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.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) premarket notification letter and a summary of the device (EzVena IPC, EzVena SQS) and its comparison to a predicate device (Flowtron ACS900) for establishing substantial equivalence.

This document focuses on:

Device Description and Intended Use: Explaining what the device is and what it's used for (intermittent pneumatic compression to prevent DVT).
Comparison to Predicate Device: Highlighting similarities and minor differences between the EzVena devices and the legally marketed Flowtron ACS900.
Non-Clinical Testing: Listing various tests (biocompatibility, electrical safety, EMC, software validation, etc.) conducted according to recognized standards to demonstrate safety and effectiveness for substantial equivalence. No clinical testing was deemed necessary.
Cybersecurity and Other Compliance: Addressing compliance with relevant FDA guidance.
Conclusion of Substantial Equivalence: Stating that the EzVena devices are substantially equivalent to the predicate.

There is no mention of a defined set of acceptance criteria (e.g., performance thresholds for sensitivity, specificity, accuracy, or specific measurements) that the device must meet, nor is there a description of a study designed to demonstrate that the device achieved these specific performance acceptance criteria. The "testing" mentioned refers to non-clinical engineering and bench tests, primarily to ensure safety, electromagnetic compatibility, and proper software function, rather than clinical performance against specific metrics.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, or details about MRMC studies, standalone performance, or ground truth establishment based on the provided text.

Summary

{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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Section 5 – 510(k) Summary

1. 510(k) Submitter:	Eezcare Medical CorpNo 3-1, Minquan St, New Taipei City 236Taipei, Tu-Cheng District, Taiwan 23679Phone: 757-224-0177Email: 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, MBAFDA 510k Consulting, LLCPalm Beach Gardens, FL 33410Phone: 386-243-4332Email: john@fda510kconsultants.com
5. Device Classification:	Trade name: EzVena IPC, EzVena SQSCommon name: DVT Pump SystemDevice: Sleeve, Limb, CompressibleClass: IIProduct Code: JOW
6. Predicate:	Applicant: Getinge (Suzhou) Co, LtdDevice: Flowtron ACS900510(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.

{4}------------------------------------------------

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 Compression	EzVena IPC	EzVena SQS
Foot	Uniform (1 Bladder)	Uniform (1 Bladder)
Calf	Uniform (1 Bladder)	Sequential (3 Bladders)
Calf/Thigh	Uniform (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

Factor	EzVena IPC	EzVena SQS
Site of Compression	Foot, Calf, Calf/Thigh	Foot, Calf, Calf/Thigh
Type of Compression	Uniform	Graded Sequential
Extent of Compression	Noncircumferential	Noncircumferential

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.

{5}------------------------------------------------

Characteristics	Subject Device	Predicate Device	SE Comparison
Device Name	EzVena IPC & EzVena SQS	Flowtron ACS900	NA
Manufacturer	Eezcare Medical Corp	Getinge (Suzhou) Co, Ltd	NA
510k Number	Applied For	K143438	NA
Device Photo(Pump/Air Hoses)	Image: EzVena IPC & EzVena SQS Pump/Air Hoses	Image: Flowtron ACS900 Pump/Air Hoses	SE
Device Photo(Calf/Thigh Garment)	Image: EzVena IPC & EzVena SQS Calf/Thigh Garment	Image: Flowtron ACS900 Calf/Thigh Garment	SE
Regulation #	870.5800	870.5800	SE
Product Code	JOW	JOW	SE
Common Description	DVT Pump System	DVT Pump System	SE
Indication For Use	To apply intermittentpneumatic compression tothe lower limbs to helpprevent deep veinthrombosis.	To help prevent deep veinthrombosis.	SE
Target Population	At risk for DVT	At risk for DVT	SE
Anatomical Site	Foot/Calf/Thigh	Foot/Calf/Thigh	SE
Rx/OTC/Both	Rx Only	Rx Only	SE
Physical Characteristics--Overall
System Description	Portable DVT pump,connecting L&R air hoses,& compressible limbsleeves (garments orcuffs)	Portable DVT pump,connecting L&R air hoses,& compressible limbsleeves (garments orcuffs)	SE
Design Concept	Pneumatic pump suppliescompressed air to inflatecompression garmentsattached to patient limbs	Pneumatic pump suppliescompressed air to inflatecompression garmentsattached to patient limbs	SE
Physical Characteristics--Compression Garment
Garment Styles	Foot, Calf, Calf/Thigh	Foot, Calf, Calf/Thigh	SE
Garment Sizes	IPC--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 offeruniform compression insingle-bladder garmentsdesigned for foot, calf,and thigh; both also offersequential compression in
Number of AirChambers (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 garmentsfor calf and thigh.
Compression--Uniform	All 1-chamber garments(IPC + SQS foot)	All 1-chamber garments(Uniform)
Compression--Sequential	All 3-chamber garments(SQS calf + thigh), withsequence from distal toproximal bladders	All 3-chamber garments(sequential), withsequence from distal toproximal bladders
CompressionSequence (each cycle)	IPC--Inflate L&Ralternating (30 sec each,60 total), uniformcompression;SQS--Inflate L&R together(60 sec total), sequentialcompression from bottomup	Inflate L&R alternating(foot 30 sec each, 60 total;calf or calf/thigh 60 seceach, 120 total; foot+calfor calf/thigh, 30 sec foot2X then 60 sec calf orcalf/thigh, 120 total)	SE--Both providealternating L&R inflationfor 1 or 2 minutes percomplete cycle. Subjectalso compresses both L&Rat same time forsequential; differencedoes not raise new issueof S&E.
Cycle Length	60 sec	60 sec (foot) or 120 sec(calf or calf/thigh)
Mode of Operation	Continuous	Continuous	SE
Pressure Range	Foot--130 $\pm$ 5mmHg;Calf/Thigh--Uniform40 $\pm$ 5mmHg, Sequential45/40/30 $\pm$ 5mmHg	Foot--130 $\pm$ 10mmHg;Calf/Thigh--Uniform40 $\pm$ 5mmHg, Sequential45 $\pm$ 5mmHg	SE--Subject steps pressuredown during sequential;difference not raise newissue of S&E (and in fact isconsidered preferablemethod).

