SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System by Jiangsu Synecoun Medical Technology Co., Ltd.

SyneCare 1100 Deep Vein Thrombosis Prevention 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 (simulating 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 dernatits, 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

SyneCare 1100 Deep Vein Thrombosis Prevention Thereinafter as SyneCare 1100) is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies, in which each sleeve has 2 compression chambers.
The device will alternatively inflate and deflate the sleeve to stimulate blood flow in the extremities (muscle contraction). The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle. There are three default modalities. Mode 1 is inflating chamber 1 up to the preset pressure and then deflating, and then inflating chamber 2 up to the preset pressure and then deflating, and repeat the above process with an interval of 40 seconds. Mode 2 is inflating chamber 1 up to the preset pressure and then inflating chamber 2 up to the preset pressure, then deflating at the same time. The above process is repeated with an interval of 40 seconds. The third mode is inflating chamber 1& 2 simultaneously to the preset pressure (50mmHg) and hold for 9 seconds, then deflating to the preset pressure (40mmHg) at the same time and hold for 10 seconds, and then deflating. The above process is repeated with an interval of 30 seconds.

AI/ML Overview

This document is a 510(k) premarket notification for the SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System. The FDA has made a substantial equivalence determination based on non-clinical testing. No clinical study data is provided to prove how the device meets specific acceptance criteria related to its performance in preventing DVT or improving human reader effectiveness.

The document states: "No clinical study is included in this submission."
Therefore, I cannot provide details on the study that proves the device meets acceptance criteria related to clinical efficacy. The information available focuses on non-clinical testing for design specifications, electrical safety, biocompatibility, and software validation.

However, I can extract the acceptance criteria (in terms of non-clinical tests) and the results reported for those tests, and then address the other points based on the available information.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Summary of Non-Clinical Test" section (Page 9), the acceptance criteria are generally implied by the tests conducted to verify that the device design meets its intended function and performance requirements. The document does not provide quantifiable "acceptance criteria" values alongside "reported device performance" values for these specific non-clinical tests. Instead, it states that the tests were conducted and the device "met all design specifications" or that results "showed the material is non-toxic, non-sensitizing and non-irritating."

Acceptance Criteria (Implied by Test Type)	Reported Device Performance (Summary)
Device Appearance is within specification	Appearance test conducted; "met all design specifications"
Buttons function correctly	Button function test conducted; "met all design specifications"
Alarms activate and function correctly	Alarm function test conducted; "met all design specifications"
Pressure delivery is accurate and consistent	Pressure delivery test conducted; "met all design specifications"
Time parameters (e.g., inflation/deflation cycles) are accurate	Time parameter test conducted; "met all design specifications"
Battery charges as expected	Battery charging test conducted; "met all design specifications"
Device operation noise is within limits	Noise test conducted; "met all design specifications"
Device components withstand pressure without bursting or leaking	Bust and leak test conducted; "met all design specifications"
Sleeve materials are biocompatible (non-toxic, non-sensitizing, non-irritating)	Cytotoxicity, Sensitization, and Irritation tests conducted; results "showed the material is non-toxic, non-sensitizing and non-irritating"
Electrical safety standards met (e.g., IEC 60601-1)	Tests conducted to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11; compliance implied by successful substantial equivalence determination
Electromagnetic compatibility (EMC) standards met	Tests conducted to IEC 60601-1-2; compliance implied by successful substantial equivalence determination
Software is verified and validated (for moderate level of concern)	Software verified and validated by the manufacturer

Regarding Clinical Studies and AI Performance:

The provided document explicitly states: "No clinical study is included in this submission." (Page 9)

Therefore, the following points cannot be answered based on the provided text, as they pertain to clinical studies, AI performance, or human reader studies, none of which were included in this 510(k) submission for the device. The device itself is an intermittent pneumatic compression system for DVT prevention, not an AI imaging or diagnostic device.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used/submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used/submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set was used/submitted.
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: Not applicable. This device is not an AI-assisted diagnostic tool; it is a physical therapy system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study or test set with ground truth was used/submitted.
8. The sample size for the training set: Not applicable, as no clinical training set was used/submitted.
9. How the ground truth for the training set was established: Not applicable, as no clinical training set was used/submitted.

In summary, the FDA's acceptance of this device was based on a "substantial equivalence" determination to a legally marketed predicate device, supported by a comprehensive suite of non-clinical performance, biocompatibility, electrical safety, electromagnetic compatibility, and software verification/validation tests, rather than clinical efficacy studies.

