VenaOne

K200285 · Vena Group, LLC · JOW · Jul 2, 2020 · Cardiovascular

Device Facts

• Record ID: K200285
• Device Name: VenaOne
• Applicant: Vena Group, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Jul 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids 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.

Device Story

VenaOne is a portable, battery-powered, prescription-only pneumatic compression system for DVT prevention and circulation enhancement. Device consists of an electronically controlled air pump, solenoid valve, and inflatable air bladder housed in a fabric cuff. Operated by healthcare professionals or patients in clinics, hospitals, or during mobility. User interface includes ON/OFF button, display, and battery status. System cycles by inflating bladder to 55 mmHg, followed by ~50-second rest/deflation period. Internal pressure switch and software monitor inflation. Device tracks usage time via USB connection to computer. Benefits include improved venous return, reduced edema, and accelerated wound healing. Provides audible/visual alarms for system faults, low pressure, and low battery.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and software validation per FDA guidance. Performance testing confirmed pressure accuracy and cycle timing.

Technological Characteristics

Portable, battery-powered pneumatic compression system. Materials: non-latex, non-woven medical fabric cuff with internal air bladder. Sensing: internal pressure switch. Energy: rechargeable battery or AC adapter. Connectivity: USB for usage tracking. Software: microprocessor-controlled, moderate level of concern. Sterilization: supplied clean, non-sterile. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients requiring venous return stimulation to prevent DVT, enhance circulation, reduce post-op pain/swelling, accelerate wound healing, and treat stasis dermatitis, venous/arterial/diabetic ulcers, chronic venous insufficiency, and lower limb edema. Contraindicated for patients with suspected/active/untreated DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection, or conditions where cuffs interfere (vein ligation, gangrene, dermatitis, open wounds, recent skin graft, massive edema, extreme deformity, or pain insensitivity).

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

• DVTCare CA5 (K130174)
• Cirona 6400 Disposable Deep Vein Thrombosis Prevention System (K161209)

Submission Summary (Full Text)

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July 2, 2020

Vena Group, LLC Bill Dai Consultant 14271 Jeffrey Rd. #246 Irvine, California 92620

Re: K200285 Trade/Device Name: VenaOne Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 1, 2020 Received: June 4, 2020

#### Dear Bill Dai:

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. 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/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.

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

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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 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,

for 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) K200285

Device Name VenaOne

#### Indications for Use (Describe)

VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;"> <span style="font-family: DejaVu Sans, sans-serif;"> <span> <span style="text-decoration: overline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </span> </span> </span> </div> | <div> <span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </div> |

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#### 510(k) Summary

#### 1. Submitter's Information

Submitter: Vena Group, LLC Address: 10 Westelm Gardens San Antonio, TX 78230 Contact Person: Kasey Vukson Tel: [phone] Date of Preparation: 01/16/2020

### 2. Subject Device

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

### 3. Predicate device

Primary Predicate Device: DVTCare CA5 510(k) Number: K130174 Clearance Date: May 2, 2013 Submitter: Ossur Americas Inc.

Predicate/Reference Device: Cirona 6400 Disposable Deep Vein Thrombosis Prevention System 510(k) Number: K161209 Clearance Date: May 31, 2016 Submitter: Devon Medical Products

### 4. Description of Subject Device

The VenaOne is a lightweight, portable battery powered prescriptive device. It is intended for stimulating blood flow in the legs (simulating muscle contractions) that helps stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). Its portable design allows patients to wear the unit during many clinical related activities, such as physical therapy sessions, wheel chair transportation, cafeteria sittings, and during general mobility throughout the clinic.

As an easy to use system. VenaOne utilizes the pneumatically controlled chamber cuff actuated by an electronically controlled air pump unit and solenoid valve. All the pump and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable air bladder. An ON/OFF button, a display, and a battery icon provide for user interface. There is also a charging port for connecting the battery charger/AC adapter plug, and a USB cable port for connecting the VenaOne device to the computer for tracking patient device use time. The detachable rechargeable battery could be mounted on the control unit or on the separate charging station for charging. Prior to use, the cut-resistant air bladder and control unit are placed inside a disposable medical fabric or equivalent medical material. The VenaOne devices are supplied clean and non-sterile.

In operation, the device could be powered on via the single ON/OFF button. The control unit then fills

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the air bladder to a pre-determined pressure (55 mmHg). The pressure of the air bladder is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned off, and the air bladder deflates to the ambient pressure through a valve inside the plastic case of the control unit. After the "rest" period of approximately 50 seconds, the cycle repeats until the unit is turned off.

