(201 days)
The EMS Nasal CPAP mask and accessories (mask, spacers, mask support ring and headgear) are used with and attached to a positive pressure air source, CPAP or Bi-level equipment, and has the Indications for Use consistent with the Indications for Use of the equipment to which it is attached.
Environment of use: Hospital, sleep laboratories or home
The EMS Nasal CPAP mask is a mask covering the nose of a patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose. It connects to a patient circuit which contains an exhalation device, tubing and perhaps a humidifier and/or bacteria filter. It is held in place with an adjustable headgear system. It made to be cleaned by soap and water.
There are optional accessories which may assist in providing more patient comfort - Foam Spacers help to reduce excessive headgear tension and relieve pressure on the bridge of the nose and Cushion Support Ring which supports the wall of the cushion.
The provided documentation for the "EMS Nasal CPAP Mask and Accessories" does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, the "Respironics Silicone Contour Nasal CPAP mask (K883825)," by comparing various attributes.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as no such performance study is presented.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria (e.g., in terms of sealing performance, pressure delivery, comfort levels against a defined standard) or corresponding reported performance metrics for the EMS Nasal CPAP Mask are provided in this submission beyond a direct comparison of features and intended use with a predicate device. The document primarily focuses on a qualitative comparison to establish substantial equivalence.
The table in the original document outlines the comparison between the EMS Nasal CPAP and the predicate device. It implies that meeting the predicate's established characteristics serves as an "acceptance" for substantial equivalence.
| Attribute | EMS/Nasal CPAP | Respironics Contour Nasal Mask K883825 | Acceptance (Implied for Substantial Equivalence) |
|---|---|---|---|
| Same indications as equipment to which it is attached such as CPAP and Bi-level devices | Yes | Yes | Yes |
| Used on adults with OSA | Yes | Yes | Yes |
| Intended to be single patient - multi-use | Yes | Yes | Yes |
| Environment Home and Hospital | Yes | Yes | Yes |
| Same dimensions as the predicate | Yes | Yes | Yes |
| Offered in multiple sizes | Yes | Yes | Yes |
| Intended to be cleaned | Yes | Yes | Yes |
| Adapts to headgear | Yes | Yes | Yes |
| Separate Exhalation port / device required | Yes | Yes | Yes |
| Compatible with 22 mm tubing | Yes | Yes | Yes |
| Optional Foam Spacers | Yes | Yes | Yes |
| Optional Cushion Support Ring | Yes | Yes | Yes |
| Cushion made of silicone | Yes | Yes | Yes |
| Cone and swivel elbow made of Polycarbonate | Yes | Yes | Yes |
| Exact materials as utilized in the predicate devices | Yes | Yes | Yes |
| Performance Standards / Specifications (None required under Section 514) | Yes | Yes | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. No performance study with a test set composed of patient data is described. The comparison is based on device specifications and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of a performance study involving patient data or expert assessment, is not established or discussed in this document.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No. The document describes a comparison of device attributes for substantial equivalence, not an MRMC study assessing human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (CPAP mask), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of a diagnostic or therapeutic performance study. The "ground truth" for this submission is implicitly the established characteristics and performance of the legally marketed predicate device (Respironics Silicone Contour Nasal CPAP mask K883825) against which the new device is being compared for substantial equivalence.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set with established ground truth.
In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence to a predicate device by comparing design, materials, and intended use, rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.
