The Humid-Vent® HEPA is a combined Heat and Moisture Exchanger (HME) and a mechanical Bacterial/Viral Filter. The device is used for humidification and bacterial/viral filtration during anesthesia and ventilator care. The device consists of a housing which incorporates a hydrophobic glass fibre filter and an HME media made of corrugated hygroscopic paper. It contains ISO Standard 15M / 22F conical connectors at the machine end as well as the patient end.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Humid-Vent® HEPA device, a combined Heat and Moisture Exchanger (HME) and bacterial/viral filter. Unfortunately, the document is quite high-level and does not contain the detailed performance data, acceptance criteria table, or study specifics that would be required to fully answer all the questions. The text explicitly states "The Humid-Vent® HEPA was subjected to a full battery of performance testing including pre-determined acceptance criteria. As expected, the device met all acceptance criteria. The performance data verified that the Humid-Vent® HEPA is substantially equivalent to the currently marketed predicate devices, adequately meets its intended use, and is acceptable for commercial distribution." However, it does not provide the acceptance criteria themselves or the specific results.

Therefore, I can only address some of the questions based on the available information, and will have to state that information about acceptance criteria and detailed study specifics is not provided in the input text for several points.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document states: "The Humid-Vent® HEPA was subjected to a full battery of performance testing including pre-determined acceptance criteria. As expected, the device met all acceptance criteria." However, the specific criteria (e.g., minimum humidification efficiency, minimum bacterial/viral filtration efficiency, maximum resistance to flow, etc.) and the corresponding quantitative results are not detailed in the provided text.	Met all acceptance criteria. Specific quantitative performance data is not provided in the document. The general statement is that "the device met all acceptance criteria" and "the performance data verified that the Humid-Vent® HEPA is substantially equivalent to the currently marketed predicate devices, adequately meets its intended use, and is acceptable for commercial distribution."

Acceptance Criteria

Reported Device Performance

Not provided in the document. The document states: "The Humid-Vent® HEPA was subjected to a full battery of performance testing including pre-determined acceptance criteria. As expected, the device met all acceptance criteria." However, the specific criteria (e.g., minimum humidification efficiency, minimum bacterial/viral filtration efficiency, maximum resistance to flow, etc.) and the corresponding quantitative results are not detailed in the provided text.

Met all acceptance criteria. Specific quantitative performance data is not provided in the document. The general statement is that "the device met all acceptance criteria" and "the performance data verified that the Humid-Vent® HEPA is substantially equivalent to the currently marketed predicate devices, adequately meets its intended use, and is acceptable for commercial distribution."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text. The submission is from Teleflex Medical Inmed Mfg.Sdn.Bhd, Malaysia, but this does not necessarily indicate the location where the testing was performed or the origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is generally applicable to diagnostic devices involving expert interpretation. For a medical device like a breathing circuit filter, the "ground truth" is typically established through laboratory testing against measurable physical and biological parameters (e.g., filtration efficiency measured by challenge with specific microorganisms, humidification effectiveness measured by hygrometers, airflow resistance measured by pressure transducers). There is no mention of human experts establishing ground truth in this context, as the performance is objectively measured by instrumentation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods (like 2+1 or 3+1) are typically used when there is subjective human assessment involved in establishing ground truth, such as in clinical image interpretation. Since this device involves objective laboratory performance testing, no adjudication method of this type would be applicable or mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is specific to AI-assisted diagnostic devices. The Humid-Vent® HEPA is a mechanical bacterial/viral filter and HME, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was performed or is relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is also specific to AI/software-based devices. The Humid-Vent® HEPA is a physical medical device. Therefore, no standalone algorithm performance study was done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a device like the Humid-Vent® HEPA, the "ground truth" for performance is established through objective laboratory measurements against established standards and validated test methods. This includes:
- Bacterial/Viral Filtration Efficiency: Determined by challenging the filter with a known concentration of microorganisms (e.g., bacteria or phages) and measuring the concentration downstream.
- Humidification Efficiency (Moisture Output): Measured by flowing gas through the HME and determining the absolute humidity returned to the breathing circuit.
- Resistance to Flow: Measured by determining the pressure drop across the device at specified flow rates.
- Dead Space Volume: Measured physically.
The document implies that these standard laboratory tests were conducted, as it mentions "performance testing."

8. The sample size for the training set

This question is relevant for machine learning models. As the Humid-Vent® HEPA is a physical medical device, there is no "training set" in the context of data-driven model development. Training for such devices involves design verification and validation testing of physical prototypes and production samples.

9. How the ground truth for the training set was established

As there is no "training set" for an AI model, this question is not applicable. The "ground truth" for the device's performance, as mentioned in point 7, is established through objective, standardized laboratory measurements and physical characterization.

Summary

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SEP

112 112 958 510(K) SUMMARY

1. SUBMITTER:

TELEFLEX MEDICAL INMED MFG.SDN.BHD, RUSCH P.O. Box 28, Kamunting Industrial Estate, Kamunting Perak, Malaysia 34600 Telephone# 605-891-5111 Establishment Registration Number: 8040412

Official contact: Telephone: Date Prepared:

Elizabeth Paul, Director, International/Domestic RA 919-433-8076 September 23, 2011

2. DEVICE:

Tradename: Humid-Vent® HEPA Classification Name: Filter, Bacterial, Breathing-Circuit Classification: Class II Common Name: Breathing circuit bacterial filter Classification Panel: Anesthesiology Product Code: CAH Regulation Number: 868.5260

3. PREDICATE DEVICES:

. Teleflex Medical's Gibeck Iso-Gard Angled and Straight Filters,
. Teleflex Medical's Gibeck Humid-Vent 2 HME, and
Covidien's Hygroster Filter / HME combination bacterial / viral filter (HEPA) . and heat / moisture exchanger (HME)

4. DEVICE DESCRIPTION:

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5. INDICATIONS FOR USE:

The Humid-Vent HEPA Filters are used for humidification and bacterial/viral filtration during anesthesia and ventilator care.

COMPARISON OF CHARACTERISTICS: ર્દ્ર.

Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics and packaging are identical or substantially equivalent to the currently marketed predicate devices.

7. PERFORMANCE DATA:

The Humid-Vent® HEPA was subjected to a full battery of performance testing including pre-determined acceptance criteria. As expected, the device met all acceptance criteria. The performance data verified that the Humid-Vent® HEPA is substantially equivalent to the currently marketed predicate devices, adequately meets its intended use, and is acceptable for commercial distribution.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Teleflex Medical Ms. Elizabeth Paul Director, International/Domestic Regulatory Affairs 2917 Weck Drive Research Triangle Park, North Carolina 27709

SEP 21 2012

Re: K112958

Trade/Device Name: Humid-Vent® HEPA Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: September 18, 2012 Received: September 19, 2012

Dear Ms. Paul:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Ms. Paul

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ph for

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Number (if known): K112958

Device Name: Gibeck Humid-Vent® HEPA

Indications for Use:

The Humid-Vent HEPA Filters are used for humidification and bacterial/viral filtration during anesthesia and ventilator care.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Y Schulto

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

510(k) Number:

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).