The SpiroPro is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.

Device Description

SpiroPro® is a recording and diagnostic system for measurement, recording and assessment of the Flow-Volume curve and Flow-Volume parameters. The analyzed data can be immediately printed out or saved to the internal memory.

The portable spirometer is small, easy to handle and allows determination of inspiratory and expiratory lung volumes (VCin, FVC, FEV1, MEF50, ... ) including pre and post measurement with date and time display. An interpretation program automatically assesses the measured data. Optionally, the measurement of the oxygen saturation of the blood (SpO2) and the pulse rate are available and a 6-minute walk test can be performed. The graphic LCD and the menu-guided graphical user interface comply with the latest technological developments. Just touch the appropriate icon with your finger to enter patient data or to select menu items (touch screen). Selfexplanatory icons and the logical menu structure safely guide you through the procedure Storage capacity is high: up to 550 measurements can be saved in the internal database.

The rechargeable lithium-ion battery allows operation of the SpiroPro® for approximately two weeks. A charging unit, able to charge the battery within two hours, is included in the delivery.

Patient data, recording results and graphs can be directly printed out on a PCL-compatible printer (for example HP DeskJet series). Of course, data transfer to a PC and vice versa is possible via the serial interface and the Bluetooth interface. The optional software package "SpiroPro® for Windows®" allows automatic transfer of data which are then saved on the PC. The easy-to-exchange, high-quality pneumotach guarantees a high degree of patient safety and provides precise recording results.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for device K092324 (SpiroPro):

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a defined set of "acceptance criteria" for the SpiroPro. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SpiroPro SpO2, K031515) through a comparison of technological characteristics and adherence to relevant standards.

The primary performance "criteria" are implied to be compliance with ATS standards for spirometry measurements and successful biocompatibility testing for new materials.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ATS (American Thoracic Society) spirometry standards	Device can apply ATS 1994 and ATS-ERS 2005 criteria for evaluation of measurements.
Biocompatibility of new mouthpiece material (Bormed GR 835 MO)	Biocompatibility test according to ISO 10993-1 was successful.
Efficacy of disinfection for reusable pneumotach	Validated for disinfection with an FDA approved disinfectant ("Cidex OPA Solution" with 510(k) K030004).
Safety requirements and mitigation of identified hazards	Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.
Compliance with Electromagnetic Compatibility (EMC) standards	EMC testing performed according to EN 60601-1-2.
Functional equivalence of Bluetooth data transmission	Bluetooth module (Mitsumi WML-C46) is identical to a previously cleared device (AM1+ / AM1+ BT, K090486).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The primary evaluation method is a comparison to a predicate device and adherence to technical standards. There is no mention of a specific sample size for a test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective).

The "testing" referenced is primarily technical verification and validation of changes (e.g., biocompatibility testing of materials, disinfection validation, EMC testing, and functional testing of the Bluetooth module).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. Given the nature of the submission (device modification for substantial equivalence based on technical changes and existing standards), there is no indication of a requirement for a ground truth established by experts in the context of clinical performance data.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. There is no mention of a clinical "test set" and thus no adjudication method for it.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

An MRMC study was not done. This device is a spirometer and oximeter, not an AI-assisted diagnostic tool for image interpretation or similar applications where MRMC studies are typically employed. There is no AI component mentioned that would assist human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Only parts of the device's performance are "standalone" in the sense that they are technical measurements or functions. For example, the spirometry measurements themselves (lung function parameters like FEV1, FVC) are generated by the device's algorithms based on sensor input. However, the device is intended for use by or with oversight from medical professionals (physicians in office/hospital, occupational medicine, or patients in the home under guidance). The document does not report on a standalone performance study in a clinical context separate from human-in-the-loop usage.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the core spirometry measurements, the "ground truth" is inherently defined by physical measurement standards and the ATS (American Thoracic Society) criteria. The device's accuracy for these measurements is presumably validated against calibrated instruments and the performance of the predicate device (SpiroPro SpO2, K031515), which was already cleared. For the new material and reusable pneumotach, the ground truth is established by biocompatibility testing standards (ISO 10993-1) and efficacy of FDA-approved disinfectants.

