(265 days)
Not Found
No
The device description details a purely mechanical device with chambers, a piston, and a flow chip. There is no mention of software, data processing, or any components that would suggest AI/ML capabilities. The performance studies focus on mechanical and material properties, not algorithmic performance.
Yes
Explanation: The device is described as an "inspiratory deep breathing positive exerciser" and a "volumetric incentive spirometer" used to provide "exercise incentive to patients who require sustained maximal inspiration (SMI)". These descriptions clearly indicate its purpose is to treat or alleviate a medical condition, making it a therapeutic device.
No
The device is an inspiratory deep breathing positive exerciser used for therapy and exercise, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a mouthpiece, chambers, a flow chip, and a piston, indicating it is a hardware device.
Based on the provided information, the Hudson RCI Voldyne Volumetric Exerciser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as an "inspiratory deep breathing positive exerciser" for patients. This is a therapeutic and monitoring function related to respiratory mechanics, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The device description details a mechanical device with chambers, a piston, and a mouthpiece used for breathing exercises. It measures and indicates breathing volume and flow. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample collection, or analysis of bodily fluids or tissues.
- Performance Studies: The performance studies focus on mechanical performance, biocompatibility, and shelf life, which are relevant to a respiratory therapy device, not an IVD.
In summary, the Hudson RCI Voldyne Volumetric Exerciser is a medical device used for respiratory therapy and monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
BWF
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).
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 yrs)
Intended User / Care Setting
Not Found
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)
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
- Biocompatibility: The Hudson RCI® Voldyne® Volumetric Exerciser is an externally ● communicating tissue contact, limited duration device (
§ 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
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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
1
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)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 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.
4
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
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, multiuse device used in hospital or home care setting.
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 Medical
Hudson RCI® Voldyne®
Volumetric Exerciser
(K182847) | Besmed Volumetric
Incentive 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 use
only | Yes | Yes |
| Usability | Multi-use | Multi-use |
| Patient Population | Adults and Pediatric
patients (above 5 years) | Patients requiring
inspiratory exercise |
| Prescription Only | Yes | Yes |
| Environments of
use | Home care settings and
hospitals | Home care settings and
hospitals |
| Volume | 2500 and 4000 cc | 2500 and 5000 cc |
| Sterile | No | No |
| Indication for Use | 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. | The Besmed Volumetric
Incentive Spirometer is
intended as an
inspiratory deep breathing
positive exerciser.
Intended for single-patient,
multi-use in a hospital or
home care setting. |
| Contraindications | None | None |
| Basic Components | Housing
1 ball / piston
Tubing
Mouthpiece | Housing
1 ball / piston
Tubing
Mouthpiece |
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| Patient Interface | Mouthpiece | Mouthpiece |
|---|---|---|
| Materials | ||
| Evaluation | The materials used in the | |
| construction of Voldyne | ||
| were evaluated per ISO | ||
| 10993-1:2009 | The materials used in the | |
| construction of predicate | ||
| were evaluated per ISO | ||
| 10993-1:2009 | ||
| Shelf-life | 1 Year | Not specified |
| Accuracy | Equivalent | $\pm$ 15% |
| Performance | ||
| Testing | Age testing (Pre and Post | |
| Aging) | ||
| Mouthpiece and Tubing | ||
| Engagement TestTubing and Housing | ||
| Engagement TestCollapsible Tubing | ||
| Leakage TestVolume Accuracy TestFlow Chip and Piston | ||
| OperationSlide 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
7
- Biocompatibility: The Hudson RCI® Voldyne® Volumetric Exerciser is an externally ● communicating tissue contact, limited duration device (