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.

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.

AI/ML Overview

The provided document, K970991, describes the Datex Engstrom Reusable Manual Resuscitator and its substantial equivalence to predicate devices, not an AI or algorithm-based device. Therefore, many of the requested categories related to AI performance, ground truth, and expert studies are not applicable.

Based on the available information for this medical device, here's an analysis of the acceptance criteria and the study proving compliance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Datex Engstrom Reusable Manual Resuscitator are primarily based on demonstrating substantial equivalence to legally marketed predicate devices (Hudson RCI - Durable Manual resuscitator - K895589 and Hudson RCI - PEEP valves - K902062) by meeting established performance standards and design characteristics.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Datex-Engstrom)	Predicate Device Performance (Hudson RCI)
Intended Use	Adjunct to artificial respiration and CPR	Yes	Yes
	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, etc.	Yes	Yes
User Qualification	Qualified medical and emergency personnel trained in pulmonary ventilation and ACLS	Yes	Yes
Reuse	Indicated for cleaning and reuse	Yes	Yes
Patient Population	Adult, child, infant	Yes	Yes
Design/Theory of Operation	Connects to face mask or endotracheal tube	Yes	Yes
	Four major components: Rebreathing valve, Silicone bag, Reservoir valve, Oxygen reservoir	Yes	Yes
	May incorporate a PEEP valve	Yes	Yes
	Available in three (3) sizes	Yes	Yes
	Has available oxygen reservoir	Yes	Yes
	Fits 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 - 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	Patient fittings - 15/22 mm (ASTM 1054 / ISO 5356)	Yes	Yes
	Meets all specifications, testing, and requirements of ASTM 920 / ISO 8382	Yes	Yes

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of an algorithm or AI. The assessment for this device is based on a comparison of design, materials, intended use, and adherence to recognized performance standards (ASTM, ISO). The provenance of this information is from the manufacturer's submission to the FDA for a 510(k) premarket notification in Sweden (Datex Engstrom AB is in Bromma, Sweden). The data is retrospective in the sense that it describes existing design features and compliance with established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device submission. The "ground truth" for a manual resuscitator is its physical properties, compliance with design specifications, and functioning according to established medical device standards. This is typically assessed through engineering design, materials testing, and adherence to international performance standards, rather than expert consensus on a test set of data.

4. Adjudication method for the test set

Not applicable. There is no "test set" or adjudication method as would be applied to an AI or diagnostic algorithm evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a traditional medical device (manual resuscitator), not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a traditional medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on adherence to:

Established Performance Standards: Specifically, ASTM 1054 / ISO 5356 for patient fittings and ASTM 920 / ISO 8382 for overall manual resuscitator performance. These standards define the expected physical and functional characteristics a device must possess.
Material Specifications: The use of specific, known biocompatible and durable materials like silicone, polysulfone, aluminum, and stainless steel.
Predicate Device Equivalence: The primary method for establishing effectiveness and safety is by demonstrating that the new device shares the same intended use, fundamental technological characteristics, and performance profile as legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable, as this is not an AI or algorithm-based device.

9. How the ground truth for the training set was established

Not applicable, as this is not an AI or algorithm-based device.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is not a clinical trial or an AI performance study in the modern sense. Instead, it's a technical comparison and declaration of compliance documented by the manufacturer as part of their 510(k) submission.

The document explicitly states:

"The Datex Engstrom manual resuscitator proposes to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976." (Implied by the 510(k) submission process itself and the FDA's final letter).
The comparison table (under "Device Description" and "Comparison to Predicate Devices") systematically details various attributes (Use, Environment of Use, Patient Population, Design/Theory of Operation, Materials, Performance Standards) for the Datex-Engstrom device and the predicate Hudson RCI device. In every listed attribute, the Datex-Engstrom device's performance or characteristic is marked "Yes," indicating it meets or is equivalent to the predicate.
A key statement is found in the "Performance Standards / Specifications" section: "Meets all specifications, testing and requirements of ASTM 920 / ISO 8382." This indicates that engineering tests were likely conducted to ensure compliance with these recognized safety and performance standards for manual resuscitators.
Finally, the document explicitly states under "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."

In summary, the device's acceptance is proven by demonstrating its substantial equivalence to predicate devices through a detailed comparison of its characteristics to those of the predicates and by confirming its adherence to relevant ASTM and ISO performance standards. This information would have been supported by internal testing and design documentation provided by Datex Engstrom AB to the FDA.

Summary

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K970991

| |

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:

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 patientend fittings	Yes	Yes
Offered with standard reusableface 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 partsmade 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 mmASTM 1054 / ISO 5356	Yes	Yes
Meets all specifications, testingand requirements ofASTM 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

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Non-Confidential Summary of Safety and Effectiveness

(continued)

page 2 of 3

March 12, 1997

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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

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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

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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

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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)

Over-the-counter use _

Page 10 of 76

Regulation Number and Section

§ 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).