Table 3 - Comparison Table

{6}------------------------------------------------

Physical Characteristics--DVT Pump

Dimensions (mm)	190L x 203W x 194H	230L x 228W x 190H	SE--minor difference
Weight	2.5Kg (5.5lb)	4.1Kg (9.0lb)	SE--minor difference
Energy Source (Mains	100~240V (60/50Hz)	100~230V (60/50Hz)	SE--minor difference
Energy Consumption	IPC: <18W; SQS: <23W	15W	SE--minor difference
Battery	Li-ion 2600mAh, 14.8V	NiMH 4000mAh, 13.8V	SE--Battery passed EStesting
Ingress Protection	IP22	IP23 (IEC 529)	SE--minor difference
Control Panel	TFT-LCD 4.3" color; 3.3V;480 RGB x 272 dots	LCD 3" black; 70 x 35 dots	SE--minor difference
Integrated Bed Mount	Yes	Yes	SE
Garment Material(Patient Contact)	Nylon brush fabric	Polyester knit-blush withTPU laminated + PU foam	SE--Garment passedbiocompatibility testing
Case Material	ABS plastic	ABS plastic	SE
Components & Accessories
Components	Pump, air hoses, garments	Pump, air hoses, garments	SE
Accessories	User manual	User manual	SE

{7}------------------------------------------------

S&E Testing

Biocompatibility(Garment)	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010	Not provided	SE (tested to recog std)
Software Validation	SW V&V IEC 62304:2006;EN 62366:2008	Not provided	SE (tested to recog std)
Risk Management	ISO 14971:2007	Not provided	SE (tested to recog std)
Electrical Safety	IEC 60601-1:2012	AAMI/ANSI ES60601-1:2005/R:2012 + A1:2012	SE (tested to recog std)
EMC	IEC 60601-1-2:2014	IEC 60601-1-2:2007	SE (tested to recog std)
Mechanical Safety	Pump SW/HWfunctionality; Garmentspressure cyclic test	Pump SW/HW function-ality; Garments pressurecyclic test	SE
Reprocessing	Pump & Air Hose--cleanbefore each use;Garment--single patientuse (discarded)	Pump & Air Hose--cleanbefore each use;Garment--single patientuse (discarded)	SE

Summary of Similarities and Differences

The subject and predicate devices share the same:

Intended use – apply intermittent pneumatic compression to lower limbs
Indications for use to help prevent deep vein thrombosis (DVT) ●
System design portable pump, air hoses, compression garments ●
Garment styles – foot, calf, and thigh
Compression methods – uniform and sequential
of air chambers – 1 (uniform compression) and 3 (sequential compression)
Energy sources – mains power and battery backup
Materials – ABS plastic (pump case) and biocompatible fabric (garments)
. Reusability – of pump and air tubing, while garments are for single-patient use

