(335 days)
MEDINET INCENTIVE SPIROMETER – RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser.
MEDINET INCENTIVE SPIROMETER - RESPIPROGRAM is intended for single use in a hospital or home care setting.
The RESPIPROGRAM is an inspiratory device used as breathing exerciser; RESPIPROGRAM is a FLOW exerciser.
The RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser. It is intended for single-patient, single use both in a hospital or for home care therapy.
RESPIPROGRAM is a single patient, single use, disposable, non-sterile device.
RESPIPROGRAM is a single use device that allows the patient to indicate visually the capacity of inhaling, even though RESPIPROGRAM doesn't have a specific measuring function. The device is a stimulator for inspiration; therefore it is indicated in all situations for when it is necessary to stimulate the patient's inhalation, under the prescription of a physician. The patient inspires through a mouthpiece that is connected to 3 chambers that have 3 balls of different colors (red, yellow and green) each one indicating a different approximate flow rate (respectively 600, 900 and 1200 ml per second).
This document describes the Medinet Incentive Spirometer - Respiprogram, an inspiratory deep breathing positive exerciser. The information provided outlines the device's technical specifications and the tests conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Predicate Device) | Reported Device Performance (Medinet Respiprogram) |
|---|---|---|
| Flow Accuracy | ± 5% | Met Predetermined Criteria: No specific numerical "acceptance criteria" for the Medinet device itself are stated, but the report explicitly says: "The results showed that all the samples tested, met the pre-determined acceptance criteria defined in the performance test protocol." The data provided for the Medinet device under various humidity conditions are: - Low humidity (cc/sec): - 600 cc/sec: 604.6 ± 5.5 - 900 cc/sec: 925.2 ± 3.28 - 1200 cc/sec: 1222.8 ± 10.0 - High humidity (cc/sec): - 600 cc/sec: 593.5 ± 4.9 - 900 cc/sec: 887.3 ± 3.7 - 1200 cc/sec: 1177.3 ± 7.5 These values are within a ±5% range of their nominal flow rates (e.g., 5% of 600 is 30, and 604.6 is certainly within 570-630). The predicate device's specified accuracy of +/- 5% is shown to be met by the Medinet device. |
| Resistance (Drop Test) | No breakage or crack | Met Predetermined Criteria: "The results showed that the samples tested met the pre-determined acceptance criteria without any breakage or crack." |
| Biocompatibility | Conforming to ISO 10993 testing | Conforming to ISO 10993 testing: - Cytotoxicity (ISO 10993-5): Performed - Irritation (ISO 10993-10): Performed - Sensitization (ISO 10993-10): Performed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for the test set used in the flow accuracy or drop tests. It refers to "new and aged samples" and "samples tested" without providing a specific count.
- Data Provenance: The tests were conducted internally by Medinet SRL to compare their device with the predicate device (BESMED TriBall). The country of origin of the data is Italy (Medinet SRL is located in Milan, Italy). The studies appear to be prospective comparative tests designed for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This question is not applicable to the type of device and study described. The Medinet Incentive Spirometer is a mechanical device, and its performance (flow accuracy, structural integrity, biocompatibility) is measured against objective technical standards and a predicate device, not against expert interpretation of medical images or symptoms. Therefore, no medical experts were involved in establishing "ground truth" for the technical performance tests.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic or prognostic tasks. Since this device's performance is measured objectively against technical specifications, no adjudication was necessary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., AI algorithms for medical imaging) to assess the impact of the device on human reader performance. The Medinet Incentive Spirometer is a therapeutic/exerciser device, not a diagnostic one that would involve human "readers" interpreting output.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable. The device is a mechanical incentive spirometer, not an algorithm. Its "standalone performance" is its inherent mechanical function as described by the flow accuracy and physical integrity tests.
7. The Type of Ground Truth Used:
The "ground truth" for these tests consisted of:
- Technical Specifications: The defined flow rates (600, 900, 1200 ml/sec) and the accepted accuracy tolerance (±5%).
- Predicate Device Performance: The predicate device's established performance served as a benchmark for comparison during the comparative flow accuracy and drop tests.
- ISO 10993 Standards: For biocompatibility, the ground truth is compliance with the specified parts of the ISO 10993 series.
