(35 days)
Not Found
No
The device description details a simple pneumatic system controlled by basic software and pressure switches. There is no mention of complex algorithms, learning capabilities, or data analysis that would indicate the use of AI/ML. The control logic is described as a fixed cycle based on pressure and time.
Yes
The device details multiple therapeutic benefits, including aiding in prevention and treatment of various conditions, enhancing circulation, and reducing pain and swelling.
No
The VenaPro Vascular Therapy System is a therapeutic device that stimulates blood flow to prevent DVT and aid in healing, rather than diagnosing conditions.
No
The device description clearly outlines hardware components including an air pump unit, solenoid valve, plastic case, tactile touch control switch, LEDs, battery charger port, and inflatable cuffs. While it mentions system software, it is integral to the operation of these physical components.
Based on the provided text, the VenaPro Vascular Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The VenaPro system works externally on the patient's lower limbs to stimulate blood flow. It does not analyze blood, tissue, or any other bodily fluid or substance.
- The intended use and device description clearly outline a mechanical therapy. The system uses pneumatic compression to aid in preventing DVT and improving circulation. This is a physical intervention, not a diagnostic test performed on a sample.
Therefore, the VenaPro Vascular Therapy System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
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 the plastic case. After the "rest" period, the cycle repeats until the unit is turned off.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower limb(s) (Calf)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-1-11 "Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment".
- (d) IEC 62133-2 "Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes -Safety Requirements For Portable Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems".
In addition to the compliance of voluntary standards, bench tests have been performed on the physical requirements, electrical requirement, and performance requirement; the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
1. Submitter's Information
Submitter: Innovamed Health, LLC Address: 270 West 500 North North Salt Lake, UT 84054 Contact Person: Luke Zeutzius Email: Luke@InnovamedHealth.com 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
4
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 | |||
| 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 | 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. | 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. | |
| 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
7.4V rechargeable battery. In
comparison, the subject device
switches to the 3.7V
rechargeable battery. The
voltage difference of batteries
used does not change the
product performance or
parameters, which will not raise
any new issue of the safety or
effectiveness. |
| Battery Charge | Takes approximately 2.5 hours (from
depleted state). | Takes approximately 1.5 hours (from
depleted state). | The difference of charging time
does not change the product
performance or parameters,
which will not raise any new
issue of the safety or
effectiveness. |
| Power Supply | Input: 100 - 240 Vac, 50 - 60 Hz,
Output: 5 Vdc @ 1 Amp) | Input: 100 - 240 Vac, 50 - 60 Hz,
Output: 10 Vdc @ 1.1 Amp) | The predicate device uses the
7.4V rechargeable battery that is
charged by a 10V charger. In
comparison, the subject device
switches to the 3.7V
rechargeable battery, which is
charged by a 5V charger. The
voltage difference of power
supply used does not change the
product performance or
parameters, which will not raise
any new issue of the safety or
effectiveness. |
| Internal rechargeable
batteries | Yes | Yes | Identical |
| Compliance with
Voluntary Standards? | Yes | Yes | Identical |
| Electrical Safety
Mechanical Safety
Chemical Safety
Thermal Safety
Radiation Safety? | Yes | Yes | Identical |
| Functions and design | 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 |
| Contraindication(s) | The VenaPro Vascular Therapy
System MUST NOT be used to treat
the following conditions: Persons with
suspected, active or untreated: deep
vein thrombosis, ischemic vascular
disease, severe arteriosclerosis,
pulmonary edema | The VenaPro Vascular Therapy
System MUST NOT be used to treat
the following conditions: Persons with
suspected, active or untreated: deep
vein thrombosis, ischemic vascular
disease, severe arteriosclerosis,
pulmonary edema | Identical |
Table 1. Comparison between the subject device and the predicate device
5
6
| | severe congestive heart failure, thrombophlebitis, or an active infection.
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.
On any neuropathy.
On extremities that are insensitive to pain.
Where increased venous or lymphatic return is undesirable. | severe congestive heart failure, thrombophlebitis, or an active infection.
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.
On any neuropathy.
On extremities that are insensitive to pain.
