(87 days)
Not Found
No
The device description focuses on physical filtration and heat/moisture exchange mechanisms, with no mention of AI or ML technologies.
No.
The device functions as a filter to protect patients and breathing circuits by providing bacterial and viral filtration and passive heat and humidification. Its primary role is protective and supportive within a breathing system, rather than directly treating a disease or condition.
No
Explanation: The device is described as a filter for bacterial and viral protection and heat/humidification in breathing circuits, not for the purpose of diagnosis. The Luer port is for monitoring patient gases after filtration, not for diagnostic purposes of a disease or condition.
No
The device description clearly details a physical filter with a housing, filter media, and a Luer port, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter bacteria and viruses from breathing systems and provide heat and humidification to the patient. This is a therapeutic and protective function related to the breathing circuit, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the physical properties of the filter (HEPA grade, hydrophobic, pleated media) and its function within the breathing circuit (filtering, humidifying, monitoring port for gas sampling). There is no mention of analyzing biological samples or providing diagnostic information about a patient's health status.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended to be a component of a breathing system for patient support and protection, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Thermovent HEPA HME breathing system filter provides bacterial and viral filtration protecting the patient and the breathing circuit or ventilator. It also provides passive heat and humidification to the patient.
The Portex Thermovent HEPA (High Efficiency Particulate) is a single use heat and moisture exchanging (HME) bacterial/viral breathing system filter with 'HEPA' grade filtration properties.
Product codes
CAH
Device Description
The Thermovent HEPA (High Efficiency Particulate Air) HME (Heat and Moisture Exchange) breathing system filter is a single use bacterial and viral filter with 'HEPA' grade filtration properties. The filter is intended for use with ventilators, anaesthesia breathing circuits, positive breathing systems and passive spontaneous breathing intubated patients.
The Thermovent HEPA is a hydrophobic filter, which acts as an effective barrier to both air and liquid borne contaminates. The filter media repels liquid and therefore prevents any liquid moving from the patient side of the device through to the ventilator circuit. To maximise the filtration surface area, the filter media is pleated before assembly into the filter housing.
The Thermovent HEPA also acts as a passive, hydrophobic humidifier. The expired gasses from the patient condense on the surface of the media, while releasing latent heat and warming the filter element. On inspiration, the airflow is warmed by the filter element, while the liquefied water is vaporised, thus allowing humidified air to be returned to the patient.
The Thermovent HEPA has a Luer port on the machine side of the housing to allow monitoring of the patients gasses, after filtration. The filter housing also features a peg where the user can park the gas sampling port is in use.
The devices are packed individually in flexible thermoformed pouch type unit packs.
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
Not Found
Intended User / Care Setting
Not Found
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
Performance data for the proposed device is shown in section 8.0 Performance.
Key Metrics
Not Found
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
NOV 2 8 2003
Image /page/0/Picture/1 description: The image shows a handwritten text string "K032716" in black ink. The text is oriented diagonally, running from the lower-left to the upper-right corner of the frame. The handwriting appears somewhat stylized, with distinct and legible characters.
Portex Ltd. Thermovent HEPA HME Breathing Filter with CO2 port. 510(K) Notification
SECTION 5.0 : 510K SUMMARY
DATE SUBMITTED: 26th August 2003
SUBMITTER:
Portex Ltd Hythe Kent England, CT21 6JL
CONTACT PERSON: Mr Steve Ogilvie, Regulatory and Scientific Affairs Director, Portex Ltd, Military Road, Hythe, Kent, England. CT21 6DB Phone 00 44 (0)1303 260551 Fax 00 44 (0)1303 262798
Portex Thermovent HEPA HME Breathing System Filter with CO2 port DEVICE NAME:
COMMON NAME AND CLASSIFICATION:
Bacterial/Viral filter and Heat and Moisture Exchanger (IIME) Class II, 73 CAH, CFR 868.5260
PREDICATE DEVICES:
- Pall BB25 Small Volume HME filter with monitoring port, already marketed in the USA under Pre-. market Notification No.K791307 (Trade name - Pall Ultipor 25 breathing system filter)
- Porous Media Corporation DBF23 Bacterial/Viral filter already marketed in the USA under Pre-market . Notification No.K964979
DEVICE DESCRIPTION:
The Thermovent HEPA (High Efficiency Particulate Air) HME (Heat and Moisture Exchange) breathing system filter is a single use bacterial and viral filter with 'HEPA' grade filtration properties. The filter is intended for use with ventilators, anaesthesia breathing circuits, positive breathing systems and passive spontaneous breathing intubated patients.
