(154 days)
Not Found
No
The device description details mechanical components for assisted ventilation and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is indicated to provide assisted ventilation, breathing, or resuscitation, which are therapeutic actions to help a patient.
No
The device is described as providing assisted ventilation, breathing, or resuscitation, which are therapeutic actions, not diagnostic ones. It helps maintain or restore breathing, rather than identifying a medical condition.
No
The device description clearly outlines physical components such as a face mask, one-way valve, filter, and mouthpiece, indicating it is a hardware device, not software-only.
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 assisted ventilation and resuscitation using a mouth-to-mask method. This is a direct intervention on a patient to support breathing, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device components (mask, valve, filter, mouthpiece) are all related to delivering air or oxygen to a patient's respiratory system. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims or interpretation of results from a sample
The device is clearly a medical device used for respiratory support and resuscitation, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Indicated to provide assisted ventilation to someone requiring assisted ventilation, breathing or resuscitation, by use of a mouth to mask method. Patient population is child / infant and adult. Those with oxygen port are prescription devices and those without the oxygen port are OTC.
Product codes (comma separated list FDA assigned to the subject device)
CBP
Device Description
The EMS Mouth to Mask resuscitators are a combination of components winion include a lave mask, one way valve, filter and mouthpiece offered with different sizes of face mask, packaging, clam shell and poly bag, and with or without flex tube extension. They are available in several styles -
Flex Tube which is an assembly of a flex tube, mouthpiece, one way valve and face mask (can be different sizes). This product is preassembled and packaged in a poly bag.
Collapsible style - This product includes a one way valve and a face mask which can be collapsed to fit into a "clam shell" style package. Besides the face mask being designed to collapse, the one way valve and mouthpiece can be removed so that all the components fit into the clam shell package.
Each style - Flex Tube and Collapsible - can incorporate a supplemental oxygen delivery port. This port is located on the one way housing. This port is a standard tapered fitting which connects to standard oxygen tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's face
Indicated Patient Age Range
child / infant and adult
Intended User / Care Setting
Hospital, Emergency Services, Home
Hospital, Emergency Medical 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
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).
0
317-335-9270
PAGE 05
K. 983919
4-7-99
| Acres of the Children
| AND AND PERSONAL | 1. Victorial Particle . Participant . Participant . Participant . Participant . Participant . Participant . Participant . Participant . Participal . Participal . Participal |
|---|---|
| Property of | Engineered Medical System |
| and the control of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comment |
8529 ZIONSVILLE ROAD • INDIANAPOUJS. IN 46268 • [317] 872-5500 • FAX (317) 872-4052
Non-Confidential Summary of Safety and Effectiveness page 1 of 3 December 18, 1998 (317) 872-5500 Tel -Engineered Medical Systems, Inc. 8529 Zionsville Rd. Fax - (317) 872-4052 Indianapolis, IN 46268 Jeff Quinn - President Official Contact: EMS Mouth to Mask resuscitators Proprietary or Trade Name: Mouth to Mask resuscitators Common/Usual Name: Classification Name: Non-rebreathing valve EMS Mouth to Mask resuscitators Device: EMS Mouth to Mask resuscitators - K881086 Predicate Devices: Formosa cj Health Partners - CPR Super - K953230 Intertech - MTM - K871407
The for the may be and of the count of the state the states to selling to the time to the may
The EMS Mouth to Mask resuscitators are a combination of components winion include a lave mask, one way valve, filter and mouthpiece offered with different sizes of face mask, packaging, clam shell and poly bag, and with or without flex tube extension. They are available in several styles -
Flex Tube which is an assembly of a flex tube, mouthpiece, one way valve and face mask (can be different sizes). This product is preassembled and packaged in a poly bag.
Collapsible style - This product includes a one way valve and a face mask which can be collapsed to fit into a "clam shell" style package. Besides the face mask being designed to collapse, the one way valve and mouthpiece can be removed so that all the components fit into the clam shell package.
