(147 days)
The Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors) amplifier is intented for use with Pro-Tech G inchrony or the censure during steep directed ing, belancing, summing and an effort 5%
Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors)
The provided document is a 510(k) clearance letter from the FDA for a medical device (Quantum-Synchrony Respiratory Effort System). This type of document primarily confirms that a device is substantially equivalent to a legally marketed predicate device and grants permission to market it. It typically does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria, such as performance metrics, sample sizes, expert qualifications, or ground truth establishment. These details are usually found in the 510(k) submission itself, which is not provided here.
Therefore,Based on the provided text, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them. The document is an FDA clearance letter and does not contain the detailed technical specifications or study results you are asking for. It confirms the device's substantial equivalence to a predicate device but does not elaborate on the performance data or methodology from the original submission.
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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 868.2375 Breathing frequency monitor.
(a)
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.(b)
Classification. Class II (performance standards).