FLOWpresso

K223729 · Medella Health Limited · IRP · Dec 21, 2023 · Physical Medicine

Device Facts

• Record ID: K223729
• Device Name: FLOWpresso
• Applicant: Medella Health Limited
• Product Code: IRP · Physical Medicine
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy are indicated. Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.

Device Story

Flowpresso is an AC-powered, software-controlled physical therapy device delivering sequential compression and heat therapy. It consists of a computerized power unit connected to inflatable garments (back/hip, extremities) with 22 internal chambers. The system inflates chambers sequentially to provide progressive pressure without flow back. Operated by healthcare professionals in clinical settings, the device uses a touch-screen interface to manage treatment duration (up to 40 minutes), temperature (86°F–104°F), and compression (5–130 mmHg). Two modes (sports or relaxation) are available. The provider monitors the patient throughout the session, adjusting settings to ensure comfort. The device aims to treat post-traumatic and post-surgical conditions by applying localized thermal and compression therapy, potentially reducing symptoms associated with these conditions.

Clinical Evidence

Bench testing only. Performance verified through pressure accuracy, seam strength, hose integrity, and failure mode testing. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10. Flammability testing conducted per 16 CFR 1610. Heating safety verified per IEC 60601-2-35:2021. No clinical data provided.

Technological Characteristics

AC-powered, software-controlled system. Garments constructed of PVC material with needle cotton, non-conductive, and non-woven lining. Sequential pneumatic inflation (22 chambers). Heating via integrated thermotherapy. Connectivity: touch-screen interface. Electrical safety: ANSI/AAMI ES60601-1, IEC 60601-1, EN60601-1. Non-sterile, multi-patient use. Software: Moderate level of concern.

Indications for Use

Indicated for patients with post-traumatic and post-surgical medical and/or surgical conditions requiring localized thermal therapy. Intended for use in rehabilitation facilities, outpatient clinics, and athletic training settings by or under the order of licensed healthcare professionals.

Regulatory Classification

Identification

A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Predicate Devices

• Therm-X (K193550)

Submission Summary (Full Text)

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December 21, 2023

Medella Health Limited % Samantha Nava Managing Director Tilia Bridge 1506 Summer City Dr Houston, Texas 77047

Re: K223729

Trade/Device Name: FLOWpresso Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IRT Dated: December 7, 2023 Received: December 12, 2023

Dear Samantha Nava:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices

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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K223729

Device Name FLOWpresso

Indications for Use (Describe)

The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat postsurgical medical and/or surgical conditions for which localized thermal therapy are indicated.

Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.

| 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

### Medella Health Ltd K223729

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92.

| Date: | 7th December 2023 |
|------------------|---------------------------------------------------------------------------------------------------------|
| Submitter: | Medella Health Ltd<br>Unit 7, 144 Third Ave<br>Tauranga 3110, New Zealand<br>[phone] |
| Primary Contact: | Samantha Nava<br>President<br>Tilia Bridge LLC<br>Tel: [phone]<br>Email: [e-mail] |
| Company Contact: | Desiree De Spong<br>Chief Executive<br>Email: [e-mail] |

#### Device Name and Classification:

| Trade Name: | Flowpresso |
|-----------------------|--------------------------------------------------|
| Common Names: | Heat and Compression Therapy |
| Classification: | Class II |
| Regulation Number: | 21CFR 890.5650, Powered Inflatable Tube Massager |
| Classification Panel: | Physical Medicine |
| Product Code: | IRP, IRT |

### Predicate Device:

| | Subject | Predicate |
|--------------------------|----------------------------------------------|------------------------------------------------|
| Trade Name: | Flowpresso | Therm-X |
| Common Name: | Heat and Compression<br>Therapy | Heat and/or Cold<br>Compression Therapy |
| 510(k) Submitter/Holder: | Medella Health Ltd | Zenith Technical<br>Innovations, LLC. (Zenith) |
| 510(k) Number: | K223729 | K193550 |
| Classification: | Class II | Class II |
| Regulation Number: | 890.5650 Powered Inflatable<br>Tube Massager | 890.5650 Powered Inflatable<br>Tube Massager |
| Classification Panel: | Physical Medicine | Physical Medicine |
| Product Code: | IRP, IRT | IRP, ILO, JOW |

### 1 Device Description

The Flowpresso Compression Device is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction, prescription, or

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supervision of a licensed healthcare professional.

