(79 days)
Not Found
No
The device description and intended use describe a purely mechanical, spring-actuated valve. There is no mention of software, algorithms, or any technology that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is an accessory that provides capabilities for therapeutic CPAP systems and ventilator circuits, indicating its use within a therapeutic context for medical treatment.
No
The device is described as an accessory to provide positive end expiratory pressure breathing capabilities, which is a therapeutic function, not a diagnostic one. It helps with breathing, but does not provide information about a patient's health status.
No
The device description clearly states it is a "spring actuated valve," indicating a physical hardware component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide positive end expiratory pressure breathing capabilities to manual resuscitators, therapeutic CPAP systems, and ventilator circuits. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a mechanical valve that provides pressure, again a therapeutic function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Indicated as an accessory to provide positive end expiratory pressure breathing capabilities to manual resuscitators, therapeutic CPAP systems and ventilator circuits.
Product codes (comma separated list FDA assigned to the subject device)
BYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, Emergency Services
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
| The first and the first and the property of the promote and the promote the first and the program and
been with and can person that the caps . " alles and an | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
DAY LINE I LINE DEALERS BOLL BOO |
.
| The for the first be and the first and the may be the county of |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A & A consideration of the Children Children
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Indicated Use -- | Indicated as an accessory to provide positive end expiratory pressure
breathing capabilities to manual resuscitators, therapeutic CPAP systems
and ventilator circuits. |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use -- | Hospital, Emergency Services |
Comparison to Predicate Devices: -
| Attribute | EMS
Adjustable | Ambu
K9323976 | Intertech
K# unknown |
|-------------------------------------------------------------|-------------------|------------------|-------------------------|
| Use | | | |
| Indicated for providing positive
end expiratory pressure | Yes | Yes | Yes |
| Used on manual resuscitators | Yes | Yes | Yes |
1
Non-Confidential Summary of Safety and Effectiveness
page 2 of 2
November 2, 1998
| Comparison to Predicate Devices: | |||
|---|---|---|---|
| Attribute | EMS | ||
| Adjustable | Ambu | ||
| K9323976 | Intertech | ||
| K# 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 range | |||
| 0-20 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.
2
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
3
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
4
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 ________________________________________________________________________________________________________________________________________________________________