Where increased venous or lymphatic return is undesirable. | | | | | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------|--|
| Target Population /
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 /
Location of treatment
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
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
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
biocompatibility compliance. | Identical or similar | |
| | | Glue | | | | | |
| Fastening between the
plastic case and the
fabric wrap | Snap and screw | Glue | The plastic case and the fabric
wrap of the predicate device are
glued together, while the plastic
case and the fabric wrap of the
subject device are snapped and
screwed together. The patients
can not reach the snap and | | | | |
7
| | | | screws that are hidden in the
subject device. Therefore, this
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. | 0.23kg | 0.23kg | Identical or similar |
| Temperature | +10 °C (50 °F) to +40 °C (104 °F) | +10 °C (50 °F) to +40 °C (104 °F) | Identical |
| Humidity | 30%-75% | 30%-75% | Identical |
| Tolerances | Pressure 5% | Pressure 5% | Identical |
| Cleaning and
Disinfecting | • Clean the outer surface of the pump
unit using a soft cloth, moistened with
soapy water or 70% isopropyl alcohol.
• Do not use abrasive or volatile
cleaners.
• Do not place cuffs in dryer.
• NEVER remove the unit from the
cuff.
• Hand wash the exterior of the cuffs
using a soft cloth, moistened with
soapy water or 70% isopropyl alcohol
and let air dry.
• To ensure the unit IS completely dry
prior to use, leave unit in the OFF
condition and disconnected from the
wall outlet for 30 minutes after
cleaning or disinfecting. | • Clean the outer surface of the pump
unit using a soft cloth, moistened with
soapy water or 70% isopropyl alcohol.
• Do not use abrasive or volatile
cleaners.
• Do not place cuffs in dryer.
• NEVER remove the unit from the
cuff.
• Hand wash the exterior of the cuffs
using a soft cloth, moistened with
soapy water or 70% isopropyl alcohol
and let air dry.
• To ensure the unit IS completely dry
prior to use, leave unit in the OFF
condition and disconnected from the
wall outlet for 30 minutes after
cleaning or disinfecting. | Identical |
| Disposal | This unit is an electromechanical
device that includes printed circuit
boards and rechargeable batteries.
Do not discard in landfill. Consult
local county requirements for proper
disposal instructions. Pump control
units contain rechargeable batteries.
Do not discard the pump unit in
regular waste. Bring the unit to your
local recycle center or contact
Innovamed Health, LLC. | This unit is an electromechanical
device that includes printed circuit
boards and rechargeable batteries.
Do not discard in landfill. Consult
local county requirements for proper
disposal instructions. Pump control
units contain rechargeable batteries.
Do not discard the pump unit in
regular waste. Bring the unit to your
local recycle center or contact
Innovamed Health, LLC. | Identical |
7. Substantial Equivalence
As shown in the above table of comparison, the subject device in this submission has the identical performance and parameter to the predicate device in K133274. The updated and optimized circuit board in the subject device does not change any product performance. And the differences between the modified subject device and the original (predicate) device do not raise any new issues of safety or effectiveness.
The subject device is substantially equivalent to the predicate devices listed in function and operating principals to achieve identical results. The predicate device utilizes microprocessor controlled pumps to deliver approximately 50 mmHg of pressurized air to bladders that are attached to the patient's lower limbs, using a cycle time of approximately 60 seconds/leg. Each cycle consists of inflation of a bladder, followed by a rest period during which the bladder deflates and the limb relaxes without any compression.
8
Identical to the predicate device, the subject device has multiple audible and visual safety alarms built into the system, including low pressure alarms, low battery alarm and system malfunction overpressure safety alarm. In addition, the cuff is comprised of single bladder PVC chambers encased in a covering of soft, non-latex, non-woven medical fabric (a Polyester blend) or equivalent medical material for increased patient comfort and biocompatibility compliance. The microprocessor and pump units are powered by internal rechargeable batteries, and can be connected to the main AC power line (through the battery charger / AC adaptor) while in use, allowing uninterrupted prolonged service.
The subject device is designed for the same intended use as the predicated device. The comparison of the specifications demonstrates the functional equivalence of the products, concluding that the subject device is substantially equivalent to the predicate device.
8. Non-Clinical Tests Performed
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-1-11 "Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment".
- (d) IEC 62133-2 "Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes -Safety Requirements For Portable Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems".
In addition to the compliance of voluntary standards, bench tests have been performed on the physical requirements, electrical requirement, and performance requirement; the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
9. Conclusion
The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.