8. The Sample Size for the Training Set:
This question is not applicable. The Medinet Incentive Spirometer is a mechanical device and does not involve AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no training set for a mechanical device.
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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
Medinet SRL % Maurizio Pantaleoni C.E.O. Isemed Srl Via A.bonetti 3/A Imola, 40026 ITALY
Re: K160837
Trade/Device Name: Medinet Incentive Spirometers - Respiprogram Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: II Product Code: BWF Dated: January 23, 2017 Received: January 25, 2017
Dear Maurizio Pantaleoni:
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 devicerelated 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" (21 CFR 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.
Tina Kiang
-s
Tina Kiang, Ph.D. 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: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160837
Device Name
MEDINET INCENTIVE SPIROMETER - RESPIPROGRAM
Indications for Use (Describe)
MEDINET INCENTIVE SPIROMETER – RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser.
MEDINET INCENTIVE SPIROMETER - RESPIPROGRAM is intended for single use in a 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 for the MEDINET INCENTIVE SPIROMETER
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
| 1. | General InformationSubmitter: | MEDINET s.r.l. is located at:Via Londonio, 12MILANOITALY |
|---|---|---|
| Contact Person: | Maurizio PantaleoniIsemed s.r.l.Via A. Altobelli Bonetti 3/A40026 Imola (BO)Mob.phone: +39 3484435155Telephone: +39 0542 683803Fax: +39 0542 698456Email: regulatory@isemed.eu |
Summary Preparation Date:
February 13, 2016
2. Names
| Device Name: | MEDINET INCENTIVE SPIROMETER- RESPIPROGRAM |
|---|---|
| Classification Name: | Incentive spirometer |
| Product Code: | BWF |
| Regulation number: | 868.5690 |
| CLASS | II |
3. Predicate Devices
The MEDINET INCENTIVE SPIROMETER RESPIPROGRAM is substantially equivalent to the following device:
| Applicant | Device name | 510(k)Number | Productcode |
|---|---|---|---|
| BESMED Health BusinessCorp. | TriBall incentive spirometer | K133873 | BWF |
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4. Device Description
The RESPIPROGRAM is an inspiratory device used as breathing exerciser; RESPIPROGRAM is a FLOW exerciser
The following model is available:
- RESPIPROGRAM – code 15 10 002 600
The RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser. It is intended for single-patient, single use both in a hospital or for home care therapy.
RESPIPROGRAM is a single patient, single use, disposable, non-sterile device.
RESPIPROGRAM is a single use device that allows the patient to indicate visually the capacity of inhaling, even though RESPIPROGRAM doesn't have a specific measuring function. The device is a stimulator for inspiration; therefore it is indicated in all situations for when it is necessary to stimulate the patient's inhalation, under the prescription of a physician. The patient inspires through a mouthpiece that is connected to 3 chambers that have 3 balls of different colors (red, yellow and green) each one indicating a different approximate flow rate (respectively 600, 900 and 1200 ml per second).
5. Indications for Use
MEDINET INCENTIVE SPIROMETER – RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser.
MEDINET INCENTIVE SPIROMETER - RESPIPROGRAM is intended for single-patient, single use in a hospital or home care setting.
6. Performance Data
The following comparative tests have been performed for the MEDINET incentive spirometer RESPIPROGRAM in comparison with its predicate device, to support the substantial equivalence
FLOW ACCURACY TESTS between
- RESPIPROGRAM and BESMED TRIBALL ●
The tests have been performed using new and aged samples and considering various humidity conditions. The results showed that all the samples tested, met the pre-determined acceptance criteria defined in the performance test protocol.
DROP TEST between:
- RESPIPROGRAM and BESMED TRIBALL
The results showed that the samples tested met the pre-determined acceptance criteria without any breakage or crack.
The following biocompatibility tests were performed:
- · Cytotoxicity
- · Irritation
- · Sensitization
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7. Substantial Equivalence Discussion & Summary of Technological Characteristics
The indications for use of the MEDINET Incentive Spirometer can be considered substantially equivalent to the identified predicate devices.
