K Number
K191937
Device Name
Ezvena IPC, Ezvena SQS
Date Cleared
2020-01-29

(194 days)

Product Code
Regulation Number
870.5800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis.
Device Description
EzVena IPC and EzVena SQS ("EzVena") is a deep vein thrombosis (DVT) pump system intended for performing non-invasive, intermittent compression of the lower limbs. The system is used to squeeze blood from the deep veins, which displaces proximally. On deflation of the cuff, the veins refill, and the intermittent nature of the system ensures periodic flow of blood through the deep veins, helping to prevent venous stasis and the formation of blood clots. System components include a mains-powered, pneumatic pump with touch-input control panel and microprocessor circuit; connecting air hoses; and foot, calf, and calf/thigh garments, or cuffs. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's left and right lower limbs. Compression is uniform in the IPC model and graded sequential in the SQS model. The system alternates between left and right cuffs in EzVena IPC and inflates both garments simultaneously in EzVena SQS.
More Information

Not Found

No
The description focuses on pneumatic compression and microprocessor control, with no mention of AI or ML terms or functionalities.

Yes
The device is intended to prevent deep vein thrombosis, which is a therapeutic purpose.

No

The device is described as a "deep vein thrombosis (DVT) pump system" that applies intermittent pneumatic compression to prevent DVT by promoting blood flow. Its function is therapeutic/prophylactic, not diagnostic (i.e., it does not identify or characterize a disease).

No

The device description explicitly states that the system components include a "mains-powered, pneumatic pump with touch-input control panel and microprocessor circuit; connecting air hoses; and foot, calf, and calf/thigh garments, or cuffs." These are physical hardware components, not solely software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The EzVena IPC and EzVena SQS system is a mechanical device that applies external pressure to the lower limbs. It does not analyze any biological samples from the patient.
  • Intended Use: The intended use is to physically prevent deep vein thrombosis by promoting blood flow, not to diagnose or detect a condition based on analyzing a sample.

The device description clearly outlines a system of pumps, hoses, and cuffs that physically interact with the patient's limbs. This is a therapeutic or preventative device, not a diagnostic one.

N/A

Intended Use / Indications for Use

To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis.

Product codes (comma separated list FDA assigned to the subject device)

JOW

Device Description

EzVena IPC and EzVena SQS ("EzVena") is a deep vein thrombosis (DVT) pump system intended for performing non-invasive, intermittent compression of the lower limbs (see Figure 1). The system is used to squeeze blood from the deep veins, which displaces proximally. On deflation of the cuff, the veins refill, and the intermittent nature of the system ensures periodic flow of blood through the deep veins, helping to prevent venous stasis and the formation of blood clots. The basic technology has proven effective across many scientific studies since its introduction in the 1970s. System components include a mains-powered, pneumatic pump with touch-input control panel and microprocessor circuit; connecting air hoses; and foot, calf, and calf/thigh garments, or cuffs. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's left and right lower limbs. Compression is uniform in the IPC model and graded sequential in the SQS model (see Table 1). The system alternates between left and right cuffs in EzVena IPC and inflates both garments simultaneously in EzVena SQS.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Foot/Calf/Thigh

Indicated Patient Age Range

Not Found

Intended User / Care Setting

EzVena may be operated only by acute-care personnel authorized and trained to treat DVT.

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)

EzVena passed the following non-clinical tests, all of which were performed to current FDA-recognized standards, except as noted:

  • Biocompatibility... ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010
  • Electrical Safety... IEC 60601-1:2012
  • EMC... IEC 60601-1-2:2014
  • Usability Engineering... EN 62366-1:2008 (not to recognized standard)
  • Software Life Cycle ... IEC 62304:2006
  • Risk Management... ISO 14971:2007
  • Symbols Used With Labels... ISO 15223-1:2012

Clinical testing was not deemed necessary.

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.

K143438

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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the full name of the agency on the right. The seal features a stylized depiction of human services, while the text part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 29, 2020

Eezcare Medical Corp % John Gillespy President FDA 510K Consultants, LLC 1100 Del Lago Cir, STE 104 Palm Beach Gardens, Florida 33410

Re: K191937

Trade/Device Name: Ezvena IPC, Ezvena SOS Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 20, 2019 Received: December 30, 2019

Dear John Gillespy:

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

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

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Indications for Use

510(k) Number (if known) K191937

Device Name EzVena IPC, EzVena SQS

Indications for Use (Describe)

To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis.

