(103 days)
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.
The Besmed Volumetric 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 ball and piston which upon the patient inhaling, creates a vacuum, which causes the ball and piston to rise, the piston reflects the inspiratory volume while the ball is an indicator for the user to maintain the optimum inspiratory flow rate. Two (2) models are offered - 2500 cc and 5000 cc. It is a single patient, multi-use, disposable, non-sterile device. The mouthpiece may be removed and cleaned by the user as needed but the main device is not to be cleaned.
As a patient improves their respiratory capacity or gets stronger they improve their inspiratory volume raising the piston. The principle of the ball indicator 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 Besmed Volumetric ICS achieves the therapeutic intent by helping the patient to improve their inspiratory volume. It is a relative improvement device that as described offers the patient the "incentive" to improve. This is the identical therapeutic intent of the predicate volume based incentive spirometer.
The provided document describes the 510(k) premarket notification for the "Besmed Volumetric Incentive Spirometer." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study proving device acceptance criteria in the context of diagnostic accuracy or comparative effectiveness with human readers.
Therefore, many of the requested sections related to clinical study design, sample sizes for test/training sets, expert adjudication, and MRMC studies are not applicable to the information contained within this 510(k) summary. This document primarily details non-clinical performance and comparisons to a predicate device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Volume Accuracy | For 2500 cc model: 4 – 15% |
| For 5000 cc model: 3 – 12% | |
| Age Testing | Pre and post-exposure |
| Environmental Testing (High/Low Temp, Humidity, Drop test) | Met performance specifications |
Note: The acceptance criteria here are derived from the observed performance of the proposed device and are compared to the predicate's (Hudson RCI K801199), which reported an accuracy of ~21%. The Besmed device's performance is stated as "equivalent (or better)."
2. Sample size used for the test set and the data provenance
The document states: "Multiple samples of each device were tested multiple times and then evaluated for consistency of performance." However, specific sample sizes (number of devices, number of tests per device) for the non-clinical performance evaluation are not explicitly provided.
Data provenance: Non-clinical testing appears to have been conducted by the manufacturer, Besmed Health Business Corp. The country of origin of the data is not explicitly stated beyond the manufacturer's location (Taiwan). It is a retrospective analysis of device performance against internal specifications and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This pertains to non-clinical device performance testing, not a study involving expert interpretation or diagnostic performance.
4. Adjudication method for the test set
Not applicable. This pertains to non-clinical device performance testing, not a study involving expert interpretation or diagnostic performance.
5. 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 document describes a physical medical device (incentive spirometer), not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device; there is no "algorithm only" performance separate from the device's inherent mechanical function.
7. The type of ground truth used
For volume accuracy, the ground truth would be the accurately measured volume of air moved by a calibrated testing system.
For age testing and environmental testing, the ground truth is the "performance specifications" that the device is expected to meet both before and after exposure to certain conditions.
8. The sample size for the training set
Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2014
Besmed Health Business Corporation C/O Mr. Paul Dryden President ProMedic, Inc. No. 5. Lane 116, Wu-Kong 2nd Rd. Wu-Ku District, New Taipei City TAIWAN
Re: K141355
Trade/Device Name: Besmed Volumetric Incentive Spirometer Regulation Number: 21 CFR 868.5690 Regulation Name: Spirometer, therapeutic (incentive) Regulatory Class: Class II Product Code: BWF Dated: August 4, 2014 Received: August 5, 2014
Dear Mr. Dryden:
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 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.
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Besmed Volumetric Incentive Spirometer
Indications for Use (Describe)
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.
