For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine-side of the circuit only. Single patient use. Duration of use up to 24 hours.

Device Description

The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Munktell Gard Filter, based on the provided documents:

Acceptance Criteria and Device Performance

Attribute	Acceptance Criteria (Predicate Reference/Standard)	Reported Device Performance (Munktell Gard Filter)
Indications for use - To filter inspired and / or expired gases	Same as predicates	Same
Intended for single patient use, up to 24 hours	Yes (Predicate functionality)	Yes
Prescription	Yes (Predicate functionality)	Yes
Intended population	Any patient (adult) (Predicate functionality)	Any patient (adult)
Intended Environment of Use	Home, Hospital, Sub-acute institutions	Home, Hospital, Sub-acute institutions
Placement at machine side of circuit only	Yes (Predicate functionality)	Yes
Gas sampling port	Yes (Predicate functionality)	Yes
Standard 15/22 mm connectors	Yes (Predicate functionality / ISO 5356-1)	Yes
Dead Space (ml)	Not explicitly stated as acceptance criteria	124 ml
Resistance to flow	≤ 1.6 cm H2O @ 60 lpm	≤ 1.6 cm H2O @ 60 lpm
Bacterial filtration - BFE	Not explicitly stated as acceptance criteria	99.9999% (Nelson Lab.)
Viral filtration - VFE	Not explicitly stated as acceptance criteria	99.9999% (Nelson Lab.)
Weight (gm)	Not explicitly stated as acceptance criteria	60 gm
Housing material	Polystyrene (Predicate functionality)	Housing polystyrene
Filter media	Not explicitly stated as acceptance criteria	Paper microfiber
Performance Standards	None under Section 514, ISO 5356-1 Conical 15/22	Yes (conforms to these)

Study Information:

The provided documents describe a premarket notification (510(k)) for substantial equivalence, not a comprehensive clinical study in the typical sense of evaluating diagnostic performance. The "study" here refers to the data presented to demonstrate substantial equivalence to predicate devices.

1. Sample size used for the test set and the data provenance:

Sample Size: Not applicable in the context of a diagnostic test set. The submission focuses on comparing the technical characteristics and performance specifications of the proposed device against predicate devices and relevant standards.
Data Provenance: The performance data (Bacterial and Viral filtration effectiveness) is attributed to "Nelson Lab." This suggests laboratory testing data. The other technical characteristics are stated directly for the device, implying internal testing or design specifications. The document does not specify a country of origin for the data beyond Nelson Lab.
Retrospective or Prospective: Not applicable as this is a device characteristic comparison, not a study on patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in this context, refers to established performance standards (e.g., ISO for connectors, or the performance of legally marketed predicate devices for filtration efficacy and resistance). Expert panels for ground truth determination are not mentioned or required for this type of submission.

3. Adjudication method for the test set:

Not applicable. No "test set" of cases or images requiring adjudication by experts is described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. An MRMC study was not done. The submission is for a breathing circuit filter, not a diagnostic imaging device that would typically undergo such a study.

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

Yes, effectively. The performance data (e.g., bacterial/viral filtration efficiency, resistance to flow) are presented as inherent characteristics of the device itself, independent of human interaction once installed. This is the standalone performance of the filter.

6. The type of ground truth used:

Regulatory Standards and Predicate Device Performance: The primary "ground truth" used is the established performance of predicate devices that are already legally marketed, as well as adherence to relevant industry standards (e.g., ISO 5356-1 for connectors) and general safety principles. For filtration efficiency, the "ground truth" is the measured efficacy by a recognized lab (Nelson Lab).

7. The sample size for the training set:

Not applicable. There is no mention of a "training set" as this is not an AI/ML device submission involving learned algorithms from datasets.

8. How the ground truth for the training set was established:

Not applicable for the reasons stated above.

Summary

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1014281

Munktell Filter AB Box 300 S 790 20, Grycksbo, Sweden

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 April 15, 2002

Munktell Filter ABBox 300S 790 20 Grycksbo, Sweden	Tel - 011 (46) 23-683-80Fax - 011 (46) 23-401-15
Official Contact:	Gustav Kyrk - Managing Director
Proprietary or Trade Name:	Gard Filter
Common/Usual Name:	Bacterial / Viral Filter
Classification Name:	Filter, Bacterial, Breathing Circuit
Predicate Devices:	Mallinckrodt Sterivent (HEPA) – K941676ARC Filter – K011212Porous Media – DBF 23 – K964979

Device Description: July 2017 11:43 11:00 11:00 10:00 10:00

The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.

Intended Use:
Indicated Use --	For use with ventilators, anesthesia machines, and open flowsystems where filtration of inspired and / or expired gases isdesired. Tobe placed at the machine-side of the circuit only.Intended for single patient use up to 24 hours.
Environment of Use --	Home. Hospital. Sub-acute Institutions

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 April 15, 2002

General Technical Characteristics

Attribute	Munktell - Proposed devices
Indications for use - To filter inspired and / orexpired gases	Same
Intended for single patient use, up to 24 hours	Yes
Prescription	Yes
Intended population	Any patient (adult)
Intended Environment of Use	Home, Hospital, Sub-acute institutions
Placement at machine side of circuit only	Yes
Design
Gas sampling port	Yes
Standard 15/22 mm connectors	Yes
Dead Space (ml)	124 ml
Resistance to flow	$≤$ 1.6 cm H2O @ 60 lpm
Bacterial filtration - BFE - Nelson Lab.	99.9999%
Viral filtration - VFE - Nelson Lab.	99.9999%
Weight (gm)	60 gm
Materials
Housing polystyrene	Yes
Filter media	Paper microfiber
Performance Standards
None under Section 514	Yes
ISO 5356-1 Conical 15/22	Yes

Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Munktell Filter AB c/o Mr. Paul Dryden ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055

Re: K014281 Gard Filter, Model # 321 111 Regulation Number: 868.5260 Regulation Name: Breathing Circuit Filter Regulatory Class: II (two) Product Code: 73 CAH Dated: April 2, 2002 Received: April 3, 2002

Dear Mr. Dryden:

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,

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Page 2 - Mr. Paul Dryden

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	Indications for Use . Me . Mar . 1988 . 1998
510(k) Number:	K014281
Device Name:	Gard Filter
Intended Use:	For use with ventilators, anesthesia machines, and open flowsystems where filtration of inspired and / or expired gases isdesired. To be placed at the machine -side of the circuit only.Single patient use. Duration of use up to 24 hours.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiqyascular & Resoir- to ... "Bevices 510(k) Number LO

Prescription Use (Per CFR 801.109)

Over-the-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).