(105 days)
No
The device description details a purely mechanical device that uses physical balls to indicate inspiratory flow rate. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
Yes
The device is described as an "inspiratory deep breathing positive exerciser" intended to "help them to improve the respiratory function with repeated uses" and states that "The TriBall achieves the therapeutic intent by helping the patient to improve their inspiratory flow rate." This clearly indicates a therapeutic purpose.
No
The device is an exerciser ("lung exercisers") designed to help patients improve their inspiratory flow rate, not to diagnose a medical condition.
No
The device description clearly outlines physical components like a flexible tube, mouthpiece, and a chamber with balls, indicating it is a hardware device, not software-only.
Based on the provided information, the Besmed Incentive Spirometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as an "inspiratory deep breathing positive exerciser" to help patients improve their respiratory function. This is a therapeutic and exercise-based purpose, not a diagnostic one.
- Device Description: The device works by providing visual feedback on inspiratory flow rate to encourage improvement. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Lack of Diagnostic Claims: There are no claims or descriptions suggesting the device is used to identify, diagnose, monitor, or screen for any disease or medical condition.
- Performance Metrics: The performance metrics focus on the accuracy of measuring inspiratory rate/volume, which is relevant to its function as an exercise device, not a diagnostic one.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or screening of diseases or conditions. The Besmed Incentive Spirometer does not fit this definition.
N/A
Intended Use / Indications for Use
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.
Product codes
BWF
Device Description
The Besmed TriBall Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a series of balls which upon the patient inhaling, creates a vacuum, which causes the balls to rise, they reflect the inspiratory flow rate in cc/sec (600, 900 and 1200).
It is a single patient, multi-use, disposable, non-sterile device.
As a patient improves their respiratory capacity or gets stronger their inspiratory flow rate raises the balls. The principle is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers".
The TriBall achieves the therapeutic intent by helping the patient to improve their inspiratory flow rate. It is a relative improvement device that as described offers the "incentive" to improve. This is the identical therapeutic intent of all predicate flow / volume based incentive spirometers.
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
Patients requiring inspiratory exercise.
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 Testing including Comparative:
We performed comparative volume accuracy to the predicate and the results demonstrated equivalent (or better) performance demonstrating the proposed device is equivalent to the -K781831 - Hudson RCI incentive spirometer.
Multiple samples of each device were tested multiple times and then evaluated for consistency of performance.
Non-Clinical Testing Summary -
Materials:
We have performed ISO 10993 testing on the component materials of the TriBall Incentive spirometer which is considered as External Communicating (Indirect gas pathway) and Surface Contact (direct skin) with the patient which means the following tests were performed.
- Cytotoxicity .
- Sensitization .
- Intracutaneous / Irritation .
Environmental:
The proposed device was exposed to various environmental conditions of high and low temperatures over time and the performance evaluated and compared before and after these tests to confirm that the proposed device met it performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K781831 - Hudson RCI TriFlo
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 0 4 2014
510(k) Summary Page 1 of 4
| Date Prepared: | 03-Apr-2014 | |
|---|---|---|
| Besmed Health Business Corp. | ||
| No. 5, Lane 116, Wu-Kong 2nd Rd, | ||
| Wu-Ku District, New Taipei City, Taiwan | Tel - 011-886-2-2290-3959 | |
| Fax - 011-886-2-2299-9076 | ||
| Official Contact: | Winnie Chung | |
| Regulatory Affairs Associate | ||
| Proprietary or Trade Name: | TriBall Incentive Spirometer | |
| Common/Usual Name: | Incentive spirometer | |
| Classification Name: | 21CFR 868.5690 | |
| BWF - spirometer, therapeutic (incentive) | ||
| Class II | ||
| Predicate Devices: | K781831 - Hudson RCI TriFlo |
Device Description:
The Besmed TriBall Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a series of balls which upon the patient inhaling, creates a vacuum, which causes the balls to rise, they reflect the inspiratory flow rate in cc/sec (600, 900 and 1200).
It is a single patient, multi-use, disposable, non-sterile device.
As a patient improves their respiratory capacity or gets stronger their inspiratory flow rate raises the balls. The principle is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers".
The TriBall achieves the therapeutic intent by helping the patient to improve their inspiratory flow rate. It is a relative improvement device that as described offers the "incentive" to improve. This is the identical therapeutic intent of all predicate flow / volume based incentive spirometers.
Indications for Use:
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.
Patient Population:
Patients requiring inspiratory exercise.
