(61 days)
The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.
The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose. insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
The ACCU-CHEK Connect Diabetes Management App is designed to facilitate efficient collecting, transmitting, and analyzing of blood glucose results and other diabetes management data. The App helps:
Wireless transfer of data from ACCU-CHEK Aviva Connect Blood Glucose Meter. Assist in general diabetes management through logging of contextual data. ACCU-CHEK Bolus Advisor support of mealtime insulin dosing calculations. Perform structured testing. Wireless transfer of data from mobile devices to ACCU-CHEK Connect Online Diabetes Management System and optionally share this data with healthcare provider (HCP) or caregiver.
The insulin bolus calculations provided by the app are meant for patients undergoing multiple daily injection therapy. Bolus calculators, such as the ACCU-CHEK Bolus Advisor, have been demonstrated to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and under the supervision of healthcare professional experienced in managing insulin-treated patients. Such calculators have also been shown to reduce patient fear of hypoglycemia and improve patient confidence in diabetes management.
The ACCU-CHEK Connect Diabetes Management App is not intended to serve as an accessory to an insulin pump.
The provided document describes a 510(k) premarket notification for the "ACCU-CHEK Connect Diabetes Management App" for iOS platform. The submission aims to demonstrate substantial equivalence to an existing predicate device, the Android OS version of the same app (K141929). The core of the argument for substantial equivalence relies on the fact that the bolus calculator algorithm and intended use have not changed, and the modifications are primarily related to adapting the app to the iOS operating system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding performance metrics for the modified device. Instead, the acceptance is based on demonstrating that the iOS version performs equivalently to the already cleared Android version. The performance is assessed by confirming that the changes do not introduce new hazards or alter the core functionality.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Equivalence | The ACCU-CHEK Connect Diabetes Management App for iOS retains all the core functionalities of the predicate Android version, including: - Electronic download of blood glucose meters - Manual data entry - Storage, display, transfer, and self-managing of blood glucose and other related health indicators - ACCU-CHEK Bolus Advisor for insulin dose/carbohydrate intake calculation - Structured testing - Wireless transfer of data to ACCU-CHEK Connect Online Diabetes Management System - Bolus calculator algorithm is unchanged from the predicate device. - Bolus calculator activation prescription control process, activation, and patient training materials, and user interface screens (related to bolus calculator) are unchanged from the predicate device. |
| Safety - Risk Assessment | A risk analysis according to ISO 14971 was carried out. Potential faulty conditions and hazards were systematically identified and evaluated using "Failure Mode Effect and Criticality Analysis." Adequate protection measures were implemented. The risk assessment for the iPhone version "relied heavily" on the risk assessment performed for the Android OS version. Post-launch monitoring of the Android version did not identify possible faulty conditions leading to hazards for the patient. |
| Performance Requirements | "Design verification bench testing on the modification of ACCU-CHEK Connect Diabetes Management App demonstrated that the device meets the performance requirements for its intended use." (Specific metrics are not provided, as the claim is equivalence to the predicate). |
| Human Factors | An "expert evaluation" (human factors) was performed to show that the predicate design validation can be used to support the iPhone version's design validation. This evaluation used side-by-side comparison of screenshots between Android and iOS versions to review changes. - Changes reviewed were due to inherent differences between OS user interface standards. - Enhancements based on results of Android version summative and iPhone version formative human factors study. - Changes to validation study tasks. "No new use-related hazard was identified during the expert evaluation." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for a "test set" in the traditional sense of a performance study with patient data.
- For functional and performance requirements: "Design verification bench testing" was conducted, but no sample size for this testing is provided. The testing aimed to confirm that the device meets performance requirements, likely through technical validation.
- For Human Factors: The human factors evaluation was an "expert evaluation" involving a comparison of screenshots and review of changes. It does not appear to be a study with user participants from a specific test set.