8. The Sample Size for the Training Set:

The document does not mention a training set. This type of submission (modification to an existing device, focusing on substantial equivalence for technical changes) generally does not involve machine learning or AI models that require training sets in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/not provided as no training set is discussed.

Summary

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K092324

510(k) Summary

SEP - 3 2009

GENERAL INFORMATION

5.1 Type of Submission

Special 510(k) Submission

07/17/2009 Submission date:

5.2 Submitter

Name:

Cardinal Health Germany 234 GmbH

Address:

Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

	Thomas Rust
Address:	Cardinal Health Germany 234 GmbHLeibnizstrasse 7, 97204 HoechbergGermany
Phone:	+49 931 49 72 - 383
FAX:	+49 931 49 72 - 62383
E-mail	Thomas.Rust@cardinalhealth.com

Contact person in the U.S. (Official Correspondent)

Cardinal Health 207 INC Address 22745 Savi Ranch Parkway Yorba Linda, CA 92887 714-283-8472 Phone/Fax: Thomas Gutierrez@cardinalhealth.com E-mail

Thomas Gutierrez

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Establishment Registration Number 5.3 ... 9615102
5.4 Common Name or Classification Name Oxymeter (CFR 870.2700, Product Code DQA) Predicted pulmonary-function value calculator (CFR 868.1890, Product Code BTY)
Trade Name

SpiroPro

Device Classification 5.6

This is a Class II device

Classification Panel

73 Anesthesiology Part 870 Code DQA and Part 868 Code BTY

Reason for Premarket Notification 5.8

Device modification to an existing Cardinal Health - device regarding "The New 510(k) Paradigm"

-- Additional data transfer to computer by blue tooth --

Legally predicate marketed device 5.9

SpiroPro SpO2
K031515 / Code DQA, BTY
AM1+ / AM1+ BT
K090486 / Code BZG

Predicate Device Company 5.10

Cardinal Health Germany 234 GmbH

Device Description 5.11

the latest technological developments. Just touch the appropriate icon with your finger to enter patient data or to select menu items (touch screen). Selfexplanatory icons and the logical menu structure safely guide you through the procedure Storage capacity is high: up to 550 measurements can be saved in the internal database.

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The rechargeable lithium-ion battery allows operation of the SpiroPro® for approximately two weeks. A charging unit, able to charge the battery within two hours, is included in the delivery.

5.12 Intended Use Statement

The SpiroPro is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro measures inspiratory and expiratory lung function parameters in adults and children 4 vears and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.

Required Components 5.13

SpiroPro (with Nonin Xpod Patient Cable Oximeter) Nonin Finger Clip Sensor Pneumotachograph set Plastic Disposable Mouthpiece Nose clip . . . . Lithium-ion battery 3,7V; rechargeable Charging unit Printer cable Printer adapter User Manual SpiroPro for Windows Software (option)

Summary Table of Comparison 5.14

	SpiroPro SpO2(K031515)	SpiroProwith Bluetooth
Indicationsfor Use	The SpiroPro is a portable, batteryoperated device and can be used byphysicians in the office or hospital, inoccupational medicine or by patientsin the home. The SpiroPro measuresinspiratory and expiratory lungfunction parameters in adults andchildren 4 years and older. In additionto the pulmonary function.measurements, oxygen saturation andheart rate can be recorded.	identical