The design features, the technological characteristics and the performances are equivalent to that of the predicate devices as shown in the table below:
| Subject Device | Predicate Devices | ||
|---|---|---|---|
| MEDINET INCENTIVE SPIROMETERRESPIPROGRAM | BESMED TriBall - K133873 | SubstantiallyEquivalent | |
| RegulationNumber: | 868.5690 | 868.5690 | Same |
| Classification | II | II | Same |
| Product Code | BWF | BWF | Same |
| Indications foruse | MEDINET INCENTIVE SPIROMETERRESPIPROGRAM is intended as aninspiratory deep breathing positiveexerciser.MEDINET INCENTIVE SPIROMETER isintended for single-patient, single use in ahospital or home care setting. | The Besmed Incentive Spirometer isintended as an inspiratory deep breathingpositive exerciser.Intended for single-patient, multi-use in ahospital or home care setting. | Equivalent. The onlydifference is thatMedinet IncentivespirometerRespiprogram is singleuse, while predicatedevice is multi-use |
| Users | |||
| Prescriptiondevices | YES | YES | Same |
| Population | Patients requiring inspiratory exercise | Patients requiring inspiratory exercise | Same |
| Single Patient,Single Use | YES | No, Single patient, Multi Use | Equivalent. The onlydifference is thatMedinet IncentivespirometerRespiprogram is singleuse, while predicatedevice is multi-use |
| Environment ofuse | Home care settings and hospitals | Home care settings and hospitals | Same |
| Design features | |||
| Basiccomponents | Housing3 ballsTubingMouthpiece | Housing3 ballsTubingMouthpiece | Same |
| Patient Interface | Mouthpiece | Mouthpiece | Same |
| AvailableModels | One model with three balls | One model with 3 balls | Same |
| Biocompatibility | |||
| Cytotoxicity | Conforming to ISO 10993 testing(ISO 10993-5) | Conforming to ISO 10993 testing | Same |
| Sensitization | Conforming to ISO 10993 testing(ISO 10993-10) | Conforming to ISO 10993 testing | Same |
| Intracutaneousirritation | Conforming to ISO 10993 testing(ISO 10993-10) | Conforming to ISO 10993 testing | Same |
| Performances | |||
| Flow | 600/900/1200 cc/sec | 600/900/1200 cc/sec | Same |
| Accuracy | +/- 5% | +/- 5% | Same |
| Resistance | Drop Test results: no breakage or crack at theend of the test | Drop Test | Same |
| Subject Device | Predicate Devices | ||
| MEDINET INCENTIVE SPIROMETERRESPIPROGRAM | BESMED TriBall - K133873 | SubstantiallyEquivalent | |
| Condition oftesting andresults | ±5% accuracy is maintained in thefollowing test conditions:- Age Testing (products recentlymanufactured and expired products)- Low Humidity Testing (products recentlymanufactured and expired products testedwith humidity < 40%)- High Humidity Testing (products recentlymanufactured and expired products testedwith humidity > 80%).Low humidity test results (cc/sec):Test at 600 cc/sec: 604,6±5,5Test at 900 cc/sec: 925,2±3,28Test at 1200 cc/sec:1222,8±10,0High humidity test results (cc/sec)Test at 600 cc/sec: 593,5±4,9Test at 900 cc/sec: 887,3±3,7Test at 1200 cc/sec:1177,3±7,5 | Accuracy specification ±5% verified in thefollowing test conditions:Age TestingHigh / Low Humidity conditionsInspiratory rate / Volume accuracydeclared :600 - 0,5%900 - 0,3%1200 - 0,1%Test results using the MEDINET testmethod - Low humidity (cc/sec):Test at 600 cc/sec: 624,0±10,1Test at 900 cc/sec: 886,8±10,2Test at 1200 cc/sec:1210,5±12,89 | Same |
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Summary of Technological Characteristics:
Both subject and predicate device are incentive spirometers. The fundamental technology of the subject and predicate device are based on the following same technological elements:
- Housing containing 3 balls
- Mouthpiece as a patient interface ●
- Flow rate of 600, 900 and 1200 ml/second
- Non Sterile Device
The following technological difference exists between the subject and the predicate device:
- Respiprogram is single use, while predicate device is multi-use.
8. Conclusion
Based on technological characteristics (intended use, dimensions and features) and performance data (comparative tests and biocompatibility tests) included in this submission, the MEDINET INCENTIVE SPIROMETER RESPIPROGRAM has been shown to be substantially equivalent to the listed predicate 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).