- Data Provenance: Not applicable in the context of this submission, as it largely focuses on the technical equivalence between two versions of the same software for different operating systems. The core bolus algorithm, if it was validated with patient data, would have been done for the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Human Factors: An "Human Factors expert" performed the evaluation. The exact number of experts (singular or plural often used generically) is not explicitly stated if it was more than one, nor are their specific qualifications (e.g., years of experience, specific certifications) detailed, beyond them being "Human Factors expert".
- Other Testing: The document does not describe the establishment of a "ground truth" for a test set in the context of clinical outcomes or diagnostic accuracy, as the device is a diabetes management app with an unchanged bolus calculator algorithm. The "ground truth" for the bolus calculation would have been established during the development and validation of the predicate device's algorithm, adhering to medical and physiological principles of insulin dosing.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method, as the studies described (bench testing, expert human factors evaluation) do not involve subjective interpretation or a need for external consensus on a "ground truth" for clinical cases in this specific 510(k) submission.
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
No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The ACCU-CHEK Connect Diabetes Management App is a diabetes management software, not an imaging diagnostic device, and thus this methodology is not relevant to its validation as described here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence, the predicate device's bolus calculator algorithm would have undergone standalone validation. The current submission explicitly states: "The insulin bolus calculator algorithm is unchanged as compared to the predicate device." This implies that the standalone performance of the algorithm itself was established during the predicate's clearance. The "Design verification bench testing" for the modified app would primarily verify that the implementation of this unchanged algorithm on the new platform correctly computes the same results.
7. The Type of Ground Truth Used
For the bolus calculator functionality (which is based on the unchanged algorithm from the predicate):
- The ground truth would be based on established medical and physiological principles for insulin dosing, as programmed into the algorithm's parameters (e.g., target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, insulin action profiles). The accuracy of its calculations would be verified against these predefined parameters and typically, in a predicate device, against known physiological models or expert-derived reference calculations.
For the human factors evaluation:
- The "ground truth" was implicitly the established safety and usability of the predicate (Android) version, and the goal was to ensure the iOS version maintained this without introducing new hazards. The "expert evaluation" served as the primary method to assess this.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This submission is for a software modification (porting to a new OS) rather than the development of a new AI/ML algorithm that typically requires a large training set. The bolus calculator algorithm is based on predefined physiological equations and parameters, not on machine learning models trained on vast datasets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML model in this submission. The bolus calculator algorithm's "ground truth" (i.e., its correctness) would have been established at the time of the predicate device's development through clinical and algorithmic validation against medical standards and physiological models, as it is a rule-based system, not a data-driven learning system.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2015
Roche Diabetes Care Inc. Ms. Chunhong Tao Regulatory Affairs Specialist 9115 Hague Road Indianapolis, IN 46250
Re: K150910
Trade/Device Name: ACCU-CHEK Connect Diabetes Management App Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: II Product Code: NDC, LZG, LFR, JQP Dated: May 6, 2015 Received: May 7, 2015
Dear Ms. Tao:
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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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)
Device Name
ACCU-CHEK Connect Diabetes Management App
Indications for Use (Describe)
The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Indications for Use
510(k) Number (if known)
Device Name
ACCU-CHEK Connect Diabetes Management App
Indications for Use (Describe)
The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose. insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter name, address, contact | Roche Diabetes Care Inc.9115 Hague Rd.Indianapolis, IN 46250(317) 521-7227Contact Person: Chunhong (Emma) Tao |
|---|---|
| Date Prepared: April 2nd, 2015 |
| 2) Device name | Proprietary Name: ACCU-CHEK Connect Diabetes Management AppCommon Name: diabetes management software |
|---|---|
| ---------------- | ---------------------------------------------------------------------------------------------------------- |
Primary
Classification Name: predictive pulmonary-function value calculator
Classification Regulation: 21 C.F.R. § 868.1890; Class II
Product Code: NDC
Secondary
Classification Regulations: 21 C.F.R. § 880.5725, 862.1345, 862.2100; Class II
Product Code: LZG, LFR, JQP