a) Comparison with SpiroPro SpO2 with 510(k) K031515

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FundamentalscientificTechnology	Spirometer:Pneumotachograph, pressure toflow conversion techniqueOximeter:Conventional dual wavelength pulsetechnique	identical
Accessories	Pneumotachograph set Finger clip sensor Nose clip	identical
Patientcontactingparts	Finger clip sensor Nose clip pad	identical
Housingmaterial	Single use mouthpiece(material: Hostalen GD 6250)	Single use mouthpiece(material: Bormed RG835 MO)
Housingmaterial	Rotec ABS 1001FR V0	identical
Pneumotachmaterial	Rotec ABS 1001FR V0	identical
Disinfection	Mouthpiece(single patient use)	identical
	Pneumotach(single patient use)	Identical(but is validated for disinfection)
Display /Key-panel	LCD touch screen12064 dots / 34 touch	Successor model
Micro-controller	Micro-controllerwith internal memory	Successor model
Interface	RS232 Interface	identical
Energy type	1 x 3,7V Lithium-ion battery	identical
Off-the-ShelfSoftware	Option	identical

・

・ .

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ATS conformity(criteria)	ATS 1994	ATS 1994 and ATS-ERS 2005
------------------------------	----------	---------------------------

Discussion to the table above:

The insignificant differences to the SpiroPro SpO2 are found as:

. Single use Mouthpiece - The material for the single use mouthpiece has changed from Hostalen GD 6250 to Bormed GR 835 MO. For the material Bormed GR 835 MO a biocompatibility test according ISO 10993-1 was successful accomplished.
· Pneumotach The pneumotach for the SpiroPro now is reusable and has been validated for disinfection with an FDA approved disinfectant. The high level disinfectant for semi-critcal devices "Cidex OPA Solution" with 510(k) K030004 can be used.
ATS criteria For evaluation of the measurement now the ATS criteria . according ATS 2005 can be selected in the setting menu beside the ATS 1994 criteria. This means, the result can also be shown on the screen of the SpiroPro according the ATS 2005 criteria.
Micro-controller has been replaced by a successor model due to the fact . that the previous Micro-controller will be not manufactured anymore. Successor model: Micro-controller MB96 F 346 / 16 bit
LCD-Display has been replaced by a successor model due to the fact that . the previous LCD display will be not manufactured anymore. Successor model: LCD module type - JCG12064A02-02
b) Comparison with AM1+ / AM1+ BT with 510(k) K090486

	AM1+ / AM1+ BT(K090486)	SpiroProwith Bluetooth
Interface	RS232 Interface & Bluetooth	identical

Discussion to the table above:

The similarities to the AM1+ / AM1+ BT are found as:

Bluetooth is used for data transfer to the computer as an additional . possibility besides the serial interface communication. The Bluetooth module for the SpiroPro device is identical to the Bluetooth module in the AM1+ / AM1+ BT. Both devices work with the Bluetooth module Mitsumi WML-C46.

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Summary of Device Testing 5.15

The following practices were followed and monitored for development of the SpiroPro with the Bluetooth data transmission:

The Bluetooth data transmission for the above device was developed in . accordance with the Cardinal Health development standard operating procedures (000490 06 - Design Control).
The risk analysis method used to assess the impact of SpiroPro with . the additional Bluetooth data transmission was a Failure Modes and Effects Analysis (FMEA).
Safety test procedures demonstrate satisfaction of all safety . requirements and mitigation of all identified hazards.
The EMC testing was performed according EN 60601-1-2. .

5.16 Conclusions

Based on the above, Cardinal Health Germany 234 GmbH concludes that the SpiroPro is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, and performs at least as well as the predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the logo.

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

Mr. Thomas Rust Regulatory Affairs Manager Viasys Healthcare GmbH Leibnizstrasse 7. D-97204 Hoechberg GERMANY

SEP - 3 2009

Re: K092324

Trade/Device Name: SpiroPro Regulation Number: 21 CFR 868.1890 Regulation Name: Oximeter Regulatory Class: II Product Code: BTY, DQA Dated: July 30, 2009 Received: August 5, 2009

Dear Mr. Rust:

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.

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. Rust

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.

for

Susan Runner, D.D.S., M.A. Acting 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):

SpiroPro

ко92324

Device Name:

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)

Schubton

109232

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Hospital Division of Antrol, Dental Devices

510(k) Number:

Page 1 of

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).