Flowpresso is a non-invasive physical suit that delivers compression, and heat therapy. The suit has air pressure and heat cables that are connected to a computerized power unit that controls ranges and duration of treatment.

The Flowpresso consists of various inflatable wraps that cover the back/hip and extremities of a fully clothed patient with Velcro fasteners. These multi patient use garments are designed to accommodate different anatomical shapes and sizes of patients that can be cleaned and disinfected in between uses to be reused for different patients. The suit has 22 individual internal chambers that inflate sequentially before its predecessor completely deflates, to provide a progressive pressure without any flow back.

Flowpresso is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust the monitor treatment times, temperature, and compression settings. Flowpresso has two separate modes: sports or relaxation, with different cycles to deliver a specific and individual experience that is supervised by a health care provider. The therapy lasts forty (40) minutes where the health provider will be available to make any adjustments throughout the duration of therapy.

The session begins with air pressure to give the patient a comfortable increased pressure, followed by heat. The health care provider is responsible for adjusting settings of pressure/heat to ensure the patient is comfortable for the entirety of the forty (40) minute session.

### 2 Indications for Use

The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat post traumatic and post-surgical medical and/or surqical conditions for which localized thermal therapy are indicated.

Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.

### 3 Risk Analysis Method

Flowpresso was assessed to determine the risks to health, associated with the device and evaluate risks related to safety, effectiveness, and usability. A risk analysis was conducted in according with ISO 14971:2007 and ISO14971:2012, Medical devices - Application of risk management to medical devices. All risks have been found acceptable.

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### 4 Substantial Equivalence Information

Flowpresso is equivalent to Therm-X (K193550) by Zenith Technical Innovations, LLC. (Zenith), currently on the market. Flowpresso has the same intended use and indications for use, as the predicate device and uses equivalent overall design and operating principals as the predicate device.

The table below provides a detailed comparison of Flowpresso to the predicate device.

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| Characteristic | Predicate Device<br>Therm-X | Subject device<br>Flowpresso | Similar | Different | Comparison |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------|-----------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Therm-X (Therm-X Home<br>and Therm-X AT) combines<br>cold,<br>heat, contrast, and<br>compression therapy.<br>Therm-X is intended to treat<br>post-surgical and acute<br>injuries to reduce edema,<br>swelling, and pain for which<br>cold and compression are<br>indicated. It is intended to<br>treat post traumatic and<br>postsurgical medical<br>and/or surgical conditions<br>for which localized thermal<br>therapy (hot or cold)<br>indicated.<br>Therm-X (Therm-X Home<br>and Therm-X AT) is<br>intended to be<br>used by, or on the order of,<br>licensed health care<br>professionals in<br>rehabilitation<br>facilities, outpatient clinics,<br>athletic training settings, and<br>home settings. | The Flowpresso Device<br>combines heat and<br>compression therapy.<br>Flowpresso is intended to treat<br>post traumatic and post-surgical<br>medical and/or surgical<br>conditions for which localized<br>thermal therapy are indicated.<br>Flowpresso is intended to be<br>used by, or on the order of,<br>licensed health care<br>professionals based in<br>rehabilitation facilities,<br>outpatient clinics and athletic<br>training settings. | | X | The major difference<br>between the subject and<br>predicate device is<br>Therm-X also combines<br>cold and contrast. |
| Characteristic | Predicate Devices<br>Therm-X | Subject device<br>Flowpresso | Similar | Different | Comparison |
| Intended<br>Users | Health Care Professionals<br>and lay users (under<br>prescription) | Health Care Professionals | | X | Flowpresso is not<br>intended for home use. |
| Number of<br>patients that<br>can be treated<br>at one time | One | One | X | | |
| Two<br>programmable<br>Cycles | Configuration of two<br>programmable cycles | Configuration of two<br>programmable cycles | X | | |

### Detailed Comparison of the Subject and Predicate Device

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### Functions

| Treatment<br>Time | Custom: 3-40 minutes | 01-40 minutes | x | | |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---|---|-----------------------------------------------|
| Heat<br>Therapy | Default: 105°F, 107°F, 110°F<br>Custom: 105°F - 110°F<br>Default, continuous:<br>105°F, 107°F<br>Custom, continuous:<br>105°F - 107°F | Default: 86°F – 104°F | | x | Flowpresso operates at a<br>lower temperature |

