(57 days)
The VIASYS Sleep Systems Mini CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg. The VIASYS Sleep Systems Mini CPAP device provides continuous positive airway pressure. The Humidifier accessory provides humidification of the air delivered to the patient.
The Mini CPAP and Humidifier Accessory provide a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The Mini CPAP device can be operated from mains supply or an optional battery. The Mini CPAP is comprised of a motorized blower assembly that provides positive air pressure. The blower speed is directly related to air pressure, and is controlled by software. The Mini CPAP and Humidifier Accessory consist of the following main components: CPAP blower, Humidifier, Power Supply, Therapy Tubing, Optional Battery and Charger. The Humidifier accessory is designed for operation only with the Mini CPAP device and utilizes a temperature controlled heated water tray and a manifold to provide humidified air to the patient. The humidification level is user adjustable. Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements. The patient interface (CPAP mask) is a commercially available accessory provided separately.
The provided document describes the safety and effectiveness of the VIASYS Sleep Systems Mini CPAP and Humidifier Accessory, primarily through demonstrating substantial equivalence to predicate devices, rather than through a traditional clinical study with pre-defined acceptance criteria based on diagnostic performance metrics.
Therefore, the requested information components (#1 through #9) related to diagnostic performance and clinical study details (e.g., sample size, ground truth, expert qualifications, MRMC studies) are not applicable in this context because:
- No clinical tests were submitted. The document explicitly states: "Clinical Tests Submitted: None".
- The evaluation focused on non-clinical performance and technological equivalence. The primary method of demonstrating safety and effectiveness was through "Laboratory, software, and standards compliance tests" and comparison to predicate devices, not through a study involving patient outcomes or diagnostic accuracy.
Here's the breakdown of what can be extracted from the provided text regarding acceptance criteria and testing:
Description of Acceptance Criteria and the Study that Proves the Device Meets Acceptance Criteria
The VIASYS Sleep Systems Mini CPAP and Humidifier Accessory demonstrated its safety and effectiveness primarily through non-clinical tests and a comparison of its technological characteristics and performance to predicate devices. The acceptance criteria were implicitly met by demonstrating compliance with applicable standards and comparable performance to established devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with applicable medical device electrical safety standards. | "The device was tested in accordance with applicable standards for medical device Electrical Safety... The Mini CPAP and Humidifier Accessory passed all of the tests." |
| Electromagnetic Compatibility | Compliance with applicable medical device electromagnetic compatibility standards. | "The device was tested in accordance with applicable standards for medical device... Electromagnetic Compatibility... The Mini CPAP and Humidifier Accessory passed all of the tests." |
| Shock and Vibration | Compliance with applicable medical device shock and vibration standards. | "The device was tested in accordance with applicable standards for medical device... Shock and Vibration... The Mini CPAP and Humidifier Accessory passed all of the tests." |
| Environmental Performance | Compliance with applicable standards for environmental temperature and humidity. | "The device was tested in accordance with applicable standards for medical device... Environmental Temperature and Humidity. The Mini CPAP and Humidifier Accessory passed all of the tests." |
| Static and Dynamic Pressure | Performance comparable to predicate devices in static and dynamic pressure characteristics. | "Static and dynamic pressure testing... was performed in comparison with the predicate devices. The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Humidifier Performance | Performance comparable to predicate devices for humidification. | "Humidifier testing was performed in comparison with the predicate devices. The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Software Verification/Validation | Embedded software verified to requirements and validated to meet intended use. | "Embedded software in the device was verified to requirements and validated to meet intended use by software and system level performance testing." |
| Biocompatibility | Moisture-contacting materials in the humidifier and therapy tube meet biocompatibility requirements. (This is stated in Device Description) | "Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements." (Implicitly met, no direct testing results reported in the "Non-Clinical Tests Submitted" section for this specific point, but stated as a characteristic, likely confirmed through material qualification). |
| Substantial Equivalence | Demonstrate technological similarity and comparable performance to predicate devices. | "The function of the Mini CPAP and Humidifier Accessory device is substantially equivalent to the predicate devices... all of the testing demonstrates that the VIASYS Sleep Systems LLC Mini CPAP and Humidifer Accessory is as safe and effective and performs in a manner equivalent to the predicate devices..." |
2. Sample size used for the test set and the data provenance
- Not Applicable. No human subjects or biological samples were used as part of a formal "test set" in the context of diagnostic performance. The testing involved medical device performance metrics against standards and predicate devices (e.g., pressure output, air flow, temperature control, electrical safety).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of diagnostic accuracy or clinical outcomes was not established as there were no clinical studies. The "ground truth" for performance testing was defined by industry standards and the specifications of predicate devices.
4. Adjudication method for the test set
- Not Applicable. No adjudication of clinical outcomes or diagnostic accuracy was performed. Mechanical and electrical performance was assessed against predefined benchmarks and predicate device specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. No MRMC study was conducted. This device is a CPAP machine, not an AI-powered diagnostic tool, and the submission explicitly states "Clinical Tests Submitted: None."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-only or AI-driven device. Its performance is entirely standalone in its function as a CPAP device; however, the question implies diagnostic algorithm performance without human intervention, which is not relevant here.
7. The type of ground truth used
- The "ground truth" was based on engineering specifications, recognized industry standards (e.g., electrical safety, EMC), and the established performance characteristics of legally marketed predicate devices. For example, pressure output was compared against the predicate device's expected pressure range.
8. The sample size for the training set
- Not Applicable. The device is not a machine learning or AI-driven system that requires a "training set" for model development.
