PORTABLE SLEEP DATA RECORDER (PSDR)

K033402 · Pro-Tech Services, Inc. · MNR · Jun 30, 2004 · Anesthesiology

Device Facts

• Record ID: K033402
• Device Name: PORTABLE SLEEP DATA RECORDER (PSDR)
• Applicant: Pro-Tech Services, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The PSDR system is a physiological recorder intended to display and to record for later playback of thoracic and abdominal respiratory effort on adults and oxygen saturation, pulse rate, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input. The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.

Device Story

Portable Sleep Data Recorder (PSDR) records physiological signals including thoracic/abdominal respiratory effort, oxygen saturation, pulse rate, and auxiliary 0-1V DC inputs (e.g., CPAP pressure). Device operates in hospital, institutional, or home environments. Data is recorded for later playback and review by healthcare professionals. System aids in monitoring respiratory and pulse parameters to assist clinical assessment of sleep-related physiological data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Physiological recorder for respiratory effort, SpO2, pulse rate, and auxiliary DC voltage signals. Designed for supervised or unsupervised use. Connectivity includes auxiliary input for external device signals (e.g., CPAP).

Indications for Use

Indicated for adults requiring physiological recording of thoracic and abdominal respiratory effort, oxygen saturation, pulse rate, and auxiliary 0-1V DC signals (e.g., CPAP pressure) in supervised (hospital/institutional) or unsupervised (home) settings.

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

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Public Health Service

JUN 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pro-Tech Services, Incorporated C/O Ms. Laura Danielson Responsible Third Party Official TÜV America, Incorporated 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

Re: K033402

Trade/Device Name: Portable Sleep Data Recorder Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: June 24, 2004 Received: June 25, 2004

Dear Ms. Danielson:

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 Eederal Register.

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Page 2 -Ms. Danielson

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 mode that to any Federal statutes and regulations administered by other Federal agencies. or the Fet of all your 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 and ifsuing (2) 2011 11:14 quality systems (QS) regulation (21 CFR Part 820); and if requirents as lectronic 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) I mis letter mtification. The FDA finding of substantial equivalence of your device to a premainer leted 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), 11 you deatte 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Portable Sleep Data Recorder

Indication for Use:

The PSDR system is a physiological recorder intended to display and to record for later pay dack of The PSDR system is a prysiclogical reborder interace and abdominal respiratory offer on whiles and oxygen Saturation, pulse Tate, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input.

The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use __ XX__OR

(Pcr 21 CFR 801 .109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Indications For Use

Qur Sulion

(Division Sign-O y, General Hospital. Division of Anesth Infection Control. 510(k) Number: