(230 days)
Not Found
No
The document describes a standard sequential pneumatic compression system with digital sensors for basic monitoring. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is used to prevent Deep Vein Thrombosis (DVT) and pulmonary embolism by increasing venous blood flow and circulation, which are therapeutic interventions.
No
The device is a sequential pneumatic compression system designed to prevent Deep Vein Thrombosis (DVT) and pulmonary embolism by increasing venous blood flow and circulation, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the product consists of "the machine, tubing sets, and disposable (single patient use) garments," which are physical hardware components. The performance studies also include tests related to hardware, such as "Electromagnetic compatibility and electrical safety," "Battery charging and discharging test report," and "Pressure accuracy test report."
Based on the provided information, the VenAir Sequential Compression System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism by applying external pressure to the limbs to improve blood circulation. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system that applies pneumatic compression to the limbs. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
The VenAir system is a therapeutic device that physically interacts with the patient's body to achieve a physiological effect (improved blood circulation).
N/A
Intended Use / Indications for Use
The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.
Product codes
JOW
Device Description
The VenAir Sequential Compression System is a sequential pneumatic compression system by applying sequential and gradient pressure to increase venous blood flow and circulation in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism.
The product consists of the machine, tubing sets, and disposable (single patient use) garments (thigh, calf, and foot optional purchase) and focuses on compressing the limbs to enhance better blood circulation.
The system has digital sensors to check the garment connections, pressure output and power supply. On the other hand, operator can follow the user manual to check the error code and action as advised.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Calf, thigh, foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of tests were performed to assess the safety and effectiveness of VenAir Sequential Compression System. All the test results demonstrate that subject device meets the requirements of its pre-defined acceptance criteria and intended use.
- Shelf life test
- Biocompatibility test
- Cytotoxicity test
- Skin irritation test
- Skin sensitization test
- Software Validation
- Electromagnetic compatibility and electrical safety
- Performance test
- Alarm function test report
- Battery charging and discharging test report
- Cycle time test report
- Pressure resistance test report
- Pressure accuracy test report
- Air tightness and pull force test report
- Venous refill detection function test report
- Usability test
All the test results demonstrate VenAir Sequential Compression System meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
No clinical test data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
Apex Medical Corp. Chieh Yang Quality Engineering Manager No. 9, Min Sheng St., Tu-Cheng, New Taipei City, 23679 Taiwan
Re: K213577
Trade/Device Name: VenAir, Sequential Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 31, 2022 Received: June 2, 2022
Dear Chieh Yang:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 Nicole Gillette 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213577
Device Name
VenAir Sequential Compression System
Indications for Use (Describe)
The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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VenAir Sequential Compression System Appendix 5 - 510(k) Summary
510(k) Summary
| 5.1 Type of submission: | Traditional |
|---|---|
| 5.2 Date of summary: | May 31, 2022 |
| 5.3 Submitter: | Apex Medical Corp. |
| Address: | No. 9, Min Sheng St., Tu-Cheng, New Taipei |
| City, 23679, Taiwan | |
| Phone: | +886-2-2268-5568 |
| Fax: | +886-2-2268-9662 |
| Contact: | Chieh Yang (meow.yang@apexmedicalcorp.com) |
| Job title: | Quality Engineering Manager |
5.4 Identification of the device:
| Proprietary/Trade name: | VenAir Sequential Compression System |
|---|---|
| Classification product | |
| Code: | JOW |
| Regulation number: | 870.5800 |
| Regulation description: | Compressible limb sleeve |
| Review panel: | Cardiovascular |
| Device class: | II |
5.5 Identification of the Predicate Device:
| Predicate device name: | Kendall SCD 700 Sequential Compression
Controller |
|------------------------------|------------------------------------------------------|
| Manufacturer: | Covidien LLC. |
| Classification product code: | JOW |
| Regulation number: | 870.5800 |
| Device class: | II |
| 510(k) number: | K120944 |
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5.6 Indication for use
The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.
