The HMEF500 is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF 500 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult and pediatric patients. The device is indicated for use by qualified medical personnel only.

Device Description

The HMEF 500 incorporates a hygroscopically treated HME media and electrostatic filter media into a housing made of translucent plastic.
Diameter: 45 mm
Length: 74 mm
Material:
HMEF 200

Housing: PP Polypropylene
HME-element: PU Polyurethane impregnated with calcium chloride CaCl2
Filter: PP and acrylic fibers
Filtration efficiency:
Filtration efficiency viral 99.9 %
Filtration efficiency bacterial 99.9999999 %
The HMEF 500 is for use in adult and pediatric patients in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators.
It incorporates standard fittings for-
15 mm ID x 22 mm OD fitting to connect to the endotracheal tube or face mask
15 mmOD x 22 mm ID fitting to connect to the breathing circuit y-piece
A gas sampling port - female luer port with cap to allow sampling of expired CO2-gases

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Datex-Ohmeda HMEF 500, a Disposable Heat and Moisture Exchanger and Bacteria/Viral Filter. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical acceptance criteria through a study.

Therefore, much of the requested information regarding a study and its results, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, cannot be extracted from this document, as it does not describe such a study.

However, it does provide acceptance criteria in the form of performance specifications for the device and its compliance with relevant standards.

Here's a summary of the available information:

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

The document compares the Datex-Ohmeda HMEF 500 to two predicate devices (Datex-Ohmeda HMEF1000 and EMS HEPA Filter and Hepa Filter/HME). The "acceptance criteria" are implied by the performance of the predicate devices and the HMEF 500's own stated specifications, particularly its filtration efficiency and resistance for different flow rates.

Acceptance Criteria / Performance Metric (Implied)	Predicate Device (HMEF 1000) Performance	Predicate Device (EMS HEPA) Performance	Datex-Ohmeda HMEF 500 Performance
Filtration efficiency bacterial	99.999999 %	99.9999%	99.9999999 %
Filtration efficiency viral	99.99%	99.9999%	99.9 %
Breathing resistance @ 60 lpm	Not specified	3.4 cm H2O	3.3 cm H2O
Moisture output @ 500 ml Tidal Volume	Differed	Not specified	Differed
Size, weight, diameter, dead space	Differed	Differed	Smaller than HMEF1000
Labeled shelf life	Differed	Not specified	Differed

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

Not Applicable: The document does not describe a clinical or performance study with a test set in the traditional sense. The performance characteristics are stated as specifications rather than outcomes of a specific observational or interventional study. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

Not Applicable: This document does not describe a study involving human experts establishing ground truth. The device's performance is based on internal testing against standards.

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

Not Applicable: No adjudication method is mentioned as there is no human-reviewed test set described.

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 device is a physical medical filter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related improvement metrics are not relevant or discussed.

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

Not Applicable: This document describes a physical medical device, not an algorithm. Performance specifications are presented as inherent characteristics of the device itself.

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

Ground Truth: The "ground truth" for the device's performance characteristics (like filtration efficiency and resistance) appears to be established through laboratory testing and compliance with recognized industry standards (e.g., ISO 9360, ASTM F 1054-8721). The document states, "The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made..." This implies a ground truth based on rigorously defined physical and biological testing protocols under controlled conditions, as outlined by these standards.

8. The sample size for the training set:

Not Applicable: As this is a physical device, there is no "training set" in the context of an algorithm or AI model development.

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

Not Applicable: No training set is described.

In summary: This 510(k) submission primarily relies on demonstrating that the new device (Datex-Ohmeda HMEF 500) is substantially equivalent to existing, legally marketed predicate devices by comparing their technical characteristics and showing compliance with established safety standards. It does not present a clinical study with a test set, human readers, or AI components. The "acceptance criteria" are the technical specifications and adherence to recognized performance standards for such devices.

Summary

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AUG 3 0 2002

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda HMEF 500

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE: August 29, 2002

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Datex-Ohmeda HMEF 500

COMMON NAME:

Disposable Heat and Moisture Exchanger and Bacteria/Viral Filter

CLASSIFICATION NAME:

The following Class II classification appears applicable:

CAH Breathing Circuit Bacterial Filter 868.5260

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda HMEF500 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda HMEF1000 (K964204) and predicate EMS HEPA Filter and Hepa Filter/HME (K013089).

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DEVICE DESCRIPTION as required by 807.92(a)(4)

The intended use for the modified device is the same as the predicate.

Indication for use: The HMEF500 is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF 500 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device is indicated for use by qualified medical personnel only.

