(79 days)
Indicated as an accessory to provide positive end expiratory pressure breathing capabilities to manual resuscitators, therapeutic CPAP systems and ventilator circuits. Available in 19mm, 22mm and 30 mm fittings. Pressure range from 0 to 20 cm H2O
The EMS PEEP valve is a adjustable valve which is placed in circuit and provides for positive end expiratory pressure for the patient. It is a spring actuated valve which adjusts from 0 to 20 cm H2O.
The provided document does not contain details about acceptance criteria, device performance, or related studies that would typically be found in a medical device submission beyond a comparison to predicate devices, which suggests substantial equivalence, rather than new performance criteria being established or met.
The document is a 510(k) premarket notification for the EMS Adjustable PEEP Valve. Such notifications primarily aim to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing new performance criteria through detailed studies as might be found in a De Novo submission or a PMA application.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or detailed performance data from a study. Instead, it relies on a comparison to predicate devices to demonstrate substantial equivalence. The "Performance Standards / Specifications" section explicitly states "None required under Section 514," indicating that specific performance standards were not mandated for this device at the time of submission.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.
2. Sample Size Used for the Test Set and Data Provenance
No information regarding a test set sample size or data provenance is provided. The submission focuses on comparison to predicate devices, not on a new testing study with a specific test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The document does not describe a study involving expert review to establish ground truth.
4. Adjudication Method
Not applicable. No study involving adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study would typically assess the improvement in human reader performance with AI assistance, which is not relevant to a PEEP valve.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The device is a mechanical PEEP valve, not an algorithm-based device. Therefore, no standalone algorithm performance study was done.
7. Type of Ground Truth Used
Not applicable. The submission does not describe a study that required establishing 'ground truth' in the context of expert consensus, pathology, or outcomes data. The basis for approval is substantial equivalence to physically existing predicate devices, not a diagnostic or prognostic performance claim needing extensive clinical validation.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as the device is a mechanical device, not one requiring machine learning or substantial data training.
9. How Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above.
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Engineered Medical Systems
500LLE BOAD + NDIANAPOLIS, IN 46268 • [317] 872-5500 • FAX (317) 872-4052
Non-Confidential Summary of Safety and Effectiveness 8529 ZION
| page 1 of 2 | |
|---|---|
| November 2, 1998 | |
| Engineered Medical Systems, Inc.8529 Zionsville Rd.Indianapolis, IN 46268 | Tel - (317) 872-5500 |
| Fax - (317) 872-4052 | |
| Official Contact: | Jeff Quinn - President |
| Proprietary or Trade Name: | EMS Adjustable PEEP Valve |
| Common/Usual Name: | PEEP valve |
| Classification Name: | Breathing attachment - positive end expiratory pressure |
| Device: | EMS PEEP Valve |
| Predicate Devices: | EMS PEEP valve - K932799 |
| Ambu - PEEP - K923976 | |
| Intertech - PEEP - K# unknown |
Device Description:
The EMS PEEP valve is a adjustable valve which is placed in circuit and provides for positive end expiratory pressure for the patient. It is a spring actuated valve which adjusts from 0 to 20 cm H2O.
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|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Indicated Use -- | Indicated as an accessory to provide positive end expiratory pressurebreathing capabilities to manual resuscitators, therapeutic CPAP systemsand ventilator circuits. |
|---|---|
| Environment of Use -- | Hospital, Emergency Services |
Comparison to Predicate Devices: -
| Attribute | EMSAdjustable | AmbuK9323976 | IntertechK# unknown |
|---|---|---|---|
| Use | |||
| Indicated for providing positiveend expiratory pressure | Yes | Yes | Yes |
| Used on manual resuscitators | Yes | Yes | Yes |
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Non-Confidential Summary of Safety and Effectiveness
page 2 of 2
November 2, 1998
| Comparison to Predicate Devices: | |||
|---|---|---|---|
| Attribute | EMSAdjustable | AmbuK9323976 | IntertechK# unknown |
| Use | |||
| Used with therapeutic CPAP systems | Yes | Yes | yes |
| Placed in the breathing circuit | Yes | Yes | Yes |
| Intended to be single patient | Yes | Yes | Yes |
| Environment Home, EMS | Yes | Yes | Yes |
| Design | |||
| Adjustable pressure range0-20 cm H₂O | Yes | Yes | Yes |
| Fitting 19, 22, 30 mm | Yes | Yes | Yes |
| Spring actuated tension | Yes | Yes | Yes |
| Materials | |||
| Materials of housing | |||
| Polycarbonate, K-resin, propionate | Yes | Yes - K-resin,Polycarbonate | Yes |
| Spring - stainless steel | Yes | Yes | Yes |
| Performance Standards / Specifications | |||
| None required under Section 514 | Yes | Yes | Yes |
Differences between Other Legally Marketed Predicate Devices . . . . . . . . . . . . . . . .
There are no significant differences between the intended device and the predicate - EMS PEEP valves -K932799, Ambu - K923976 and Intertech - K unknown.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three heads, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 22 1999
Mr. Jeff Quinn President Engineered Medical Systems 8529 Zionsville Road Indianapolis, IN 46268
Re : K983920 PEEP valves Requlatory Class: II (two) Product Code: BYE Dated: November 2, 1998 Received: November 4, 1998
Dear Mr. Quinn:
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 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). 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 Requlations, 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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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.
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, ² Misbranding by reference to premarket notification² (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
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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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.
ATIONS FOR USE
| 510(k) Number: | K983920 (to be assigned) |
|---|---|
| Device Name: | EMS PEEP Valves |
| Intended Use: | Indicated as an accessory to provide positive end expiratory pressure breathing capabilities to manual resuscitator, therapeutic CPAP systems, ventilator circuits. Available in 19mm, 22mm and 30 mm fittings. Pressure range from 0 to 20 cm H2O |
| Environment of use: | Hospital, Emergency Medical Services |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per CFR 801.109)
✓
or
Over-the-counter use ___
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).