(155 days)
The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the W estMed V ixOne) t o c onvert c ertain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.
The VigorMist™ Compressor is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer. It measures 11 7/8" x 7 1/8" x 4 1/2" and weights 4.6 lbs.
The device has a thermal protector that will automatically shut off the device when overheated. The operating components are located internally. The compressor, some minor wiring and exhaust/intake tubing are located inside .. External components include a switch, filter with housing, AC cord and cover or accessories compartment. The accessories coming with the compressor include a nebulizer, Air tube and mouthpiece.
The provided information for the VigorMist Compressor Nebulizer (K031413) primarily focuses on its intended use, description, and regulatory details for a 510(k) submission. It does not include detailed studies or data proving specific acceptance criteria in the way a modern AI/software device submission would.
Based on the provided text, I can infer some general acceptance criteria for a medical device like this (e.g., performance specifications, biocompatibility, standards conformity), but the document does not present quantitative metrics or specific study designs to demonstrate these.
Here's an attempt to structure the information based on your request, highlighting what is present and what is conspicuously absent:
Acceptance Criteria and Device Performance for VigorMist Compressor Nebulizer (K031413)
The provided 510(k) summary for the VigorMist Compressor Nebulizer (K031413) indicates that the device underwent testing to ensure it met performance specifications and regulatory requirements. However, the document does not present specific quantitative acceptance criteria or detailed results of a study designed to demonstrate performance against those criteria in a format typical for complex AI or diagnostic devices.
Instead, the submission states that "The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications." This indicates that some form of internal validation was conducted, likely against engineering and safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Specifications (e.g., air pressure, flow rate, aerosol conversion efficiency) | "The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications." (No specific numerical values or ranges are provided in this document.) |
| Biocompatibility | Successfully completed. (No details on tests or results.) |
| Standards Conformity | Successfully completed. (No specific standards listed as evidence within this document, though general conformity to medical device regulations is implied by the 510(k) clearance.) |
| Safety (Thermal Protection) | "The device has a thermal protector that will automatically shut off the device when overheated." (This is a design feature, not a direct performance metric with acceptance criteria.) |
Regarding the Study That Proves the Device Meets Acceptance Criteria:
The document refers to "Performance Testing" but does not describe a clinical study or a detailed technical study with the characteristics requested (sample size, ground truth, expert adjudication, etc.). This submission is for a Compressor Nebulizer, a relatively simple electro-mechanical device, and the regulatory pathway in 2003 for such devices generally relied on demonstrating substantial equivalence to predicates through engineering testing and adherence to recognized standards, rather than large-scale clinical trials or AI-specific validation studies.
Here's what can be inferred or explicitly stated from the document in response to your specific questions:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of what is provided. The document refers to "testing," but it's likely referring to bench testing, engineering validation, and standards conformity for the device hardware itself, not a test set of data like one would use for an AI algorithm.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not relevant to the type of testing described for this device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Assistance
- MRMC Study: No. This type of study is not relevant for a compressor nebulizer.
- Effect Size of AI Improvement: Not applicable, as there is no AI component mentioned.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Standalone Study: No. This device is a hardware compressor; it does not contain an algorithm in the sense of a software-based diagnostic or analytical tool.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a compressor nebulizer, "ground truth" would relate to engineering specifications (e.g., precise measurements of air pressure, flow rate, aerosol particle size distribution determined by calibrated instruments, and compliance with safety standards). The document states testing was completed for "biocompatibility, standards conformity," and "performance specifications," indicating these were the basis for demonstrating quality and safety.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
Conclusion:
The provided 510(k) summary for the VigorMist Compressor Nebulizer (K031413) serves as a regulatory document demonstrating substantial equivalence to predicate devices, focusing on the device's design, intended use, and a general statement of successful completion of performance, biocompatibility, and standards conformity testing. It does not contain the detailed study descriptions, quantitative acceptance criteria, or ground truth methodologies that would be expected for a modern AI-powered diagnostic device submission, as it is a mechanical device.
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OCT = 7 2003
510(k) Summary for the VigorMist COMPRESSOR NEBULIZER (per 21CFR807.92)
SUBMITTER 1.
Vega Technologies Inc. 11F-13, No.100 Chang Chun Road Taipei City Taiwan 104
Contact Person: Joseph Lu +886-2541-6996 Telephone: Fax: +886-2521-3803 E-mail: v6996@ms24.hinet.net Date Prepared: January 03, 2003
2. DEVICE NAME
| Proprietary Name: | VigorMist Compressor Nebulizer |
|---|---|
| (Model: CN-01W) | |
| K031413 | |
| Common/Usual Name: | Compressor Nebulizer |
| Classification Name: | Nebulizer (Direct patient interface) |
| Regulation Number: 21 CFR, 868.5630 |
3. PREDICATE DEVICE
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DEVICE DESCRIPTION 4.
The VigorMist™ Compressor is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer. It measures 11 7/8" x 7 1/8" x 4 1/2" and weights 4.6 lbs.
The device has a thermal protector that will automatically shut off the device when overheated. The operating components are located internally. The compressor, some minor wiring and exhaust/intake tubing are located inside .. External components include a switch, filter with housing, AC cord and cover or accessories compartment. The accessories coming with the compressor include a nebulizer, Air tube and mouthpiece.
INTENDED USE 5.
The VigorMist™ Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the WestMed VixOne) to convert certain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.
6. PERFORMANCE TESTING
Testing provided in this premarket notification includes biocompatibility, standards conformity.. The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications.
Page A-2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2-2008
Vega Technologies, Incorporated C/O Mr. Tzu - Wei Li Responsible Third Party Official Center for Measurement Standards of Industrial Technology Research Institute Bldg 16, 321 Kuang Fu Road Sec. 2 Hsinchu TAIWAN 30042, R.O.C.
Re: K031413
Trade/Device Name: Vigormist Compressor Nebulizer (Model: CN-01W) Regulation Number: 21 CFR 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI, CAF Dated: September 18, 2003 Received: September 23, 2003
Dear Mr. Li:
This letter corrects our substantially equivalent letter of October 7, 2003.
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 (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 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. Li
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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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-fsee OC organization structure below for correct phone extension]. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muhammad Yerdima
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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510(k) Number: K031413
Device Name: VIGORMIST Compressor Nebulizer (model: CN-01W)
Indications For Use:
The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the W estMed V ixOne) t o c onvert c ertain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
e. Iatach
Control Der
510(k) Number. K031413
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.