9. How the ground truth for the training set was established
- Not Applicable. As there was no training set, this question is not relevant.
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JUN 1 % 2007
Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
Company Name: VIASYS Sleep Systems LLC 9305 Eton Ave Chatsworth CA 91311
Contact: Keith Bosecker, Regulatory Affairs
Phone: 818-341 4131
Fax: 818-341 4135
Email: keith.bosecker@viasyshc.com
Summary Date: April 12, 2007
Trade Name: Mini CPAP and Humidifier Accessory
Common Name: CPAP and Humidifier Device
Common Classification/Name: Ventilator, non-continuous, non-life supporting; Humidifier, respiratory gas
Product Code(s): 21 CFR 868.5905 73 BZD & 21 CFR 868.5450 73 BTT
Class: Class II
Predicate Device(s):
- BreatheX Omega CPAP Device, Model 322 Predicate Device: .
- 510K Number: K052597 ●
- Hoffman Laboratories (now VIASYS Sleep Systems) Manufacturer: .
- Predicate Device: HC200 CPAP .
- 510K Number: K973161 .
- Manufacturer: Fisher & Paykel Healthcare .
Reason for Submission: New Device
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Description of Device
The Mini CPAP and Humidifier Accessory provide a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The Mini CPAP device can be operated from mains supply or an optional battery.
The Mini CPAP is comprised of a motorized blower assembly that provides positive air pressure. The blower speed is directly related to air pressure, and is controlled by software.
The Mini CPAP and Humidifier Accessory consist of the following main components:
- CPAP blower t
- Humidifier �
- Power Supply ●
- Therapy Tubing .
- Optional Battery and Charger .
The Humidifier accessory is designed for operation only with the Mini CPAP device and utilizes a temperature controlled heated water tray and a manifold to provide humidified air to the patient. The humidification level is user adjustable. Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements.
The patient interface (CPAP mask) is a commercially available accessory provided separately. The patient interface is not covered in this submission.
Intended Use
The Mini CPAP provides continuous positive airway pressure (CPAP) intended for use in the treatment of obstructive sleep apnea (OSA). This is by the delivery of continuous positive airway pressure at a specified pressure level in order to prevent airway obstruction.
The Mini CPAP and Humidifier Accessory are used while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). The Humidifier Accessory provides humidification of the air delivered to the patient.
The Mini CPAP and Humidifier Accessory are for use on adult patients weighing at least 30 kg, spontaneously breathing (non-ventilator dependent) patients at home or in the sleep clinic.
The Mini CPAP and Humidifier are not intended for life support.
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Indications for Use
The VIASYS Sleep Systems Mini CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg.
The VIASYS Sleep Systems Mini CPAP device provides continuous positive airway pressure.
The Humidifier accessory provides humidification of the air delivered to the patient.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Technology
The Mini CPAP device utilizes similar technological characteristics as the predicate CPAP devices. All devices employ a computer controlled blower system which is attached via tubing to a nasal mask/exhaust port to deliver a specified mono-level CPAP treatment to a patient. The humidifier in the Mini CPAP has the same operating principles, a heated water container, as the predicate device.
The Mini CPAP operates from a mains powered 12 V power supply or an optional battery. The Humidification accessory utilizes a mains powered 12 V power supply only.
Non-Clinical Tests Submitted:
The device was tested in accordance with applicable standards for medical device Electrical Safety, Electromagnetic Compatibility, Shock and Vibration, and Environmental Temperature and Humidity. The Mini CPAP and Humidifier Accessory passed all of the tests.
Static and dynamic pressure testing and humidifier testing was performed in comparison with the predicate devices. The device met specified requirements and was comparable to the applicable specifications of the predicate devices.
Embedded software in the device was verified to requirements and validated to meet intended use by software and system level performance testing.
Clinical Tests Submitted: None
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Conclusions
The function of the Mini CPAP and Humidifier Accessory device is substantially equivalent to the predicate devices. Laboratory, software, and standards compliance tests are provided to support the safety and performance of the Mini CPAP and Humidifier Accessory.
As described above, all of the testing demonstrates that the VIASYS Sleep Systems LLC Mini CPAP and Humidifer Accessory is as safe and effective and performs in a manner equivalent to the predicate devices, the Fisher and Paykel HC200 and Hoffman Laboratories (now VIASYS Sleep Systems) BreatheX Omega CPAP Device, Model 322.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three overlapping wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith Bosecker Regulatory Affairs VIASYS Sleep Systems, LLC 9305 Eton Avenue Chatsworth, California 91311
JUN 1 2 2007
Re: K071069
Trade/Device Name: VIASYS Sleep Systems Mini CPAP Device with Humidification Accessory Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilators (IPPB) Regulatory Class: II Product Code: BZD Dated: March 15, 2007 Received: April 16, 2007
Dear Mr. Bosecker:
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 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. Bosecker
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suite Y. Michanoms.
Chiu Lin, Ph.D. 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):
VIASYS Sleep Systems Mini CPAP Device with Humidification Accessory Device Name:
Indications for use:
The VIASYS Sleep Systems Mini CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg.
The VIASYS Sleep Systems Mini CPAP device provides continuous positive airway pressure.
The Humidifier accessory provides humidification of the air delivered to the patient.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Prescription Use X (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)
sion Sign-Offi vision of Anesthesiology, General Hospital, Claciton Control, Dental Devices
510(k) Number: k 071069
Page 1 of 1 __
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).