MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS

K013905 · Pro-Tech Services, Inc. · MNR · Apr 22, 2002 · Anesthesiology

Device Facts

• Record ID: K013905
• Device Name: MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
• Applicant: Pro-Tech Services, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Apr 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The amplifier is intented for use with Pro-Tech G inchrony or the censure during steep directed ing, belancing, summing and an effort 5%

Device Story

Quantum-Synchrony Respiratory Effort System (modified EZ-1 System) functions as a signal amplifier for respiratory effort sensors. Device inputs include signals from respiratory sensors; these are processed via balancing and summing functions to produce output for sleep-directed monitoring. Used in clinical settings by healthcare professionals to assist in respiratory effort assessment. Output facilitates clinical decision-making regarding patient sleep and respiratory health.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench-level review of the modified respiratory sensor system.

Technological Characteristics

Respiratory effort amplifier; functions as a signal conditioner for sleep monitoring sensors. Connectivity involves integration with Pro-Tech Synchrony systems. Class II device under 21 CFR 868.2375.

Indications for Use

Indicated for use with Pro-Tech Synchrony or sensors during sleep-directed monitoring, balancing, summing, and effort recording. Prescription use only.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 2 2002

Mr. Neil Sheller Pro-Tech Services, Inc. 4338 Harbour Pointe Blvd. SW Mukilteo, WA 98275

Re: K013905

Modification EZ-1 System Respiratory Sensors Regulation Number: 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: II (two) Product Code: MNR Dated: April 4, 2002 Received: April 5, 2002

Dear Mr. Sheller:

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 for are cased in 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. Neil Sheller

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loast be devilod that I bromination that your device complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any I vith 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 Of It Fut 607), ideoming (21 CFR Part 820); and if applicable, the electronic forth in also quarty by by wisions (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) rms let notification. The FDA finding of substantial equivalence of your device to a legally premaince medicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D.
Acting Director
Division of Cardiovascular
and Respiratory Devices

and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K013905

Device Name: Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors)

Indications For Use:

uplifier is intented for use with Pro-Tech G inchrony or । he censure during steep directed ing, belancing, summing and an effort 5%

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number R013905

Prescription Use (Per 21 CFR 801.109 OR

Over-The-Counter Use_

(Optional Format 1-2-96)