(180 days)
The V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+ Software Options is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional setting under the direction of a physician.
The ventilator is intended to support pediatric patients weighing 20 kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.
The V60 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
The modifications to the currently marketed V60 Ventilator are two-fold; addition of PPV and Auto-Trak+ Software Options.
PPV is an assist mode of ventilation. It combines patient- triggered breaths that deliver pressure in proportion to patient effort. PPV provides ventilation support similar to that of the V60 Ventilator, specifically the S/T mode.
Auto-Trak+ is a Software Option that provides the clinician the means to adjust the trieger and cycle thresholds while retaining the functionality of Auto-Trak Sensitivity.
The provided document, K102985, describes a 510(k) premarket notification for the V60 Ventilator with Proportional Pressure Ventilation (PPV) and Auto-Trak+ Software Options. The document focuses on demonstrating substantial equivalence to a predicate device (V60 Ventilator) and outlines verification and validation activities.
However, the submission does not contain explicit acceptance criteria or a detailed study report that directly describes the device meeting specific quantitative or qualitative acceptance criteria with a statistical analysis based on human or algorithm performance data.
Here's a breakdown of what can be extracted and what information is missing based on your requested format:
1. Table of Acceptance Criteria and Reported Device Performance
Observation: This document does not explicitly state specific, quantifiable acceptance criteria for the performance of the PPV and Auto-Trak+ software options, nor does it present device performance data in a detailed table format to demonstrate compliance against such criteria.
The document generally states:
- "All software activities, including verification and validation have been successfully completed in accordance with Respironics California, Inc. policies and procedures and the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005."
- "Bench testing has been successfully completed and waveform data, performed to ASTM F1100-90, comparing the V60 Ventilator with PPV and Auto-Trak+ Software Options with the currently marketed V60 Ventilator are contained in the submission."
- "In addition to the software verification and validation activities and performance testing, a comparison of performance characteristics has been conducted and documented in this submission."
Without the full submission, the specific "waveform data" and "comparison of performance characteristics" are not detailed here. Therefore, a table of acceptance criteria and reported performance cannot be generated from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
Observation: The document does not specify a sample size for a "test set" in the context of clinical or human-in-the-loop performance evaluation. It mentions "bench testing" and "waveform data" but does not describe a test set in terms of patient data or clinical scenarios, nor does it mention data provenance (country of origin, retrospective/prospective). This submission primarily focuses on engineering verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Observation: This information is not provided because the document does not describe a study involving expert-established ground truth for a test set. The validation appears to be engineering-focused.
4. Adjudication Method for the Test Set
Observation: This information is not provided as no "test set" with expert review is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Observation: No MRMC comparative effectiveness study is mentioned or implied. The submission addresses the addition of new features (PPV and Auto-Trak+software options) to an existing cleared device (V60 Ventilator) by demonstrating that these additions do not alter the fundamental scientific technology or raise new safety/effectiveness questions. The primary evidence presented is engineering verification and validation, along with bench testing comparing the modified device to the predicate device.
6. Standalone (Algorithm Only) Performance Study
Observation: While "software verification and validation activities" were conducted, the document does not provide details of a standalone (algorithm only) performance study in terms of specific metrics like sensitivity, specificity, or accuracy that would typically be associated with AI algorithms or complex decision-support systems. The PPV and Auto-Trak+ are described as "software options" that enhance ventilation modes and sensitivity adjustments, not as standalone diagnostic or treatment algorithms that would typically undergo such standalone performance evaluation in the way AI models are tested today. The evaluation seems to be integrated into the overall device performance through bench testing.
7. Type of Ground Truth Used
Observation: The term "ground truth" as typically understood in AI/algorithm performance studies (e.g., pathology, outcomes data, expert consensus) is not applicable or not explicitly discussed in this submission. The validation relies on technical specifications, engineering principles, and comparison to existing validated device performance through bench testing (e.g., waveform data conforming to ASTM F1100-90).
8. Sample Size for the Training Set
Observation: This document does not mention a "training set" as the device's software options are not described as machine learning or AI models that require data training. The software modifications enhance existing ventilation functionality.