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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Section 5 – 510(k) Summary

| 1. 510(k) Submitter: | Eezcare Medical Corp
No 3-1, Minquan St, New Taipei City 236
Taipei, Tu-Cheng District, Taiwan 23679
Phone: 757-224-0177
Email: michelle.mitchell@eezcare.com.tw |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Company Contact: | Michelle C Mitchell |
| 3. Date of Submission: | July 8, 2019 |
| 4. 510(k) Preparer: | John F. Gillespy, MBA
FDA 510k Consulting, LLC
Palm Beach Gardens, FL 33410
Phone: 386-243-4332
Email: john@fda510kconsultants.com |
| 5. Device Classification: | Trade name: EzVena IPC, EzVena SQS
Common name: DVT Pump System
Device: Sleeve, Limb, Compressible
Class: II
Product Code: JOW |
| 6. Predicate: | Applicant: Getinge (Suzhou) Co, Ltd
Device: Flowtron ACS900
510(k) Number: K143438 |

    1. Device Description... EzVena IPC and EzVena SQS ("EzVena") is a deep vein thrombosis (DVT) pump system intended for performing non-invasive, intermittent compression of the lower limbs (see Figure 1).
      The system is used to squeeze blood from the deep veins, which displaces proximally. On deflation of the cuff, the veins refill, and the intermittent nature of the system ensures periodic flow of blood through the deep veins, helping to prevent venous stasis and the formation of blood clots. The basic technology has proven effective across many scientific studies since its introduction in the 1970s.

System components include a mains-powered, pneumatic pump with touch-input control panel

Image /page/3/Picture/6 description: The image shows an EzVena Pump and Air Hoses (IPC). The pump is white and blue, and it has a screen with buttons on the front. There are two gray air hoses connected to the pump, and an orange power cord is visible in the background. The pump is sitting on a gray surface.

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and microprocessor circuit; connecting air hoses; and foot, calf, and calf/thigh garments, or cuffs. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's left and right lower limbs.

Compression is uniform in the IPC model and graded sequential in the SQS model (see Table 1). The system alternates between left and right cuffs in EzVena IPC and inflates both garments simultaneously in EzVena SQS.

Site of CompressionEzVena IPCEzVena SQS
FootUniform (1 Bladder)Uniform (1 Bladder)
CalfUniform (1 Bladder)Sequential (3 Bladders)
Calf/ThighUniform (1 Bladder)Sequential (3 Bladders)

Table 1 - Uniform Vs Sequential Compression

Graded sequential compression (in SQS) is accomplished through the use of three bladders in calf and calf/thigh garments (by contrast, IPC cuffs and all foot garments contain but one bladder) (see Table 2). The distal bladder is inflated first, and at the highest pressure; then the central and proximal bladders are inflated in turn at steppeddown pressures. In case of power failure, the pump has battery backup.

Table 2 - Compression Differentiation

FactorEzVena IPCEzVena SQS
Site of CompressionFoot, Calf, Calf/ThighFoot, Calf, Calf/Thigh
Type of CompressionUniformGraded Sequential
Extent of CompressionNoncircumferentialNoncircumferential

EzVena may be operated only by acute-care personnel authorized and trained to treat DVT. The device is intended for patients at risk for the medical condition. The system is portable, and it includes a bed mount for secure placement at the foot of the patient's bed. The garments, which come in three sizes (S/M/L), contact the patient.

The pump and air hoses are reusable and cleaned before each use. The garments are for patient single use.

    1. Mechanism of Action... Intermittent compression of air inflates and deflates cuffs, ensuring blood flow in the deep veins.
    1. Indications For Use... To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis.

The device is intended for prescription use only.