There has been no change to the fundamental scientific technology from the predicate.

The device description of the Datex-Ohmeda HMEF500 is as follows:

The HMEF 500 incorporates a hygroscopically treated HME media and electrostatic filter media into a housing made of translucent plastic.

Diameter: 45 mm

Length: 74 mm

Material:

HMEF 200

Housing: PP Polypropylene
HME-element: PU Polyurethane impregnated with calcium chloride CaCl2
Filter: PP and acrylic fibers

Filtration efficiency:

Filtration efficiency viral 99.9 %
Filtration efficiency bacterial 99.9999999 %

The HMEF 500 is for use in adult and pediatric patients in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators.

It incorporates standard fittings for-

15 mm ID x 22 mm OD fitting to connect to the endotracheal tube or face mask

15 mmOD x 22 mm ID fitting to connect to the breathing circuit y-piece

A gas sampling port - female luer port with cap to allow sampling of expired CO2-gases

The modifications to the device are:

The Datex-Ohmeda HMEF500 has the following differences when compared to the Datex-Ohmeda HMEF 1000 predicate device:

The devices differ in size, weight, diameter, dead space

The devices differ in Moisture output (a) 500 ml. Moisture loss. Breathing resistance @30 litre/minute and Tidal Volume

The devices differ in labeled shelf life

Filtration efficiency against bacteria: HMEF 1000 99,999999%, HMEF 500 99.99999999%
Filtration efficiency against virus: HMEF 1000 99,99%, HMEF 500 99,9%

The main differences between the Datex-Ohmeda HMEF500 and Datex-Ohmeda HMEF1000 (K964204) are due to fact that the size of the Datex-Ohmeda HMEF500 is smaller than the Datex-Ohmeda HMEF1000 (K964204). This makes the HMEF500 suitable for use in patients with lower tidal volumes.

The HMEF 500 has a lower breathing resistance at 60 lpm than the predicate EMS HEPA Filter and Hepa Filter/HME (K013089). The HMEF 500 resistance at 60 lpm is 3.3 cm H2O compared to is 3.4 cm H2O for the predicate EMS HEPA Filter and Hepa Filter/HME (K013089).

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INTENDED USE as required by 807.92(a)(5)

Indication for use: The HMEF500 is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF 500 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult and pediatric patients. The device is indicated for use by qualified medical personnel only.

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda HMEF500 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) EMS HEPA Filter and Hepa Filter/HME (K013089) and Datex-Ohmeda HMEF1000 (K964204).

The Datex-Ohmeda HMEF500 has the following similarities to the EMS HEPA Filter and Hepa Filter/HME and Datex-Ohmeda HMEF1000 predicate devices:

-have basically the same indicated use

-Both the HMEF 500 and predicate EMS HEPA Filter and Hepa Filter/HME, HMEF 1000 give efficient protection against transfer of bacteria / viruses between patients, personnel and equipment

The Datex-Ohmeda HMEF500 has the following differences when compared to the EMS HEPA Filter and Hepa Filter/HME and Datex-Ohmeda HMEF1000 predicate devices: -The devices differ in size, weight, diameter, dead space

The devices differ in Moisture output @ 500, Breathing resistance @30 litre/minute, @60 litre/minute and Tidal Volume

-Filtration efficiency against bacteria: HMEF 1000 99.999999 %, HMEF 500 99.9999999 % and EMS HEPA Filter and Hepa Filter/HME 99,9999%.

-Filtration efficiency against virus: HMEF 1000 99.99%, HMEF 500 99.9% and EMS HEPA Filter and Hepa Filter/HME 99.9999%

In summary, the Datex-Ohmeda HMEF500, described in this submission is substantially equivalent to the predicate devices.

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SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The Datex-Ohmeda HMEF 500 complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:

ISO 9360: 1992 .
ISO 5356-1:1996 .
ISO 594-1:1986" .
ISO 594-2:1998 .
EN 980: 1996 .
EN 1041:1998 .
EN 13014
ASTM F 1054-8721 .

Conclusion:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda HMEF 500 as compared to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its head.

AUG 3 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel C. Kent Manager, Quality and Regulatory Affairs Datex-Ohmeda 86 Pilgrim Road Needham, Massachusetts 02492

Re: K021265

Trade/Device Name: Datex-Ohmeda HMEF500 Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: July 31, 2002 Received: August 1, 2002

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 – Mr. Kent

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timot . Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____K021265

Device Name: Datex-Ohmeda HMEF 500

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

La Valdrusk

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Denta

510(k) Number. K021265

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).