(335 days)
Not Found
No
The device description and performance studies focus on mechanical flow measurement and physical properties, with no mention of AI/ML algorithms or data processing.
Yes
The device is intended for "inspiratory deep breathing positive exerciser" and "for home care therapy," indicating a therapeutic purpose to improve breathing capacity.
No
This device is an inspiratory exerciser designed to stimulate and encourage deep breathing. It does not measure conditions, identify diseases, or monitor physiological states.
No
The device description clearly outlines a physical, disposable device with chambers and balls, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as an "inspiratory deep breathing positive exerciser." This describes a device used to help patients improve their lung function through breathing exercises.
- Device Description: The description reinforces this, calling it a "breathing exerciser" and a "stimulator for inspiration." It focuses on the mechanical action of breathing and providing visual feedback on inhalation capacity.
- Lack of Diagnostic Function: The description explicitly states that the device "doesn't have a specific measuring function" and is a "stimulator for inspiration." IVD devices are designed to perform tests on specimens (like blood, urine, or tissue) to diagnose diseases or conditions. This device does not perform any such tests.
- No Mention of Specimens: There is no mention of collecting or analyzing any biological specimens.
- Performance Studies: The performance studies focus on flow accuracy, resistance (drop test), and biocompatibility, which are relevant to a mechanical breathing device, not a diagnostic test.
In summary, the MEDINET INCENTIVE SPIROMETER – RESPIPROGRAM is a therapeutic device used for breathing exercises, not a diagnostic device used to test specimens for medical information.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BWF
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).
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
+/- 5% accuracy
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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
2
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) | |
|---|---|---|
| -- | ----------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Information
Submitter: | MEDINET s.r.l. is located at:
Via Londonio, 12
MILANO
ITALY |
|----|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Maurizio Pantaleoni
Isemed s.r.l.
Via A. Altobelli Bonetti 3/A
40026 Imola (BO)
Mob.phone: +39 3484435155
Telephone: +39 0542 683803
Fax: +39 0542 698456
Email: 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 | Product
code |
|---------------------------------|------------------------------|------------------|-----------------|
| BESMED Health Business
Corp. | TriBall incentive spirometer | K133873 | BWF |
4
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
5
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 SPIROMETER | |||
| RESPIPROGRAM | BESMED TriBall - K133873 | Substantially | |
| Equivalent | |||
| Regulation | |||
| Number: | 868.5690 | 868.5690 | Same |
| Classification | II | II | Same |
| Product Code | BWF | BWF | Same |
| Indications for | |||
| use | MEDINET INCENTIVE SPIROMETER | ||
| RESPIPROGRAM is intended as an | |||
| inspiratory deep breathing positive | |||
| exerciser. | |||
| MEDINET INCENTIVE SPIROMETER is | |||
| intended for single-patient, single use in a | |||
| hospital or home care setting. | 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. | Equivalent. The only | ||
| difference is that | |||
| Medinet Incentive | |||
| spirometer | |||
| Respiprogram is single | |||
| use, while predicate | |||
| device is multi-use | |||
| Users | |||
| Prescription | |||
| devices | 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 only |
| difference is that | |||
| Medinet Incentive | |||
| spirometer | |||
| Respiprogram is single | |||
| use, while predicate | |||
| device is multi-use | |||
| Environment of | |||
| use | Home care settings and hospitals | Home care settings and hospitals | Same |
| Design features | |||
| Basic | |||
| components | Housing | ||
| 3 balls | |||
| Tubing | |||
| Mouthpiece | Housing | ||
| 3 balls | |||
| Tubing | |||
| Mouthpiece | Same | ||
| Patient Interface | Mouthpiece | Mouthpiece | Same |
| Available | |||
| Models | 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 | |
| Intracutaneous | |||
| irritation | 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 the | ||
| end of the test | Drop Test | Same | |
| Subject Device | Predicate Devices | ||
| MEDINET INCENTIVE SPIROMETER | |||
| RESPIPROGRAM | BESMED TriBall - K133873 | Substantially | |
| Equivalent | |||
| Condition of | |||
| testing and | |||
| results | ±5% accuracy is maintained in the | ||
| following test conditions: |
- Age Testing (products recently
manufactured and expired products) - Low Humidity Testing (products recently
manufactured and expired products tested
with humidity 80%).
Low humidity test results (cc/sec):
Test at 600 cc/sec: 604,6±5,5
Test at 900 cc/sec: 925,2±3,28
Test at 1200 cc/sec:1222,8±10,0
High humidity test results (cc/sec)
Test at 600 cc/sec: 593,5±4,9
Test at 900 cc/sec: 887,3±3,7
Test at 1200 cc/sec:1177,3±7,5 | Accuracy specification ±5% verified in the
following test conditions:
Age Testing
High / Low Humidity conditions
Inspiratory rate / Volume accuracy
declared :
600 - 0,5%
900 - 0,3%
1200 - 0,1%
Test results using the MEDINET test
method - Low humidity (cc/sec):
Test at 600 cc/sec: 624,0±10,1
Test at 900 cc/sec: 886,8±10,2
Test at 1200 cc/sec:1210,5±12,89 | Same |
6
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.