The Hudson RCI Voldyne Volumetric Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 yrs) patients. It is a single patient, multi-use device used in hospital or home care setting.

Device Description

The Hudson RCI® Voldyne® Volumetric Exerciser ("Voldyne") is a volumetric incentive spirometer. It is a single patient multi-use device. The primary interface of the user with the device is through a mouthpiece. The device contains two chambers; one for the flow chip, and one for the piston. The piston chamber is marked with a graduation from 500 ml to 4,000 ml (for the Voldyne 4000) or 250 ml to 2,500 ml (for the Voldyne 2500 and Voldyne Pediatric) on the front and the back of the main housing. The flow chip chamber for the device is marked with a happy face symbol with arrows pointing to the optimum position of the Voldyne Pediatric version includes a sticker sheet with clouds and trees graphics, which can be placed onto the device. When the patient inhales the flow chip and piston rise due to the negative pressure created; this indicates breathing volume and flow, while the device provides an exercise incentive to patients who require sustained maximal inspiration (SMI).

AI/ML Overview

This document describes the premarket notification (510(k)) for the Teleflex Medical, Inc. Hudson RCI® Voldyne® Volumetric Exerciser (K182847). The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the Besmed Volumetric Incentive Spirometer (K141355).

Based on the provided text, the device is an incentive spirometer, a medical device used for inspiratory deep breathing exercises. The information provided heavily focuses on justifying substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study with an "AI" component. Therefore, much of the requested information regarding AI device performance, expert review, MRMC studies, and ground truth definitions for AI models is not present in the provided 510(k) summary, as this is a traditional medical device, not an AI/ML software as a medical device (SaMD).

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format typically seen for AI/ML device evaluations against specific metrics like sensitivity, specificity, or AUC. Instead, it relies on demonstrating equivalence to the predicate device and meeting applicable standards and internal performance specifications for a mechanical device.

The closest to "acceptance criteria" and "reported performance" for an incentive spirometer device, as presented in this document, are:

Acceptance Criterion (implicitly by comparison to predicate/standards)	Reported Device Performance (Hudson RCI® Voldyne® Volumetric Exerciser)
Classification Name: Spirometer, Therapeutic (Incentive)	Matches predicate
Product Code: BWF	Matches predicate
Class: II	Matches predicate
Regulation Number: 868.5690	Matches predicate
Single Patient Use: Yes	Matches predicate
Usability: Multi-use	Matches predicate
Patient Population: Adults and Pediatric patients (above 5 years)	Similar to predicate (patients requiring inspiratory exercise, though specific age for predicate not detailed beyond "Pediatric above 5 yrs")
Prescription Only: Yes	Matches predicate
Environments of Use: Home care settings and hospitals	Matches predicate
Sterile: No	Matches predicate
Indication for Use: Inspiratory deep breathing positive exerciser for adult and pediatric (above 5 yrs) patients; single patient, multi-use; hospital or home care setting.	Substantially equivalent to predicate, which also describes an inspiratory deep breathing positive exerciser for single-patient, multi-use in hospital or home care setting.
Contraindications: None	Matches predicate
Basic Components: Housing, 1 ball/piston, Tubing, Mouthpiece	Matches predicate
Patient Interface: Mouthpiece	Matches predicate
Materials Evaluation (Biocompatibility): Per ISO 10993-1:2009	Materials evaluated per ISO 10993-1:2009, 10993-5:2009, 10993-10:2010, 10993-11:2017. Results demonstrated biocompatibility.
Shelf-life: Not explicitly specified for predicate, but generally expected.	1 Year
Accuracy: $\pm$ 15% (for predicate)	Equivalent (implies meets or is comparable to predicate's $\pm$ 15%)
Performance Testing: (Age, Mouthpiece/Tubing Engagement, Leakage, Volume Accuracy, Flow Chip/Piston Operation, Slide Operation)	Performed: Age testing (Pre and Post Aging), Mouthpiece and Tubing Engagement Test, Tubing and Housing Engagement Test, Collapsible Tubing Leakage Test, Volume Accuracy Test, Flow Chip and Piston Operation, Slide Operation. Also tested to ISO 5356-1:2015.
Volume: 2500 and 4000 cc	Compared to predicate's 2500 and 5000 cc; similar volumes offered.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it pertains to a clinical study dataset for an AI/ML device. The performance data refers to device engineering tests (e.g., shelf life, cleaning validation, biocompatibility, mechanical performance tests like volume accuracy and leakage). Details on specific sample sizes for these engineering tests are not provided in this summary, nor is data provenance in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as this is not an AI/ML device requiring expert adjudication for ground truth.

