The Synecare 1000 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

· Aid in the prevention of DVT

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

· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Device Description

The SyneCare 1000 deep vein thrombosis prevention therapy system (referred as SyneCare 1000 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies.

The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 60 seconds

AI/ML Overview

The provided document describes the SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System and its substantial equivalence to a predicate device (VenaPro, K133274). The acceptance criteria and the study conducted are primarily focused on engineering performance, biocompatibility, electrical safety, and software verification rather than clinical effectiveness per se.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a non-AI medical device (Deep Vein Thrombosis Prevention Therapy System), the "acceptance criteria" are related to its engineering performance and safety, rather than diagnostic accuracy or clinical outcomes as might be seen for devices using AI or for drug approvals. The device's performance is demonstrated through various engineering tests to show substantial equivalence to the predicate device.

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance	Justification/Reference
Functional Performance	Pressure Accuracy	Met requirements (implied)	RDTR-IP-001.01: Pressure Accuracy Test Report. Device provides 50mmHg pressure.
	Cycle Time	Met requirements (implied)	RDTR-IP-002.01: Cycle Time Test Report. Preset at 60 seconds (inflation and deflation).
	Alarm Function	Met requirements (implied)	RDTR-IP-003.01: Alarm Function Test Report. Audible and visual alarms for system faults.
	Battery Life	Met requirements (implied)	RDTR-IP-004.01: Battery Life Test Report. Ensures functionality despite different battery from predicate.
	Air Tightness	Met requirements (implied)	RDTR-IP-005.01: Air Tightness Test Report.
	Operational Parameters (Pressure, Cycle time, GUI, UI)	Same as predicate (50mmHg, 60s cycle, no GUI, one-button UI)	Technological Characteristics comparison table.
Biocompatibility	Contact with human skin (sleeve material)	Met requirements (Cytotoxicity, Sensitization, Irritation)	Biocompatibility testing at CCIC Huatongwei International Inspection (Suzhou) Co.,Ltd. PVC bladder with brushed Nylon.
Sterilization & Shelf Life	Sterility and Shelf Life (3 years)	Sterilization not applicable; Shelf life verified	SyneCare 1000 Accelerated Aging Test Report.
Electrical Safety & EMC	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-11	Met relevant standards (EMC tests conducted)	EMC tests conducted according to specified IEC standards.
Software V&V	Software Verification and Validation	Documentation provided; considered "moderate" level of concern	Software verification and validation conducted.
Clinical Equivalence	Indications for Use, Contraindications	Substantially equivalent to predicate (K133274)	Technological Characteristics comparison table.

Summary of Device Performance: The device's performance is reported as meeting all tested functional and operational requirements, demonstrating substantial equivalence to the predicate device (VenaPro, K133274) across all comparable features. The differences (e.g., battery voltage) were specifically tested to ensure they do not negatively impact effectiveness.

2. Sample size used for the test set and the data provenance

The document specifies that "samples of the device underwent function and mechanical testing." However, the exact sample size (N) for these performance tests (e.g., how many devices were tested for pressure accuracy, battery life, etc.) is not explicitly stated in the provided text.

The data provenance is implicit: the tests were conducted by Jiangsu Synecoun Medical Technology Co., Ltd. and by CCIC Huatongwei International Inspection (Suzhou) Co.,Ltd. The device manufacturer is based in China. The data is retrospective in the sense that the tests were performed on finished product samples for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device and submission. This device is a mechanical/pneumatic system, not an AI or diagnostic imaging device that requires expert interpretation to establish ground truth for a test set. The "ground truth" here is objective physical measurements and adherence to engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., images) by multiple experts. For this device, the tests are primarily objective engineering measurements and compliance checks against established standards, which do not involve expert adjudication in that sense.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. A Multi-Reader Multi-Case (MRMC) study is relevant for AI-powered diagnostic or screening devices that assist human readers (e.g., radiologists interpreting images). The SyneCare 1000 is a physical compression therapy system and does not involve human "readers" or AI assistance in diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This device is a physical therapy system and does not have a "standalone algorithm" in the context of AI or diagnostic interpretation. Its performance is evaluated as an integrated system (pump and sleeve).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the engineering and safety tests, the "ground truth" used is:

Established engineering specifications and standards: For pressure accuracy, cycle time, alarm function, air tightness, electrical safety (IEC standards), and software validation.
Defined biological response endpoints: For biocompatibility tests (cytotoxicity, sensitization, irritation).
Defined performance over time: For shelf life/accelerated aging tests.

