MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM

K160837 · Medinet Srl · BWF · Feb 23, 2017 · Anesthesiology

Device Facts

• Record ID: K160837
• Device Name: MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
• Applicant: Medinet Srl
• Product Code: BWF · Anesthesiology
• Decision Date: Feb 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Inspiratory flow exerciser; stimulates deep breathing. Patient inhales through mouthpiece connected to three chambers containing colored balls (red, yellow, green); balls indicate approximate flow rates of 600, 900, and 1200 ml/second. Device provides visual feedback on inhalation capacity; no specific measurement function. Used in hospital or home care settings; operated by patient under physician prescription. Single-patient, single-use disposable device. Benefits patient by encouraging deep inspiration to improve lung function.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate device included flow accuracy tests (600, 900, 1200 cc/sec) and drop tests. Accuracy verified within ±5% across various humidity conditions and product ages. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Incentive spirometer; non-sterile, single-use, disposable. Components: plastic housing, 3 balls, tubing, mouthpiece. Sensing principle: mechanical flow-based visual indicator. Flow rates: 600, 900, 1200 ml/s. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients requiring inspiratory exercise to stimulate inhalation under physician prescription. Suitable for hospital or home care settings.

Regulatory Classification

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.

Predicate Devices

• TriBall incentive spirometer (K133873)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

| | <span> <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
|--|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 Information<br>Submitter: | MEDINET s.r.l. is located at:<br>Via Londonio, 12<br>MILANO<br>ITALY |
|----|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Maurizio Pantaleoni<br>Isemed s.r.l.<br>Via A. Altobelli Bonetti 3/A<br>40026 Imola (BO)<br>Mob.phone: [phone]<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

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)<br>Number | Product<br>code |
|---------------------------------|------------------------------|------------------|-----------------|
| BESMED Health Business<br>Corp. | 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 SPIROMETER<br>RESPIPROGRAM | BESMED TriBall - K133873 | Substantially<br>Equivalent |
| Regulation<br>Number: | 868.5690 | 868.5690 | Same |
| Classification | II | II | Same |
| Product Code | BWF | BWF | Same |
| Indications for<br>use | MEDINET INCENTIVE SPIROMETER<br>RESPIPROGRAM is intended as an<br>inspiratory deep breathing positive<br>exerciser.<br>MEDINET INCENTIVE SPIROMETER is<br>intended for single-patient, single use in a<br>hospital or home care setting. | The Besmed Incentive Spirometer is<br>intended as an inspiratory deep breathing<br>positive exerciser.<br>Intended for single-patient, multi-use in a<br>hospital or home care setting. | Equivalent. The only<br>difference is that<br>Medinet Incentive<br>spirometer<br>Respiprogram is single<br>use, while predicate<br>device is multi-use |
| Users | | | |
| Prescription<br>devices | YES | YES | Same |
| Population | Patients requiring inspiratory exercise | Patients requiring inspiratory exercise | Same |
| Single Patient,<br>Single Use | YES | No, Single patient, Multi Use | Equivalent. The only<br>difference is that<br>Medinet Incentive<br>spirometer<br>Respiprogram is single<br>use, while predicate<br>device is multi-use |
| Environment of<br>use | Home care settings and hospitals | Home care settings and hospitals | Same |
| Design features | | | |
| Basic<br>components | Housing<br>3 balls<br>Tubing<br>Mouthpiece | Housing<br>3 balls<br>Tubing<br>Mouthpiece | Same |
| Patient Interface | Mouthpiece | Mouthpiece | Same |
| Available<br>Models | One model with three balls | One model with 3 balls | Same |
| Biocompatibility | | | |
| Cytotoxicity | Conforming to ISO 10993 testing<br>(ISO 10993-5) | Conforming to ISO 10993 testing | Same |
| Sensitization | Conforming to ISO 10993 testing<br>(ISO 10993-10) | Conforming to ISO 10993 testing | Same |
| Intracutaneous<br>irritation | Conforming to ISO 10993 testing<br>(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<br>end of the test | Drop Test | Same |
| | Subject Device | Predicate Devices | |
| | MEDINET INCENTIVE SPIROMETER<br>RESPIPROGRAM | BESMED TriBall - K133873 | Substantially<br>Equivalent |
| Condition of<br>testing and<br>results | ±5% accuracy is maintained in the<br>following test conditions:<br>- Age Testing (products recently<br>manufactured and expired products)<br>- Low Humidity Testing (products recently<br>manufactured and expired products tested<br>with humidity < 40%)<br>- High Humidity Testing (products recently<br>manufactured and expired products tested<br>with humidity > 80%).<br>Low humidity test results (cc/sec):<br>Test at 600 cc/sec: 604,6±5,5<br>Test at 900 cc/sec: 925,2±3,28<br>Test at 1200 cc/sec:1222,8±10,0<br>High humidity test results (cc/sec)<br>Test at 600 cc/sec: 593,5±4,9<br>Test at 900 cc/sec: 887,3±3,7<br>Test at 1200 cc/sec:1177,3±7,5 | Accuracy specification ±5% verified in the<br>following test conditions:<br>Age Testing<br>High / Low Humidity conditions<br>Inspiratory rate / Volume accuracy<br>declared :<br>600 - 0,5%<br>900 - 0,3%<br>1200 - 0,1%<br>Test results using the MEDINET test<br>method - Low humidity (cc/sec):<br>Test at 600 cc/sec: 624,0±10,1<br>Test at 900 cc/sec: 886,8±10,2<br>Test 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.