(44 days)
No
The summary describes a physical CPAP mask and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for the "treatment of adult obstructive sleep apnea," indicating a therapeutic purpose.
No
The device is a nasal CPAP mask used for treating obstructive sleep apnea. Its function is therapeutic (delivering positive airway pressure) rather than diagnostic (identifying or characterizing disease).
No
The device description clearly states it is a nasal CPAP mask, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of adult obstructive sleep apnea using positive airway pressure. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a nasal CPAP mask, which is a physical interface used to deliver air pressure. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on physical standards and leakage, which are relevant to the function of a mask in delivering air pressure, not to diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is intended to be used with positive airway pressure devices operating at or above 4cmH2O for the treatment of adult obstructive sleep apnea.
Product codes
BZD
Device Description
A nasal CPAP mask that is used with positive airway pressure equipment recommended by a physician, sleep technician, or respiratory therapist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
Adult population
Intended User / Care Setting
Home, hospital, or sleep lab.
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)
Performance Testing
Meets ASTM F1054-87 & ISO 5356-1 Standards
Meets ISO 17510-2:2003 Standard
Minimum 12 lpm @ 4 cm H2O Mask Leakage To Prevent CO Rebreathing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SleepNet Corporation IQ™ Mask - K993269
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JUN 3 0 2004
510(k) SUMMARY OF SAFETY & EFFECTIVENESS May 13, 2004
Marquest Medical Products, Inc. 11039 East Lansing Circle Englewood, CO 80112 (A division of Vital Signs, Inc.)
Tel – (303) 790-4835 ext. 412 Fax - (303) 799-0210
| Official Contact: | Tom Dielmann, Vice President of RA/QA |
|---|---|
| Proprietary or | |
| Trade Name: | iMask ™ (K041309) |
| Common/Usual Name: | Nasal CPAP Mask |
| Classification Name: | 73 BZD - Ventilator, Non-Continuous |
| (Respirator) | |
| Subsection 868.5905 | |
| Intended Device: | CPAP Nasal Mask |
| Predicate Device: | SleepNet Corporation IQ™ Mask - K993269 |
| Device Description: | A nasal CPAP mask that is used with positive airway |
| pressure equipment recommended by a physician, sleep | |
| technician, or respiratory therapist. | |
| Indicated Use: | This device is intended to be used with positive airway |
| pressure devices operating at or above 4cmH2O for the | |
| treatment of adult obstructive sleep apnea. | |
| Targeted Population: | Adult population using a continuous positive airway |
| pressure device. | |
| Environment of Use: | Home, hospital, or sleep lab. |
1
510(k) SUMMARY OF SAFETY & EFFECTIVENESS (continued)
| Attribute | Marquest/VSI iMask™ | SleepNet IQ™ Mask
K993269 |
|----------------------------------------------------------------------------|---------------------|------------------------------|
| Use
Intended for use in
respiratory therapy | Yes | Yes |
| Intended to be used with
any CPAP device | Yes | Yes |
| Indicated for single patient use
In home, hospital, or sleep lab | Yes | Yes |
| Indicated for use with
adult cases | Yes | Yes |
| Design/Performance
Comfortable face cushion | Yes | Yes |
| 15mm swivel elbow connection | Yes | Yes |
| 3-point headstrap connection | Yes | Yes |
| Adequate venting to minimize
rebreathing CO2 | Yes | Yes |
| Vent design to minimize noise | Yes | Yes |
| No latex materials | Yes | Yes |
| No sharp edges | Yes | Yes |
| Mask is lightweight | Yes - 64 grams | Yes - 60 grams |
| Polybag packaging
(clean non-sterile) | Yes | Yes |
| Attribute | Marquest/VSI iMask™ | SleepNet IQ™ Mask |
| Materials
Polyurethane Housing | Yes | Yes |
| Polycarbonate & Acetal Copolymer
15mm Swivel Elbow | Yes | Yes |
| Wire Insert Molded Into Mask
Housing | Yes | Yes |
| Soft Facial Contact Cushion | Yes | Yes |
| Polycarbonate 3-Point Headstrap
Bracket | Yes | Yes |
| Airway & direct contact component
materials meet USP Class VI standards | Yes | Yes |
| Performance Testing
Meets ASTM F1054-87 &
ISO 5356-1 Standards | Yes | Yes |
| Meets ISO 17510-2:2003 Standard | Yes | Yes |
| Minimum 12 lpm @ 4 cm H2O
Mask Leakage To Prevent CO
Rebreathing | Yes | Yes |
2
510(k) SUMMARY OF SAFETY & EFFECTIVENESS (continued)
Differences
The only difference between the iMask™ and the predicate device is the face cushion material. The iMask™ cushion material was submitted for required biocompatability testing (cytotoxicity, sensitization, and irritation/intracutaneous reactivity). The mask materials have passed the USP Class VI tests (see attachment).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird with three curved lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2004
Vital Signs, Incorporated C/O Mr. Thomas Dielmann Vice President, Quality and Regulatory Affairs Marquest Medical Products, Incorporated 11039 East Lansing Circle Englewood, Colorado 80112
Re: K041309
Trade/Device Name: iMask TM Nasal CPAP Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: May 14, 2004 Received: May 17, 2004
Dear Mr. Dielmann:
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.
4
Page 2 - Mr. Dielmann
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours.
Ohr Lin, Ph.D.
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
5
INDICATIONS FOR USE
K041309 510(k) Number:
iMask ™Nasal CPAP Mask Device Name:
This device is intended to be used with Indications For Use: positive airway pressure devices operating at or above 4cmH2O for the treatment of adult obstructive sleep apnea.
Prescription Use __ X -(per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 510(k) Number