There is no expert consensus, pathology, or outcomes data used as "ground truth" in the manner typically seen for diagnostic devices, as this is a therapeutic device whose safety and performance are assessed through objective engineering and biocompatibility evaluations.

8. The sample size for the training set

This question is not applicable. Since the device is not an AI/machine learning system, there is no "training set" in the computational learning sense.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set for this device.

Summary

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April 2, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure. To the right of the symbol is the FDA acronym in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Jiangsu Synecoun Medical Technology Co., Ltd. Yue Li Project Manager East of 1/F. No. 50, G60, Eastside of Lujia Road, Westside of Koutai Road. CMC Taizhou, Jiangsu 225316 China

Re: K203310

Trade/Device Name: SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 11, 2021 Received: March 3, 2021

Dear Yue Li:

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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K203310

Device Name

Synecare 1000 Deep Vein Thrombosis Prevention Therapy System

Indications for Use (Describe)

This device can be used in the home or clinical settings to:

· Aid in the prevention of DVT

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

· As a 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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FORM FDA 3881 (7/17)

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510K Summary

Submitter:

Jiangsu Synecoun Medical Technology Co.,Ltd. 1/2F East side No 50 Building G60 East of Lujia Road West of Koutai Road, CMC Taizhou Jiangsu, China Phone: +86-523-86868618 Contact Person: Lei Zhu Date Prepare: October 9, 2020

Device:

Common Names: Intermittent Pneumatic Compression Device Proprietary Name: SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System Regulatory Class: II Product Code: JOW

Predicate Devices:

The SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System is equivalent to the following:

Predicate Device	Manufacturer	510(k)#
VenaPro	Innovamed Health, LLC	K133274

Device Description

Premarket notification device:

SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

Intended Use:

The SyneCare 1000 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in

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patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to:

Aid in the prevention of DVT •
Enhance blood circulation
Diminish post-operative pain and swelling
. Reduce wound healing time
Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Technological Characteristics:

Below is a table of comparison for the technological characteristics against the predicate device:

Feature	SyneCare 1000	VenaPro	S/D
Manufacturer	Jiangsu Synecoun MedicalTechnology Co.,Ltd.	Innovamed Health, LLC	S
FDA 510(k)	This submission	K133274	S
Indications for Use	The SyneCare 1000 deep veinthrombosis prevention system isintended to be an easy to useportable system, prescribed by aphysician, to help prevent theonset of DVT in patients bystimulating blood flow in theextremities (simulating musclecontractions).This device can be used in thehome or clinical setting to:* Aid in the prevention of DVT* Enhance blood circulation* Diminish post-operative painand swelling* Reduce wound healing time"Aid in the treatment of stasisdermatitis, venous stasis ulcers,arterial and diabetic legulcers, chronic venousinsufficiency and reduction ofedema in the lower limbs;* As a prophylaxis for DVT bypersons expecting to bestationary for long periods oftime	The VenaPro Vascular TherapySystem model VP-31 ill isintended to be an easy to useportable system, prescribed by aphysician, to help prevent theonset of DVT in patients bystimulating blood flow in theextremities (simulating musclecontractions).This device can be used in thehome or clinical settings to:•Aid in the prevention of DVT•Enhance blood circulation•Diminish post-operative painand swelling•Reduce wound healing time•Aid in the treatment of stasisdermatitis, venous stasis ulcers,arterial and diabetic leg ulcers,chronic venous insufficiency andreduction of edema in the lowerlimbs•As a prophylaxis for DVT bypersons expecting to bestationary for long periods oftime	S
Prescription Use	Yes	Yes	S
Contraindications	The SyneCare 1000 seriessystem should NOT be usedin the following conditions:Severearteriosclerosis orother ischemicvascular diseases Acute or active deep veinthrombosis Existing pulmonaryedema, pulmonaryembolisms, and/orcongestive cardiacfailure On patients withneuropathy, activeinfections, and/orthrombophlebitis On extremities that areextremely deformed,insensitive to pain, orwhere increased venousor lymphatic return isundesirable Any local skin ortissue condition inwhich the garmentswould interfereincluding but notlimited to: Vein ligation Gangrene Open wounds Recent skin graft Dermatitis Massive edema	The VenaPro Vascular TherapySystem model VP-3 1111 mustnot be used to treat the followingconditions:Persons with suspected, activeor untreated: deep veinthrombosis, ischemnic vasculardisease, severe arteriosclerosis,pulmonary edema, congestiveheart failure, thrombophlebitis oran active infection On a leg where cuffs wouldinterfere with the followingconditions: vein ligation,gangrene, dermatitis, openwounds, a recent skin graft,massive edema or extremedeformity of the leg On patients with neuropathy On extremities that areinsensitive to pain Where increased venous orlymphatic return is undesirable	S
Use settings	Home and clinical	Home and clinical	S
Application	Non-invasive / external	Non-invasive / external	S
Portability	Portable, ambulant	Portable, ambulant	S
Basis ofoperation	Aids venous return by usingcyclic, intermittent, pneumaticpressureapplication (inflation followedby deflation) to compress thelower Hmb(s).	Aids venous return by usingcyclic, intermittent, pneumaticpressureapplication (inflation followedby deflation) to compress thelower Hmb(s).	S
Location oftreatmentapplication	Lower limb(s) (Calf)	Lower limb(s) (Calf)	S
Systemmanagement	Electronic,microprocessor controlled	Electronic,microprocessor controlled	S
Treatmentdelivery	Uses electronicmicroprocessor andpneumatics to inflate anddeflate bladder cuffs toachieve compression	Uses electronicmicroprocessor andpneumatics to inflate anddeflate bladder cuffs toachieve compression	S
Pressure Source	Micropump controlled byelectronic processor	Micropump controlled byelectronic processor	S
Physical components	Pump and sleeve comeassembled	Pump and sleeve comeassembled	S
OperatingModes	One	One	S
Cycle time(One inflationand deflationper limb)	Preset at 60 seconds	Preset at 60 seconds	S
Pressure	50mmHg	50mmHg	S
GUI	No	No	S
User interface	One-button operation	One-button operation	S
Systemdiagnostics	Audible and visual alarmsprompt recognition ofsystem faults	Audible and visual alarmsprompt recognition ofsystem faults	S
Leg cuffs(garments)material	PVC bladder covered withbrushed Nylon	PVC bladder covered withbrushed Nylon	S
Leg cuff Sterile/Not Sterile	Clean / non sterile	Clean / non sterile	S
Leg cuff usage	Single patient use	Single patient use	S
Battery	3.7 V Li-ion Battery	7.4 V Li-ion Battery	D
PowerRequirement	Rechargeable batteryand/or AC	Rechargeable batteryand/or AC	S
	*D – Different	*S - Same

