VenaPro Vascular Therapy System

K193020 · Innovamed Health, LLC · JOW · Dec 4, 2019 · Cardiovascular

Device Facts

• Record ID: K193020
• Device Name: VenaPro Vascular Therapy System
• Applicant: Innovamed Health, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 4, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VenaPro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: - Aid in the prevention of DVT; - Enhance blood circulation; - Diminish post-operative pain and swelling; - Reduce wound healing time; - Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Device Story

VenaPro Vascular Therapy System is a portable, battery-powered, prescription-only device for home or clinical use. It consists of a control unit with an air pump and solenoid valve, permanently attached to a single-use inflatable PVC cuff encased in polyester fabric. The device operates by applying cyclic, intermittent pneumatic pressure (50 mmHg) to the lower limb to stimulate blood flow and muscle contractions. A 60-second cycle includes inflation followed by a rest period for deflation. The user operates the device via a single tactile switch; status is indicated by a tri-color LED. Internal software and a pressure switch monitor cuff pressure. Audible and visual alarms alert the user to leaks, low pressure, or low battery. The device aids in DVT prevention, circulation enhancement, and wound healing. It is intended for patients needing venous return support, including those stationary for long periods.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment requirements (IEC 60601-1-11), and battery safety (IEC 62133-2). Software verification was conducted per FDA guidance.

Technological Characteristics

Portable, battery-powered (3.7V) pneumatic compression device. Components: PVC air bladder, polyester blend fabric cover, micro-pump, solenoid valve, microprocessor controller. Dimensions: 131x66x37mm; Weight: 0.23kg. Operation: Cyclic pneumatic pressure (50 mmHg, 60s cycle). Connectivity: Includes port for battery charger/AC adapter and unused port for future data reporting. Software: Microprocessor-controlled. Sterilization: Clean, non-sterile.

Indications for Use

Indicated for patients requiring venous return stimulation to prevent DVT, enhance circulation, reduce post-op pain/swelling, accelerate wound healing, or treat venous/arterial/diabetic ulcers, stasis dermatitis, chronic venous insufficiency, and lower limb edema. Also indicated for DVT prophylaxis in stationary individuals. Contraindicated for patients with suspected/active/untreated DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection, or where increased venous/lymphatic return is undesirable. Not for use on legs with vein ligation, gangrene, dermatitis, open wounds, recent skin grafts, massive edema, extreme deformity, neuropathy, or insensitive extremities.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• VenaPro Vascular Therapy System (K133274)

Submission Summary (Full Text)

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December 4, 2019

Innovamed Health, LLC % Bill Dai Manager Jkh Usa, LLC 20505 Valley Blvd. Suite 108 Walnut, California 91789

Re: K193020

Trade/Device Name: VenaPro Vascular Therapy System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: October 26, 2019 Received: October 30, 2019

Dear Bill Dai:

We have reviewed vour 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 (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,

Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular 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) K193020

Device Name VenaPro Vascular Therapy System

#### Indications for Use (Describe)

The VenaPro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:

- · Aid in the prevention of DVT;
- · Enhance blood circulation;
- · Diminish post-operative pain and swelling;
- · Reduce wound healing time;
- · Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### 1. Submitter's Information

Submitter: Innovamed Health, LLC Address: 270 West 500 North North Salt Lake, UT 84054 Contact Person: Luke Zeutzius Email: [e-mail] Date of Preparation: 09/30/2019

## 2. Subject Device

Trade/Device Name: VenaPro Vascular Therapy System Common Name: Compressible Limb Sleeve Device Regulation Medical Specialty: Neurology Review Panel: Cardiovascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription

## 3. Predicate device

Trade Name: VenaPro Vascular Therapy System 510(k) Number: K133274 Clearance Date: February 12, 2014 Submitter: Innovamed Health, LLC

## 4. Description of Subject Device

The VenaPro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep yein thrombosis (DVT).

The system utilizes pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid valve. All pump, battery and control components are protectively housed in a plastic case that is permanently attached to a single use inflatable cuff. A single tactile touch control switch, tri-color LED for ON, LOW BATTERY, CHARGING and CHARGE COMPLETED indication, and a blue LED (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug, and a currently unused port for future use in usage data reporting.

The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric (a Polyester blended medical fabric) or equal , which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs (1 left and 1 right side).

