The CareFusion MicroGard® II filter series is indicated for use in prevention of contamination of pulmonary function testing equipment and associated valves and hoses by aerosols and particulates which may be present in a patient's exhaled gas volumes. The MicroGard® II filter should be used only on patients with a minimum body weight of 27.5 kg.

Device Description

The CareFusion MicroGard II filter is a disposable barrier type filter intended to protect both, patient and instrument, by preventing the transmission of pathogens by droplets and aerosolized particles between the patient and the spirometer, or pulmonary function testing instrument.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the MicroGard II filter to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Specification	Acceptance Criteria (Predicate Device)	Reported Device Performance (MicroGard II)
Resistance	0.7 cmH2O/L/sec @ 12L/sec	< 0.4 cmH2O/L/sec @ 1L/sec
Dead Space	50ml	55ml
Filter efficiency (BFE)	> 99% (at 30L/min)	> 99% (at 30L/min)
Filter efficiency (VFE)	> 99% (at 30L/min)	> 99% (at 30L/min)
Filter efficiency (B. atrophaeaus)	Not specified (new test)	> 96% (at 750L/min)
Filter efficiency (MS-2 coliphage)	Not specified (new test)	> 97% (at 750L/min)

Note: The resistance and filter efficiency for B. atrophaeaus and MS-2 coliphage were measured at different flow rates or were new tests for the MicroGard II, indicating an improvement or additional testing for the modified device.

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

The document mentions that filtration efficiency has been tested at Nelson test laboratory in the USA and at Health Protection Agency in the UK. However, it does not explicitly state the sample size used for these tests. The data provenance is from USA and UK laboratories, and based on the context of testing a manufactured medical device, these would be prospective tests performed on the device.

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

This information is not provided in the document. The testing described (filtration efficiency, biocompatibility, resistance, dead space) are objective laboratory measurements, not subjective evaluations requiring expert interpretation of ground truth in the same way, for example, a diagnostic imaging study would.

4. Adjudication method for the test set:

This information is not applicable for the type of objective laboratory testing described. Adjudication methods are typically used when there are disagreements among experts in subjective evaluations.

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 is not applicable. The device described is a physical filter for pulmonary function testing equipment, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is a physical filter, not an algorithm.

7. The type of ground truth used:

For the performance specifications (resistance, dead space, filtration efficiency), the "ground truth" is established through standardized laboratory testing protocols and measurements. For biocompatibility, the ground truth is established through biocompatibility testing according to ISO 10993-1 standard.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device (a filter), not an AI algorithm that requires a training set.

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

This information is not applicable as there is no training set for a physical filter.

Summary

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K111408

OCT 1 7 2011

510(k) Summary

GENERAL INFORMATION

5.1 Type of Submission

Special 510(k) Submission

Submission date: 10/05/2011

5.2 Submitter

Name:
CareFusion Germany 234 GmbH

Address:

Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

(Regulatory Affairs Specialist) Address:

Elmar Niedermeyer CareFusion Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany +49 931 49 72 - 361 +49 931 49 72 - 62361 elmar.niedermeyer@carefusion.com

Phone: FAX: E-mail

Contact person in the U.S .:

(Official Correspondent) Address

Carol Emerson

CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 714-919-3342 714-283-8420 carol.emerson@carefusion.com

Phone: Fax: E-mail:

5.3 Establishment Registration Number 9615102

5.4 Common Name or Classification Name

Filter, Bacterial, Breathing-Circuit (CFR 868.5260, Product Code CAH)

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5.5 Trade Name MicroGard II

5.6 Device Classification This is a Class II device

5.7 Classification Panel 73 Anesthesiology Part 868 Code CAH

5.8 Reason for Premarket Notification

--- Modification of legally marketed devices ---Change to the existing CareFusion MicroGard filter

5.9 Legally predicate marketed device SensorMedics MicroGard Microbial Filter K934272 Code CAH

5.10 Predicate Device Company CareFusion

5.11 Device Description

5.12 Intended Use Statement

5.13 Required Components

Filter MicroGard IIB (filter with integrated mouthpiece) .
Filter MicroGard IIC (filter with cone OD 30 for adapting a mouthpiece) .
Instruction for Use .

