(44 days)
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.
A nasal CPAP mask that is used with positive airway pressure equipment recommended by a physician, sleep technician, or respiratory therapist.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The provided document describes a 510(k) Premarket Notification for the iMask™ Nasal CPAP Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright proving safety and effectiveness through extensive clinical trials for de novo approval. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence to the predicate device, the SleepNet IQ™ Mask.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the characteristics and performance attributes of the predicate device (SleepNet IQ™ Mask). The "reported device performance" refers to how the iMask™ meets or is substantially equivalent to these attributes.
| Acceptance Criteria (Predicate: SleepNet IQ™ Mask) | Reported Device Performance (iMask™) |
|---|---|
| Use | |
| Intended for use in respiratory therapy | Yes |
| Intended to be used with any CPAP device | Yes |
| Indicated for single patient use in home, hospital, or sleep lab | Yes |
| Indicated for use with adult cases | Yes |
| Design/Performance | |
| Comfortable face cushion | Yes |
| 15mm swivel elbow connection | Yes |
| 3-point headstrap connection | Yes |
| Adequate venting to minimize rebreathing CO2 | Yes |
| Vent design to minimize noise | Yes |
| No latex materials | Yes |
| No sharp edges | Yes |
| Mask is lightweight (60 grams) | Yes - 64 grams |
| Polybag packaging (clean non-sterile) | Yes |
| Materials | |
| Polyurethane Housing | Yes |
| Polycarbonate & Acetal Copolymer 15mm Swivel Elbow | Yes |
| Wire Insert Molded Into Mask Housing | Yes |
| Soft Facial Contact Cushion | Yes |
| Polycarbonate 3-Point Headstrap Bracket | Yes |
| Airway & direct contact component materials meet USP Class VI standards | Yes |
| Performance Testing | |
| Meets ASTM F1054-87 & ISO 5356-1 Standards | Yes |
| Meets ISO 17510-2:2003 Standard | Yes |
| Minimum 12 lpm @ 4 cm H2O Mask Leakage To Prevent CO2 Rebreathing | Yes |
Study Proving Acceptance Criteria (Substantial Equivalence):
The "study" proving the device meets the acceptance criteria is a substantial equivalence comparison to the predicate device, the SleepNet IQ™ Mask. This is not a traditional efficacy study, but rather a demonstration that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a "test set" in the context of clinical data for performance assessment of the iMask™ against specific patient outcomes. The evaluation is primarily a comparison of technical and material specifications against the predicate device and relevant standards.
- Data Provenance: The data primarily consists of bench testing results (e.g., meeting ASTM, ISO standards, leakage rates) and material biocompatibility testing. This is not patient-derived data in the typical sense. It is likely prospective for the iMask™'s own testing. The country of origin of the data is not explicitly stated but would be assumed to be from the manufacturer's testing facilities (Marquest Medical Products, Inc. in Englewood, CO, USA) or their chosen test labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts & Qualifications: This information is not provided and is generally not applicable in this type of 510(k) submission. "Ground truth" in this context refers to established engineering standards (ASTM, ISO), material science standards (USP Class VI), and the characteristics of the predicate device. These are objectively measurable or documented attributes, not subjective expert interpretations of clinical data.
4. Adjudication Method for the Test Set:
- Adjudication Method: This information is not provided and is not typically relevant for a substantial equivalence determination based on technical specifications and bench testing. There is no ambiguous clinical data requiring adjudication.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is used to assess the impact of a device on reader performance (e.g., radiologists interpreting images with or without AI assistance). The iMask™ is a physical medical device (CPAP mask), not an interpretive or diagnostic AI system.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this concept is not applicable. The iMask™ is a physical medical device, not an algorithm, and doesn't operate in a "standalone" algorithmic capacity. Its performance is assessed through bench testing and material compatibility, and its intended use is with a human patient and CPAP machine.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's validation is primarily based on:
- Established engineering standards: ASTM F1054-87, ISO 5356-1, ISO 17510-2:2003.
- Biocompatibility standards: USP Class VI for materials.
- Characteristics and performance of the legally marketed predicate device: SleepNet IQ™ Mask.
- Bench test results (e.g., mask leakage at specified pressure).
8. The Sample Size for the Training Set:
- Training Set Sample Size: This concept is not applicable. The iMask™ is a physical device, not an AI algorithm that undergoes a "training phase" with a dataset.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: This concept is not applicable as there is no "training set" or AI component to the device.
In summary, the provided document details a substantial equivalence argument for a physical medical device (CPAP mask). The "acceptance criteria" are the characteristics of the predicate device and relevant industry standards, and the "study" demonstrating compliance involves bench testing and material biocompatibility assessments, not clinical trials with patient data or expert interpretation.
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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 orTrade 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 airwaypressure equipment recommended by a physician, sleeptechnician, or respiratory therapist. |
| Indicated Use: | This device is intended to be used with positive airwaypressure devices operating at or above 4cmH2O for thetreatment of adult obstructive sleep apnea. |
| Targeted Population: | Adult population using a continuous positive airwaypressure device. |
| Environment of Use: | Home, hospital, or sleep lab. |
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510(k) SUMMARY OF SAFETY & EFFECTIVENESS (continued)
| Attribute | Marquest/VSI iMask™ | SleepNet IQ™ MaskK993269 |
|---|---|---|
| UseIntended for use inrespiratory therapy | Yes | Yes |
| Intended to be used withany CPAP device | Yes | Yes |
| Indicated for single patient useIn home, hospital, or sleep lab | Yes | Yes |
| Indicated for use withadult cases | Yes | Yes |
| Design/PerformanceComfortable face cushion | Yes | Yes |
| 15mm swivel elbow connection | Yes | Yes |
| 3-point headstrap connection | Yes | Yes |
| Adequate venting to minimizerebreathing 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 |
| MaterialsPolyurethane Housing | Yes | Yes |
| Polycarbonate & Acetal Copolymer15mm Swivel Elbow | Yes | Yes |
| Wire Insert Molded Into MaskHousing | Yes | Yes |
| Soft Facial Contact Cushion | Yes | Yes |
| Polycarbonate 3-Point HeadstrapBracket | Yes | Yes |
| Airway & direct contact componentmaterials meet USP Class VI standards | Yes | Yes |
| Performance TestingMeets ASTM F1054-87 &ISO 5356-1 Standards | Yes | Yes |
| Meets ISO 17510-2:2003 Standard | Yes | Yes |
| Minimum 12 lpm @ 4 cm H2OMask Leakage To Prevent CORebreathing | Yes | Yes |
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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).
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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.
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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
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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
§ 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).