9. How the Ground Truth for the Training Set Was Established
Observation: This information is not applicable as no training set or machine learning model is described.
Summary of Findings:
The K102985 submission for the V60 Ventilator with PPV and Auto-Trak+ Software Options is a premarket notification primarily focused on demonstrating substantial equivalence through mechanical and software verification and validation, and bench testing, rather than a clinical performance study with defined acceptance criteria for AI or human performance. It asserts that the modifications do not alter the fundamental technology or raise new safety/effectiveness questions, making it substantially equivalent to the predicate device. The information requested (especially regarding clinical study design, expert review, and AI performance metrics) is largely absent from this particular document, which is typical for 510(k)s focusing on modifications to established device types where extensive de novo clinical trials are not required.
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K102985 APR - 5 2011
510(k) Summary
[Refer to 21 CFR 807.92]
| Owner: | Respironics California, Inc.2271 Cosmos CourtCarlsbad, CA 92011 |
|---|---|
| Contact Person: | Tamatha LeyRegulatory Affairs SpecialistPhone: (760) 918-1026Fax: (760) 918-0169 |
| Date Prepared: | October 01, 2010 |
| Proprietary Name: | V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+Software Options |
| Common Name: | Ventilator |
| ClassificationName: | Continuous Ventilator (21 CR 868.5895, Product Code 73 MNT) |
| Predicate Devices: | Manufacturer: Respironics California, Inc.Device Name: V60 Ventilator510(k) Number: K082660 |
Intended Use of the Device:
The V60 Ventilator with Proportional Pressure Ventilation (PPV) and Auto-Trak+ Software Options is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional setting under the direction of a physician.
The ventilator is intended to support pediatric patients weighing 20 kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.
Device Description:
The V60 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
The modifications to the currently marketed V60 Ventilator are two-fold; addition of PPV and Auto-Trak+ Software Options.
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PPV is an assist mode of ventilation. It combines patient- triggered breaths that deliver pressure in proportion to patient effort. PPV provides ventilation support similar to that of the V60 Ventilator, specifically the S/T mode.
: :
::" "
Auto-Trak+ is a Software Option that provides the clinician the means to adjust the trieger and cycle thresholds while retaining the functionality of Auto-Trak Sensitivity.
Substantial Equivalence: The addition of the PPV and Auto-Trak+Software Options does not alter the fundamental scientific technology of the V60 Ventilator.
The V60 Ventilator with PPV and Auto-Trak+ Software Options has the same intended use as the currently marketed V60 Ventilator and similar design and technological characteristics as the other standard, currently marketed ventilators.
The V60 Ventilator with PPV and Auto-Trak+ Software Options installed is similar to the existing unmodified V60 Ventilators in that the technological characteristics with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, environmental specifications, hardware and performance specifications remain unchanged.
All software activities, including verification and validation have been successfully completed in accordance with Respironics California, Inc. policies and procedures and the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005.
Bench testing has been successfully completed and waveform data, performed to ASTM F1100-90, comparing the V60 Ventilator with PPV and Auto-Trak+ Software Options with the currently marketed V60 Ventilator are contained in the submission.
In addition to the software verification and validation activities and performance testing, a comparison of performance characteristics has been conducted and documented in this submission.
Collectively, the results of the aforementioned activities support the assertion that the V60 Ventilator with PPV and Auto-Trak+Software Options is substantially equivalent to currently marketed devices previously cleared by the FDA and these changes do not raise any new questions regarding safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring. MD 20993-0002
Ms. Tamatha Ley Regulatory Affairs Specialist Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92011
APR - 5 2011
Re: K102985
Trade/Device Name: V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+ Software Options Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: March 30, 2011 Received: March 31, 2011
Dear Ms. Lev:
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. 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.
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Page 2 - Ms. Ley
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
hn for
Anthony Watson, B.S., M.S., M.B.A. 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: V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+ Software Options
Indications for Use:
The V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+ Software Options is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional setting under the direction of a physician.
The ventilator is intended to support pediatric patients weighing 20 kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.
Prescription Use X Over-the-Counter Use (Part 21 CFR 801, Subpart D) (Part 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)
L. Schull
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devious
$10(k) Number: K102985
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).