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| Characteristi<br>C | Predicate Devices<br>Therm-X | Subject device<br>Flowpresso | Simila<br>r | Different | Comparison |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Compression<br>Pressure<br>Levels | Available in following levels:<br>Lite (5 mm Hg)<br>Low (20 mm Hg)<br>Medium (45 mm Hg)<br>High (70 mm Hg)<br>Calf: 50 - 70 mmHg<br>Foot: 90 – 130mmHg | 5-130mm/Hg | | × | Flowpresso delivers up to<br>130mm/Hg.<br>Pressure range is<br>dependent on patient<br>comfort levels and are<br>adjusted in real-time. |
| Static or<br>Intermittent<br>Pressure | Both | Both | × | | |
| Power<br>Down | Available | Available | × | | |
| Password<br>Protection | Available | Not Available | | × | |
| Storage<br>Cycle Usage<br>Data | Available | Not Available | | × | |

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## Physical Unit

| Characteristic | Predicate Device<br>Therm-X | Subject device<br>Flowpresso | Similar | Different | Comparison |
|---------------------------|-----------------------------------|------------------------------|---------|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions<br>(W x H x D) | 10.5" x 9" x 15" | 12" x 6" x 15.5" | X | | |
| Weight | 15 pounds when full of<br>coolant | 18 pounds | X | | |
| Heating<br>Mechanism | Thermoelectric | Thermotherapy | | X | Thermotherapy consists<br>of application of heat or<br>for the purpose of<br>changing the cutaneous,<br>intra-articular and core<br>temperature of soft tissue<br>with the intention of<br>improving the symptoms<br>of certain conditions. |
| User Interface | Touch Screen | Touch Screen | X | | |

## Electrical

| Line<br>voltage | 100-240V | 110-220V | X | |
|-----------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---|--|
| Line<br>Frequency | 50/60 Hz | 50/60 Hz | X | |
| Electrical<br>Safety<br>Standards | ANSI/AAMI<br>ES60601-1:2005/(R)2012<br>CAN/CSA C22.2 No.<br>60601-1:2014 Type B<br>IEC 60601-1-2 | ANSI/AAMI ES60601-<br>1:2005 + A1:2012<br>IEC 60601-1:2005 +<br>A1:2012<br>EN60601-1:2006 +A1:2013 | X | |

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## Environment

| Characteristic | Predicate Device<br>Therm-X | Subject device<br>Flowpresso | Similar | Different | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating<br>Temperature | 60°F - 80°F (16°C – 27°C) | 60°F - 80°F (16°C - 27°C) | X | | |
| Storage<br>Temperature | 33°F - 122°F (1°C - 50°C) | 33°F - 122°F (1°C - 50°C) | X | | |
| Operating<br>Humidity | Below 60% Noncondensing | Below 60% Noncondensing | X | | |
| Storage<br>Humidity | Below 60% Noncondensing | Below 60% Noncondensing | X | | |
| Operating<br>Atmospheric<br>Pressure and<br>Altitude | 700 hPa – 1060 hPa<br>(corresponds to a max. elevation<br>of 9,842 ft. 6 in (3000 m)) | 700 hPa – 1060 hPa<br>(corresponds to a max. elevation<br>of 9,842 ft. 6 in (3000m)) | X | | |
| Characteristic | Predicate Device<br>Therm-X | Subject device<br>Flowpresso | Similar | Different | Comparison |
| | | | | | |
| Types of<br>Garments | Various anatomical thermal<br>garments for: Back, Elbow,<br>Shoulder, Knee, Ankle, Hip.<br>DVT Garments: Calf and Foot | Various anatomical<br>thermal/compression garments<br>for: Back/Hip, arm, leg, feet | X | | Both devices are<br>intended to be an<br>upper body, lower<br>body, or full body<br>experience, which is<br>based on the patients'<br>individual needs. |
| Patient<br>Contacting<br>Material | Thermal garment reusable<br>(multi-patient) - 30 denier<br>nylon coated in urethane.<br>DVT – 200 denier nylon<br>coated in urethane. | Needle cotton, non-conductive<br>and non-woven lining. All<br>encompassed with a PVC<br>material. | X | | Flowpresso device is<br>PVC material that<br>internally holds needle<br>cotton, non-conductive<br>heat, and non-woven<br>lining. |
| Multi-Patient<br>Use and Single-<br>Patient Use<br>Wraps | Multi-Patient Use and Single-<br>Patient Use Available | Multi-Patient Use | | X | Flowpresso wraps are<br>not available for single<br>use |
| Biocompatibility | Cytotoxicity testing per ISO<br>10993-5<br>Sensitization testing per ISO<br>10993-10<br>Irritation testing per<br>ISO 10993-10 | Cytotoxicity testing per ISO<br>10993-5<br>Sensitization testing per ISO<br>10993-10<br>Irritation testing per<br>ISO 10993-10 | X | | |
| Garment<br>Flammability<br>Testing | - | 16 CFR 1610 Standard for the<br>Flammability of Clothing Textiles | | X | Flowpresso material<br>was tested to meet<br>safety standards. |
| Sterile/Non-<br>Sterile | Non-sterile only | Non-sterile only | X | | |
| Characteristic | Predicate Device<br>Therm-X | Subject device<br>Flowpresso | Similar | Different | Comparison |
| Cleaning<br>Disinfection<br>Validation of<br>Labeling | Yes- for Multi-Patient use<br>reusable wraps | Yes- for Multi-Patient use<br>reusable wraps | X | | |
| Human Factors<br>testing to<br>confirm<br>intended users<br>have found<br>instructions for<br>cleaning and<br>disinfection<br>easy to use | Yes- for Multi-Patient use<br>reusable wraps | Yes- for Multi-Patient use<br>reusable wraps | X | | |
| Expected Life of<br>Garments | Based on frequency of use<br>and continued functional<br>performance | Based on frequency of use and<br>continued functional<br>performance | X | | |
| Validation of<br>repeated<br>cleaning and<br>disinfection for<br>reusable<br>garments | Yes- for Multi-Patient use<br>reusable wraps | Yes- for Multi-Patient use<br>reusable wraps | X | | |