5.7 Device description
The VenAir Sequential Compression System is a sequential pneumatic compression system by applying sequential and gradient pressure to increase venous blood flow and circulation in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism.
The product consists of the machine, tubing sets, and disposable (single patient use) garments (thigh, calf, and foot optional purchase) and focuses on compressing the limbs to enhance better blood circulation.
The system has digital sensors to check the garment connections, pressure output and power supply. On the other hand, operator can follow the user manual to check the error code and action as advised.
5.8 Non-clinical testing
A series of tests were performed to assess the safety and effectiveness of VenAir Sequential Compression System. All the test results demonstrate that subject device meets the requirements of its pre-defined acceptance criteria and intended use.
- . Shelf life test
- Biocompatibility test .
- Cytotoxicity test -
- -Skin irritation test
- Skin sensitization test -
Test results performed in biocompatibility test reports demonstrated that subject device complies with ISO 10993-1: 2018, ISO 10993-2: 2006, ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 10993-12:2021, USP : 2020, OECD404: 2015, OECD406: 1992.
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- . Software Validation
- . Electromagnetic compatibility and electrical safety
- . Performance test
- Alarm function test report -
- Battery charging and discharging test report -
- Cycle time test report -
- -Pressure resistance test report
- Pressure accuracy test report -
- Air tightness and pull force test report -
- Venous refill detection function test report -
- · Usability test
All the test results demonstrate VenAir Sequential Compression System meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
5.9 Clinical testing
No clinical test data was used to support the decision of substantial equivalence.
5.10 Substantial equivalence determination
VenAir Sequential Compression System submitted in this 510(k) file is substantially equivalent to the predicate device. Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name | VenAir Sequential
Compression System | Kendall SCD 700 Sequential
Compression Controller | Similar.
Indication for use of both devices has slight different.
However, both devices are designed to help prevent deep vein thrombosis and |
| 510(k) No. | K213577 | K120944 | |
| Indication for use | The intended use of the VenAir
Sequential Compression System
(hereby referenced as “VenAir
system”) is to help prevent Deep
Vein Thrombosis (DVT) and
pulmonary embolism. The | The Kendall SCD TM 700 Sequential
Compression System (hereby
referenced as "Kendall SCD TM 700
Series") is designed to apply
intermittent pneumatic compression
to increase venous blood flow in | |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| Proprietary name
510(k) No. | VenAir Sequential
Compression System
K213577 | Kendall SCD 700 Sequential
Compression Controller
K120944 | |
| | garments are single patient use - do
not reuse. The VenAir system is
intended for use only in
professional healthcare facility
environment by trained medical
staff. It is not for use in the home
healthcare environment. The
VenAir system should be used as
part of a prescribed plan of care. | at-risk patients in order to help
prevent deep vein thrombosis and
pulmonary embolism. The Kendall
SCD ™ 700 Series is a prescription
device for use in a clinical setting or
in the home. | pulmonary embolism. It
doesn't raise any new
issues of substantial
equivalence. |
| Type of use
Mechanism of
action | Prescription Use
The device is a sequential
pneumatic compression system by
applying sequential and gradient
pressure to increase venous blood
flow and circulation in at-risk
patients that aids in the prevention
of deep vein thrombosis (DVT) a
potentially life threatening
condition which can lead to
pulmonary embolism. | Prescription Use
The device is a sequential pneumatic
compression system by applying
sequential and gradient pressure to
increase venous blood flow and
circulation in at-risk patients that
aids in the prevention of deep vein
thrombosis (DVT) a potentially life
threatening condition which can lead
to pulmonary embolism. | Equivalence
Equivalence |
| Intended use
environment | Healthcare facilities. | Clinical, home use | Similar.
