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

Diameter: 45 mm .
. Length: 64 mm
. Housing: PP Polypropylene
. HME-element: PU Polyurethane impregnated with calcium chloride CaCl2
Filter: PP and acrylic fibers .
Filtration efficiency:
Filtration efficiency viral 99.98 % ●
. Filtration efficiency bacterial 99.999 %
The HMEF Mini is for use in small 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 mm OD 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 document describes a 510(k) premarket notification for the Datex-Ohmeda HMEF Mini, a disposable heat and moisture exchanger and bacteria/viral filter. The document focuses on demonstrating substantial equivalence to a predicate device, the Datex-Ohmeda HMEF500 (K021265), rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

Therefore, the information required to answer the questions in the prompt, such as sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, and ground truth establishment for an AI/algorithm device, is not present in this document. The provided text details the physical characteristics, intended use, and non-clinical testing of a physical medical device.

However, I can extract the acceptance criteria (performance specifications) and reported device performance from the document where applicable for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Differences: The document explicitly states differences in length, weight, dead space, moisture output, moisture loss, breathing resistance, and minimum tidal volume between the HMEF Mini and the HMEF500, primarily due to the HMEF Mini's smaller size. However, specific numerical acceptance criteria (e.g., "dead space must be < X ml") are not provided for these parameters, only that they differ. The most significant difference highlighted and explained is the BFE, with the current BFE for both devices being 99.999% due to different laboratory measurement sensitivities.

The remaining questions (2-9) are typically relevant for AI/algorithm-based medical devices which involve analyzing data sets and establishing ground truth based on expert consensus or pathology. This document describes a physical medical device (a heat and moisture exchanger/filter), and therefore, these questions are not applicable to the information provided. The "study" mentioned in the document refers to nonclinical testing and verification against safety standards rather than a clinical trial or algorithm performance study.

Given the nature of the device (physical filter) and the type of document (510(k) summary for substantial equivalence), information about:

Sample size for test set and data provenance
Number/qualifications of experts for ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone performance (algorithm only)
Type of ground truth (for an algorithm)
Sample size for the training set (for an algorithm)
How ground truth for the training set was established (for an algorithm)

...is not contained within this 510(k) submission. The "ground truth" for a physical device like this is typically established by physical measurements and standardized testing procedures (e.g., filtration efficiency tests in accredited labs), rather than expert consensus on medical images or pathology.

Summary

{0}------------------------------------------------

Page 1 of 4

Image /page/0/Picture/1 description: The image shows a handwritten text string. The string appears to be "K0236.". The characters are written in a cursive style with thick, dark strokes, suggesting the use of a marker or pen with a bold tip. The background is plain white, providing a clear contrast to the dark text.

NOV 2 7 2002

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

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:

October 28, 2002

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

TRADE NAME:

Datex-Ohmeda HMEF Mini

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 HMEF Mini is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda HMEF500 (K021265).

{1}------------------------------------------------

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

The intended use and indications for use for the modified device are the same as the predicate.

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

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

Dimensions and Materials

Diameter: 45 mm .
. Length: 64 mm
. Housing: PP Polypropylene
. HME-element: PU Polyurethane impregnated with calcium chloride CaCl2
Filter: PP and acrylic fibers .

Filtration efficiency:

Filtration efficiency viral 99.98 % ●
. Filtration efficiency bacterial 99.999 %

The HMEF Mini is for use in small 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 mm OD 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 HMEF Mini has the following differences when compared to the Datex-Ohmeda HMEF500 predicate device:

The devices differ in length, weight, dead space, moisture output, moisture loss, breathing resistance and minimum tidal volume

The main differences between the Datex-Ohmeda HMEF Mini and the predicate Datex-Ohmeda HMEF500 (K021265) are due to fact that the size of the Datex-Ohmeda HMEF Mini is less than the Datex-Ohmeda HMEF500 (K021265). This makes the dead space of the HMEF Mini lower than HMEF500. The HMEF Mini can be used with smaller patients compared to the HMEF 500. The predicate HMEF 500 has a bacterial filtration efficiency (BFE) of 99.999999% when measured in CAMR lab. UK. Now both HMEF500 and HMEF Mini have a BFE of 99.999%. The bacterial filtration efficiency differs because the measurements were made in different laboratories (Nelson lab. and CAMR). The HMEF Mini and the predicate HMEF 500 have the same (99.98%) Viral Filtration efficiency (VFE). The predicate HMEF500 has exactly the same viral filtration efficiency as before, only the stated accuracy has increased from 99.9% to 99.98%.

The changes in the labels and instructions for use were made to add the specifications and name of the new device to the IFU. No changes in the warnings, cautions or contraindications have been made.