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)
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Anya C. Harry -S 2014.08.29 07:11:29 -04'00'
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510(k) Summary Page 1 of 4
| Date Prepared: | 20-Aug-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 Chung, Regulatory Affairs |
| Proprietary or Trade Name: | Volumetric Incentive Spirometer |
| Common/Usual Name: | Incentive spirometer |
| Classification Name: | 21CFR 868.5690, Class 2BWF - spirometer, therapeutic (incentive) |
| Predicate Devices: | K801199 – Hudson RCI Voldyne |
Device Description:
The Besmed Volumetric 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 ball and piston which upon the patient inhaling, creates a vacuum, which causes the ball and piston to rise, the piston reflects the inspiratory volume while the ball is an indicator for the user to maintain the optimum inspiratory flow rate. Two (2) models are offered - 2500 cc and 5000 cc. It is a single patient, multi-use, disposable, non-sterile device. The mouthpiece may be removed and cleaned by the user as needed but the main device is not to be cleaned.
As a patient improves their respiratory capacity or gets stronger they improve their inspiratory volume raising the piston. The principle of the ball indicator 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 Besmed Volumetric ICS achieves the therapeutic intent by helping the patient to improve their inspiratory volume. It is a relative improvement device that as described offers the patient the "incentive" to improve. This is the identical therapeutic intent of the predicate volume based incentive spirometer.
Indications for Use:
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.
Patient Population:
Patients requiring inspiratory exercise.
Environments of use:
Hospital and home care settings
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510(k) Summary
Comparison to Predicates
| Attribute | Hudson RCIK801199 | ProposedBesmed Volumetric ICS |
|---|---|---|
| Indications for Use | Intended as an inspiratory deep breathing positive exerciser.Intended for single-patient, multi-use in a hospital or home care setting. | The Besmed Volumetric Incentive Spirometer is intended as aninspiratory deep breathing positive exerciser.Intended for single-patient, multi-use in a hospital or home care setting. |
| Environments of use | Home care settings and hospitals | 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 (maybe removed and cleaned) | Mouthpiece (maybe removed and cleaned) |
| Basic components | Housing1 ball / pistonTubingMouthpiece | Housing1 ball / pistonTubingMouthpiece |
| Volume range | 2500 and 5000 cc | 2500 and 5000 cc |
| Accuracy | Not reported but ~ 21% when comparative testing performed | +/- 15% |
| Performance testing | Volume accuracy2500 cc – 14 – 21%5000 cc – 16 – 21% | Volume accuracy2500 cc – 4 – 15%5000 cc – 3 – 12%Age TestingPre and post- exposureEnvironmental TestingHigh / Low and Humidity conditionsDrop test |
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510(k) Summary Page 3 of 4 20-Aug-2014
Substantial Equivalence Discussion
Table 1 compares the key features of the proposed Besmed Volumetric 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 -K801199 - Hudson RCI Voldyne 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 - K801199 - Hudson RCI Voldyne incentive spirometer.
Discussion - The design is a 1 ball / piston volume based system that upon the patient inhaling raises the piston to indicate the volume of inspired air while there is a ball which indicates the inspiratory flow rate that the patient should try and maintain.
Environment of Use -
The environments of use are identical to predicate - K801199 - Hudson RCI Voldyne incentive spirometer.
Discussion - The environments of use are identical to the predicate K801199 - Hudson RCI Voldyne incentive spirometer.
Patient Population -
The patient population of patients requiring inspiratory exercise is equivalent to the predicate -K801199 – Hudson RCI Voldyne incentive spirometer.
Discussion - The patient populations are equivalent to the predicate - K801199 - Hudson RCI Voldyne incentive spirometer.
Non-Clinical Testing Summary -
Materials:
The materials are identical to our reference Besmed TriBall ICS cleared under K133873. We consider the device as External Communicating (Indirect gas pathway) and Surface Contact (direct skin) with limited duration of use (< 24 hours). The following tests were performed.
- Cytotoxicity
- Sensitization ●
- Intracutaneous / Irritation ●
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510(k) Summary Page 4 of 4 20-Aug-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 volume accuracy / repeatability and comparative volume accuracy and the results demonstrated equivalent (or better) performance demonstrating the proposed device is equivalent to the - K801199 - Hudson RCI Voldyne incentive spirometer.
Multiple samples of each device were tested multiple times and then evaluated for consistency of performance.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.
§ 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).