission Summary (Full Text)

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## Section 5: 510(k) Summary

## K071047

JUN - 8 2007

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>PHONE [phone]<br>FAX [phone] |
|--------------------------------------|---------------------------------------------------------------------------------------------------|
| 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<br>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.

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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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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 [phone]. 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 [phone] or [phone] 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:

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