Tables 4 and 5 highlight the similarities in compression methods and other factors:

Table 4 - Uniform Vs Sequential Compression

	EzVena IPC &	EzVena SQS &
Site of Compression	ACS900 Uniform Mode	ACS900 Sequential Mode
Foot	Uniform (1 Bladder)	Uniform (1 Bladder)
Calf	Uniform (1 Bladder)	Sequential (3 Bladders)
Calf/Thigh	Uniform (2 Bladders)	Sequential (3 Bladders)

{8}------------------------------------------------

	EzVena IPC &	EzVena SQS &
Factor	ACS900 Uniform Mode	ACS900 Sequential Mode
Site of Compression	Foot, Calf, Calf/Thigh	Foot, Calf, Calf/Thigh
Type of Compression	Uniform	Sequential
Extent of Compression	Noncircumferential	Noncircumferential

Table 5 - Compression Differentiation

Minor differences between EzVena (subject) and Flowtron ACS900 (predicate) include:

Compression cycle lengths - both offer 60-second cycles except that the predicate increases cycle length to 120 seconds for cycles that include calf or thigh; since application is continuous over long time periods (days and weeks, not hours or minutes), this difference is immaterial.
Pressure ranges – both increase bladder air pressure to 130 mmHg for foot treatment, 40mmHg for uniform compression of calf and thigh, and start at 45mmHg for sequential compression of calf and thigh; the subject then steps down sequential pressure for calf or thigh to 40 and 35 mmHg in the second and third bladders, respectively (while the predicate continues to reach 45mmHg in the second and third bladders). Both DVT treatment options-continuous 45 mmHg and step-down to 35mmHg-are common in the industry.
Compression sequence – both devices alternatively inflate left and right cuffs during uniform compression treatments; the predicate continues to inflate left and right on a rotating basis for sequential compression, while the subject device chooses to inflate both sides in tandem. Either option is common in the industry.

None of the differences noted above raise new issues of safety and effectiveness.

1. Non-Clinical Testing... 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.

1. Patient-Contacting Materials... The only EzVena component that comes into contact with patients is the compression garment fabric which covers the patient's lower limbs. The garment material is polyester knit-blush with thermoplastic polyurethane (TPU) laminated + polyurethane foam.

{9}------------------------------------------------

According to ISO 10993-1, the garment is a surface device in contact with intact skin. Biological evaluation was performed in accordance with ISO 10993-1:2009 and FDA's guidance document, "Use of International Standard ISO 10993" (2016), and test results showed the material is biocompatible.

1. Software Verification and Validation... Software verification and validation testing were conducted in line with the requirements of FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005). The software for this device was considered as a "moderate level of concern" and software verification and validation reports have been included in this submission.
1. Cybersecurity... EzVena is in compliance with FDA's guidance, "Management of Cybersecurity in Medical Devices" (2014). The device is not capable of connecting (wirelessly or hard-wired) to another device, to the Internet or other network, or to portable media (e.g. USB or CD).
1. Substantial Equivalence... Many of the features and technical characteristics of EzVena IPC and EzVena SQS are identical to those of the Flowtron ACS900 predicate device, and where there are differences, such differences do not raise new issues of safety and effectiveness and do not have an impact on the safety or effectiveness of the subject device.

EzVena IPC and EzVena SQS successfully followed the pathway to Substantial Equivalence in the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" (2014). The steps are summarized below:

. The predicate device is legally marketed and was found substantially equivalent through 510(k) premarket submission.
. The subject and predicate devices have the same intended use.
. Technological differences between the subject and predicate were evaluated; none of the differences raised different issues of safety and effectiveness.
. The following methods for evaluation of the effects of different characteristics on safety and effectiveness were deemed acceptable-testing for biocompatibility, electrical safety, EMC, usability engineering, and mechanical performance; software verification and validation and life cycle documentation; and risk management assessment. Evaluation methods were conducted to FDArecognized standards.
. Data from these tests demonstrated equivalence and support the indications for use.

In summary, all necessary testing has been performed and the results support the conclusion that EzVena IPC and EzVena SQS is substantially equivalent to the legally marketed predicate, Flowtron ACS900, based on both (a) comparison of intended use, materials, technology, and design and (b) testing to FDA-recognized standards, and the device thus does not raise any new concerns of safety or effectiveness.

{10}------------------------------------------------

Based on the information contained within this submission, it is concluded that EzVena IPC and EzVena SQS is substantially equivalent to the identified predicate device and warrants clearance for marketing activities.

Regulation Number and Section

§ 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).