← Product Code [CAH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH) · K111408 # MICROGARD II (K111408) _Carefusion Germany 234 GmbH · CAH · Oct 17, 2011 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94therapeutic-devices/CAH/K111408 ## Device Facts - **Applicant:** Carefusion Germany 234 GmbH - **Product Code:** [CAH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH.md) - **Decision Date:** Oct 17, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5260 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Pediatric ## 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. ## Device Story MicroGard II is a disposable barrier filter for pulmonary function testing (PFT) equipment; protects instruments and patients from cross-contamination via exhaled aerosols/particulates. Device consists of a housing (Polystyrene 454C) and filter media (Polypropylene/Modacrylic fiber). Available as MicroGard IIB (integrated mouthpiece) or MicroGard IIC (adapter for external mouthpiece). Used in clinical settings by healthcare providers during PFT procedures. Input is patient exhaled gas; filter captures pathogens/particulates; output is filtered air passing into PFT equipment. Benefits include reduced risk of equipment contamination and patient-to-patient pathogen transmission. Biocompatibility tested per ISO 10993-1; filtration efficiency validated at high flow rates (750 L/min). ## Clinical Evidence Bench testing only. Filtration efficiency validated for BFE/VFE > 99% at 30 L/min; B. atrophaeus > 96% and MS-2 coliphage > 97% at 750 L/min. Biocompatibility testing performed per ISO 10993-1. No clinical data presented. ## Technological Characteristics Disposable barrier filter. Housing: Polystyrene 454C. Filter media: Polypropylene and Modacrylic fiber. Resistance: < 0.4 cmH2O/L/sec @ 1L/sec. Dead space: 55ml. Biocompatibility per ISO 10993-1. Risk management per ISO 14971. Usability per IEC 62366. ## Regulatory 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. ## Predicate Devices - SensorMedics MicroGard Microbial Filter ([K934272](/device/K934272.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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) {1}------------------------------------------------ ### 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 . {2}------------------------------------------------ ## 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

MicroGard IIC:
Identical | | | | | | Performance
specification | 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 efficiency
B. atrophaeaus > 96% (at 750L/min)
MS-2 coliphage > 97% (at 750L/min) | | Patient
contacting parts | no direct contact to patient | MicroGard IIB:
integrated mouthpiece with direct
contact to the patient | | | | MicroGard IIC:
Identical | | Sterilization | single patient use | Identical | ・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {3}------------------------------------------------ ## 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. {4}------------------------------------------------ ## 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ ## 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 _ 7 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94therapeutic-devices/CAH/K111408](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94therapeutic-devices/CAH/K111408) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com