Summary

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November 18, 2021

Jiangsu Synecoun Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K211937

Trade/Device Name: SyneCare 1100 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: October 11, 2021 Received: October 14, 2021

Dear Ivy Wang:

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

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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette Acting 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) K211937

Device Name

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System

Indications for Use (Describe)

· 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 dernatits, 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Date of summary prepared: 2021-11-17

A. Applicant:

Jiangsu Synecoun Medical Technology Co., Ltd. Address: 1/2F East Side, No. 50, Building G60, East of Lujia Road, West of Koutai Road, China Medical City, Taizhou, Jiangsu, China Contact person: Lei Zhu Tel: +86-523-86511020 Fax: +86-523-86511020

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System Common Name: Compressible Limb Sleeve Device Model: SyneCare 1100

Regulatory Information Classification Name: Compressible limb sleeve Classification: Class II Product code: JOW Regulation Number: 870.5800 Review Panel: Cardiovascular

C. Predicate device:

510(k) #	Device name	Manufacturer
K203310	SyneCare 1000 Deep Vein Thrombosis PreventionTherapy System	Jiangsu Synecoun MedicalTechnology Co., Ltd.
K203016	DVT-2600	Daesung Maref Co., LTD

D. Indications for use of the device:

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patients by stimulating blood flow in the extremities (simulating 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.

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

E. Contraindications:

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System should NOT be used to treat the following conditions:

Severe arteriosclerosis or other ischemic vascular diseases
Acute or active deep vein thrombosis
Existing pulmonary edema, pulmonary embolisms, and/or congestive cardiac failure
On patients with neuropathy, active infections, and/or thrombophlebitis
On extremities that are extremely deformed, insensitive to pain, or where increased venous or lymphatic return is undesirable
Any local skin or tissue condition in which the garments would interfere including but not limited to: o Vein ligation
- o Gangrene
- o Open wounds
- o Recent skin graft
- o Dermatitis
- o Massive edema

ﺖ Device Description:

The device will alternatively inflate and deflate the sleeve to stimulate blood flow in the extremities (muscle contraction). The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle. There are three default modalities. Mode 1 is inflating chamber 1 up to the preset pressure and then deflating, and then inflating chamber 2 up to the preset pressure and then deflating, and repeat the above process with an interval of 40 seconds. Mode 2 is inflating chamber 1 up to the preset pressure and then inflating chamber 2 up to the preset pressure, then deflating at the same time. The above process is repeated with an interval of 40 seconds. The third mode is inflating chamber 1& 2 simultaneously to the preset pressure (50mmHg) and hold for 9 seconds, then deflating to the preset pressure (40mmHg) at the same time and hold for 10 seconds, and then deflating. The above process is repeated with an interval of 30 seconds.

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G. Comparison with predicate device