| 3) Predicate device | ACCU-CHEK Connect Diabetes Management App (K141929), concurrence received on March 16, 2015. |
|---|---|
| --------------------- | ---------------------------------------------------------------------------------------------- |
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| 4) DeviceDescription | The ACCU-CHEK Connect Diabetes Management App is designed tofacilitate efficient collecting, transmitting, and analyzing of blood glucoseresults and other diabetes management data. The App helps:Wireless transfer of data from ACCU-CHEK Aviva Connect BloodGlucose Meter. Assist in general diabetes management through logging of contextualdata. ACCU-CHEK Bolus Advisor support of mealtime insulin dosingcalculations. Perform structured testing. Wireless transfer of data from mobile devices to ACCU-CHEKConnect Online Diabetes Management System and optionally sharethis data with healthcare provider (HCP) or caregiver.The insulin bolus calculations provided by the app are meant for patientsundergoing multiple daily injection therapy. Bolus calculators, such as theACCU-CHEK Bolus Advisor, have been demonstrated to facilitate theoptimization of glycemic control in patients who are trained in multiple dailyinsulin injection therapy and under the supervision of healthcare professional |
|---|---|
| -------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
experienced in managing insulin-treated patients. Such calculators have also been shown to reduce patient fear of hypoglycemia and improve patient confidence in diabetes management.
The ACCU-CHEK Connect Diabetes Management App is not intended to serve as an accessory to an insulin pump.
Continued on next page
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- Intended For Over-the-Counter Use: use The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. For Prescription Use: The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on userentered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software. 6) Substantial The ACCU-CHEK Connect Diabetes Management App utilizes the equivalence processing power of a mobile phone operating system platform to transfer data from a blood glucose meter, transfer data to an online diabetes management system, facilitate structured testing data collection, assist in general diabetes management through logging of contextual data, and calculate insulin bolus in response to blood glucose, health events, and carbohydrate input. The App is compatible with glucose meters with BLE transmitter. The insulin bolus calculator algorithm is unchanged as compared to the predicate device. The modification of the ACCU-CHEK Connect Diabetes Management App to work on iOS platform does not change the App's intended use or the interface to the ACCU-CHEK Aviva Connect meter or the ACCU-CHEK Connect Online diabetes management system. The modification of ACCU-CHEK Connect Diabetes Management App is substantially equivalent to ACCU-CHEK Connect Diabetes Management App (K141929).
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Modifying the ACCU-CHEK Connect Diabetes Management App to work on 7) Data demonstrating iOS platform does not change the App's intended use or its place within the substantial ACCU-CHEK Connect Diabetes Management System. The modification to equivalence the ACCU-CHEK Connect Diabetes Management App does not change the data collection, tracking, trending, or transmission functions, the bolus calculator algorithm, the bolus calculator activation prescription control process, the bolus calculator activation and patient training materials, or the bolus calculator user interface screens.
The risk assessment for the iPhone version relied heavily on the risk assessment performed for the Android OS version of the App. The project management staff assessed potential faulty conditions and monitored ACCU-CHEK Connect Diabetes Management App post launch (Android OS version) to identify any possible faulty conditions that might lead to possible hazards for the patient. A risk analysis according to the "Risk Reduction Principle" laid down in the harmonized ISO standard "14971 Medical Devices -Application of risk management to medical devices" was carried out for the ACCU-CHEK Connect App. Possible hazards and consequences were systematically identified and evaluated by using the "Failure Mode Effect and Criticality Analysis" technique. Where appropriate, adequate protection measures relating to the risk that cannot be eliminated have been implemented, as well as safety information described in the instructions for use.
Design verification bench testing on the modification of ACCU-CHEK Connect Diabetes Management App demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the new device is substantially equivalent to the predicate device.
A Human Factors expert evaluation was performed to show that the predicate design validation can be used to support iPhone version's design validation. Three types of changes were reviewed using side-by-side comparison of screenshots from the Android version and the iPhone version:
-
- Changes based on the inherent differences between the iOS and Android operating systems (OS) user interface standards
-
- Enhancements that were made based upon results of the Android version summative and iPhone version formative human factors study
-
- Changes to Validation study tasks
All of the changes are attributed to user interface standard differences between iOS and Android operating systems or to enhancements to the user experience. No new use-related hazard was identified during the expert evaluation. This expert evaluation supports design validation of the product.
