(143 days)
Not Found
No
The description details a pneumatic compression system with fixed pressure and cycle time parameters, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device description and intended use clearly state that it is a "deep vein thrombosis prevention therapy system" and is intended to "aid in the prevention of DVT," "enhance blood circulation," "diminish post-operative pain and swelling," and "aid in the treatment of various medical conditions" related to circulation. These functions directly correspond to therapeutic purposes.
No
The device description and intended use state that it prevents DVT by stimulating blood flow, rather than diagnosing conditions.
No
The device description explicitly states it is a "pneumatic compression system" consisting of "a pair of pumps and sleeve assemblies," which are hardware components.
Based on the provided information, the Synecare 1000 deep vein thrombosis prevention system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Synecare 1000 is a pneumatic compression system that applies external pressure to the extremities to stimulate blood flow. It does not analyze any biological samples from the patient.
The device's intended use and description clearly indicate it's a therapeutic device that physically interacts with the patient's body to prevent DVT and improve circulation, rather than a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for 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 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
Product codes (comma separated list FDA assigned to the subject device)
JOW
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower limb(s) (Calf)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribed by a physician.
Home and clinical settings.
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)
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
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
Shelf Life:
The shelf life of the product is 3 years. The shelf life was verified. The SyneCare 1000 Accelerated Aging Test Report was performed.
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:
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.
Key Results:
The conclusions drawn from the performance tests demonstrate that the device is performing as intended and is substantially equivalent to the predicate. All the results demonstrate that the SyneCare 1000 DVT performs equivalently to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
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
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Synecare 1000 Deep Vein Thrombosis Prevention Therapy System
Indications for Use (Describe)
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
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."
FORM FDA 3881 (7/17)
3
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
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
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
4
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 Medical | ||
| Technology Co.,Ltd. | Innovamed Health, LLC | S | |
| FDA 510(k) | This submission | K133274 | S |
| Indications for 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 patients by | |||
| stimulating blood flow in the | |||
| extremities (simulating muscle | |||
| contractions). |
This device can be used in the
home or clinical setting 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 | The VenaPro Vascular Therapy
System model VP-31 ill 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 | S |
| Prescription Use | Yes | Yes | S |
| Contraindications | The SyneCare 1000 series
system should NOT be used
in 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: Vein ligation Gangrene Open wounds Recent skin graft Dermatitis Massive edema | The VenaPro Vascular Therapy
System model VP-3 1111 must
not be used to treat the following
conditions:
Persons with suspected, active
or untreated: deep vein
thrombosis, ischemnic vascular
disease, severe arteriosclerosis,
pulmonary edema, congestive
heart failure, thrombophlebitis or
an active infection On a leg where cuffs would
interfere with the following
conditions: vein ligation,
gangrene, dermatitis, open
wounds, a recent skin graft,
massive edema or extreme
deformity of the leg On patients with neuropathy On extremities that are
insensitive to pain Where increased venous or
lymphatic 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 of
operation | Aids venous return by using
cyclic, intermittent, pneumatic
pressure
application (inflation followed
by deflation) to compress the
lower Hmb(s). | Aids venous return by using
cyclic, intermittent, pneumatic
pressure
application (inflation followed
by deflation) to compress the
lower Hmb(s). | S |
| Location of
treatment
application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | S |
| System
management | Electronic,
microprocessor controlled | Electronic,
microprocessor controlled | S |
| Treatment
delivery | Uses electronic
microprocessor and
pneumatics to inflate and
deflate bladder cuffs to
achieve compression | Uses electronic
microprocessor and
pneumatics to inflate and
deflate bladder cuffs to
achieve compression | S |
| Pressure Source | Micropump controlled by
electronic processor | Micropump controlled by
electronic processor | S |
| Physical components | Pump and sleeve come
assembled | Pump and sleeve come
assembled | S |
| Operating
Modes | One | One | S |
| Cycle time
(One inflation
and deflation
per 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 |
| System
diagnostics | Audible and visual alarms
prompt recognition of
system faults | Audible and visual alarms
prompt recognition of
system faults | S |
| Leg cuffs
(garments)
material | PVC bladder covered with
brushed Nylon | PVC bladder covered with
brushed 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 |
| Power
Requirement | Rechargeable battery
and/or AC | Rechargeable battery
and/or AC | S |
| | *D – Different | *S - Same | |
5
6
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 .
7
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
8
- 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.