(122 days)
The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent™ Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.
The Provent Nasal Cannula was developed to transmit pressure signals from the Provent Professional Sleep Apnea Therapy device to a pressure transducer of a physiologic recorder during sleep evaluations. The Provent Nasal Cannula is specifically designed to attach the Provent Professional Sleep Apnea Therapy (Provent PSAT, K071560) device to standard pressure transducers.
The Provent Nasal Cannula is essentially identical to standard nasal cannulae except for its custom connection to the Provent PSAT. The Provent Nasal Cannula is comprised of the same design elements as a standard nasal cannula:
- a bifurcated tube with a luer lock connector,
- an anti-microbial filter at one end, and
- a component to hold the tubes in the correct location near the nostrils at the other end.
The Provent nasal cannula is worn in the same way as the standard nasal cannulae, with the proximal ends held in place in the path of nasal airflow and the tubing routed over the ears and under the chin.
The document describes the Provent Nasal Cannula, indicated for transmitting respiratory airflow signals during sleep studies, specifically with the Provent Professional Sleep Apnea Therapy device. The submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "Performance Data" section briefly states that "Bench data were submitted to support the 510(k) Notification. The bench testing demonstrated that the device is safe and effective for its intended use." However, it does not elaborate on specific quantitative acceptance criteria or results.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench testing" but does not specify a "test set" in the context of human subjects or clinical data. There is no information regarding sample size, data provenance (e.g., country of origin, retrospective or prospective), as the testing appears to be primarily laboratory-based to confirm basic functionality and safety.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided as the submission does not detail a clinical study involving human interpretation or ground truth establishment by experts. The focus is on the device's physical and functional equivalence to existing devices for signal transmission.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-reviewed test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, nor is it relevant given the nature of the device (a nasal cannula for signal transmission). The study does not involve human interpretation with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a physical medical device (nasal cannula), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable. The "performance data" refers to bench testing of the physical properties and function of the cannula.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) is not applicable in the context presented. The "ground truth" for the bench testing would be predefined engineering specifications or performance standards for pressure signal transmission, rather than clinical ground truth established by experts.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, the establishment of ground truth for it is irrelevant.
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Korogrz3
:AUG - 7 2008
510(K) SUMMARY
| 510(k) Applicant: | Ventus Medical, Inc.1301 Shoreway Rd., Suite 340Belmont, CA 94002(650) 632-4199 (phone)(650) 632-4198 (fax) |
|---|---|
| ------------------- | ----------------------------------------------------------------------------------------------------------------------------- |
Cindy Domecus. R.A.C. (US & EU) Contact: Domecus Consulting Services LLC (650) 343-4813
Date Summary Prepared: July 17, 2008
Provent™ Nasal Cannula Name of Device:
Nasal Cannula Common Name:
Classification Name: Breathing Frequency Monitor (21 CFR 868.2375, Product Code MNR)
Predicate Device: Predicate devices included in the 510(k) Notification are as follows: K051313. Salter Labs Bi-NAPS Nasal Airflow and Snore Transducer K984431. Braebon Medical Ultima Airflow Sensor
K971501, Bio-logic Airflow Pressure Transducer K053063, Pro-Flow Multipurpose Cannula
Device Description:
The Provent Nasal Cannula was developed to transmit pressure signals from the Provent Professional Sleep Apnea Therapy device to a pressure transducer of a physiologic recorder during sleep evaluations. The Provent Nasal Cannula is specifically designed to attach the Provent Professional Sleep Apnea Therapy (Provent PSAT, K071560) device to standard pressure transducers.
The Provent Nasal Cannula is essentially identical to standard nasal cannulae except for its custom connection to the Provent PSAT. The Provent Nasal Cannula is comprised of the same design elements as a standard nasal cannula:
-
- a bifurcated tube with a luer lock connector,
-
- an anti-microbial filter at one end, and
-
- a component to hold the tubes in the correct location near the nostrils at the other end.
4-1
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The Provent nasal cannula is worn in the same way as the standard nasal cannulae, with the proximal ends held in place in the path of nasal airflow and the tubing routed over the ears and under the chin.
