The Hudson RCI Triflo II Incentive Deep Breathing Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 years) patients.

Intended for single-patient, multi-use in a hospital or home care setting.

Device Description

The Hudson RCI Triflo II Incentive Deep Breathing Exerciser. The device is a non-diagnostic, therapeutic spirometer (inspiratory deep-breathing exerciser) designed for a maximum flow rate of approximately 1200 cc/sec. It is supplied in clean, sanitary condition, ready for use. It is designed for single patient use and discarded when no longer needed by the patient to whom assigned. By sequentially lifting the balls that are inside every chamber it provides an exercise incentive to patients who require sustained maximal inspiration (SMI), or similar maneuvers.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically an Incentive Spirometer. It contains information about the device, its intended use, comparison with predicate devices, and performance data.

However, the document does not describe a study involving:

An AI/algorithm-based device.
Establishment of ground truth by experts.
Sample sizes for test sets or training sets in the context of an AI study.
Multi-reader multi-case (MRMC) studies.
The effect size of human readers improving with AI assistance.
Standalone algorithm performance.

The "Performance Data" section (Section VII) details bench testing for the physical device (biocompatibility, cleaning validation, and various physical performance tests like flow accuracy, useful life, drop testing, packaging). These are standard engineering and safety tests for a physical medical device, not a study evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving an AI device meets acceptance criteria. The document describes a traditional medical device (an incentive spirometer) and its associated regulatory clearance process.

If you can provide a document that discusses the development and validation of an AI-powered medical device, I would be happy to analyze it against your specified criteria.

Summary

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October 25, 2022

Medline Industries, Inc. % Joy Gutermuth Senior Specialist (Consultant) Ram+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146

Re: K220565

Trade/Device Name: Hudson RCI Triflo II Incentive Deep Breathing Exerciser Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive spirometer Regulatory Class: Class II Product Code: BWF Dated: October 25, 2022 Received: October 25, 2022

Dear Joy Gutermuth:

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.

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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 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.

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220565

Device Name

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

Indications for Use (Describe)

The Hudson RCI Triflo II Incentive Deep Breathing Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 years) patients.

Intended for single-patient, multi-use in a hospital or home care setting.

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510K SUMMARY

510(k) SUMMARY

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

I. Submitter

Medline Industries, Inc. 1 Three Lake Dr. Northfield, IL 60093

Phone: 724-640-9680

Contact Person: Nicole Schaffer Date Prepared: October 25, 2022

II. Device

Name of Device: Hudson RCI Triflo II Incentive Deep Breathing Exerciser Common or Usual Name: Incentive Spirometer Classification Name: Spirometer, Therapeutic (Incentive) Regulatory Class: II Regulation: 868.5690 Product Code: BWF

III. Predicate Device

Besmed TriBall Incentive Spirometer, K133873

IV. Description of Device

V. Indications for Use

The Hudson RCI Triflo II Incentive Deep Breathing Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 years) patients.

Intended for single-patient, multi-use in a hospital or home care setting.

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VI. Comparison of the Technological Characteristics with the Predicate Device

510(k) Substantial Equivalence Summary of Key Attributes
Product Features	ProposedHudson RCI Triflo IIIncentive DeepBreathing Exerciser	PredicateBesmed IncentiveSpirometer (K133873)	ReferenceHudson RCI Voldyne (K182847)	AssessmentofEquivalence
Classification	Class II	Class II	Class II	Same
Product Code	BWF	BWF	BWF	Same
Regulation Number	§868.5690	§868.5690	§868.5690	Same
Regulation Name	Incentive Spirometer	Incentive Spirometer	Incentive Spirometer	Same
Indications for Use	The Hudson RCI Triflo II Incentive DeepBreathing Exerciser isintended as aninspiratory deepbreathing positiveexerciser for adult andpediatric (above 5years) patients.Intended for single-patient, multi-use in ahospital or home caresetting.	The Besmed IncentiveSpirometer is intended asan inspiratory deepbreathing positiveexerciser.Intended for single-patient,multi-use in a hospital orhome care setting.	The Hudson RCI VoldyneVolumetric Exerciser is intendedas an inspiratory deep breathingpositive exerciser for adult andpediatric (above 5 yrs) patients.It is a single patient, multi-usedevice used in hospital or homecare setting.	Similar

510(k) Substantial Equivalence Summary of Key Attributes
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K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser

510(k) Substantial Equivalence Summary of Key Attributes
Product Features	ProposedHudson RCI Triflo IIIncentive DeepBreathing Exerciser	PredicateBesmed IncentiveSpirometer (K133873)	ReferenceHudson RCI Voldyne (K182847)	AssessmentofEquivalence
Basic Components	Image: Hudson RCI Triflo II Incentive Deep Breathing ExerciserHousing3 ballsTubingMouthpieceGross particulatefilter	Image: Besmed Incentive Spirometer (K133873)Housing3 ballsTubingMouthpieceGross particulate filter	Image: Hudson RCI Voldyne (K182847)Housing1 ball / pistonTubingMouthpiece	Similar
Patient Population	Adult and pediatric(above 5 years) patients	Patients requiringinspiratory exercise	Adult and pediatric (above 5years) patients	Similar
Environment	Hospital or home caresetting.	Hospital or home caresetting.	Hospital or home care setting.	Same
Principle of Operation	Non-powered; patientplaces mouth onmouthpiece andinhales.	Non-powered; patientplaces mouth onmouthpiece and inhales.	Non-powered; patient placesmouth on mouthpiece andinhales.	Same
Sterilization Method	Non-sterile	Non-sterile	Non-sterile	Same
Patient ContactingMaterials	Polystyrene,polypropylene, ethylenevinyl acetate,reticulated polyesterpolyurethane foam, dye	Thermoplastics	Thermoplastics	Similar
Usability	Single patient, Multi-use	Single Patient, Multi-use	Single Patient, Multi-use	Same
510(k) Substantial Equivalence Summary of Key Attributes
Product Features	ProposedHudson RCI Triflo IIIncentive DeepBreathing Exerciser	PredicateBesmed IncentiveSpirometer (K133873)	ReferenceHudson RCI Voldyne (K182847)	AssessmentofEquivalence
Biocompatibility	• Externalcommunicating,Prolonged contactduration device thatindirectly contactstissue/bone/dentin.• Indirect gas pathway	• Surface, limited contactdevice that directlycontacts intact skin• Indirect gas pathway	• External communicatingtissue contact, limitedduration	Similar
Standards Utilized	ISO 18562-1ISO 18562-2ISO 18562-3ISO 10993-1ISO 10339-5ISO 10993-10ISO 10993-11ISO 10993-18	ISO 10993-1ISO 10993-5ISO 10993-10	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11	Similar
Non-Clinical Testing	PackagingSimulatedDistributionEnvironmentalConditioning (highand low humidity)AgingFlow testing/accuracyUseful life testingCleaning processDrop testing	AgingEnvironmental (high andlow humidity)Flow testingDrop testing	Age testingMouthpiece and TubingEngagement TestTubing and HousingEngagement TestCollapsible TubingLeakage TestVolume Accuracy TestFlow Chip and PistonOperationSlide Operation	Similar
Flow/Volume range	600, 900, and 1200cc/sec	600, 900, and 1200cc/sec	2500 and 4000 cc	Similar
510(k) Substantial Equivalence Summary of Key Attributes
Product Features	ProposedHudson RCI Triflo IIIncentive DeepBreathing Exerciser	PredicateBesmed IncentiveSpirometer (K133873)	ReferenceHudson RCI Voldyne (K182847)	AssessmentofEquivalence
Accuracy of flow rate	Flow variation withnominal based onRMS calculation:600 cc/s: 7.4%900 cc/s: 9.3%1200 cc/s: 4.6%	10% (RMS)	$\pm$ 15%	Similar

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K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser

510(k) Substantial Equivalence Summary of Kev Attributes

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K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser

510/k) Substantial Equivalence Su of Kev Attribute

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VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Hudson RCI Triflo II Incentive Deep Breathing Exerciser was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued September 4, 2020. The battery of testing included the following tests:

Cytotoxicity
Sensitization
Intracutaneous Reactivity ●
Acute Systemic toxicity ●
Material Mediated Pyrogenicity
Particulate Matter
. Volatile Organic Compounds

The following standards have been utilized:

ISO 18562-1
ISO 18562-2
ISO 18562-3
ISO 10993-1
ISO 10993-5 ●
ISO 10993-10 ●
. ISO 10993-11
ISO 10993-18 ●

Cleaning Validation

Cleaning validation was performed to verify the effectiveness of the manual cleaning effectiveness for the subject device using mild detergent. This study utilized a simulated test soil to evaluate the effectiveness of the cleaning procedure based on protein residual analysis, carbohydrate residual analysis and visual inspection.

Performance Bench Testing

The following bench testing was performed:

Visual Inspection
Flow Test/Accuracy ●
Useful Life
Flow Test After Useful Life
Drop Testing
. Simulated Distribution
. Packaging

VIII. Conclusions

The subject device, the Hudson RCI Triflo II Incentive Deep Breathing Exerciser, is substantially equivalent to the predicate device, the Besmed TriBall.

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).