It does not raise new issue
of substantial equivalence. |
| Application | Non-invasive, external | Non-invasive, external | Equivalence |
| Anatomic location | Calf, thigh, foot | Leg (calf and thigh), foot | Equivalence |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| Proprietary name | VenAir Sequential
Compression System | Kendall SCD 700 Sequential
Compression Controller | |
| 510(k) No. | K213577 | K120944 | |
| Dimension of
pump (mm) | 195×178×186 | 196x173x185 (free standing)
196x173x114 (place on foot board) | Different.
It does not raise new issue
of substantial equivalence. |
| Weight | 2.765 kg
2.977 kg (Inc. Battery) | 2.3 kg | Different.
It does not raise new issue
of substantial equivalence. |
| Power supply | 100-240 V A.C., 50/60 Hz | 100-240 V A.C., 50/60 Hz | Equivalence |
| Battery | Yes | Yes | Equivalence |
| Battery type | Lithium Battery | Lithium Battery | Equivalence |
| Electrical
classification | Class I, Type BF | Class I, Type BF | Equivalence |
| Ingress of water
protection | IP23 | IP23 | Equivalence |
| Control panel | Yes | Yes | Equivalence |
| Mode of operation | Continuous | Continuous | Equivalence |
| Set pressure | Calf, thigh: 45 mmHg
Foot: 130 mmHg | Leg (calf and thigh): 45 mmHg
Foot: 130 mmHg | Equivalence |
| Inflation time | Calf / thigh: 11 sec
Foot: 5 sec | Leg (calf and thigh): 11 sec
Foot: 5 sec | Equivalence |
| Deflation time | Calf / thigh:
Based on Venous Reflux Sensing
Technology
Foot: 60 sec | Leg (calf and thigh):
Based on Vascular refill detection
measurement technology
Foot: 60 sec | Both devices complied
with the IEC 62304.
Differences do not raise
new issue of substantial
equivalence. |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| Proprietary name | VenAir Sequential
Compression System | Kendall SCD 700 Sequential
Compression Controller | |
| 510(k) No. | K213577 | K120944 | |
| Applied part | Calf garment,
Thigh garment,
Foot garment | Leg (calf and thigh) sleeves,
Foot cuff | Similar
It does not raise new issue
of substantial equivalence. |
| Main material of
applied part | Polyester, Polyvinyl Chloride,
Polyamide, Nylon, Polyurethane | Meet ISO10993-1 requirement | Similar
Both devices complied
with the ISO10993. It does
not raise new issue of
substantial equivalence. |
| Applied
part
chamber | Calf, thigh: 3
Foot: 1 | Leg (calf and thigh): 3
Foot: 1 | Equivalence |
| Operating
conditions | - | - | |
| Temperature | 5° C to 40° C | 10°C to 40°C | Different.
It does not raise new issue
of substantial equivalence. |
| Relative humidity | 30% to 75% non-condensing | 85% Maximum, non-condensing | |
| Atmospheric
pressure | 752 hPa to 1,060 hPa | 700 hPa to 1060 hPa | |
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VenAir Sequential Compression System Appendix 5 - 510(k) Summary
7
VenAir Sequential Compression System
8
VenAir Sequential Compression System Appendix 5 - 510(k) Summary
5.11 Similarity and difference
The VenAir Sequential Compression System has been compared with Kendall SCD 700 Sequential Compression Controller (K120944). The subject device has the similar indication for use, intended use environment, intended use anatomical location, set pressure and applied part as the predicate devices.
Although the dimension, weight, inflation time and deflation time are different between the subject device and predicate devices, a series testing were demonstrate that the differences do not raise any new issue of substantial equivalence.
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In conclusion, the subject device has undergone a series of testing, and the results complied with the test requests; therefore, the difference between the subject device and the predicate device did not raise any problem of safe and effectiveness. The subject device is substantially equivalent to the predicate devices as it claims.
5.12 Conclusion
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that VenAir Sequential Compression System is substantially equivalent to the predicate device.