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.

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.

AI/ML Overview

The provided text describes the 510(k) summary for the Besmed TriBall Incentive Spirometer. I will extract the requested information based on the content.

Acceptance Criteria and Device Performance

Acceptance Criteria (e.g., Accuracy of flow/volume range)	Reported Device Performance (Besmed TriBall Incentive Spirometer)
Inspiratory Rate / Volume accuracy: Accuracy specification - +/- 5%	600 cc/sec: 0.5%
	900 cc/sec: 0.3%
	1200 cc/sec: 0.1%
Environmental: Maintain performance specifications after exposure to high/low temperatures and humidity	Performance evaluated and compared before and after environmental tests to confirm specifications were met.
Materials: Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous/Irritation) for external communicating (indirect gas pathway) and surface contact.	All listed ISO 10993 tests (Cytotoxicity, Sensitization, Intracutaneous/Irritation) were performed.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states, "Multiple samples of each device were tested multiple times." However, specific numerical sample sizes for devices or tests, or data provenance (country of origin, retrospective/prospective) are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This device is a physical medical device (incentive spirometer), not an imaging or diagnostic AI-driven device that typically requires expert-established ground truth. Therefore, this information is not applicable and not provided in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is a performance test for a physical device, not an assessment requiring expert adjudication of data. The performance was measured directly against technical specifications.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool involving human readers/interpreters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The "performance testing" described is for the physical device itself, in terms of its inspiratory rate/volume accuracy, and its ability to withstand environmental conditions, not for an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance testing of the incentive spirometer was based on pre-defined technical specifications for inspiratory rate/volume accuracy (+/- 5%) and the ability to maintain performance after environmental stressors. This is a direct measurement against engineering and design standards, not a clinical ground truth like pathology or expert consensus.
The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for the physical product’s performance characteristics.
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.

Summary

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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 - 011-886-2-2290-3959Fax - 011-886-2-2299-9076
Official Contact:	Winnie ChungRegulatory Affairs Associate
Proprietary or Trade Name:	TriBall Incentive Spirometer
Common/Usual Name:	Incentive spirometer
Classification Name:	21CFR 868.5690BWF - spirometer, therapeutic (incentive)Class II
Predicate Devices:	K781831 - Hudson RCI TriFlo

Device Description:

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

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510(k) Summary

Comparison to Predicate

Attribute	Hudson RCIK781831	ProposedBesmed 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	Housing3 ballsTubingMouthpieceGross particulate filter	Housing3 ballsTubingMouthpieceGross particulate filter
Flow / Volume range	600 / 900 / 1200 cc/sec	600 / 900 / 1200 cc/sec
Performance testing	Inspiratory Rate / Volume accuracy600 - 16.7%900 - 1.6%1200 - 11.3%Accuracy specification - not stated	Inspiratory Rate / Volume accuracy600 - 0.5%900 - 0.3%1200 - 0.1%Accuracy specification - +/- 5%Age TestingPre and post- exposureEnvironmental TestingHigh/Low and Humidity conditionsDrop test

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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 .

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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.

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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.

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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

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

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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 -SDN: c=US, o=U.S. Government,ou=HHS, ou=FDA, ou=People,cn=Anya C. Harry -S,0.9.2342.19200300.100.1.1=001131559Date: 2014.04.03 11:45:44 -04'00'

FORM FDA 3881 (9/13) PDF Page 41 of 266 Page 4.2 EF

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).