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

A MRMC study comparing human performance with and without AI assistance was not done. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone algorithm performance study was not done. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as it relates to AI/ML models is not applicable here. For this physical medical device, the "ground truth" for its performance is derived from:

Physical measurements: Accuracy of volume, leakage tests, engagement tests.
Compliance with standards: ISO 10993 (biocompatibility), ISO 5356-1 (conical connectors).
Bench testing: Age testing (pre and post aging).

8. The sample size for the training set

This information is not applicable as this is a traditional medical device, not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable as this is a traditional medical device, not an AI/ML device that requires a "training set" with established ground truth.

In summary:

The provided document is a 510(k) summary for a traditional medical device (incentive spirometer). It focuses on demonstrating substantial equivalence to an existing predicate device through comparative feature analysis and engineering performance testing (e.g., biocompatibility, mechanical performance). It does not involve any Artificial Intelligence (AI) or Machine Learning (ML) components, and therefore, many of the questions related to AI acceptance criteria, clinical study designs for AI, expert reviews, and ground truth for AI models are not addressed in this document. The "study that proves the device meets the acceptance criteria" refers to the engineering and biocompatibility tests conducted, not a clinical trial or AI performance study.

Summary

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July 1, 2019

Teleflex Medical, Inc Sirisha Kommana Regulatory Affairs Specialist 3015 Carrington Mill Blvd, Suite 600 North Morrisville, North Carolina 27560

Re: K182847

Trade/Device Name: Hudson RCI® Voldyne® Volumetric Exerciser Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: May 22, 2019 Received: May 23, 2019

Dear Sirisha Kommana:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for James J. Lee, PhD Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K182847

Device Name Hudson RCI® Voldyne® Volumetric Exerciser

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 (K182847)

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-433-4831 Fax: 919-361-3939

B. Contact Person

Sirisha Kommana Regulatory Affairs Specialist, Respiratory Division

C. Date Prepared

July 1, 2019

D. Device Name

Trade Name:	Hudson RCI® Voldyne® Volumetric Exerciser
Common Name:	Incentive Spirometer
Product Code:	BWF
Regulation Number:	868.5690
Classification:	II
Classification Panel:	Anesthesiology

E. Predicate Device

This submission demonstrates substantial equivalence to Besmed Volumetric Incentive Spirometer (K141355).

F. Device Description

The device contains two chambers; one for the flow chip, and one for the piston. The piston chamber is marked with a graduation from 500 ml to 4,000 ml (for the Voldyne 4000) or 250 ml to 2,500 ml (for the Voldyne 2500 and Voldyne Pediatric) on the front and the back of the main housing. The flow chip chamber for the device is marked with a happy face symbol with arrows pointing to the optimum position of the Voldyne Pediatric version includes a sticker sheet with clouds and trees graphics, which can be placed onto the device.

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When the patient inhales the flow chip and piston rise due to the negative pressure created; this indicates breathing volume and flow, while the device provides an exercise incentive to patients who require sustained maximal inspiration (SMI).

G. Indications for Use

H. Contraindications

None

l. Substantial Equivalence

The proposed device is substantially equivalent to the predicate device.