In operation, the user simply turns the power ON via the single button I/O control switch. A single user "cuff" containing air bladders is permanently connected to the unit. The control unit then fills the cuff to a pre-determined pressure (50 mmHg). Cuff pressure is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned OFF for an approximately 50 second "rest" period, and the cuff deflates to ambient pressure through a valve inside

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the plastic case. After the "rest" period, the cycle repeats until the unit is turned off.

## 5. Indications for Use

### Prescription Use:

The VenaPro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:

- Aid in the prevention of DVT; ●
- Enhance blood circulation;
- Diminish post-operative pain and swelling:
- Reduce wound healing time; ●
- Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ● ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

### 6. Summary of Substantial Equivalence

The following comparison Table 1 summarizes the comparison between the modified subject device and the original predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.

| | Subject Device | Predicate Device | Equivalence |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K133274 | |
| Submitter | Innovamed Health, LLC | Innovamed Health, LLC | Identical |
| Device Name/Model | VenaPro Vascular Therapy System | VenaPro Vascular Therapy System | Identical |
| Intended Use | Prescription Use: | Prescription Use: | Identical |
| | The VenaPro Vascular Therapy<br>System is intended to be an easy to use<br>portable system, prescribed by a<br>physician, for use in the home or<br>clinical setting to help prevent the<br>onset of DVT in patients by<br>stimulating blood flow in the<br>extremities (stimulating muscle<br>contractions). This device can be used<br>to:<br><br>• Aid in the prevention of<br>DVT;<br>• Enhance blood circulation;<br>• Diminish post-operative pain<br>and swelling;<br>• Reduce wound healing time;<br>• Aid in the treatment and<br>healing of stasis dermatitis,<br>venous stasis ulcers, arterial | The VenaPro Vascular Therapy<br>System is intended to be an easy to use<br>portable system, prescribed by a<br>physician, for use in the home or<br>clinical setting to help prevent the<br>onset of DVT in patients by<br>stimulating blood flow in the<br>extremities (stimulating muscle<br>contractions). This device can be used<br>to:<br><br>• Aid in the prevention of<br>DVT;<br>• Enhance blood circulation;<br>• Diminish post-operative pain<br>and swelling;<br>• Reduce wound healing time;<br>• Aid in the treatment and<br>healing of stasis dermatitis,<br>venous stasis ulcers, arterial | |
| | | | |
| | and diabetic leg ulcers,<br>chronic venous insufficiency<br>and reduction of edema in<br>the lower limbs.<br><br>The unit can also be used as an aid in<br>the prophylaxis for DVT by persons<br>expecting to be stationary for long<br>periods of time. | and diabetic leg ulcers,<br>chronic venous insufficiency<br>and reduction of edema in<br>the lower limbs.<br><br>The unit can also be used as an aid in<br>the prophylaxis for DVT by persons<br>expecting to be stationary for long<br>periods of time. | |
| Prescription or OTC | Prescription | Prescription | Identical |
| Power Source(s) | Rechargeable battery | Rechargeable battery | Identical |
| Battery Specifications | 3.7V rechargeable battery | 7.4V rechargeable battery | The predicate device uses the<br>7.4V rechargeable battery. In<br>comparison, the subject device<br>switches to the 3.7V<br>rechargeable battery. The<br>voltage difference of batteries<br>used does not change the<br>product performance or<br>parameters, which will not raise<br>any new issue of the safety or<br>effectiveness. |
| Battery Charge | Takes approximately 2.5 hours (from<br>depleted state). | Takes approximately 1.5 hours (from<br>depleted state). | The difference of charging time<br>does not change the product<br>performance or parameters,<br>which will not raise any new<br>issue of the safety or<br>effectiveness. |
| Power Supply | Input: 100 - 240 Vac, 50 - 60 Hz,<br>Output: 5 Vdc @ 1 Amp) | Input: 100 - 240 Vac, 50 - 60 Hz,<br>Output: 10 Vdc @ 1.1 Amp) | The predicate device uses the<br>7.4V rechargeable battery that is<br>charged by a 10V charger. In<br>comparison, the subject device<br>switches to the 3.7V<br>rechargeable battery, which is<br>charged by a 5V charger. The<br>voltage difference of power<br>supply used does not change the<br>product performance or<br>parameters, which will not raise<br>any new issue of the safety or<br>effectiveness. |
| Internal rechargeable<br>batteries | Yes | Yes | Identical |
| Compliance with<br>Voluntary Standards? | Yes | Yes | Identical |
| Electrical Safety<br>Mechanical Safety<br>Chemical Safety<br>Thermal Safety<br>Radiation Safety? | Yes | Yes | Identical |
| Functions and design | Aids venous return by using cyclic,<br>intermittent, pneumatic pressure<br>application (inflation followed by<br>deflation) to compress the lower<br>limb(s). | Aids venous return by using cyclic,<br>intermittent, pneumatic pressure<br>application (inflation followed by<br>deflation) to compress the lower<br>limb(s). | Identical |
| Contraindication(s) | The VenaPro Vascular Therapy<br>System MUST NOT be used to treat<br>the following conditions: Persons with<br>suspected, active or untreated: deep<br>vein thrombosis, ischemic vascular<br>disease, severe arteriosclerosis,<br>pulmonary edema | The VenaPro Vascular Therapy<br>System MUST NOT be used to treat<br>the following conditions: Persons with<br>suspected, active or untreated: deep<br>vein thrombosis, ischemic vascular<br>disease, severe arteriosclerosis,<br>pulmonary edema | Identical |

