Who is the manufacturer of Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

Medline Industries, Inc. filed the 510(k) submission for Hudson RCI Triflo II Incentive Deep Breathing Exerciser (K220565).

What is the FDA product code for Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

BWF. It is classified under 21 CFR 868.5690 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

Q: What are the predicate devices for Hudson RCI Triflo II Incentive Deep Breathing Exerciser?

Besmed TriBall Incentive Spirometer (K133873).

K220565 · Medline Industries, Inc. · BWF · Oct 25, 2022 · Anesthesiology

Device Facts

Record ID	K220565
Device Name	Hudson RCI Triflo II Incentive Deep Breathing Exerciser
Applicant	Medline Industries, Inc.
Product Code	BWF · Anesthesiology
Decision Date	Oct 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5690
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

Non-powered, therapeutic incentive spirometer; used for sustained maximal inspiration (SMI) exercises. Device consists of housing, three internal balls, tubing, mouthpiece, and gross particulate filter. Patient inhales through mouthpiece; airflow causes balls to rise within chambers; provides visual feedback to patient. Used in hospital or home care settings; operated by patient. Output is visual incentive (ball movement) to encourage deep breathing; helps improve lung function/prevent pulmonary complications. Single-patient, multi-use device; discarded after use.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included flow accuracy (RMS variation 4.6%–9.3%), drop testing, simulated distribution, useful life testing, and cleaning validation. Biocompatibility testing conducted per ISO 10993-1.

Technological Characteristics

Non-powered, mechanical incentive spirometer. Materials: polystyrene, polypropylene, ethylene vinyl acetate, reticulated polyester polyurethane foam, dye. Dimensions/form factor: 3-chamber housing with balls. Connectivity: None. Sterilization: Non-sterile. Standards: ISO 18562-1/2/3, ISO 10993-1/5/10/11/18.

Indications for Use

Indicated for adult and pediatric patients (above 5 years) requiring sustained maximal inspiration (SMI) or similar inspiratory deep breathing exercises.

Regulatory Classification

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.

Predicate Devices

Besmed TriBall Incentive Spirometer (K133873)

Reference Devices

Hudson RCI Voldyne (K182847)

Related Devices

K133873 — TRIBALL INCENTIVE SPIROMETER · Besmed Health Business Corp · Apr 4, 2014
K160837 — MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM · Medinet Srl · Feb 23, 2017
K141355 — VOLUMETRIC INCENTIVE SPIROMETER · Besmed Health Business Corporation · Sep 3, 2014
K053149 — SPIRO-BALL · Leventon, S.A. · Dec 13, 2005
K994074 — TRI-BALL · Leventon, S.A. · Jun 8, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div style="display:flex; align-items:center;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | > 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." {3}------------------------------------------------ # 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 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. # 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. {4}------------------------------------------------ # VI. Comparison of the Technological Characteristics with the Predicate Device | 510(k) Substantial Equivalence Summary of Key Attributes | | | | | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Product Features | Proposed Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Predicate Besmed Incentive Spirometer (K133873) | Reference Hudson RCI Voldyne (K182847) | Assessment of Equivalence | | 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 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. | The Besmed Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting. | 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. | Similar | | 510(k) Substantial Equivalence Summary of Key Attributes | | | |----------------------------------------------------------|--|--| |----------------------------------------------------------|--|--| {5}------------------------------------------------ K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser | 510(k) Substantial Equivalence Summary of Key Attributes | | | | | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Product Features | Proposed Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Predicate Besmed Incentive Spirometer (K133873) | Reference Hudson RCI Voldyne (K182847) | Assessment of Equivalence | | Basic Components | Image: Hudson RCI Triflo II Incentive Deep Breathing Exerciser Housing 3 balls Tubing Mouthpiece Gross particulate filter | Image: Besmed Incentive Spirometer (K133873) Housing 3 balls Tubing Mouthpiece Gross particulate filter | Image: Hudson RCI Voldyne (K182847) Housing 1 ball / piston Tubing Mouthpiece | Similar | | Patient Population | Adult and pediatric (above 5 years) patients | Patients requiring inspiratory exercise | Adult and pediatric (above 5 years) patients | Similar | | Environment | Hospital or home care setting. | Hospital or home care setting. | Hospital or home care setting. | Same | | Principle of Operation | Non-powered; patient places mouth on mouthpiece and inhales. | Non-powered; patient places mouth on mouthpiece and inhales. | Non-powered; patient places mouth on mouthpiece and inhales. | Same | | Sterilization Method | Non-sterile | Non-sterile | Non-sterile | Same | | Patient Contacting Materials | Polystyrene, polypropylene, ethylene vinyl acetate, reticulated polyester polyurethane 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 | Proposed Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Predicate Besmed Incentive Spirometer (K133873) | Reference Hudson RCI Voldyne (K182847) | Assessment of Equivalence | | Biocompatibility | • External communicating, Prolonged contact duration device that indirectly contacts tissue/bone/dentin. • Indirect gas pathway | • Surface, limited contact device that directly contacts intact skin • Indirect gas pathway | • External communicating tissue contact, limited duration | Similar | | Standards Utilized | ISO 18562-1 ISO 18562-2 ISO 18562-3 ISO 10993-1 ISO 10339-5 ISO 10993-10 ISO 10993-11 ISO 10993-18 | ISO 10993-1 ISO 10993-5 ISO 10993-10 | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-11 | Similar | | Non-Clinical Testing | Packaging Simulated Distribution Environmental Conditioning (high and low humidity) Aging Flow testing/accuracy Useful life testing Cleaning process Drop testing | Aging Environmental (high and low humidity) Flow testing Drop testing | Age testing Mouthpiece and Tubing Engagement Test Tubing and Housing Engagement Test Collapsible Tubing Leakage Test Volume Accuracy Test Flow Chip and Piston Operation Slide Operation | Similar | | Flow/Volume range | 600, 900, and 1200 cc/sec | 600, 900, and 1200 cc/sec | 2500 and 4000 cc | Similar | | 510(k) Substantial Equivalence Summary of Key Attributes | | | | | | Product Features | Proposed Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Predicate Besmed Incentive Spirometer (K133873) | Reference Hudson RCI Voldyne (K182847) | Assessment of Equivalence | | Accuracy of flow rate | Flow variation with nominal based on RMS calculation: 600 cc/s: 7.4% 900 cc/s: 9.3% 1200 cc/s: 4.6% | 10% (RMS) | $\pm$ 15% | Similar | {6}------------------------------------------------ K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser 510(k) Substantial Equivalence Summary of Kev Attributes {7}------------------------------------------------ K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser ### 510/k) Substantial Equivalence Su of Kev Attribute ______________________________________________________________________________________________________________________________________________________________________________ {8}------------------------------------------------ #### 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.

Hudson RCI Triflo II Incentive Deep Breathing Exerciser

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Technological Characteristics

Indications for Use

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Hudson RCI Triflo II Incentive Deep Breathing Exerciser

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Intended Use

Device Story

Clinical Evidence

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Indications for Use

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Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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