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Comparison of Predicate vs. Proposed Device

Features	Teleflex MedicalHudson RCI® Voldyne®Volumetric Exerciser(K182847)	Besmed VolumetricIncentive Spirometer(Predicate Device-K141355)
Classification Name	Spirometer, Therapeutic(Incentive)	Spirometer, Therapeutic(Incentive)
Product Code	BWF	BWF
Class	II	II
Regulation Number	868.5690	868.5690
Single Patient useonly	Yes	Yes
Usability	Multi-use	Multi-use
Patient Population	Adults and Pediatricpatients (above 5 years)	Patients requiringinspiratory exercise
Prescription Only	Yes	Yes
Environments ofuse	Home care settings andhospitals	Home care settings andhospitals
Volume	2500 and 4000 cc	2500 and 5000 cc
Sterile	No	No
Indication for Use	The Hudson RCI VoldyneVolumetric Exerciser isintended as an inspiratorydeep breathing positiveexerciser for adult andpediatric (above 5 yrs)patients. It is a singlepatient, multi-use deviceused in hospital or homecare setting.	The Besmed VolumetricIncentive Spirometer isintended as aninspiratory deep breathingpositive exerciser.Intended for single-patient,multi-use in a hospital orhome care setting.
Contraindications	None	None
Basic Components	Housing1 ball / pistonTubingMouthpiece	Housing1 ball / pistonTubingMouthpiece

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Patient Interface	Mouthpiece	Mouthpiece
MaterialsEvaluation	The materials used in theconstruction of Voldynewere evaluated per ISO10993-1:2009	The materials used in theconstruction of predicatewere evaluated per ISO10993-1:2009
Shelf-life	1 Year	Not specified
Accuracy	Equivalent	$\pm$ 15%
PerformanceTesting	Age testing (Pre and PostAging)Mouthpiece and TubingEngagement TestTubing and HousingEngagement TestCollapsible TubingLeakage TestVolume Accuracy TestFlow Chip and PistonOperationSlide Operation	Age Testing-Pre and post-exposure

J. Comparison to the Predicate

The basic technological and operating principles are for both devices. Both the predicate and subject device have similar indications for use. Both the subject and predicate device are intended for similar patient populations. Both the subject and predicate device are intended to be used in home care and hospital settings. Both the subject and predicate devices are disposable, non-sterile, single patient use devices. The proposed Voldyne® Volumetric Exerciser is substantially equivalent to the predicate device.

K. Performance Data

Teleflex performed a number of tests to demonstrate that the Voldyne® Volumetric Exerciser meets its performance specifications and that it is substantially equivalent to the predicate Besmed Volumetric Incentive Spirometer (K141355).

The following tests were performed on the proposed devices:

Shelf Life
Cleaning validation
ISO 5356-1:2015- Anaesthetic and respiratory equipment -- Conical connectors -Part 1: . Cones and sockets, applicable sections

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Biocompatibility: The Hudson RCI® Voldyne® Volumetric Exerciser is an externally ● communicating tissue contact, limited duration device (<24 hours).
- ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and o Testing Within a Risk Management Process
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices Part 5: Tests for In o Vitro Cytotoxicity
- ISO 10993:10: 2010 Biological Evaluation of Medical Devices Part 10: Tests for O Irritation and Skin Sensitization
- ISO 10993:11: 2017 Biological Evaluation of Medical Devices Part 11: Tests for o Systemic Toxicity

The proposed devices were tested to the requirements of ISO 5356-1:2015. Cytotoxicity, Sensitization, Irritation and Systemic Toxicity were performed to demonstrate biocompatibility of the patient contacting materials to the requirements of ISO 10993-1:2009. Overall, the results are comparable to the predicate and support a determination of substantial equivalence.

L. Conclusion

The Voldyne® Volumetric Exerciser has similar indication for use and technological characteristics as its predicate. The device data and test results demonstrate that the device meets the applicable standards for Voldyne® Volumetric Exerciser and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).