    1. Comparison To Predicate and Reference Devices... See Table 3 on the following pages.

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CharacteristicsSubject DevicePredicate DeviceSE Comparison
Device NameEzVena IPC & EzVena SQSFlowtron ACS900NA
ManufacturerEezcare Medical CorpGetinge (Suzhou) Co, LtdNA
510k NumberApplied ForK143438NA
Device Photo
(Pump/Air Hoses)Image: EzVena IPC & EzVena SQS Pump/Air HosesImage: Flowtron ACS900 Pump/Air HosesSE
Device Photo
(Calf/Thigh Garment)Image: EzVena IPC & EzVena SQS Calf/Thigh GarmentImage: Flowtron ACS900 Calf/Thigh GarmentSE
Regulation #870.5800870.5800SE
Product CodeJOWJOWSE
Common DescriptionDVT Pump SystemDVT Pump SystemSE
Indication For UseTo apply intermittent
pneumatic compression to
the lower limbs to help
prevent deep vein
thrombosis.To help prevent deep vein
thrombosis.SE
Target PopulationAt risk for DVTAt risk for DVTSE
Anatomical SiteFoot/Calf/ThighFoot/Calf/ThighSE
Rx/OTC/BothRx OnlyRx OnlySE
Physical Characteristics--Overall
System DescriptionPortable DVT pump,
connecting L&R air hoses,
& compressible limb
sleeves (garments or
cuffs)Portable DVT pump,
connecting L&R air hoses,
& compressible limb
sleeves (garments or
cuffs)SE
Design ConceptPneumatic pump supplies
compressed air to inflate
compression garments
attached to patient limbsPneumatic pump supplies
compressed air to inflate
compression garments
attached to patient limbsSE
Physical Characteristics--Compression Garment
Garment StylesFoot, Calf, Calf/ThighFoot, Calf, Calf/ThighSE
Garment SizesIPC--Foot (Univ/L), Calf (S/
M/L), Calf/Thigh (S/M/L);
SQS--Foot (Univ/L), Calf
(S/M/L), Calf/Thigh
(S/M/L)Uniform--Foot (Reg, L),
Calf (Std, L), Calf/Thigh
(Std, L, XL);
Sequential--Calf (Reg, L,
XL), Thigh (Reg),
Calf/Thigh (L)SE--Both devices offer
uniform compression in
single-bladder garments
designed for foot, calf,
and thigh; both also offer
sequential compression in
Number of Air
Chambers (Bladders)IPC--1 (foot, calf,
calf/thigh);
SQS--1 (foot), 3 (calf,
calf/thigh)Uniform--1 (foot, calf,
calf/thigh);
Sequential--3 (calf,
calf/thigh)triple-bladder garments
for calf and thigh.
Compression--
UniformAll 1-chamber garments
(IPC + SQS foot)All 1-chamber garments
(Uniform)
Compression--
SequentialAll 3-chamber garments
(SQS calf + thigh), with
sequence from distal to
proximal bladdersAll 3-chamber garments
(sequential), with
sequence from distal to
proximal bladders
Compression
Sequence (each cycle)IPC--Inflate L&R
alternating (30 sec each,
60 total), uniform
compression;
SQS--Inflate L&R together
(60 sec total), sequential
compression from bottom
upInflate L&R alternating
(foot 30 sec each, 60 total;
calf or calf/thigh 60 sec
each, 120 total; foot+calf
or calf/thigh, 30 sec foot
2X then 60 sec calf or
calf/thigh, 120 total)SE--Both provide
alternating L&R inflation
for 1 or 2 minutes per
complete cycle. Subject
also compresses both L&R
at same time for
sequential; difference
does not raise new issue
of S&E.
Cycle Length60 sec60 sec (foot) or 120 sec
(calf or calf/thigh)
Mode of OperationContinuousContinuousSE
Pressure RangeFoot--130 $\pm$ 5mmHg;
Calf/Thigh--Uniform
40 $\pm$ 5mmHg, Sequential
45/40/30 $\pm$ 5mmHgFoot--130 $\pm$ 10mmHg;
Calf/Thigh--Uniform
40 $\pm$ 5mmHg, Sequential
45 $\pm$ 5mmHgSE--Subject steps pressure
down during sequential;
difference not raise new
issue of S&E (and in fact is
considered preferable
method).

Table 3 - Comparison Table

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Physical Characteristics--DVT Pump

Dimensions (mm)190L x 203W x 194H230L x 228W x 190HSE--minor difference
Weight2.5Kg (5.5lb)4.1Kg (9.0lb)SE--minor difference
Energy Source (Mains100~240V (60/50Hz)100~230V (60/50Hz)SE--minor difference
Energy ConsumptionIPC: