The Micro I spirometer is intended to measure the maximal volume and flow of air that can be moved out of a patient's lungs. The system is intended for use with pediatic and addlt patients over the age of 3 years in hospitals, physician offices, laboratories and occupational health testing environments.

Device Description

The Micro I spirometer is a hand held portable microprocessor based device designed to measure expiratory flows and volumes. To perform a spirometry test the user first inserts a mouthpiece into the mouthpiece holder of the spirometer, which aligns it with the volume transducer. The unit is then turned on and displays instructions and prompts according to the device type. When prompted to do so by the operator, the patient inhales as deeply as possible, seals his/her lips around the mouthpiece and exhales as hard and as fast as possible until no more air can be exhaled. The device converts the airflow to an electrical signal, and the onboard software calculates the required values.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Micro I spirometer, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria (Predicate: MicroLab K031102 & Micro Diary K100928/ATS/ERS)	Reported Device Performance (Micro I K113096)
Indications for Use	Measure maximal volume and flow of air for pulmonary function testing. (Microlab: prescription use, pediatric (4-17), adult (18-99). Micro Diary: measures FEV1, FVC, FEV6, PEF).	Measures maximal volume and flow of air moved out of patient's lungs. For pediatric and adult patients over 3 years in hospitals, physician offices, laboratories, and occupational health.
Target Population	Pediatric (4-17 years), Adult (18-99 years) for Microlab. 4 years and older for Micro Diary.	Over the age of 3 years.
Performance Specifications (Measurements)	MicroLab: VC, FEV1, FEV3, FEV6, FVC, PEF, FEV1/FVC, etc. Micro Diary: FEV1, FVC, FEV6, PEF.	FEV1, FVC, FEV6, FEV1/FVC, FEV1/FEV6, PEF, FEF25, FEF75, FEF25-75.
Transducer Material (Breathing Path Contacting)	MicroLab/Micro Diary: Turbine swirl plate (Polycarbonate/Makrolon 2607), Turbine van (Polyester type 427), Turbine tube (Clear Acrylic/Makrolon 2607), Pivot (Nivapoint stainless steel).	Identical to K100928 (Micro Diary).
Transducer Type	MicroLab: Type 36-TDX 1048 CareFusion Bi-Directional Digital Volume. Micro Diary: Type 36-TDX 1050 CareFusion Uni-Directional Digital Volume.	Type 36-TDX 1051 CareFusion Uni-Directional Digital Volume.
Resolution	0.01 liter.	Identical to K100928 & K031102.
Accuracy (FEV1/FVC/PEF)	+/- 3% to ATS Recommendations (MicroLab). To the requirements of the ATS/ERS Taskforce: Standardization of Spirometry 2005 (Micro Diary).	Identical to K100928 (i.e., conforms to ATS/ERS 2005).
Volume Range	0.1 - 8 Litres (MicroLab). 0 - 8 l as per ATS/ERS (Micro Diary).	Identical to K100928 (0 - 8 l as per ATS/ERS).
Flow Range	0.2 - 15 Litres/Second (MicroLab & Micro Diary).	0 - 14 l as per ATS/ERS.
Sterilization	Turbine can be sterilized or cleaned.	Identical to K100928 & K031102.
Environmental Specifications	Operating: 0 to +40 °C, 30% to 90% RH (MicroLab & Micro Diary).	Operating: 10 to +35 °C, 20% to 80% RH.

Summary of Device Testing (Evidence of Meeting Acceptance Criteria):

The document states that the following practices were followed and monitored for the development of the Micro I Spirometer, forming the basis of its substantial equivalence claim:

Design and Development QP 0301: Device was developed in accordance with CareFusion's internal design and development quality procedure.
IEC 62366 (Usability): Modifications were developed according to this usability standard.
ISO 14971 (Risk Analysis): A Failure Modes and Effects Analysis (FMEA) was used to assess the impact of modifications.
Biocompatibility (ISO 10993-1): Tested for patient-contacting materials at Nelson test laboratory in the USA.
Safety and EMC Testing (IEC 60601-1 and IEC 60601-2): Device underwent electrical safety and electromagnetic compatibility testing.
Packaging Test: Performed.
Environmental Testing (Climatic Chamber): Performed to evaluate performance under various environmental conditions.
Testing according to ATS/ERS standardization of lung function testing: This is the most direct evidence for the spirometry performance characteristics (accuracy, volume/flow ranges, etc.). The device's accuracy and volume/flow ranges are stated to be "Identical to K100928" or "as per ATS/ERS," directly referring to these standards as the acceptance criteria.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "Testing according ATS/ERS standardization of lung function testing," which implies that the device was validated against the performance requirements outlined in these standards. However, the exact number of test subjects or a specific test dataset is not provided.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The testing was carried out by CareFusion internally and via a third-party lab (Nelson Test Laboratory for biocompatibility, located in the USA).

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set in the traditional sense of clinical studies with expert reviewers. The ground truth for spirometer performance is typically established by comparing the device's measurements against established, precisely calibrated reference systems or standards (like those from ATS/ERS).

4. Adjudication Method

Not applicable. Since the 'ground truth' for this type of device is based on technical standards and calibrated measurements rather than expert consensus on diagnostic images or clinical outcomes, an adjudication method like 2+1 or 3+1 is not relevant here.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is typically performed for AI-powered diagnostic devices where human readers are interpreting data (like medical images) with and without AI assistance to measure improvement in diagnostic performance. The Micro I is a measurement device (spirometer), not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The "Testing according ATS/ERS standardization of lung function testing" would be a standalone performance evaluation of the device's measurement algorithms and hardware against established standards, without human interpretation as part of the primary measurement. The spirometer outputs numerical values (e.g., FEV1, FVC), and its accuracy is assessed against a gold standard for these measurements.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is technical standards and calibrated measurements, specifically those established by the American Thoracic Society (ATS) / European Respiratory Society (ERS) standardization of lung function testing (2005). These standards define the acceptable accuracy, volume range, and flow range for spirometers.

8. Sample Size for the Training Set

Not applicable. The Micro I spirometer is described as a microprocessor-based device converting airflow to an electrical signal, and
calculating values using "onboard software." It does not appear to be an AI/machine learning-based device that would typically have a "training set" in the sense of supervised learning. Its algorithms are likely deterministic and based on physical principles of flow and volume measurement.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention or indication of a training set in the context of machine learning. The device's operation is based on established scientific principles and engineering design, with performance validated against international standards.

Summary

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510(k) Summary

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GENERAL INFORMATION

5.1 Type of Submission

Traditional 510(k) Submission

Submission date: 10/10/2011

5.2 Submitter

Name:

CareFusion Germany 234 GmbH

Address:

Phone:

FAX:

E-mail

Phone: Fax:

E-mail:

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

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

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5.3 Establishment Registration Number 9615102
5.4 Common Name or Classification Name Spirometer, Diagnostic (CFR 868.1840, Product Code BZG)
5.5 Trade Name Micro I
5.6 Device Classification This is a Class II device
5.7 Classification Panel 73 Anesthesiology Part 868 Code BZG
5.8 Reason for Premarket Notification --- new device ---

5.9 Legally predicate marketed devices

Microlab Spirometer . K031102 Code BZG
. Micro Diary K100928 Code BZG
5.10 Predicate Device Company CareFusion

5.11 Device Description

Description & function:

Scientific Concept:

The scientific concept which forms the basis of this device is the Carefusion uni-directional digital volume transducer. The transducer consists of an acrylic tube with a freely rotating vane supported on iewelled bearings positioned between a fixed swirl plate and a cross bar. As air is passed through the transducer, a vortex is created by the

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swirl plate, which causes the low inertia vane to rotate. The rotation of the vane is detected by the interruption of an infra red beam which produces an electrical pulse train at the output of a phototransistor. The number of rotations is proportional to the volume of air passed through the turbine, and the rate of rotation is proportional to the flow rate. Using the integrated software the Micro I calculates a range of expiratory indices.

Significant physical & performance characteristics:

Performance (measurements) Forced Expired Volume in 1 second (FEV1) Forced Expired Volume in 6 second (FEV6) Forced Vital Capacity (FVC) Forced Expiratory Ratio (FEV1/FEV6) Forced Expiratory Ratio (FEV1/FVC) Peak Expiratory Flow Rate (PEF) Mid Expiratory Flow (FEF25-75) Expiratory Flow at 75% of volume remaining (FEF75) Expiratory Flow at 25% of volume remaining (FEF75) Dimensions 162 x 61 x 30mm Weight 152g Display 128 x 128 pixel graphic backlit monochrome LDC Transducer type CareFusion Uni-Directional Digital Volume Power supply 2 x AA size NiMH rechargeable cells

5.12 Intended Use Statement

The Micro I spirometer is intended to measure the maximal volume and flow of air that can be moved out of a patient's lungs. The system is intended for use with pediatric and adult patients over the age of 3 years in hospitals, physician offices, laboratories and occupational health testing environments.

5.13 Required Components

. Micro I spirometer
Digital Volume Transducer .
Cardboard Mouthpieces .
USB/Charging cable .
. Cardboard Mouthpiece Adapter
Instruction for Use .
ban .
Accessories .

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5.14 Summary Table of Comparison

MicroLab K031102	Micro Diary K100928	Micro IK113096 (new)
Indicationsfor Use	The Microlab spirometer isintended, for prescription use only,to measure the maximal volumeand flow of air that can be moved inand out of a patient's lungs. Thesystem is intended for use withpediatric (4 to 17 years) and adult(18 to 99 years) patients inhospitals, physician offices,laboratories and occupationalhealth testing environments.	The Micro Diary Spirometer is usedin pulmonary function testing tomeasure the volume of gas movingin or out of a patient's lungs.Specifically, the Micro DiarySpirometer measures the followinglung function parameters: FEV1,FVC, FEV6 and PEF.	The Micro I spirometer is intendedto measure the maximal volumeand flow of air that can be movedout of a patient's lungs. The systemis intended for use with pediatricand adult patients over the age of 3years in hospitals, physician offices,laboratories and occupationalhealth testing environments.
Targetpopulation	Pediatric (4 to 17 years)Adult (18 to 99 years)	The device can be used on patientswho require lung functionmeasurements. These patients areusually suffering from diseasessuch as asthma andchronic obstructive pulmo-narydisorder. It can be utilized forpatients from 4 years and older,providing that they are able tofollow the medical practitioner'sinstructions.	Over the age of 3 years
Perfor-mancespecifica-tion(measure-ment para-meter)	VC, FEV75, FEV1, FEV3, FEV6,FVC, PEF, FEV75/VC,FEV75/FVC, FEV1/VC,FEV1/FVC, FEV3/VC, FEV3/FVC,FEV75/FEV6, FEV1/FEV6, FEF75,FEF50, FEF25, FEF25-75,FEF50/VC, FEF50/FVC, MVV,FIV1, FIVC, PIF, FIV1/FIVC,FIF25, FIF50, FIF75,FEF50/FIF50, MET2575, FET, TV,ERV, IRV, IC, EVC, IVC, FR, Ti,Te, Ti/Ttot, TV/TI	FEV1, FVC, FEV6, PEF	FEV1, FVC, FEV6,FEV1/FVC, FEV1/FEV6,PEF, FEF25, FEF75,FEF25-75
Transducermaterial(breathingpathcontacting)	Turbine swirl plate(Polycarbonate)Turbine van(Polyester type 427)Turbine tube(Clear Acrylic)Pivot(Nivapoint stainless steel)	Turbine swirl plate(Makrolon 2607)Turbine van(Polyester type 427)Turbine tube(Makrolon 2607)Pivot(Nivapoint stainless steel)	Identical(to K100928)
	Turbine Flow deflector(stainless steel)Mouthpiece holder(ABS Plastic)	N/A	Turbine Flow deflector(stainless steel)Mouthpiece holder(PC/ABS Cycoloy C2800)
Transducer(type)	Type 36-TDX 1048CareFusion Bi-Directional DigitalVolume	Type 36-TDX 1050CareFusion Uni-Directional DigitalVolume	Type 36-TDX 1051CareFusion Uni-Directional DigitalVolume
Resolution	0,01 liter	0,01 liter	Identical(to K100928 & K031102)
	MicroLab K031102	Micro Diary K100928	Micro IK113096 (new)
Accuracy(FEV1/FVC/PEF)	+/- 3% to ATSRecommendations	to the requirements of theATS/ERS Taskforce:Standardization ofSpirometry 2005	Identical(to K100928)
VolumeRange	0.1 - 8 Litres	0 - 8 l as per ATS/ERS	Identical(to K100928)
Flow Range	0.2 - 15 Litres/Second	0.2 - 15 Litres/Second	0 - 14 l as per ATS/ERS
Sterilization	Turbine can be sterilized orcleaned	Turbine can be sterilized orcleaned	Identical(to K100928 & K031102)
User inputtype	Touchscreen(PC/ABS)	Keypad 5 key(Silicon rubber)	Keypad 4 key(Silicon rubber)
Anatomicalsites(Housing)	255 x 120 x 35 mmWeight: 630gHandle (transducer):50 x 60 x 90	130 x 57 x 37 mmWeight: 100g	162 x 61 x 30 mmWeight: 152g
Housingmaterial(patientcontacting)	PC/ABS Cycoloy C2950(Housing)Polyurethane "rubber feel"& black ABS(Transducer)	PC/ABS Babyblend T65(Housing)	PC/ABS Cycoloy C2800(upper & lower casing & MLD1621Mouthpiece adaptor)PC/ABS LEXAN 141 Resin(case tube)Alexit 401-75 soft coating(coating for upper & lower case)
Display	Colour 1/4 VGA LCD	Graphic LCD monochromesize 44,0 x 27,0100 x 64 dot matrix	Graphic LCD monochromesize 33,90 x 33,90128 x 128 dot matrix
Display &keypad foilmaterial(patientcontacting)	PC/ABS(Cycoloy C 2950)no patient contact	Clarex Precision OpticalSheet(Cast Acrylic sheet)	Identical(to K100928)
Energyused(battery)	8,4V NiMH1000mAh	3V Lithium Coin Cell(CR2450), 600mAh	2.4V NiMH AA, 1600mAh
Environ-mentalspecifi-cations	Operating:0 to +40 °C30% to 90% RHStorage:-20 to +70 °C10% to 90% RH	Operating:0 to +40 °C30% to 90% RHStorage:-20 to +70 °C10% to 90% RH	Operating:10 to +35 °C20% to 80% RHStorage:-20 to +70 °C30% to 90% RH
	MicroLab K031102	Micro Diary K100928	Micro IK113096 (new)
Accessory(patientcontacting)	VOL2104 Nose Clips (packof 5)Body material: PolyacetalPad material:Ethylene Vinyl Acetate	VOL2104 Nose Clips (packof 5)Body material: PolyacetalPad material:Ethylene Vinyl Acetate	Identical(to K100928 & K031102)
	PSA1000 Adult DisposableMouthpiece(material: Polyethylene coatedbleached kraft paper)SST1250 One-way SafetyMouthpiece (250 per box)(material: Polyethylene coatedbleached kraft paper / Safetywheel & valve: Polystyrene &Rectaleen 8/170)SST1000 One-way SafetyMouthpiece (500 per box)(material: Polyethylene coatedbleached kraft paper / Safetywheel & valve: Polystyrene &Rectaleen 8/170)PSA1200 PaediatricDisposable Mouthpiece(material: Polyethylene coatedbleached kraft paper)	PSA2200 Mouthpiece(material: ABS)	Identical(to K031102 & also used inMicro Diary Card K965042)
	PSA1100 Paediatricadapter(Polypropylene co-polymer, naturalStamylan P512MN10, colourUN0001 white)	N/A	Identical(to K031102)

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・

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Summary to the table above:

The Micro I and the main predicate device MicroLab have the same indication for use only the sentence for the patient population has been changed into "over the age of 3 years" instead of "4 years to 17 years" and "18 to 99 years". The Micro I has the same technological characteristics as the predicate devices. For the materials used in the Micro I spirometer which are not identical to the predicate devices a biocompatibility test has been done. The patient contacting accessories are the same as used in the predicate devices.

5.15 Summary of Device Testing

The following practices were followed and monitored for development of the Micro I Spirometer:

. The modification for the above device was developed in accordance with the CareFusion Design and Development QP 0301.
The modifications were developed according to IEC 62366 (Usability) . standard.

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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 Nelson test laboratory in the USA.
Safety and EMC testing to IEC 60601-1 and IEC 60601-2 .
Packaging test .
Environmental Testing (climatic chamber) .
Testing according ATS/ERS standardization of lung function testing .

5.16 Conclusion

Based on the above, CareFusion 232 UK concludes that the Micro I Spirometer is substantially equivalent to the legally marketed predicate devices, the CareFusion Microlab Spirometer K031102 and Micro Diary K100928 and is safe and effective for its intended use, and performs at least as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

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

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

Re: K113096

Trade/Device Name: Micro I Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: February 27, 2012 Received: February 29, 2012

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 Eederal Register.

APR 1 3 2012

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh 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):

K113096

Device Name:

Micro I

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)

റ

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number:

Page 1 of

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).