(395 days)
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of > 3.0 cm H₂O at the mask is required. Single patient, multi-use
The EMS Multi-strap Full Face mask covers both the nose and mouth and includes a nonrebreathing / anti-asphyxia valve, which is activated under flow / pressure from a CPAP or bilevel ventilator. It is open to ambient air when the ventilator is not ON allowing the patient to breath ambient air. It has a quick release mask harness system. It is single patient, multi-use.
The information provided describes the Engineered Medical Systems, Inc. Multi-strap Full Face Mask and its 510(k) summary for clearance. However, the document does NOT contain a study that proves the device meets specific acceptance criteria with reported device performance metrics in the way a clinical or performance study for an AI/ML medical device would.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (a CPAP mask). The "acceptance criteria" here are characteristics and design features that are compared to legally marketed predicate devices, rather than performance metrics from a formal study with a test set, ground truth, or expert review as typically seen in AI/ML device submissions.
Therefore, many of the requested fields cannot be directly answered from the provided text, as they pertain to performance studies not conducted or reported in this type of submission.
Here's the breakdown based on the provided text, addressing the points where information is available or inferable within the context of a substantial equivalence claim for a physical device:
1. Table of Acceptance Criteria and the Reported Device Performance
For this type of device, "acceptance criteria" are typically defined by functional specifications and comparison to predicate devices, demonstrating that the new device performs as intended and is as safe and effective. The "reported device performance" is a demonstration that these specifications are met and that the device is substantially equivalent to predicates.
| Attribute / Acceptance Criteria (as per functional specifications and comparison to predicates) | Reported Device Performance / Status (as per 510(k) summary) |
|---|---|
| Indications for use: A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of > 3.0 cm H₂O at the mask is required. | Meets this indication, as it is the stated intended use. Substantially equivalent to predicates for this use. |
| Single patient, multi-use | Yes (device is designed for this) |
| Prescription | Yes (device is intended for prescription use) |
| Intended population: Any patient | Meets this intention. |
| Intended Environment of Use: Hospital, Sub-acute Institutions, Home | Meets this intention. |
| Mask covers nose and mouth | Yes (design feature) |
| Quick release mask harness | Yes (design feature) |
| Non-rebreathing / anti-asphyxia valve | Yes (design feature) |
| Must be used with exhalation valve in circuit | Yes (design feature/requirement) |
| Open to ambient when ventilator off | Yes (design feature) |
| Valve opens at > 3 cm H₂O | Yes (design feature, aligns with minimum pressure) |
| Can be cleaned | Yes (design feature, implies reusability for single patient) |
| Materials: Mask cone and Elbow - PC; Mask cushion - PVC; Flap valve - Silicone | Yes (materials specified and used) |
| Performance Standards: None under Section 514 | No specific 514 standards apply or are cited as met. |
| Overall Safety and Effectiveness | Demonstrated safe and effective, substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on substantial equivalence based on design, materials, and intended use comparison to predicate devices, not on a formal clinical or performance test study with a "test set" in the context of an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. There was no "test set" requiring expert ground truth in the context of this 510(k) for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No "test set" requiring adjudication was reported.
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
This information is not applicable/provided. This is a submission for a physical medical device (CPAP mask), not an AI/ML diagnostic tool, and therefore no MRMC study would be relevant or expected.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This is a physical medical device; there is no "algorithm" or "standalone performance" in the context described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided. For this physical medical device, the "ground truth" for demonstrating equivalence largely relies on engineering specifications, material properties, and comparison of functional design features to existing legally marketed devices.
8. The sample size for the training set
This information is not applicable/provided. This document does not describe a training set as would be relevant for an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided. This document does not describe a training set or its ground truth establishment.
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DEC = 1 2003
2.1 510(k) Summary of Safety and Effectiveness
Engineered Medical Systems, Inc. 2055 Executive Dr. Indianapolis, IN 46241
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 October 31, 2002
| Engineered Medical Systems | Tel (317) 246-5500 |
|---|---|
| 2055 Executive Dr. | Fax (317) 246-5501 |
| Indianapolis, IN 46241 |
| Official Contact: | Bonnie A. Holly - Quality Manager |
|---|---|
| Proprietary or Trade Name: | Multi-strap Full Face Mask |
| Common/Usual Name: | Full Face CPAP Mask |
| Classification Name: | Non-continuous ventilator (IPPB) accessory |
| Predicate Devices: | Caradyne - Whisperflow mask - K982283 |
| Respironics - Spectrum Full Face Mask - K961915 | |
| ResMed -- Sullivan Mirage Full Face Mask - K982530 |
Device Description:
The EMS Multi-strap Full Face mask covers both the nose and mouth and includes a nonrebreathing / anti-asphyxia valve, which is activated under flow / pressure from a CPAP or bilevel ventilator. It is open to ambient air when the ventilator is not ON allowing the patient to breath ambient air. It has a quick release mask harness system. It is single patient, multi-use.
Intended Use:
| Indicated Use -- | A patient interface accessory for use with CPAPand bi-level systems used in the treatment of adultOSA and / or ventilatory support. |
|---|---|
| A minimum pressure of $\geq$ 3.0 cm H2O at the mask isrequired. | |
| Environment of Use -- | Hospital, Sub-acute Institutions, Home |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 October 31, 2002
General Technical Characteristics
| Attribute | EMS – Proposed device |
|---|---|
| Indications for use | A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. A minimum pressure of > 3.0 cm H₂O at the mask is required. |
| Single patient, multi-use | Yes |
| Prescription | Yes |
| Intended population | Any patient |
| Intended Environment of Use | Hospital, Sub-acute Institutions, Home |
| Design | |
| Mask covers nose and mouth | Yes |
| Quick release mask harness | Yes |
| Non-rebreathing / anti-asphyxia valve | Yes |
| Must be used with exhalation valve in circuit | Yes |
| Open to ambient when ventilator off | Yes |
| Valve opens at > 3 cm H2O | Yes |
| Can be cleaned | Yes |
| Materials | |
| Mask cone and Elbow - PC | Yes |
| Mask cushion - PVC | Yes |
| Flap valve - Silicone | Yes |
| Performance Standards | |
| None under Section 514 | Yes |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially cquivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the three branches of government.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2003
Engineered Medical Systems, Inc. C/O Mr. Paul Dryden Regulatory Consultant Promedic, Inc. 6329 West Waterview Court McCordsville, Indiana 46055-9501
Re: K023683
Trade/Device Name: Multi-Strap Full Face Mask Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator Regulatory Class: II Product Code: BZD Dated: October 8, 2003 Received: October 9, 2003
Dear Mr. Dryden:
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 cither 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. Dryden
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) 594-4646. 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,
Susa Ruine
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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2.3 Indications for Use
Page 1 of 1
| 510(k) Number: | K023683 (To be assigned) |
|---|---|
| Device Name: | Multi-strap Full Face Mask |
| Intended Use: | A patient interface accessory for use with CPAPand bi-level systems used in the treatment of adultOSA and / or ventilatory support. |
| A minimum pressure of > 3.0 cm H₂O at the mask isrequired. | |
| Single patient, multi-use |
Concurrencc of CDRH, Office of Device Evaluation (ODE)
Fisther
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K823683
Prescription Use (Per CFR 801.109)
or
Over-the-counter use _
§ 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).