Device	Proposed Device	Predicate Device	Reference Device	Result
510K #	K211937	K203310	K203016	-
Manufacturer	Jiangsu Synecoun Medical Technology Co., Ltd.	Jiangsu Synecoun Medical Technology Co., Ltd.	Daesung Maref Co., LTD	-
Classification	Class II Device, JOW (21 CFR870.5800)	Class II Device, JOW (21 CFR870.5800)	Class II Device, JOW (21 CFR870.5800)	Same
Indications for use	SyneCare 1100 Deep Vein Thrombosis Prevention 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 (simulating 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.• As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.	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.	A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE.	Same
Prescription Use	Yes	Yes	Yes	Same
Contraindications	SyneCare 1100 should NOT be used to treat the following conditions:• Severe arteriosclerosis or other	SyneCare 1000 series system should NOT be used to treat the following conditions:• Severe arteriosclerosis or other	The DVT-2600 system is not recommended for use with the following conditions:-pre-existing deep vein	Same
	ischemic vascular diseases• Acute or active deep vein thrombosis• Existing pulmonary edema, pulmonaryembolisms, and/or congestive cardiacfailure• On patients with neuropathy, activeinfections, and/or thrombophlebitis• On extremities that are extremelydeformed, insensitive to pain, orwhere increased venous or lymphaticreturn is undesirable• Any local skin or tissue condition inwhich the garments would interfereincluding but not limited to:o Vein ligationo Gangreneo Open woundso Recent skin grafto Dermatitiso Massive edema	ischemic vascular diseases• Acute or active deep vein thrombosis• Existing pulmonary edema, pulmonaryembolisms, and/or congestive cardiacfailure• On patients with neuropathy, activeinfections, and/or thrombophlebitis• On extremities that are extremelydeformed, insensitive to pain, orwhere increased venous or lymphaticreturn is undesirable• Any local skin or tissue condition inwhich the garments would interfereincluding but not limited to:o Vein ligationo Gangreneo Open woundso Recent skin grafto Dermatitiso Massive edema	thrombosis, phlebothrombosisor pulmonary embolism-presumptive evidence ofcongestive heart failure-inflammatory phlebitis process-severe arteriosclerosis or otherischemic vascular disease-decompensated cardiacinsufficiency-carcinoma metastasis in theaffected extremity-lymphatic return is undesirable-severe arteriosclerosis or activeinfection
Use settings	Home and clinical	Home and clinical	Professional healthcareenvironment	Same
Application	Non-invasive / external	Non-invasive / external	Non-invasive / external	Same
Portability	Portable, ambulant	Portable, ambulant	Portable	Same
Basisofoperation	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).	Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the treated area.	Same
Locationoftreatmentapplication	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Lower limbs (Calf, Thigh, Foot)	Same
System	Electronic, microprocessor controlled	Electronic, microprocessor controlled	Electronic, microprocessor	Same
management			controlled
Treatmentdelivery	Uses electronic microprocessor andpneumatics to inflate and deflate bladder cuffsto achieve compression therapy	Uses electronic microprocessor andpneumatics to inflate and deflate bladder cuffsto achieve compression therapy	Uses electronic microprocessorand pneumatics to inflate anddeflate bladder cuffs to achievecompression therapy	Same
Pressure Source	Micropump controlled by electronic processor	Micropump controlled by electronic processor	Micropump controlled byelectronic processor	Same
Physicalcomponents	Pump and sleeve come assembled	Pump and sleeve come assembled	Controller, air connectable hose,AC power cord	Same
OperatingModes	3 different modesImage: Mode 1Image: Mode 2Image: Mode 3	1 modeImage: 1 mode	2 different modesDVT operation modeImage: DVT operation modeLymph operation modeImage: Lymph operation mode	DifferentAlthough theoperating modesare different, theworking pressurerange is same, noadverse effectwould cause by thisdifference.
Hold time	Mode 1 & 2: 0sMode 3: 9+10s	0s	0s	DifferentThe hold time isdifferent due to theoperating modes,while the workingpressure range issame, no adverseeffect would causeby this difference.This difference willnot affect safety.
Number ofchambers	1	2	3
Workingpressure	50 mmHg	50 mmHg, 40 mmHg	LEG: 20-60mmHgFOOT: 120-140mmHg	DifferentSimilar and lessthan the referencedevice.
Systemdiagnostics	Audible and visual alarms prompt recognitionof system faults	Audible and visual alarms prompt recognitionof system faults	Not available	Same
Leg cuffsmaterial	PVC bladder covered with brushed Nylon	PVC bladder covered with brushed Nylon	Not available	Same
Leg cuff Sterile/Not Sterile	Clean / non sterile	Clean / non sterile	Clean / non sterile	Same
Leg cuff usage	Single patient use	Single patient use	Single patient use	Same
Battery	3.7 V Li-ion Battery	3.7 V Li-ion Battery	3200mAh, 3350mAh	Same
PowerRequirement	Rechargeable battery and/or AC	Rechargeable battery and/or AC	Rechargeable Battery and/or AC	Same

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H. Summary of Non-Clinical Test

Non-clinical tests were conducted to verify that the proposed device met all design specifications as same to the predicate device.

Performance tests

The following tests were conducted to verify that the device design meet its function and performance requirements.

Appearance test
Button function test
Alarm function test
Pressure delivery test
Time parameter test
Battery charging test
Noise test
Bust and leak test

Biocompatibility

The sleeve parts are directly contact human body. Biocompatibility testing including Cytotoxicity, Sensitization and Irritation were conducted and the test results showed the material is non-toxic, non-sensitizing and non-irritating.

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

• 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

The software was considered as a "moderate" level of concern and had been verified and validated by the manufacturer.

l. Summary of Clinical Test

No clinical study is included in this submission.

J. Conclusion

Based on the comparison and analysis above, the proposed device is same or similar in design, intended use, technological characteristics to the predicate device. Differences between the subject device and predicate devices did not raise any new concerns regarding safety and effectiveness.

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The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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).