(28 days)
Not Found
No
The description details a passive mechanical device for humidification and filtration, with no mention of computational or adaptive elements.
No.
The device is a Heat and Moisture Exchanger Filter (HMEF) used in breathing circuits. Its primary functions are humidification of ventilator gases and filtration to reduce cross-contamination. These are supportive functions for ventilation, not direct therapeutic interventions themselves. While it aids in patient care, it does not treat a specific condition or disease.
No
The device is described as a disposable single-use device that provides humidification and filtration for ventilator gases, reducing cross-contamination. Its function is therapeutic and preventative, not diagnostic.
No
The device description clearly outlines physical components (housing, HME-element, filter) and materials, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to humidify ventilator gases and filter airborne particles to reduce cross-contamination. This is a therapeutic and protective function related to breathing support, not a diagnostic test performed on biological samples.
- Device Description: The device description details its physical components and filtration capabilities, which are relevant to its function in a breathing circuit. It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There are no reagents, test strips, or analytical methods described.
The device is clearly intended for use in a breathing circuit to modify the inhaled air and filter exhaled air, which falls under the category of respiratory support devices, not in vitro diagnostics.
N/A
Intended Use / Indications 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.
Product codes
CAH
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
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 are due to the smaller size of the HMEF Mini, resulting in a lower dead space. The HMEF Mini can be used with smaller patients compared to the HMEF 500. Both HMEF500 and HMEF Mini now have a BFE of 99.999%, although the previous HMEF 500 had a BFE of 99.999999% when measured in a different lab (CAMR). The HMEF Mini and the predicate HMEF 500 have the same (99.98%) Viral Filtration efficiency (VFE). The stated accuracy for VFE on the predicate HMEF500 increased from 99.9% to 99.98%.
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 and pediatric patients / small adult and pediatric patients
Intended User / Care Setting
Qualified medical personnel only. In hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators.
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Filtration efficiency viral 99.98 %
- Filtration efficiency bacterial 99.999 %
Predicate Device(s)
Reference Device(s)
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
§ 868.5260 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).
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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.
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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
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Page 1 of 1
510(k) Number (if known): KO236 41
Device Name: Datex-Ohmeda HMEF Mini
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.
(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
OR
510(k) Number: K023641