(23 days)
No
The device description focuses on physical components and filtration efficiency, with no mention of AI or ML.
No
The device provides humidification and filtration for ventilator gases and does not directly treat a disease or condition.
No
This device is described as a humidifier and filter for ventilator gases, designed to reduce cross-contamination and provide humidification. Its function is therapeutic and supportive, not diagnostic, even though it has a port for sampling expired CO2 gases which might be used for diagnostic purposes by other equipment. The device itself does not perform diagnostics.
No
The device description clearly outlines physical components made of plastic, polyurethane, and fibers, and describes dimensions and fittings. This indicates a hardware device, not software only.
Based on the provided information, the HMEF 750 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for humidification and filtration of ventilator gases delivered to patients. This is a direct interaction with the patient's respiratory system, not the analysis of samples taken from the body.
- Device Description: The description focuses on the physical components and their function in humidifying and filtering air. There is no mention of reagents, assays, or any components designed to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The HMEF 750 is a medical device used in the respiratory support of patients, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The HMEF 750 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 750 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 750 incorporates a hygroscopically treated HME media and electrostatic filter media into a housing made of translucent plastic.
Dimensions and Materials
- Diameter: 62 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 99.998 % ●
- Filtration efficiency bacterial 99.9999 % ●
The HMEF 750 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
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
hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device is indicated for use by qualified medical personnel only.
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 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 9360:2000
- 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 99.998 %
Filtration efficiency bacterial 99.9999 %
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
JUN 2 0 2003
Image /page/0/Picture/1 description: The image shows the text "K031653" in a handwritten style. Below this text, the words "Page 1 of 4" are printed in a smaller font size. The text appears to be part of a document or form, possibly indicating a page number within a larger set of pages.
Image /page/0/Picture/2 description: The image is a logo that features a stylized letter 'D' inside of a circle. The 'D' is white and the circle is black, creating a contrast. There is a small black square in the upper right corner of the circle, resembling a camera flash or a design element. The logo has a modern and minimalist aesthetic.
Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda HMEF 750
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:
May 19, 2002
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Datex-Ohmeda HMEF 750
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 750 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 750 incorporates a hygroscopically treated HME media and electrostatic filter media into a housing made of translucent plastic.
Dimensions and Materials
- Diameter: 62 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 99.998 % ●
- Filtration efficiency bacterial 99.9999 % ●
The HMEF 750 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 750 has the following differences when compared to the Datex-Ohmeda HMEF 500 predicate device:
The devices differ in length, weight, dead space, moisture output, moisture loss, breathing resistance and maximum tidal volume
The main differences between the Datex-Ohmeda HMEF 750 and the predicate Datex-Ohmeda HMEF500 (K021265) are due to fact that the length of the Datex-Ohmeda HMEF 750 is shorter and the width of the HMEF 750 is wider than the Datex-Ohmeda HMEF500 (K021265). This makes the dead space of the HMEF 750 little bit larger than HMEF500 but gives much lower breathing resistances and better moisture output. The HMEF 750 can be used larger patient than predicate HMEF 500.
The predicate HMEF 500 has a bacterial filtration efficiency (BFE) of 99.999% and the HMEF 750 has BFE of 99.9999%.
The predicate HMEF 500 has the Viral Filtration efficiency (VFE) of 99.98% and the HMEF 750 has VFE of 99.998%.
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 750 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 750 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 750 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda HMEF500 (K021265).
The Datex-Ohmeda HMEF 750 has the following similarities to the Datex-Ohmeda HMEF 500 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 750 and predicate HMEF 500 give efficient protection against transfer of bacteria / viruses between patients, personnel and equipment
The Datex-Ohmeda HMEF 750 has the following differences when compared to the Datex-Ohmeda HMEF 500 predicate device:
-The devices differ in length, weight, dead space
-Filtration efficiency against virus
-Filtration efficiency against bacteria
-The devices differ in Moisture output, Moisture loss, Breathing resistance and Maximum Tidal Volume
The main differences between the Datex-Ohmeda HMEF 750 and the predicate Datex-Ohmeda HMEF 500 (K021265) are due to fact that the length of the Datex-Ohmeda HMEF 750 is shorter and the width of the HMEF 750 is wider than the Datex-Ohmeda HMEF 500 (K021265). This makes the dead space of the HMEF 750 little bit larger than HMEF 500 but gives much lower breathing resistances and better moisture output.
The predicate HMEF 500 has a bacterial filtration efficiency (BFE) of 99.999% and the HMEF 750 has BFE of 99.9999%.
The predicate HMEF 500 has the Viral Filtration efficiency (VFE) of 99.98% and the HMEF 750 has VFE of 99.998%.
In summary, the Datex-Ohmeda HMEF 750, 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 750 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 9360:2000
- 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 750 as compared to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
(JUN 2 0 2003
Mr. Joel C. Kent Manager, Ouality Assurance and Regulatory Affairs Datex Ohmeda 86 Pilgrim Road Needham, MA 02492
Re: K031653
Trade/Device Name: Datex-Ohmeda HMEF 750 Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: May 27, 2003 Received: May 28, 2003
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.
5
Page 2 – Mr. Joel C. 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Susan Runner, DDS, MA Interim 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): ____________________________________________________________________________________________________________________________________________________
Device Name: Datex-Ohmeda HMEF 750
The HMEF 750 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 750 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) | X |
|---|---|
| --------------------------------------- | ---------- |
OR
| Over-The-Counter Use | _________________ |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K031653 |
|---|---|
| ---------------- | --------- |
| 6/20/03 | |
|---|---|
| -- | --------- |