Each style - Flex Tube and Collapsible - can incorporate a supplemental oxygen delivery port. This port is located on the one way housing. This port is a standard tapered fitting which connects to standard oxygen tubing.
2-2
1
Non-Confidential Summary of Safety and Effectiveness page 2 of 3 December 18, 1998
. ﻟﻠﺴﻠﺔ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
ಕ್ಕೃತ .
| Indicated Use -- | Indicated to provide assisted ventilation to someone requiring assisted ventilation, breathing or resuscitation, by use of a mouth to mask method. Patient population is child / infant and adult. Those with oxygen port are prescription devices and those without the oxygen port are OTC. | ||
|---|---|---|---|
| Environment of Use -- | Hospital, Emergency Services, Home | ||
| Medium | EMS | ||
| Indicated for use in resuscitation | Yes | Yes | |
| To be placed in contact with the patient's face | Yes | Yes | |
| Indicated for single use | Yes | Yes | |
| Indicated population - adult and child / infant | Yes | Yes | |
| Environment Home, EMS, Hospital | Yes | Yes | |
| Unit with oxygen port prescription device | Yes | Yes | |
| Unit without oxygen port is OTC | Yes | Yes | |
| Utilizes a face mask for patient seal | Yes | Yes | |
| Face mask cushion pre-inflated | Yes | Yes | |
| Offered in 2 face mask sizes | Yes | Yes | |
| Made in clear materials | Yes | Yes | |
| Utilizes a one way valve to direct air flow from user to patient | Yes | Yes | |
| Exhaled patient breath diverted to atmosphere away from giver | Yes | Yes | |
| Has an integral particulate / barrier filter | Yes | Yes | |
| Has a flex tube and mouth piece | Yes | Yes | |
| Packaged in a "clam shell" or poly bag | Yes | Yes | |
| Can incorporate an oxygen delivery port | Yes | Yes | |
| 2-3 | |||
| Materials of filter media - 3 M Filtrete | Yes | Yes | |
| Mask cushion - PVC | Yes | Yes | |
| Duckbill valve / one way - SR synthetic rubber | Yes | Yes | |
| Housing materials - Polycarbonate, K-resin | Yes | Yes | |
| Extension tube - Polyethylene | Yes | Yes | |
| Elastic band - polypropylene (PP), latex | Yes | Yes | |
| Case - polyethylene (PE) | Yes | Yes | |
| Filtration efficiency claims | None | None | |
| Meets appropriate sections of ASTM 920-93 | Yes | Yes | |
| None required under Section 514 | Yes | Yes |
2
. '
Non-Confidential Summary of Safety and Effectiveness
page 3 of 3
i
.
December 18, 1998
. . .
. **
్లు చేశారు.
మూలాలు నాలు
ుండ్రి 'ఒ కి ముఖ్యమైన మూలాలు మూలాలు
మూలాలు
ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ .. ... .. -- -% ﻨﺘﺸ
Supportures
There are no significant differences between the intended devices and the predicates.
2-4
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 APR
Mr. Jeff Quinn President Engineered Medical Systems 8529 Zionsville Road Indianapolis, IN 46268
Re: K983919 Trade Name: EMS Mouth to Mask Resuscitators Requlatory Class: II Product Code: СВР February 10, 1999 Dated: February 11, 1999 Received:
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 Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 regulatory 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.
4
Page 2 - Mr. Jeff Quinn
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (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. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 2
SIB
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: | (to be assigned) |
|---|---|
| Device Name: | EMS Mouth to Mask Resuscitators |
| Intended Use: | Indicated to provide assisted ventilation to someone |
| requiring assisted ventilation, breathing or resuscitation, by | |
| use of a mouth to mask method. Patient population is | |
| child / infant and adult. | |
| Those with oxygen port are prescription devices and those | |
| without the oxygen port are OTC. | |
| Environment of use: | Hospital, Emergency Medical Services |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Artt A. Cichowski
510
Prescription Use ﺮ (Per CFR 801.109)
or
Over-the-counter use √