(186 days)
The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive air treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multi-use
The device is a silicone elastomer nasal mask composed of a moulded, form fitting face mask, connected to standard 16 mm ventilator tubing via a standard 22 mm terminal fitting and fitted with a neoprene harness.
I am sorry, but the provided text does not contain the detailed information required to fill out all the sections of your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) summary for a medical device (Maskmedic Concept Nasal Mask) that focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed report of a performance study with acceptance criteria.
Here's what I can extract and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative criteria or benchmarks. The comparison is against the predicate device. | "Comparative performance testing has demonstrated performance equivalent to the predicate device, and the performance of the device is not compromised by storage in extreme environmental conditions or after cleaning." |
| "A risk assessment concluded that there were no significant new safety concerns raised by the design of the Maskmedic Concept Nasal Mask." |
Explanation: The 510(k) summary asserts "performance equivalent to the predicate device." However, it does not provide specific numerical acceptance criteria (e.g., leakage rates, pressure drop) or detailed results from the comparative performance testing.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While "Comparative performance testing" is mentioned, no details about participant numbers or study design are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device (nasal mask), not an AI/diagnostic device where expert ground truth would typically be established. The "testing" referred to is likely engineering/bench testing, not clinical evaluation with expert interpretation as ground truth.
4. Adjudication method for the test set:
- Not applicable for the same reasons as #3.
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:
- No. This is a physical device (nasal mask), not an AI/diagnostic algorithm that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device, not an algorithm.
7. The type of ground truth used:
- For the physical performance testing mentioned ("Comparative performance testing"), the "ground truth" would likely be established through engineering specifications, validated test methods, and comparison against the predicate device's known performance characteristics (e.g., manufacturing specifications, regulatory clearances). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.
8. The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI algorithm that requires a training set.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (a nasal mask). It mentions "comparative performance testing" but does not contain the detailed study results, acceptance criteria, or methodological specifics that would be required for a comprehensive answer to your questions, especially those related to AI or diagnostic studies.
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KO60067
510(K) SUMMARY
JUL 1 4 2006
Contact Person: Elaine Duncan Paladin Medical Inc. PO Box 560 Stillwater MN 55082 Tel: (715) 549 6035 Fax: (715) 549 5380
| Brand Name: | Maskmedic Concept Nasal Mask |
|---|---|
| Common Name: | Nasal Mask |
| Classification Name: | Non-continuous ventilator (21CFR 868.5905) |
| Product Code: | BZD |
| Predicate Device: | Resmed Mirage Activa (K030798) |
| Date Prepared: | 21 December 2005; Revised July 10, 2006 |
Description Of The Device:
The device is a silicone elastomer nasal mask composed of a moulded, form fitting face mask, connected to standard 16 mm ventilator tubing via a standard 22 mm terminal fitting and fitted with a neoprene harness.
Indications For Use:
The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive airway treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multo-use.
Summary of Equivalence: The Maskmedic Concept Nasal Mask is substantially equivalent to the Resmed Mirage Activa (K030798). Both the Maskmedic Concept Nasal Masy aqd the predicate devices are nasal masks suitable for use with currently marketed standard Continuous Positive Airway Pressure (CPAP) and bi-level positive airway treatment devices.
The technical designs and manufacture are essentially identical to the predicate devices, being composed of a form fitting nasal mask and harness, and connected to 16 mm ventilator, cubing via a standard 22 mm terminal fitting. Comparative performance testing has demonstrated performance equivalent to the predicate device, and the performance of the device is not compromised by storage in extreme environmental conditions or after cleaning. A risk assessment concluded that there were no significant new safety concerns raised by the design of the Maskmedic Concept Nasal Mask.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2006
Maskmedic Pty. Ltd. C/O Ms. Elaine Duncan President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082
Re: K060067
Trade/Device Name: Maskmedic Concept Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 10, 2006 Received: July 11, 2006
Dear Ms. Duncan:
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 - Ms. Duncan
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Judite Y. Michael Davis.
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): K060067:
Device Name: Maskmedic Concept Nasal Mask
Indications For Use:
The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive airway treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multi-use
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
liuu Sylvain
on of Anesthesiology, General Hospital, non Control, Dental Device
Number: K066067
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§ 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).