Environments of use:
Hospital and home care settings
1
510(k) Summary
Comparison to Predicate
| Attribute | Hudson RCI
K781831 | Proposed
Besmed TriBall |
|---------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended as an inspiratory deep breathing positive exerciser. | The Besmed Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. |
| Environments of use | Intended for single-patient, multi-use in a hospital or home care setting.
Home care settings and hospitals | Intended for single-patient, multi-use in a hospital or home care setting.
Home care settings and hospitals |
| Prescriptive | Yes | Yes |
| Patient population | Patients requiring inspiratory exercise | Patients requiring inspiratory exercise |
| Single patient, multi-use | Yes | Yes |
| Patient interface | Mouthpiece | Mouthpiece |
| Basic components | Housing
3 balls
Tubing
Mouthpiece
Gross particulate filter | Housing
3 balls
Tubing
Mouthpiece
Gross particulate filter |
| Flow / Volume range | 600 / 900 / 1200 cc/sec | 600 / 900 / 1200 cc/sec |
| Performance testing | Inspiratory Rate / Volume accuracy
600 - 16.7%
900 - 1.6%
1200 - 11.3%
Accuracy specification - not stated | Inspiratory Rate / Volume accuracy
600 - 0.5%
900 - 0.3%
1200 - 0.1%
Accuracy specification - +/- 5%
Age Testing
Pre and post- exposure
Environmental Testing
High/Low and Humidity conditions
Drop test |
2
510(k) Summary Page 3 of 4 03-Apr-2014
Substantial Equivalence Discussion
Table 1 compares the key features of the proposed Besmed TriBall incentive spirometer with the identified predicate and demonstrates that the device can be found to be substantially equivalent.
In summary one can conclude that substantial equivalence is met based upon the following:
Indications for Use -
The indications for use are identical for the proposed device when compared to the predicate -K781831 - Hudson RCI incentive spirometer.
Discussion - Each device is indicated for use volumetric inspiratory deep breathing positive exerciser.
Technology and construction -
The design, components, shape, size, etc. are equivalent to the predicate - K 781831 - Hudson RCI incentive spirometer.
Discussion - The design is a 3 ball system that upon the patient inhaling raises the balls to indicate the volume of inspired air.
Environment of Use -
The environments of use are identical to predicate - K781831 - Hudson RCI incentive spirometer.
Discussion - The environments of use are identical to the predicate K781831 - Hudson RCI incentive spirometer.
Patient Population -
The patient population of patients requiring inspiratory exercise is equivalent to the predicate -K781831 - Hudson RCI incentive spirometer.
Discussion - The patient populations are equivalent to the predicate - K781831 - Hudson RCI incentive spirometer.
Non-Clinical Testing Summary -
Materials:
We have performed ISO 10993 testing on the component materials of the TriBall Incentive spirometer which is considered as External Communicating (Indirect gas pathway) and Surface Contact (direct skin) with the patient which means the following tests were performed.
- Cytotoxicity .
- Sensitization .
- Intracutaneous / Irritation .
3
510(k) Summary Page 4 of 4 03-Apr-2014
Environmental:
The proposed device was exposed to various environmental conditions of high and low temperatures over time and the performance evaluated and compared before and after these tests to confirm that the proposed device met it performance specifications.
Performance Testing including Comparative:
We performed comparative volume accuracy to the predicate and the results demonstrated equivalent (or better) performance demonstrating the proposed device is equivalent to the -K781831 - Hudson RCI incentive spirometer.
Multiple samples of each device were tested multiple times and then evaluated for consistency of performance.
Substantial Equivalence Conclusion -
The proposed device has been found to be substantially equivalent to the predicate. Differences between the proposed device and the predicate do not raise new questions of safety or efficacy.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2014
Besmed Health Business Corp C/O Mr. Paul Dryden, President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134
Re: K133873
Trade/Device Name: TriBall Incentive Spirometer Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive spirometer Class: II · Product Code: BWF Dated: March 5, 2014 Received: March 6, 2014
Dear Ms. Chung:
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. 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 tiability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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.
5
Page 2 - Ms. Chung
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K33873
Device Name Besmed TriBall Incentive Spirometer
Indications for Use (Describe)
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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| K133873 | Anya C. Harry -S |
| Digitally signed by Anya C. Harry -S | |
| DN: c=US, o=U.S. Government, | |
| ou=HHS, ou=FDA, ou=People, | |
| cn=Anya C. Harry -S, | |
| 0.9.2342.19200300.100.1.1=001131559 | |
| Date: 2014.04.03 11:45:44 -04'00' |
FORM FDA 3881 (9/13) PDF Page 41 of 266 Page 4.2 EF