Table 1. Comparison between the subject device and the predicate device

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| | severe congestive heart failure, thrombophlebitis, or an active infection.<br>On the legs where cuffs would interfere with the following conditions: vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg.<br>On any neuropathy.<br>On extremities that are insensitive to pain.<br>Where increased venous or lymphatic return is undesirable. | severe congestive heart failure, thrombophlebitis, or an active infection.<br>On the legs where cuffs would interfere with the following conditions: vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg.<br>On any neuropathy.<br>On extremities that are insensitive to pain.<br>Where increased venous or lymphatic return is undesirable. | | | | | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------|--|
| Target Population /<br>Intended Users | Patients who need venous return. | Patients who need venous return. | Identical | | | | |
| Where Used | Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility | Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility | Identical | | | | |
| Application | Non-invasive / external | Non-invasive / external | Identical | | | | |
| Portability | Portable, ambulant | Portable, ambulant | Identical | | | | |
| Basis of operation | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower limb(s). | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower limb(s). | Identical | | | | |
| Anatomical Site /<br>Location of treatment<br>application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Identical | | | | |
| System management | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Identical | | | | |
| Pressure Source | Micro pump controlled by electronic processor | Micro pump controlled by electronic processor | Identical | | | | |
| Operating Modes | Default mode one | Default mode one | Identical | | | | |
| Working Pressure | Default mode is preset at 50 mmHg | Default mode is preset at 50 mmHg | Identical | | | | |
| Cycle Time | 60 seconds | 60 seconds | Identical | | | | |
| System diagnostics | Audible and visual alarms prompt recognition of system faults | Audible and visual alarms prompt recognition of system faults | Identical | | | | |
| Modes | 1 Modality | 1 Modality | Identical | | | | |
| Air delivery from pump<br>to cuff bladder | Via flexible plastic (PVC) tube(s) connected directly to the air bladder. | Via flexible plastic (PVC) tube(s) connected directly to the air bladder. | Identical | | | | |
| Sterility | Clean / non-sterile | Clean / non-sterile | Identical | | | | |
| Leg cuff usage | Single Patient Use | Single Patient Use | Identical | | | | |
| Material Used | | Single bladder PVC chambers encased in a covering of soft, nonlatex, non-woven medical fabric (a Polyester blend) or equivalent medical material for increased patient comfort and | for increased patient comfort and<br>biocompatibility compliance. | Single bladder PVC chambers encased in a covering of soft, nonlatex, non-woven medical fabric (a Polyester blend) or equivalent medical material for increased patient comfort and | for increased patient comfort and<br>biocompatibility compliance. | Identical or similar | |
| | | Glue | | | | | |
| Fastening between the<br>plastic case and the<br>fabric wrap | Snap and screw | Glue | The plastic case and the fabric<br>wrap of the predicate device are<br>glued together, while the plastic<br>case and the fabric wrap of the<br>subject device are snapped and<br>screwed together. The patients<br>can not reach the snap and | | | | |

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| | | | screws that are hidden in the<br>subject device. Therefore, this<br>difference will not raise any new |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | | | issue of safety and effectiveness. |
| Biocompatibility | Biocompatible | Biocompatible | Identical |
| Software | Moderate | Moderate | Identical |
| Dimensions | 131x66x37mm | 131x66x37mm | Identical of similar |
| Weight Approx.…