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972603
JAN 2 8 1998
Engineered Medical Systems
8529 ZIONSVILLE ROAD • INDIANAPOLIS, IN 46268 • [317] 872-500 · FAX (317) 872-4052
| page 1 of 3 | |
|---|---|
| July 8, 1997 | |
| Engineered Medical Systems, Inc.8529 Zionsville Rd. | Tel - (317) 872-5500 |
| Indianapolis, IN 46268 | Fax - (317) 872-4052 |
| Official Contact: | Bonnie Holly - Quality Manager |
| Proprietary or Trade Name: | EMS Nasal CPAP Mask and Accessories |
| Common/Usual Name: | Face Mask |
| Classification Name: | Anesthetic Gas mask |
| Device: | EMS Nasal CPAP mask |
| Predicate Devices: | Respironics Silicone Contour Nasal CPAP mask - K883825 |
Device Description:
The EMS Nasal CPAP mask is a mask covering the nose of a patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose. It connects to a patient circuit which contains an exhalation device, tubing and perhaps a humidifier and/or bacteria filter. It is held in place with an adjustable headgear system. It made to be cleaned by soap and water.
There are optional accessories which may assist in providing more patient comfort - Foam Spacers help to reduce excessive headgear tension and relieve pressure on the bridge of the nose and Cushion Support Ring which supports the wall of the cushion.
Intended Use:
Same indication for the equipment to which it is the mask is attached Indicated Use --Environment of Use --Hospital and Home CPAP and Bi-level positive pressure systems, e.g. Respironics REM Star Equipment --CPAP and BiPAP Systems, with a separate exhalation device and 22 mm flexible tubing.
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Non-Confidential Summary of Safety and Effectiveness
page 2 of 3
July 8, 1997
Comparison to Predicate Devices: Devices: John Comparison
| Attribute | EMS/NasalCPAP | RespironicsContour Nasal MaskK883825 |
|---|---|---|
| Use |
Same indications as equipment to which it is
| attached such as CPAP and Bi-level devices | Yes | Yes |
|---|---|---|
| Used on adults with OSA | Yes | Yes |
| Intended to be single patient - multi-use | Yes | Yes |
| Environment Home and Hospital | Yes | Yes |
Design
| Same dimensions as the predicate | Yes | Yes |
|---|---|---|
| Offered in multiple sizes | Yes | Yes |
| Intended to be cleaned | Yes | Yes |
| Adapts to headgear | Yes | Yes |
| Separate Exhalation port / device required | Yes | Yes |
| Compatible with 22 mm tubing | Yes | Yes |
| Optional Foam Spacers | Yes | Yes |
| Optional Cushion Support Ring | Yes | Yes |
Materials ্ট
| Cushion made of silicone | Yes | Yes |
|---|---|---|
| Cone and swivel elbow made ofPolycarbonate | Yes | Yes |
| Exact materials as utilized in thepredicate devices | Yes | Yes |
{2}------------------------------------------------
Non-Confidential Summary of Safety and Effectiveness
page 3 of 3
July 8, 1997
| Attribute | EMS Nasal CPAP | Respironics Contour Nasal Mask K883825 |
|---|---|---|
| Performance Standards / Specifications | ||
| None required under Section 514 | Yes | Yes |
Differences between Other Legally Marketed Predicate Devices
There are no significant differences between the intended device and the Respironics Silicone Contour Nasal CPAP mask approved under K883825.
Page 5 of 31
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three stylized wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 1998
Ms. Bonnie Holly Engineered Medical Systems 8529 Zionsville Road Indianapolis, IN 46268
Re: K972605 EMS Nasal CPAP Mask Regulatory Class: II (two) Product Code: 73 BZD November 28, 1997 Dated: December 2, 1997 Received:
Dear Ms. Holly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) ---inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Bonnie Holly
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callshan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 3
INDICATIONS FOR USE
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number: | K972605 |
|---|---|
| Device Name: | EMS Nasal CPAP mask |
| Intended Use: | The EMS Nasal CPAP mask and accessories (mask, spacers, mask support ring and headgear) are used with and attached to a positive pressure air source, CPAP or Bi-level equipment, and has the Indications for Use consistent with the Indications for Use of the equipment to which it is attached. |
| Environment of use: | Hospital, sleep laboratories or home |
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Png
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K972605
Prescription Use (Per CFR 801.109)
or
Over-the-counter use _
Revised 9/30/97 Page 8 of 31
§ 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).