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| 8)Similarities/Differences | The following is a listing of the key similarities and differences between themodified ACCU-CHEK Connect Diabetes Management App and thepredicate device. | |
|---|---|---|
| Feature /Claim | Modified ACCU-CHEK ConnectDiabetes Management App | ACCU-CHEK Connect DiabetesManagement App (#K141929) |
| Intended Use | The ACCU-CHEK ConnectDiabetes Management App isindicated as an aid in the treatmentof diabetes. The software providesfor electronic download of bloodglucose meters, manual data entry,storage, display, transfer, and self-managing of blood glucose andother related health indicators whichcan be shown in report andgraphical format.The ACCU-CHEK Bolus Advisor,as a component of the ACCU-CHEK Connect DiabetesManagement App, is indicated forthe management of diabetes bycalculating an insulin dose orcarbohydrate intake based on user-entered data. Before its use, aphysician or healthcare professionalmust activate the bolus calculatorand provide the patient-specifictarget blood glucose, insulin-to-carbohydrate ratio, and insulinsensitivity parameters to beprogrammed into the software. | Same |
| Prescription /over-the-counteruse? | Over-the-counter distribution ofApp, with bolus calculator functiondisabled until activated by physician | Same |
| User Group | Diabetes patients treated withmultiple daily insulin injection(MDI) therapy | Same |
| Accessory toBlood GlucoseMeters? | ACCU-CHEK Aviva Connect bloodglucose meter | Same |
| Feature /Claim | Modified ACCU-CHEK ConnectDiabetes Management App | ACCU-CHEK Connect DiabetesManagement App (#K141929) |
| Bolus CalculatorSet-up stage | During the modified ACCU-CHEKConnect Diabetes ManagementApp's bolus calculator set-up stage,the following information must beentered.• Time Blocks• Target Range• Carb Ratio• Insulin Sensitivity• Health Event Percentages• Meal Rise• Snack Size• Acting Time• Offset Time | Same |
| Bolus Calculatorinputs | Once the set-up stage has beencompleted, the patient may beginusing the ACCU-CHEK BolusAdvisor in the modified ACCU-CHEK Connect DiabetesManagement App. Bolusrecommendations can be triggeredby inputting the followinginformation prior to each meal:• Measure blood glucose• Enter carbohydrates• Enter Health Event | Same |
| Communicatewith insulinpumps? | No | No |
| Software Level ofConcern | Major | Major |
| Connectivity toMeter | Bluetooth Low Energy (BLE) | Same |
| Control or affectthe blood glucosemeter'smeasurements? | No | No |
| Reports, graphs,and ElectronicLog Book | Yes | Yes |
| Feature /Claim | Modified ACCU-CHEK Connect Diabetes Management App | ACCU-CHEK Connect Diabetes Management App (#K141929) |
| Structured Testing | Facilitate the collection ofStructured Testing data | Same |
| Carbohydrate Calculator | Calculate carbohydrate intake basedon user-entered data | Same |
| Bolus Calculator | Yes | Yes |
| Bolus Calculator Security | The patients will be instructed torequest an activation code fromtheir healthcare providers; thehealthcare providers will decidewhether any additional multipledaily injection therapy trainingshould be provided to the patientprior to activating the app's boluscalculator function. | Same |
| Allow manual entry? | Yes | Yes |
| Back-calculation prevents insulin stacking? | Yes | Yes |
| Operating platform | iOS platform | Android platform |
| UI Standards | iOS standards | Android standards |
| Size and Spacing | iOS phones with smaller viewablescreens | Android phones with largerviewable screens |
| Meter Pairing Code | iOS standard Bluetooth pairing code | Android standard Bluetooth pairingcode |
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§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).