(89 days)
Not Found
No
The summary describes a manual resuscitator and does not mention any AI or ML components or functionalities.
Yes
The device is described as an "adjunct to artificial respiration and cardiopulmonary resuscitation" and is used to ventilate patients, which directly treats a medical condition (apnea or insufficient breathing).
No
The device is a manual resuscitator used to ventilate patients, augmenting respiration and oxygen delivery. Its purpose is to provide respiratory support, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly states it is a "manual resuscitator," which is a hardware device used for ventilation. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "manual resuscitator" used for "ventilating the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient." This is a device that directly interacts with the patient's respiratory system to provide mechanical support.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely mechanical ventilation.
Therefore, the Datex Engstrom manual resuscitator falls under the category of a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To ventilate the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient. For use as an adjunct to artificial respiration and cardiopulmonary resuscitation.
Product codes (comma separated list FDA assigned to the subject device)
73 BTM
Device Description
The Datex Engstrom manual resuscitator is designed for use as an adjunct to artificial respiration and CPR. It can be used to ventilate the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient.
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
Adult, child and infant
Intended User / Care Setting
Emergency medical services, hospital, patient transport, Operating Room (OR), and where assisted ventilation may be required.
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
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
| |
Non-Confidential Summary of Safety and Effectiveness
JUN | 6 iser
page 1 of 3 March 12, 1997
Datex Engstrom AB Box 20109 S-16102 Bromma SWEDEN
| Tel - 011-46-8-629-3100 | Fax - 011-46-8-298418 |
|---|---|
| Official Contact: | Arne Salo, President |
| Proprietary or Trade Name: | Datex Engstrom reusable manual resuscitator |
| Common/Usual Name: | Manual resuscitator |
| Classification Name: | Ventilator, Emergency, Manual (Resuscitator) |
| Device: | Datex Engstrom Reusable Manual Resuscitator |
| Predicate Devices: | Hudson RCI - Durable Manual resuscitator - K895589 |
| Hudson RCI - PEEP valves - K902062 |
Device Description:
The Datex Engstrom manual resuscitator is designed for use as an adjunct to artificial respiration and CPR. It can be used to ventilate the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient.
| Indicated Use -- | Provide assisted ventilation | |
|---|---|---|
| Environment of Use -- | Emergency medical services, hospital, patient transport, | |
| Operating | Room (OR), and where assisted ventilation may be required. | |
| Patient population -- | Adult, child and infant | |
| Attribute | Datex-Engstrom | Hudson RCI |
| Use | ||
| Intended for use an adjunct to artificial respiration and CPR | Yes | Yes |
| Can be used to ventilate apnoeic patients | Yes | Yes |
| Augment ventilation and / or oxygen delivery to spontaneously breathing patients | Yes | Yes |
| Environment of use - Hospital, OR, anesthesia, PACU, ICU, transport, EMS, where assisted ventilation may be required or needed | Yes | Yes |
| Intended for use by qualified medical and emergency personnel trained in pulmonary ventilation and advanced cardiac life support techniques | Yes | Yes |
| Indicated for cleaning and reuse | Yes | Yes |
| Indicated population - adult, child, infant | Yes | Yes |
| Design / Theory of Operation | ||
| Connects to a Face mask or endotracheal tube | Yes | Yes |
| Has four major components Rebreathing valve, Silicone bag, Reservoir valve, Oxygen reservoir | Yes | Yes |
| May incorporate a PEEP valve | Yes | Yes |
| Available is three (3) sizes | Yes | Yes |
| Has available oxygen reservoir | Yes | Yes |
| Attribute | Datex-Engstrom | Hudson RCI |
| Design / Theory of Operation | ||
| Fits to standard 15 / 22 mm patient | ||
| end fittings | Yes | Yes |
| Offered with standard reusable | ||
| face mask - various styles | Yes | Yes |
| May be taken apart and cleaned | Yes | Yes |
| Cleaning methods - autoclave, EtO | Yes | Yes |
| Materials | ||
| Bag and duckbill valve - silicone | Yes | Yes |
| Patient connector, housing parts | ||
| made of Polysulfone | Yes | Yes |
| Pop-off valve - aluminum | Yes | Yes |
| PEEP valve spring stainless steel | Yes | Yes |
| Face mask - silicone or PVC | Yes | Yes |
| Reservoir bag - PVC | Yes | Yes |
| Performance Standards / Specifications | ||
| Patient fittings - 15 / 22 mm | ||
| ASTM 1054 / ISO 5356 | Yes | Yes |
| Meets all specifications, testing | ||
| and requirements of | ||
| ASTM 920 / ISO 8382 | Yes | Yes |
Comparison to Predicate Devices:
page 4 of 76
Dates-Eng-Irom AB
Postadress/Postal address Box 2:11:14
Telefon/Telephone Nat 08-629 31 19
lelefax Nat 08-29 84 18
1
Non-Confidential Summary of Safety and Effectiveness
(continued)
page 2 of 3
March 12, 1997
2
Non-Confidential Summary of Safety and Effectiveness
(continued)
page 3 of 3
March 12, 1997
Differences between Other Legally Marketed Predicate Devices
There is no differences between the intended device and the predicate devices which would be significant to patient safety or effectiveness.
Page 6 of 76
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1997
Mr. Paul Dryden Datex Engstrom AB c/o ProMedic, Inc. 6329 W. Waterview Court McCordsville, Indiana 46055-9501
Re: K970991 Datex-Engstrom Medical Reusable Manual Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: March 13, 1997 Received: March 19, 1997
Dear Mr. Dryden:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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
4
Page 2 - Mr. Paul Dryden
can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Druq Administration (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.
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 the labeling regulation (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 qeneral 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.qov/cdrh/dsmamain.html".
Sincerely yours,
DA Spyker
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Kadiological Health
Enclosure
5
JUN 1 6 1991
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: | K970991 (To be assigned) |
|---|---|
| Device Name: | Reusable Manual Resuscitator |
| Intended Use : | To ventilate the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient. For use as an adjunct to artificial respiration and cardiopulmonary resuscitation. |
| Environment of use: | Hospital - Emergency Medical Services, Operating Room, during patient transport, Intensive Care Units, where patient assisted ventilation may be administered or required. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christy Harman
(Division Sign-Off)
Division of Cardiovascular, Re a: . Neurological Devices 510(k) Number
Prescription Use
(Per CFR 801.109)
or
Over-the-counter use _
Page 10 of 76