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.

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.

AI/ML Overview

The provided document does not contain a study or detailed acceptance criteria for a device's performance. Instead, it is a 510(k) summary and FDA clearance letter for the Portex Thermovent HEPA HME Breathing Filter.

The document indicates that the device's performance was evaluated against a set of voluntary standards rather than through a specific clinical or performance study with defined acceptance criteria and statistical analysis.

Therefore, I cannot extract the requested information as it is not present in the provided text.

However, I can extract the information related to the standards the device complies with, which implicitly serve as its performance "acceptance criteria" in the context of this 510(k) submission.

Here's what can be extracted based on the provided text, focusing on the compliance with standards:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 23328-1:Draft, BS EN 13328-1:2001 (Salt test method for filtration)	The proposed device complies with this standard.
ISO 23328-2:2002, BS EN 13328-2:2002 (Non-filtration aspects)	The proposed device complies with this standard.
BS EN ISO 9360-1:2000 (Heat and moisture exchanges)	The proposed device complies with this standard.
ISO 594-2:1998, BS EN 20594-2:1994 (Conical fittings - Luer taper)	The proposed device complies with this standard.
ISO 5356-1:1996, BS EN 1281-1:1997 (Conical Connectors)	The proposed device complies with this standard.
Code of Federal Regulations, Title 42, Volume 1 Part 84 (Respiratory Protective Devices)	The proposed device complies with this standard.

Regarding the other requested information (2-9), the document does not provide these details as it describes compliance with existing standards rather than a de novo study:

2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document refers to compliance with standards, which would involve specific tests defined by those standards, but the sample sizes for those tests are not detailed here. Data provenance is not specified.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable/Not provided, as there was no "ground truth" to establish in the context of a study described here. Compliance with standards is typically verified by testing laboratories.
4. Adjudication method for the test set: Not applicable/Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document does not mention an MRMC study or any comparison of human readers with/without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical filter, not an AI algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" here is compliance with the specifications and performance requirements outlined in the cited standards.
8. The sample size for the training set: Not applicable/Not provided. This is not an AI device with a training set.
9. How the ground truth for the training set was established: Not applicable/Not provided.

In summary: The provided text is a 510(k) summary demonstrating substantial equivalence by showing compliance with recognized performance standards, not a report of an independent clinical or performance study with detailed acceptance criteria, ground truth establishment, or human-in-the-loop evaluations.

Summary

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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 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.

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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:

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.

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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

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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

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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)

Prescription Use ☑

CFR 801.109

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11/28/03

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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number:

716

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COUNTER USE

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).