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### Accessories/Garments

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### 5 Testing:

Flowpresso was verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed.

### Electromagnetic Compatibility / Electrical Safety:

Electromagnetic Compatibility/Electrical Safety testing was performed in accordance with the following standards:

- ANSI/AAMI ES60601-1:2005 + A1:2012. Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1:2005 + A1:2012. Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- EN60601-1:2006 +A1:2013. Medical electrical equipment Part 1: General requirements for basic safety and essential performance

Verification results indicated that the device is safe.

### Biocompatibility:

The Flowpresso patient contact materials were verified in accordance with the following standards:

- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and . skin sensitization.
- ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and ● skin sensitization.

### Material Heat Testing:

The Flowpresso garment material testing was conducted in accordance with 16 CFR 1610 Standard for the Flammability of Clothing Textiles and the Test Procedure as per 16 CFR 1610.6. According to the test result, the submitted sample met the class 1 - normal flammability requirements defined in 16.CFR 1610. Further testing was conducted in accordance with IEC 60601-2-35:2021 Medical Electrical equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads, and mattresses and intended for heating in medical use showing that all pieces remain well within tolerance of 40°C.

### 6 Cleaning, Disinfection and Shelf-Life Testing:

Flowpresso garments are intended for use over clothed skin only. They are provided nonsterile and not intended to be user sterilized. Cleaning instructions are provided for multipatient use garments.

The Flowpresso components and garments do not have a definitive shelf live based on

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packaging or time. Expected life is based on frequency of use and continued functional performance. Durability test has been performed and has confirmed the safe use and disinfection of a Flowpresso garment for the duration of the garment's life without evidence of deterioration of the garment due to cleaning.

### 7 Software Validation:

Medella Health has conducted software validation testing on the Flowpresso software and confirmed that Flowpresso software meets its performance requirements and specifications. Software Validation has been completed according to an established Validation procedure and FDA Guidance Documents and Industry Standards:

- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 11, 2002
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005

The Software is a Moderate Level of Concern as per FDA guidance. All required items related to software as required by FDA guidance have been included in this submission.

### 8 Performance - Bench:

Flowpresso has been tested for performance to verify the proper operation of the system. Test and verification results indicate that Flowpresso conforms to its predetermined specifications and operates within safety limits.

The following Tests have been performed:

- Pressure Accuracy Test .
- Seam Strength Test
- Hose Integrity Test ●
- Failure Mode Test ●
- Garment V&V Testing Report

### 9 Substantial Equivalence Conclusions

In conclusion, the intended use for Flowpresso is substantially equivalent to that of the predicate device. The technological characteristics comparison demonstrates that Flowpresso is equivalent to the predicate device, and the testing shows that Flowpresso is substantially equivalent to the predicate device and assures that Flowpresso is as safe and effective as the predicate devices.