For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.

For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults).

Single patient use. Duration of use up to 24 hours.

Device Description

The Munktell Bacstop Filter and Filter / HME are available in multiple sizes and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Munktell Bacstop Filter and Filter/HME:

Acceptance Criteria and Device Performance

Attribute	Acceptance Criteria (from Predicate/Standard)	Reported Device Performance (Munktell Bacstop)
Resistance to Flow (Adult)	< 2.1 cm H2O @ 60 lpm	< 2.1 cm H2O @ 60 lpm
Resistance to Flow (Pediatric)	< 0.82 cm H2O @ 15 lpm	< 0.82 cm H2O @ 15 lpm
Bacterial Filtration (BFE)	(Not explicitly stated as a separate criterion, but predicate devices' performance would set the bar)	99.999% (Nelson Lab. testing)
Viral Filtration (VFE)	(Not explicitly stated as a separate criterion, but predicate devices' performance would set the bar)	99.99+% (Nelson Lab. testing)
Humidification Output (Adult)	(Not explicitly stated as a separate criterion, but predicate devices' performance would set the bar)	31 mg H2O /L at TV of 1000 ml
Humidification Output (Pediatric)	(Not explicitly stated as a separate criterion, but predicate devices' performance would set the bar)	32 mg H2O /L at TV of 250 ml
Tidal Volume Range (Pediatric)	(Implied by predicate devices and intended use)	150 - 500 ml
Tidal Volume Range (Adult)	(Implied by predicate devices and intended use)	> 250 ml
Dead Space	(Implied by predicate devices' performance for similar devices)	23 to 85 ml
Intended Use	For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired/expired gases is desired and to add and retain moisture. For pediatric (150-500ml TV) and adult (>250ml TV) patients. Up to 24 hours use.	Same
Single Patient Use	Yes	Yes
Environment of Use	Home, Hospital, Sub-acute Institutions, Emergency Services	Same
Gas Sampling Port	Yes (as per predicate design, implicitly)	Yes
Standard 15/22 mm connectors	Yes (as per predicate design, implicitly)	Yes
ISO 5356-1 Conical 15/22	Yes (Standard conformance)	Yes
ISO 594-2 Luer Fittings	Yes (Standard conformance)	Yes
ISO 9360- HME moisture output	Yes (Standard conformance)	Yes

Study Information

Based on the provided Non-Confidential Summary of Safety and Effectiveness (510(k) K014282), the "study" is primarily a bench-testing and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial with human subjects.

Here's the breakdown of the requested information based on the document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated for specific tests. The document refers to "Nelson Lab." for bacterial and viral filtration, implying laboratory testing. For other parameters like resistance and humidification, it would involve testing multiple units to ensure consistency, but specific numbers are not provided.
- Data provenance: "Nelson Lab." is mentioned for BFE and VFE, which is a known independent testing laboratory. The overall data likely originates from testing performed by or for Munktell Filter AB (Sweden). The studies appear to be prospective bench tests designed to evaluate specific performance attributes.
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 not applicable to this type of device submission. Medical device filters do not typically use expert ground truth for performance metrics in the same way an imaging AI algorithm would. Performance is measured against physical standards and laboratory methods (e.g., measuring pressure drop, bacterial retention, water vapor content). The "ground truth" is defined by the physical or microbiological measurement standards themselves.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. Adjudication methods are typically used in clinical studies or expert review of image interpretation, which is not relevant for the bench testing of a breathing circuit filter.
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
- No. An MRMC study is relevant for an AI-powered diagnostic imaging device involving human readers. This submission is for a medical filter, which does not involve human readers or AI assistance in its function.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in spirit. The performance metrics (BFE, VFE, resistance, humidification) are "standalone" in that they measure the device's intrinsic physical and biological filtering capabilities without human intervention during its operation. There is no "algorithm" in the sense of software interpreting data, but the filter itself performs its function independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance claims in this submission is the measured output from standardized laboratory testing. For example:
  - Bacterial Filtration (BFE) and Viral Filtration (VFE): Ground truth is established by standardized microbiological testing methods (e.g., aerosol challenge tests) that measure the percentage of bacteria/viruses retained by the filter.
  - Resistance to flow: Ground truth is established by physical measurement of pressure drop across the filter at specified flow rates using calibrated equipment.
  - Humidification Output: Ground truth is established by standardized tests (e.g., ISO 9360) that measure the absolute humidity delivered by the HME.
The sample size for the training set
- Not applicable. This device is hardware (a filter), not an AI algorithm that requires a "training set."
How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of device.

Summary

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K0142f2

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

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 April 18, 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:	Bacstop, Bacstop Mini, Bacstop Humini
Common/Usual Name:	Bacterial / Viral Filter and Heat and Moisture Exchanger
Classification Name:	Filter, Bacterial, Breathing Circuit
Predicate Devices:	Gibeck - Humid-Vent Filter - K881657Hudson RCI (Artema) Aqua +FH - K945359Mallinckrodt - Hygroboy and Hygrobac - K941381Mallinckrodt - Barrierbac and Barrierbac "S" - K941536

Device Description: 100 100 100 100 11 11 11 11 11 11 11 11 11 11 13 13 13

Intended Use:
Indicated Use --	For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.For pediatric patients with tidal volumes 150-500 ml and adult patients with tidal volumes >250 ml. Duration of use up to 24 hours. Single patient use.
Environment of Use --	Home, Hospital, Sub-acute Institutions, Emergency Services

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 April 18, 2002

General Technical Characteristics

Attribute	Munktell - Proposed devices
Indications for use - To filter inspired and / orexpired gases and add and retain moisture	Same
Intended for single patient, up to 24 hours	Yes
Prescription	Yes
Intended population	Any patient, including adults and pediatrics
Intended Environment of Use	Home, Hospital, Sub-acute Institutions,Emergency Services
Placement in various locations in circuit	Yes
Design
Gas sampling port	Yes
Standard 15/22 mm connectors	Yes
Dead Space (ml)	23 to 85 ml
Resistance to flow	<2.1 cm H2O @ 60 lpm - Adult<0.82 cm H2O @ 15 Ipm - Pediatric
Bacterial filtration - BFE - Nelson Lab.	99.999%
Viral filtration - VFE - Nelson Lab.	99.99+%
Weight (gm)	13 to 40 gm
Humidification output (mg H2O/l)	31 mg H2O /L at TV of 1000 ml - adult32 mg H2O /L at TV of 250 ml - pediatric
Tidal volume ranges	150 - 500 ml - pediatric> 250 ml - adult
Materials
Housing polystyrene	Yes
Filter media	Electrostatic polypropylene
HME media	Foam
Performance Standards
None under Section 514	Yes
ISO 5356-1 Conical 15/22	Yes
ISO 594-2 Luer Fittings	Yes
ISO 9360- HME moisture output	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/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized image of an eagle with three heads in profile, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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 46055-9501

Re: K014282

Munktell Bacstop Filter and Filter/HME, Model # 321 201, 321 202, 321 203, 321 204 Adults, Model # 321 209, 321 210 Pediatric Regulation Number: 868.5260 Regulation Name: Breathing Circuit Filter Regulatory Class: II (two) Product Code: 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. Iisting 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 (OS) 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	Page 1 of 1
510(k) Number:	K014282
Device Name:	Bacstop Filter and Filter / HME
Intended Use:	For use with ventilators, anesthesia machines, and open flowsystems where filtration of inspired and / or expired gases isdesired and to add and retain moisture in the circuit as required.For patients with a tidal volume 150-500 ml (pediatrics) and>250 ml (adults).Single patient use. Duration of use up to 24 hours.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K01428

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).