(130 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of the HMEF, with no mention of AI or ML.
Yes.
The device is used to provide humidification and filtration during the delivery of ventilator gases, which directly affects patient health by preventing cross-contamination and ensuring proper respiratory function.
No
Explanation: The device is indicated for humidification and filtration of ventilator gases, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components (housing, HME-element, filter) made of specific materials and with defined dimensions and fittings. It is a hardware device for humidification and filtration of ventilator gases.
Based on the provided information, the HMEF500 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to humidify ventilator gases and provide filtration for reducing cross-contamination during ventilation. This is a direct interaction with the patient's breathing circuit and the gases being delivered, not the analysis of samples taken from the body.
- Device Description: The device description focuses on the physical components, materials, dimensions, and filtration capabilities related to gas exchange and filtration within the breathing circuit. There is no mention of reagents, calibrators, controls, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on safety standards related to breathing circuits, connectors, and filtration efficiency of airborne particles, not the accuracy or reliability of diagnostic measurements.
- Key Metrics: The key metrics are related to filtration efficiency, moisture output, and breathing resistance, all of which are relevant to the function of a breathing circuit component, not an IVD.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The HMEF500 does not perform this function. It is a component used in the delivery of respiratory support.
N/A
Intended Use / Indications 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.
Product codes
CAH
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
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
Intended User / Care Setting
qualified medical personnel, 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 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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Filtration efficiency viral 99.9 %
Filtration efficiency bacterial 99.9999999 %
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 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).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image shows a handwritten string of characters, "KO21265". Below the string, the text "Page 1 of 4" is printed in a smaller font size. The characters appear to be written with a dark ink on a white background.
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).
1
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).
2
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%
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).
In summary, the Datex-Ohmeda HMEF500, described in this submission is substantially equivalent to the predicate devices.
3
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.
4
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.
5
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
6
510(k) Number (if known): ____K021265
Device Name: Datex-Ohmeda HMEF 500
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
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