The Thermovent HEPA is a hydrophobic filter, which acts as an effective barrier to both air and liquid borne contaminates. The filter media repels liquid and therefore prevents any liquid moving from the patient side of the device through to the ventilator circuit. To maximise the filtration surface area, the filter media is pleated before assembly into the filter housing.
The Thermovent HEPA also acts as a passive, hydrophobic humidifier. The expired gasses from the patient condense on the surface of the media, while releasing latent heat and warming the filter element. On inspiration, the airflow is warmed by the filter element, while the liquefied water is vaporised, thus allowing humidified air to be returned to the patient.
1
Portex Ltd. Thermovent HEPA HME Breathing Filter with CO2 port. 510(K) Notification
SECTION 5.0 : 510K SUMMARY
The Thermovent HEPA has a Luer port on the machine side of the housing to allow monitoring of the patients gasses, after filtration. The filter housing also features a peg where the user can park the gas sampling port is in use.
The devices are packed individually in flexible thermoformed pouch type unit packs.
INTENDED USE:
The Thermovent HEPA HME breathing system filter provides bacterial and viral filtration protecting the patient and the breathing circuit or ventilator. It also provides passive heat and humidification to the patient.
TECHNOLOGICAL CHARACTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:
- The proposed device is substantially equivalent to Predicate device 1 Pall BB25 Small Volume HME . filter with monitoring port, (Pre-market Notification No.K791307) in all aspects except the following:
- Differences in filter internal volumes (dead space) as listed in section 7, Table 4. The . instructions for use for the proposed device prescribe that the acceptability of the filter's dead space be evaluated on an individual patient basis.
PERFORMANCE / CLINICAL DATA:
Performance data for the proposed device is shown in section 8.0 Performance.
NONCLINICAL TESTING FOR THE DEVICE AND CONCLUSIONS:
- The proposed device complies with the standards below and is therefore safe and effective for the � intended use. The proposed device has been tested through validation and verification of specifications. Verification of compliance with the following voluntary standards has been conducted.
- ISO 23328-1:Draft, BS EN 13328-1:2001 Breathing system filters for anaesthetic and . respiratory use. Salt test method to assess filtration performance
- ISO 23328-2:2002, BS EN 13328-2:2002 Breathing system filters for anaesthesia and . • respiratory use. Non-filtration aspects
- BS EN ISO 9360-1:2000 Anaesthetic and Respiratory Equipment Heat and moisture . exchanges for use in humidifying respired gases in humans.
- ISO 594-2:1998, BS EN 20594-2:1994 Conical fittings with a 6% (Luer) taper for syringes, ● needles and certain other medical equipment - Part 2: Lock fittings.
- ISO 5356-1: 1996, BS EN 1281-1:1997 Anaesthetic and Respiratory Equipment Conical . Connectors , Part 1: Cones and Sockets
- Code of Federal Regulations, Title 42, Volume 1 Part 84--Approval of Respiratory Protective . Devices
CONCLUSION:
Comparison of the proposed device to the predicate device supports the conclusion that the proposed Connpairson or un propouvalent in safety and effectiveness in its intended use to the existing legally marketed device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2003
Mr. Steve Ogilvie Portex LTD Military Road Hythe Kent CT21 6JL England
Rc: K032716
Trade/Device Name: Thermovent HEPA HME Breathing Filter, Sterile Thermovent HEPA HME Breathing Filter, Non-sterile Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Codc: CAH Dated: August 26, 2003 Received: September 2, 2003
Dear Mr. Ogilvie:
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, thereforc, 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
3
Page 2 – Mr. Steve Ogilvie
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of any 1 ederal ticalled in Ecquirements, including, but not limited to: registration 1 ou intibe configer and 807); labeling (21 CFR Part 801); good manufacturing practice and issues (2) corrents 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) Fine feter will as the FDA finding of substantial equivalence of your device to a premarket notification. >>> device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire spccific advice for your device on our labeling regulation (21 CFR Part 801), 11 you donto 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 maj overall 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 .
Sincercly yours,
Шилий базал lov:
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Portex Ltd. Thermovent HEPA HME Breathing Filter with CO2 port. 510(K) Notification
SECTION 4.0: STATEMENT OF INDICATIONS FOR USE
K032716
GENERAL DESCRIPTION OF USE:
The Portex Thermovent HEPA (High Efficiency Particulate) is a single use heat and moisture exchanging (HME) bacterial/viral breathing system filter with 'HEPA' grade filtration properties.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OV
Prescription Use ☑
CFR 801.109
. Sogard
11/28/03
SAwathh
Over.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number:
716
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COUNTER USE