{2}------------------------------------------------

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

Indication for use: The HMEF Mini 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 Mini 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 HMEF Mini is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda HMEF500 (K021265). The Datex-Ohmeda HMEF Mini has the following similarities to the Datex-Ohmeda HMEF500 predicate device: -have the same indicated use -have the same fundamental scientific technology and use the same operating principle -are manufactured using the same processes -constructed of identical materials -Both the HMEF Mini and predicate HMEF 500 give efficient protection against transfer of bacteria / viruses between patients, personnel and equipment -Filtration efficiency against virus -Filtration efficiency against bacteria The Datex-Ohmeda HMEF Mini has the following differences when compared to the Datex-Ohmeda HMEF500 predicate device: -The devices differ in length, weight, dead space -The devices differ in Moisture output, Moisture loss, Breathing resistance and Minimum Tidal Volume The main differences between the Datex-Ohmeda HMEF Mini and the predicate Datex-Ohmeda HMEF500 (K021265) are due to fact that the size of the Datex-Ohmeda HMEFMini is less than the Datex-Ohmeda HMEF500 (K021265). This makes the dead space of the HMEF Mini lower than HMEF500. The HMEF Mini can be used with smaller patients compared to the HMEF 500. The predicate HMEF 500 has a bacterial filtration efficiency (BFE) of 99.999999% when measured in CAMR lab. UK. Now both HMEF500 and HMEF Mini have a BFE of 99.999%. The bacterial filtration efficiency

differs because the measurements were made in different laboratories (Nelson lab. and CAMR). The laboratories have different sensitivities in measurement devices. The previous laboratory (CAMR) uses different micro-organisms at higher challenge levels. The HMEF Mini and the predicate HMEF 500 have the same (99.98%) Viral Filtration efficiency (VFE). The predicate HMEF500 has exactly the same viral filtration efficiency as before, only the stated accuracy has increased from 99.9% to 99.98%.

In summary, the Datex-Ohmeda HMEF Mini, described in this submission is substantially equivalent to the predicate HMEF 500 (K021265).

{3}------------------------------------------------

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

The Datex-Ohmeda HMEF Mini 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 Mini as compared to the predicate device.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

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

Re: K023641

Trade/Device Name: Datex-Ohmeda HMEF Mini Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: October 28, 2002 Received: October 30, 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.

Image /page/4/Picture/10 description: The image shows a partial view of a logo or emblem, featuring the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern. The text curves along the upper and left edges of the image, suggesting it forms part of a larger circular design. To the right of the text, there are stylized graphic elements that appear to be abstract representations of human profiles or faces, possibly symbolizing the department's focus on health and human services. The overall design is simple and uses a monochromatic color scheme.

{5}------------------------------------------------

Page 2 -- Mr. Kent

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. 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), 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Ulletowski

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

Enclosure

{6}------------------------------------------------

Page 1 of 1

510(k) Number (if known): KO236 41

Device Name: Datex-Ohmeda HMEF Mini

(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)

Iththth

510(k) Number: K023641

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).

Acceptance Criteria (Predicate [HMEF500] Performance)	Reported Device Performance (HMEF Mini)
Bacterial Filtration Efficiency (BFE): 99.999999% (CAMR lab, UK)	Bacterial Filtration Efficiency (BFE): 99.999% (Nelson lab)
Viral Filtration Efficiency (VFE): 99.9% (stated accuracy prior to update)	Viral Filtration Efficiency (VFE): 99.98% (same as predicate, accuracy increased)
Intended Use: Same as predicate	Intended Use: Same as predicate
Fundamental Scientific Technology: Same as predicate	Fundamental Scientific Technology: Same as predicate
Operating Principle: Same as predicate	Operating Principle: Same as predicate
Manufacturing Processes: Same as predicate	Manufacturing Processes: Same as predicate
Materials: Identical to predicate	Materials: Identical to predicate
Efficient protection against transfer of bacteria/viruses: Yes	Efficient protection against transfer of bacteria/viruses: Yes
Compliance with ISO 9360:1992	Compliance with ISO 9360:1992
Compliance with ISO 5356-1:1996	Compliance with ISO 5356-1:1996
Compliance with ISO 594-1:1986	Compliance with ISO 594-1:1986
Compliance with ISO 594-2:1998	Compliance with ISO 594-2:1998
Compliance with EN 980:1996	Compliance with EN 980:1996
Compliance with EN 1041:1998	Compliance with EN 1041:1998
Compliance with EN 13014	Compliance with EN 13014
Compliance with ASTM F 1054-8721	Compliance with ASTM F 1054-8721