# 5. Indications for Use

### Prescription Use:

VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids 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.

### 6. Summary of Substantial Equivalence

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

| | Subject Device | Primary Predicate Device | Predicate/Reference Device | Equivalence |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200285 | K130174 | K161209 | N/A |
| Submitter | Vena Group, LLC | Ossur Americas Inc. | Devon Medical Products | N/A |
| Device<br>Name/Model | VenaOne | DVTCare CA5 | Cirona 6400 Disposable Deep<br>Vein Thrombosis Prevention<br>System | N/A |
| Intended Use | VenaOne is an easy to use<br>system prescribed by<br>healthcare professionals for<br>stimulating blood flow in the<br>legs (simulating muscle<br>contractions) that aids in the<br>prevention of DVT, enhances<br>blood circulation, diminishes<br>post-operative pain and<br>swelling, reduces wound<br>healing time, and aids in the<br>treatment and healing of: stasis<br>dermatitis, venous stasis ulcers,<br>arterial and diabetic leg ulcers,<br>chronic venous insufficiency,<br>and reduction of edema in the<br>lower limbs. | The DVTcare CA5 is intended<br>to be a portable system that is<br>prescribed by healthcare<br>professionals to help prevent<br>the onset of DVT in patients,<br>by stimulating blood flow in<br>the legs (simulating muscle<br>contractions). Furthermore, the<br>unit can be used as an aid in the<br>prophylaxis for DVT by<br>persons traveling, or those<br>expecting to be stationary for<br>long periods of time (> 4<br>hours). This device can also be<br>used to: aid in the prevention of<br>DVT, enhance blood<br>circulation, diminish post-<br>operative pain and swelling.<br>reduce wound healing time,<br>and aid in the treatment and<br>healing of stasis dermatitis,<br>venous stasis ulcers, arterial<br>and diabetic leg ulcers, chronic<br>venous insufficiency, and<br>reduction of edema in the lower<br>limbs | The Cirona 6400 disposable<br>deep vein thrombosis<br>prevention system is intended<br>to be an easy to use portable<br>system, prescribed by a<br>physician, to help prevent the<br>onset of DVT in patients by<br>stimulating blood flow in the<br>extremities (stimulating muscle<br>contractions).<br>This device can be used in the<br>home or clinical setting to:<br>• Aid in the prevention of 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<br>and diabetic leg ulcers, chronic<br>venous insufficiency and<br>reduction of edema in the lower<br>limbs | Identical |
| | | | • As a prophylaxis for DVT by<br>persons expecting to be<br>stationary for long periods of<br>time | |
| Prescription or OTC | Prescription | Prescription | Prescription | Identical |
| Power Source(s) | Rechargeable battery | Rechargeable battery | Rechargeable battery | Identical |
| Battery<br>Specifications | 3.7V rechargeable battery | 7.4V rechargeable battery | 3.7V rechargeable battery | Identical or similar. The<br>voltage difference of<br>batteries will not raise<br>any new issue of the<br>safety or effectiveness. |
| Battery Charge | Takes approximately 4 hours<br>(from depleted state). | Takes approximately 3 - 5<br>hours (from depleted state). | Takes approximately 3 hours<br>(from depleted state). | Similar. The difference<br>of charging time does<br>not change the product<br>performance or<br>parameters, which will<br>not raise any new issue<br>of the safety or<br>effectiveness. |
| Power Supply | Input: 100 - 240 Vac, 50 - 60<br>Hz,<br>Output: 12 Vdc @ 2 Amp) | Input: 100 - 240 Vac, 50 - 60<br>Hz,<br>Output: 10 Vdc @ 1.1 Amp) | Input: 100 - 240 Vac, 50 - 60<br>Hz,<br>Output: 5 Vdc @ 2 Amp) | Similar. The voltage<br>difference of power<br>supply used does not<br>change the product<br>performance or<br>parameters, which will<br>not raise any new issue<br>of the safety or<br>effectiveness. |
| Internal<br>rechargeable<br>batteries | Yes | Yes | Yes | Identical |
| Compliance with<br>Voluntary<br>Standards? | Yes | Yes | Yes | Identical |
| Electrical Safety<br>Mechanical Safety<br>Chemical Safety<br>Thermal Safety<br>Radiation Safety? | Yes | Yes | Yes | Identical |