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The SyneCare 1000 and VenaPro are very similar in construction and operation principle. Both devices work in a preset 50mmHg with one button to control the start/stop of the therapy.

SyneCare1000 and VenaPro use different batteries. Though SyneCare 1000 has a lower voltage battery, battery tests and functional tests were conducted to ensure the difference in battery does not affect the effectiveness of the device.

In summary, the SyneCare 1000 is substantially equivalent in device construction, indications for use and contraindications for use to the predicate VenaPro (K133274). Any noted differences between the devices do no raise new issues of the safety and effectiveness. All the results demonstrate that the SyneCare 1000 DVT performs equivalently to the predicate devices .

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Performance Tests

To verify that the device design met its function and performance requirements, samples of the device underwent function and mechanical testing. The following tests were conducted:

Function Performance Tests
RDTR-IP-001.01	Pressure Accuracy Test Report
RDTR-IP-002.01	Cycle Time Test Report
RDTR-IP-003.01	Alarm Function Test Report
RDTR-IP-004.01	Battery Life Test Report
RDTR-IP-005.01	Air Tightness Test Report

The conclusions drawn from the performance tests demonstrate that the device is performing as intended and is substantially equivalent to the predicate.

Biocompatibility

For the sleeve, the SyneCare 1000 uses the same direct body contact method.Biocompatibility testing was done at CCIC Huatongwei International Inspection (Suzhou) Co.,Ltd. The following tests were done:

. Cytotoxicity
Sensitization
Irritation

Sterilization and Shelf Life

Sterilization is not applicable to SyneCare 1000.

The shelf life of the product is 3 years. The shelf life was verified.

The following tests were done:

SyneCare 1000 Accelerated Aging Test Report

Electrical Safety and Electromagnetic Compatibility (EMC)

EMC tests were conducted according to the following standards:

. IEC 60601-1: 2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for . safety - Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices

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IEC 60601-1-11: 2015 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

Software Verification and Validation

Software verification and validation was conducted and documentation is provided. The software was considered as a "moderate" level of concern", since a failure or latent flaw in the software could directly result in serious injury to the patient or operator.

Animal Study and Clinical Study

No animal study or clinical study was conducted.

Statement of Substantial Equivalence

The SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.

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).