Indications for Use:
The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.
Comparison to Predicate Devices:
The table below shows a comparison the Provent Nasal Cannula to its predicates.
| ProventNasalCannula | Salter LabsBI-NAPSNasal Airflowand SnoreTransducer | BiologicAirflowPressureTransducer | BraebonMedical UltimaAirflowSensor | Pro-FlowMultipurpose Cannula | |
|---|---|---|---|---|---|
| Indicationsfor Use | The ProventNasalCannula isindicated forthetransmissionof respiratoryairflowsignalsbetween theProventProfessionalSleep ApneaTherapydevice andthe pressuretransducersused withphysiologicrecordersduring sleepstudies. | The SalterLabs AirflowPressureTransducer isa reusabledeviceintended foruse duringsleep disorderstudies todetectrespiratoryairflow andsnoring forrecording ontoapolysomnography recordervia nasalpressurechanges. | The Bio-logicAirflowPressureTransducer isindicated foruse duringsleep disorderstudies todetectrespiratoryairflow forrecording on aphysiologicalrecorder. It is abattery-powereddevice, with adisposablenasal cannulawhich attachesto the patientand plugs intothe input of theAirflowPressureTransducerdevice. | The UlitmaAirflowPressureSensor isintended foruse duringsleep disorderstudies as aqualitativemeasure ofrespiratoryairflow ... Adisposablenasal cannulawith a 0.2-micronhydrophobicfilter attachesto the patientand connectsto the input ofthe UltimaAirflowPressureSensor. | Intended foruse forsimultaneous detectionofrespiratoryairflow andsampling, ordelivery, ofgases, suchas EtCO2 oroxygen |
| ProductCode | MNR | MNR | MNR | BZQ | CCK |
| Purpose | Carry nasalairflowsignals | Carry andprocess nasalairflow signals | Carry andprocess nasalairflow signals | Carry andprocess nasalairflow signals | Carry nasalairflowsignals andsample ordeliver gas |
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| ProventNasalCannula | Salter LabsBI-NAPSNasal Airflowand SnoreTransducer | BiologicAirflowPressureTransducer | BraebonMedical UltimaAirflowSensor | Pro-FlowMultipurpose Cannula | |
|---|---|---|---|---|---|
| Interfacewith nasalair flow | Two opentubing endswhich attachto theProventProfessionalSleep ApneaTherapydevice,which, in turnenters thenares | Two opentubing ends onnasal prongswhich enterthe nares | Two opentubing ends onnasal prongswhich enter thenares | Two opentubing ends onnasal prongswhich enter thenares | Two opentubing endson nasalprongswhich enterthe nares |
| Cannulainterfacewithpressuretransducer | Single Luerfitting | Single Luerfitting | Single Luerfitting | Single Luerfitting | One Luerfitting foreachpurpose(one forairflowmonitoringand one forgasdelivery/sampling) |
| Method ofpressuresignaltransmission | Hollowtubing | Hollow tubing | Hollow tubing | Hollow tubing | Hollowtubing |
| Reuse | Single use,disposable | Cannulaportion issingle use,disposable | Cannulaportion is singleuse, disposable | Cannulaportion is singleuse, disposable | Single use,disposable |
Table 4-1. Comparison of the Provent Nasal Cannula with predicate devices
Performance Data:
Bench data were submitted to support the 510(k) Notification. The bench testing demonstrated that the device is safe and effective for its intended use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ventus Medical, Incorporated C/O Ms. Cindy Domecus Principal Domecus Consulting Services LLC 1301 Shoreway Road, Suite 340 Belmont, California 94002
AUG - 7 2008
Re: K080983
Trade/Device Name: Provent™ Nasal Cannula Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: July 17, 2008 Received: July 21, 2008
Dear Ms. Domecus:
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 vour 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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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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
Chiu S. Lin, Ph. D Division 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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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Provent™ Nasal Cannula
Indications for Use:
The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent™ Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.
Prescription Use × Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080983
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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).