(202 days)
The device is intended for the spot measurement of respiration rate of an adult patient in a home or clinical setting. It is not a vital signs monitor or an apnea monitor. It should not be used on patients that exhibit uncontrolled limb movement.
Not Found
The provided text does not contain detailed information about the acceptance criteria, the specific study that proves the device meets the acceptance criteria, or the various aspects of the study design such as sample size, data provenance, expert qualifications, or adjudication methods.
The document is an FDA 510(k) clearance letter for the "Breathe Easy Mobile Respiratory Monitor (MRM)," indicating that the device has been found substantially equivalent to a legally marketed predicate device. It defines the "Indications for Use" for the device, stating it's for "spot measurement of respiration rate of an adult patient in a home or clinical setting. It is not a vital signs monitor or an apnea monitor. It should not be used on patients that exhibit uncontrolled limb movement."
However, it does not provide the specific data requested in your prompt regarding acceptance criteria, performance metrics, or study methodology. This type of detailed technical data is typically found in the 510(k) submission summary or associated technical documentation, which is not included in the provided text.
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November 23, 2021
Sound Life Sciences, Inc. % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K211387
Trade/Device Name: Breathe Easy Mobile Respiratory Monitor (MRM) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZO Dated: October 22, 2021 Received: October 25, 2021
Dear Robert Packard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality
Center for Devices and Radiological Health Enclosure
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Indications for Use
510(k) Number (if known) K211387
Device Name
Breathe Easy Mobile Respiratory Monitor (MRM)
Indications for Use (Describe)
The device is intended for the spot measurement of respiration rate of an adult patient in a home or clinical setting. It is not a vital signs monitor or an apnea monitor. It should not be used on patients that exhibit uncontrolled limb movement.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).