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5.14 Summary Table of Comparison

Comparison with the predicate device

	Sensormedics MicroGardK934272	MicroGard® II(MicroGard IIB / MicroGard IIC)
Indications forUse	The SensorMedics MicroGard™Microbial filter is indicated for usein prevention of contamination ofpulmonary function testingequipment and associated valvesand hoses by aerosols andparticulates which may be presentin a patient's exhaled gasvolumes.	The CareFusion MicroGard® IIfilter series is indicated for use inprevention of contamination ofpulmonary function testingequipment and associated valvesand hoses by aerosols andparticulates which may be presentin a patient's exhaled gasvolumes. The MicroGard® II filtershould be used only on patientswith a minimum body weight of27.5 kg.
Patientpopulation	no limitation	According ATS recommendation
Housing material	Polystyrene resin	Polystyrene 454C
Filter material	3M GS-100	Polypropylene & Modacrylic fiber
Dimensionalspecifications	length 3,94 inch (10,01 cm)diameter 3,54 inch (8,99 cm)	MicroGard IIB:length = 10,6 cmdiameter = 9,0 cmMicroGard IIC:length = 10,7 cmdiameter = 9,0 cm
Connection topatient userinterface	30mm ID & 30mm OD Tapered Port	MicroGard IIB:30mm ID & integrated mouthpiecewith tooth markerMicroGard IIC:Identical

Performancespecification	Resistance:0.7 cmH2O/L/sec @ 12L/sec	Resistance:< 0.4 cmH2O/L/sec @ 1L/sec
	Dead Space:50ml	Dead Space:55ml
	Filter efficiency:BFE > 99% (at 30L/min)VFE > 99% (at 30L/min)	Filter efficiency:BFE > 99% (at 30L/min)VFE > 99% (at 30L/min)
		Filter efficiencyB. atrophaeaus > 96% (at 750L/min)MS-2 coliphage > 97% (at 750L/min)
Patientcontacting parts	no direct contact to patient	MicroGard IIB:integrated mouthpiece with directcontact to the patient
		MicroGard IIC:Identical
Sterilization	single patient use	Identical

・

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Discussion to the device differences:

The insignificant differences are:

The MicroGard II filter is available in two types, the MicroGard IIB with integrated mouthpiece and the MicroGard IIC without mouthpiece.

The indication for use for the MicroGard II is similar to the Sensormedics MicroGard filter. Only a patient body weight recommendation was added according to the ATS recommendation on dead space for younger patients.

The change in filter material was necessary as the MicroGard II Bacterial/Viral Filter is constructed as a high flow filter with a filter efficiency of more than 96% tested at a high flow of 750 l/min.

The MicroGard IIB is equipped with an integrated mouthpiece and has direct patient contact. For the material a biocompatibility test was accomplished at Namsa test laboratory.

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5.15 Summary of Device Testing

The following practices were followed and monitored for development of the MicroGard II Bacterial/Viral Filter:

The modification for the above device was developed in accordance . with the CareFusion Design and Development SWI (0301-5001-000-SWI).
The modifications were developed according to IEC 62366 (Usability) . standard.
The risk analysis method used to assess the impact of the . modifications was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971.
Biocompatibility for the patient contacting material has been tested . according ISO 10993-1 standard at Namsa test laboratory in the USA.
Filtration efficiency has been tested at Nelson test laboratory in the . USA and at Health Protection Agency in the UK.

5.16 Conclusion

Based on the above, CareFusion Germany 234 GmbH concludes that the MicroGard II is substantially equivalent to the legally marketed predicate device, the "Sensormedics MicroGard K934272" and is safe and effective for its intended use, and performs at least as well as the predicate device.

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Image /page/5/Picture/1 description: The image shows a logo or emblem. It features a stylized depiction of three curved lines or shapes, arranged vertically and overlapping each other, resembling a wing or a symbol of flight. To the left of this symbol, there is a partial circular text that reads 'DEPARTMENT OF HEALTH & HUMAN'. The text is oriented along the curve of the circle, suggesting it is part of a larger seal or emblem. The overall design appears to be associated with a health or human services organization.

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

OCT 1 7 2011

Mr. Elmar Niedermeyer Regulatory Affairs Specialist CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg, Bavaria Germany 97204

Re: K111408

Trade/Device Name: MicroGard® II Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: October 5, 2011 Received: October 11, 2011

Dear Mr. Niedermeyer:

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 -- Mr. Niedermeyer

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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Indications for Use

510(k) Number (if known):

K11408

Device Name:

MicroGard® II

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

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

510(k) Number

Page 1 of _

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).