Pulmonary resuscitation during respiratory and/or cardiac arrest.
Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.

Device Description

The EMT automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.

AI/ML Overview

The provided text describes a 510(k) submission for the EMT Resuscitator, claiming substantial equivalence to the Genesis® II A/C device (K932170). The documentation focuses on non-clinical performance data and does not contain details about a clinical study with human patients, nor does it include information about AI integration or expert review for ground truth.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria, but implied by adherence to standards and equivalence claims.	Performance "within specification" when compared to the predicate device (Genesis® II).
Adherence to ISO 8382-1988	References made to ISO 8382-1988

Explanation: The documentation indicates that the device's performance was compared against thepredicate device and relevant standards (ISO 8382-1988). The conclusion states that the EMT Resuscitator performs "within specification" when compared to the predicate device. However, specific numerical performance metrics, thresholds, or "acceptance criteria" are not detailed in this section of the 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. The submission incorporated "significant amount of non-clinical test data." This suggests bench testing or simulated environments, not a test set derived from a patient population.
Data Provenance: Not applicable. As it's non-clinical test data, there's no country of origin or retrospective/prospective classification in the sense of patient data. The manufacturer is O-Two Systems International Inc. from Canada.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The study is non-clinical performance testing against specifications and standards, not a study requiring expert-established ground truth on medical conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a human-adjudicated test set.

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

No. This is a 510(k) submission for a medical device (resuscitator), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or reported.

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

No. This is a mechanical resuscitator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards (like ISO 8382-1988) as demonstrated through non-clinical testing.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set is mentioned.

Summary of Device Performance Study:

The provided information describes a substantial equivalence claim for the EMT Resuscitator. The study to support this claim consisted of non-clinical test data that reviewed the device's performance against both domestic and international standards (specifically referencing ISO 8382-1988) and compared it to the legally marketed predicate device, Genesis® II A/C. The conclusion states that the EMT Resuscitator performed "within specification" when compared to the predicate device. This type of submission relies on demonstrating that the new device has "similar technological characteristics" and performs comparably to a device already on the market, primarily through bench testing and adherence to recognized standards, rather than clinical trials with human subjects or AI-specific validation.

Summary

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K983705

OCT 2 9 1998

SAFETY AND EFFECTIVNESS STATEMENT.

EMT Resuscitator TRADE NAME:

COMMON NAME: AUTOMATIC RESUSCITATOR

REGULATORY CLASS: II

510K # : TO BE SUPPLIED

LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED:

510K #: K932170 GENESIS® II A/C - - - - -

DESCRIPTION OF THE DEVICE:

The EMT automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress.

The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

This device is designed to meet the ever-changing needs of the emergency respiratory care market. This device is similar in terms of features to the Genesis® II product -510K # K932170 except in the removal of the demand breathing and auto shut off functions. In addition the calibration for each setting has been amended to incorporate an extra automatic setting.

ASSESSMENT OF PERFORMANCE DATA

The submission incorporated a significant amount of non-clinical test data to support the claim of substantial equivalence. This test data reviewed the performance of the device against both the current domestic and international standards for these devices.

In particular, references were made to ISO 8382-1988.

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CONCLUSIONS BASED ON PERFORMANCE DATA

The testing undertaken verified that the EMT Resuscitator device, when compared with the performance of the device to which substantial equivalence is claimed, performed within specification.

CONTACT PERSON: KEVIN BOWDEN, DIRECTOR OF PRODUCT TECHNOLOGY

. 【送料無料】【送料無料】【送料無料】

Doc. #: SER/EMT/Oct 98

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DEPARTMENT OF HEALTH & HUMAN SERVICES-USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 29 1998

Mr. Kevin Bowden O-Two Systems International Inc. 7575 Kimbel Street Mississauga, Ontario Canada L5S 1C8

Re: K983705 EMT Resuscitator Regulatory Class: II (two) Product Code: BTL October 19, 1998 Dated: Received: October 21, 1998

Dear Mr. Bowden:

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 reqistration, listing of devices, qood 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 A substantially equivalent determination assumes compliance to 895. 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 assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements requlatory action. 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 requlations.

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Page 2 - Mr. Kevin Bowden

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, "Misbranding by reference to premarket notification"(21 CFR 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__________________________________________________________________________________________________________________________________________________________________________

510K Number (if known):

Device Name: EMT Resuscitator

Indications for Use:

Pulmonary resuscitation during respiratory and/or cardiac arrest. []
Short term ventilatory support for both inter and intra-hospital transport of [] non-breathing patients.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Name (Division Sign-Off)	Mark Kreme
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K983705

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator 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).