(239 days)
No
The device description and performance studies focus on mechanical function and flow rate, with no mention of AI or ML.
Yes.
The device description explicitly states it is a "therapeutic spirometer (inspiratory deep-breathing exerciser)" and its intended use is for "inspiratory deep breathing positive exerciser for adult and pediatric (above 5 years) patients" to help them achieve sustained maximal inspiration.
No
The device description explicitly states, "The device is a non-diagnostic, therapeutic spirometer..."
No
The device description clearly states it is a physical spirometer with chambers and balls, indicating it is a hardware device, not software-only.
Based on the provided information, the Hudson RCI Triflo II Incentive Deep Breathing Exerciser is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "deep breathing positive exerciser" for patients requiring sustained maximal inspiration. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description explicitly states it is a "non-diagnostic, therapeutic spirometer (inspiratory deep-breathing exerciser)".
- Lack of Diagnostic Function: The device's mechanism involves lifting balls based on airflow, providing an exercise incentive. It does not analyze biological samples (blood, urine, tissue, etc.) or provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on physical characteristics, flow accuracy, and durability, not on diagnostic performance metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Hudson RCI Triflo II does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric (above 5 years) patients
Intended User / Care Setting
hospital or home care setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data:
Biocompatibility testing was conducted in accordance with ISO 10993-1, including Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic toxicity, Material Mediated Pyrogenicity, Particulate Matter, and Volatile Organic Compounds.
Cleaning Validation: A study was performed to verify the effectiveness of manual cleaning using a mild detergent, evaluating protein residual analysis, carbohydrate residual analysis, and visual inspection.
Performance Bench Testing: Tests included Visual Inspection, Flow Test/Accuracy, Useful Life, Flow Test After Useful Life, Drop Testing, Simulated Distribution, and Packaging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flow variation with nominal based on RMS calculation:
600 cc/s: 7.4%
900 cc/s: 9.3%
1200 cc/s: 4.6%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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) |
|---|
| ☑ 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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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.