| Functions and<br>design | Aids venous return by using<br>cyclic,<br>intermittent, pneumatic<br>pressure application (inflation<br>followed by deflation) to<br>compress the lower<br>limb(s). | Aids venous return by using<br>cyclic,<br>intermittent, pneumatic<br>pressure application (inflation<br>followed by deflation) to<br>compress the lower<br>limb(s). | Aids venous return by using<br>cyclic,<br>intermittent, pneumatic<br>pressure application (inflation<br>followed by deflation) to<br>compress the lower<br>limb(s). | Identical |
| Contraindication(s) | The VenaOne MUST NOT be<br>used to treat the following<br>conditions: Persons with<br>suspected, active or untreated<br>deep vein thrombosis, ischemic<br>vascular disease, severe<br>arteriosclerosis, pulmonary<br>edema, severe congestive heart<br>failure, thrombophlebitis, or an<br>active infection.<br>On the legs where cuffs would<br>interfere with the following<br>conditions: vein ligation,<br>gangrene, dermatitis, open<br>wounds, a recent skin graft,<br>massive edema or extreme<br>deformity of the leg. | The DVTCare CA5 System<br>should not be used by persons<br>with the following conditions:<br>suspected, active or untreated<br>deep vein thrombosis, ischemic<br>vascular disease, severe<br>arteriosclerosis, pulmonary<br>edema, severe congestive heart<br>failure, thrombophlebitis, or an<br>active infection.<br>Not recommended for use on a<br>leg where the cuffs would<br>interfere with the following<br>conditions: vein ligation,<br>gangrene, dermatitis, open<br>wounds, a recent skin graft,<br>massive edema or extreme<br>deformity of the leg. | The Cirona® 6400 series<br>system should NOT be used in<br>the following conditions:<br>• Severe arteriosclerosis or<br>other ischemic vascular<br>diseases<br>• Acute or active deep vein<br>thrombosis<br>• Existing pulmonary edema,<br>pulmonary embolisms, and/or<br>congestive cardiac failure<br>• On patients with neuropathy,<br>active infections, and/or<br>thrombophlebitis<br>• On extremities that are<br>extremely deformed,<br>insensitive to pain, or where | Identical |
| | On extremities that are<br>insensitive to pain.<br>Where increased venous or<br>lymphatic return is undesirable. | Not for use with patines with<br>neuropathy.<br>Do not use on extremities that<br>are insensitive to pain.<br>Do not use where increased<br>venous or lymphatic return is<br>undesirable.<br>Leg cuffs may cause irritation<br>when used in direct contact<br>with skin. | increased venous or lymphatic<br>return is undesirable<br>• Any local skin or tissue<br>condition in which the<br>garments would interfere<br>including but not limited to:<br>Vein ligation, Recent skin<br>graft, Gangrene, Dermatitis,<br>Open wounds, Massive edema | |
| Target Population /<br>Intended Users | Patients who need venous<br>return. | Patients who need venous<br>return. | Patients who need venous<br>return. | Identical |
| Where Used | Hospital, Surgery Center,<br>Altitude travel, areas of limited<br>mobility | Home, Hospital, Surgery<br>Center, Altitude travel, areas of<br>limited mobility | Home, Hospital, Surgery<br>Center, Altitude travel, areas of<br>limited mobility | Identical or Similar |
| Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | Identical |
| Portability | Portable, ambulant | Portable, ambulant | Portable, ambulant | Identical |
| Basis of operation | Aids venous return by using<br>cyclic, intermittent, pneumatic<br>pressure application (inflation<br>followed by deflation) to<br>compress the lower limb(s). | Aids venous return by using<br>cyclic, intermittent, pneumatic<br>pressure application (inflation<br>followed by deflation) to<br>compress the lower limb(s). | Aids venous return by using<br>cyclic, intermittent, pneumatic<br>pressure application (inflation<br>followed by deflation) to<br>compress the lower limb(s). | Identical |
| Anatomical Site /<br>Location of<br>treatment<br>application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Identical |
| System<br>management | Electronic, microprocessor<br>controlled | Electronic, microprocessor<br>controlled | Electronic, microprocessor<br>controlled | Identical |
| Pressure Source | Micro pump controlled by<br>electronic processor | Micro pump controlled by<br>electronic processor | Micro pump controlled by<br>electronic processor | Identical |
| Operating Modes | Default mode one | 'Single leg' mode<br>'Double leg' mode | Default mode one | Identical or similar |
| Working Pressure | Preset at 55 mmHg | Preset at 50 mmHg, and<br>adjustable 20 - 65 mmHg | preset at 40 mmHg | Identical or similar |
| Cycle Time | Approximately 60 seconds | Approximately 60 seconds…