(155 days)
Not Found
No
The description focuses on the mechanical function of an air compressor and does not mention any AI/ML components or capabilities.
Yes
The device is intended to treat asthma, COPD, and other respiratory ailments, which are medical conditions, thus making it a therapeutic device.
No
The device is described as an air compressor for converting inhalable drugs into an aerosol form for treatment, not for diagnosing conditions.
No
The device description clearly states it is a physical air compressor with internal and external hardware components (compressor, wiring, tubing, switch, filter, AC cord, cover) and accessories (nebulizer, air tube, mouthpiece). It is not solely software.
Based on the provided information, the VigorMist Compressor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to convert inhalable drugs into an aerosol form for inhalation by a patient. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details an air compressor designed to power a nebulizer, which is consistent with a drug delivery device.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing. IVDs are specifically designed for these purposes.
The VigorMist Compressor is a medical device used for drug delivery in the treatment of respiratory conditions.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BTI, CAF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, or infant
Intended User / Care Setting
Home care market
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing provided in this premarket notification includes biocompatibility, standards conformity.. The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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.
3
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
4
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)