Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical filtration properties of the device, with no mention of AI or ML.

Therapeutic

No
The device is described as a barrier filter for pulmonary function testing equipment to prevent contamination, not to treat a medical condition.

Diagnostic

No

Explanation: The device is a filter designed to prevent contamination of pulmonary function testing equipment. Its purpose is to protect equipment and patients from aerosols and particulates, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "disposable barrier type filter," indicating a physical hardware component. The performance studies also focus on physical properties like filtration efficiency and resistance, not software performance.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to prevent contamination of pulmonary function testing equipment and protect both the patient and the instrument from the transmission of pathogens. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on biological specimens to diagnose a condition.
Device Description: The description clearly states it's a "disposable barrier type filter."
Lack of Diagnostic Function: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
Performance Metrics: The performance metrics listed (Resistance, Dead Space, Filter efficiency) relate to the physical and filtration properties of the device, not to the accuracy or reliability of a diagnostic test.

IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. The MicroGard II filter does not perform this type of function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

CAH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The MicroGard® II filter should be used only on patients with a minimum body weight of 27.5 kg.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Resistance: 99% (at 30L/min)
VFE > 99% (at 30L/min)
Filter efficiency
B. atrophaeaus > 96% (at 750L/min)
MS-2 coliphage > 97% (at 750L/min)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K934272

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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

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.

5.12 Intended Use Statement

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 pulontis with a minimum body weight of 27.5 kg.

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 MicroGard
K934272 | MicroGard® II
(MicroGard IIB / MicroGard IIC) |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The SensorMedics MicroGard™
Microbial filter 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 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. |
| Patient
population | no limitation | According ATS recommendation |
| Housing material | Polystyrene resin | Polystyrene 454C |
| Filter material | 3M GS-100 | Polypropylene & Modacrylic fiber |
| Dimensional
specifications | length 3,94 inch (10,01 cm)
diameter 3,54 inch (8,99 cm) | MicroGard IIB:
length = 10,6 cm
diameter = 9,0 cm

MicroGard IIC:
length = 10,7 cm
diameter = 9,0 cm |
| Connection to
patient user
interface | 30mm ID & 30mm OD Tapered Port | MicroGard IIB:
30mm ID & integrated mouthpiece
with tooth marker

・

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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:

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.

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 _

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