(247 days)
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No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or processes typically associated with AI/ML in medical devices (like image processing for analysis, complex pattern recognition beyond standard signal processing, or descriptions of training/test sets for algorithms).
No
The device is described as intended to "measure respiratory system impedance," which is a diagnostic function, not a therapeutic one. It does not mention treating or alleviating any condition.
No
The text states the device is "intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT)". While measuring impedance can be a component of diagnosis, the primary stated intended use is measurement, not the direct diagnosis of a condition.
No
The description explicitly states the device "is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT)". FOT is a physical measurement technique that requires hardware to generate oscillations and measure the resulting impedance. The summary does not mention any software-only implementation of this technique.
Based on the provided information, the PulmoScan is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PulmoScan's Function: The PulmoScan measures respiratory system impedance using the Forced Oscillation Technique (FOT). This is a non-invasive technique that involves applying small pressure oscillations to the airway and measuring the resulting flow and pressure. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use describes measuring a physiological parameter (respiratory impedance) directly from the patient, not analyzing a biological sample.
Therefore, the PulmoScan falls under the category of a medical device that performs a physiological measurement, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PulmoScan is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). PulmoScan is intended for use with pediatic and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers, similarly trained personnel and patients in hospitals, clinics, private physician offices or home.
Product codes
PNV
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
respiratory system
Indicated Patient Age Range
pediatic and adult patients 4 years of age or older
Intended User / Care Setting
pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers, similarly trained personnel and patients in hospitals, clinics, private physician offices or home.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
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March 18, 2020
Cognita Labs, LLC Rajoshi Biswas Architect and Clinical Lead 700 N Main St. Ste C1 Santa Ana, California 92701
Re: K191876
Trade/Device Name: PulmoScan Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: PNV Dated: February 16, 2020 Received: February 18, 2020
Dear Rajoshi Biswas:
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 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
1
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,
for Michael Ryan Division Director DHT1C: Division of ENT, 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
2
Indications for Use
510(k) Number (if known)
Device Name PulmoScan
Indications for Use (Describe)
The PulmoScan is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). PulmoScan is intended for use with pediatic and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers, similarly trained personnel and patients in hospitals, clinics, private physician offices or home.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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