VenAir, Sequential Compression System

K213577 · Apex Medical Corp. · JOW · Jun 28, 2022 · Cardiovascular

Device Facts

• Record ID: K213577
• Device Name: VenAir, Sequential Compression System
• Applicant: Apex Medical Corp.
• Product Code: JOW · Cardiovascular
• Decision Date: Jun 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The VenAir Sequential Compression System is a pneumatic device that applies sequential and gradient pressure to a patient's limbs (calf, thigh, or foot) to increase venous blood flow and circulation. The system consists of a controller unit, tubing, and single-patient-use disposable garments. It is operated by trained medical staff in professional healthcare facilities. The device includes digital sensors to monitor garment connections, pressure output, and power supply. Operators use the control panel to manage settings and refer to the user manual for error codes. By enhancing blood circulation, the device aids in the prevention of DVT and pulmonary embolism in at-risk patients.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. The device was evaluated through bench testing, including biocompatibility (ISO 10993 series), software validation, electromagnetic compatibility, electrical safety, and performance testing (alarm function, battery, pressure accuracy, and venous refill detection).

Technological Characteristics

Sequential pneumatic compression system; Class I, Type BF electrical classification; IP23 ingress protection. Materials include polyester, PVC, polyamide, nylon, and polyurethane. Features digital sensors for pressure and connection monitoring. Powered by 100-240V AC or internal lithium battery. Complies with IEC 62304 for software and ISO 10993 for biocompatibility.

Indications for Use

Indicated for at-risk patients to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism in professional healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• Kendall SCD 700 Sequential Compression Controller (K120944)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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<br>City, 23679, Taiwan |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Chieh Yang ([e-mail]) |
| Job title: | Quality Engineering Manager |

# 5.4 Identification of the device:

| Proprietary/Trade name: | VenAir Sequential Compression System |
|---------------------------------|--------------------------------------|
| Classification product<br>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<br>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 <87>: 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<br>equivalence<br>determination |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary name | VenAir Sequential<br>Compression System | Kendall SCD 700 Sequential<br>Compression Controller | Similar.<br>Indication for use of both devices has slight different.<br>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<br>Sequential Compression System<br>(hereby referenced as “VenAir<br>system”) is to help prevent Deep<br>Vein Thrombosis (DVT) and<br>pulmonary embolism. The | The Kendall SCD TM 700 Sequential<br>Compression System (hereby<br>referenced as "Kendall SCD TM 700<br>Series") is designed to apply<br>intermittent pneumatic compression<br>to increase venous blood flow in | |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Proprietary name<br>510(k) No. | VenAir Sequential<br>Compression System<br>K213577 | Kendall SCD 700 Sequential<br>Compression Controller<br>K120944 | |
| | garments are single patient use - do<br>not reuse. The VenAir system is<br>intended for use only in<br>professional healthcare facility<br>environment by trained medical<br>staff. It is not for use in the home<br>healthcare environment. The<br>VenAir system should be used as<br>part of a prescribed plan of care. | at-risk patients in order to help<br>prevent deep vein thrombosis and<br>pulmonary embolism. The Kendall<br>SCD ™ 700 Series is a prescription<br>device for use in a clinical setting or<br>in the home. | pulmonary embolism. It<br>doesn't raise any new<br>issues of substantial<br>equivalence. |
| Type of use<br>Mechanism of<br>action | Prescription Use<br>The device is a sequential<br>pneumatic compression system by<br>applying sequential and gradient<br>pressure to increase venous blood<br>flow and circulation in at-risk<br>patients that aids in the prevention<br>of deep vein thrombosis (DVT) a<br>potentially life threatening<br>condition which can lead to<br>pulmonary embolism. | Prescription Use<br>The device is a sequential pneumatic<br>compression system by applying<br>sequential and gradient pressure to<br>increase venous blood flow and<br>circulation in at-risk patients that<br>aids in the prevention of deep vein<br>thrombosis (DVT) a potentially life<br>threatening condition which can lead<br>to pulmonary embolism. | Equivalence<br>Equivalence |
| Intended use<br>environment | Healthcare facilities. | Clinical, home use | Similar.<br>It does not raise new issue<br>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<br>equivalence<br>determination |
| Proprietary name | VenAir Sequential<br>Compression System | Kendall SCD 700 Sequential<br>Compression Controller | |
| 510(k) No. | K213577 | K120944 | |
| Dimension of<br>pump (mm) | 195×178×186 | 196x173x185 (free standing)<br>196x173x114 (place on foot board) | Different.<br>It does not raise new issue<br>of substantial equivalence. |
| Weight | 2.765 kg<br>2.977 kg (Inc. Battery) | 2.3 kg | Different.<br>It does not raise new issue<br>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<br>classification | Class I, Type BF | Class I, Type BF | Equivalence |
| Ingress of water<br>protection | IP23 | IP23 | Equivalence |
| Control panel | Yes | Yes | Equivalence |
| Mode of operation | Continuous | Continuous | Equivalence |
| Set pressure | Calf, thigh: 45 mmHg<br>Foot: 130 mmHg | Leg (calf and thigh): 45 mmHg<br>Foot: 130 mmHg | Equivalence |
| Inflation time | Calf / thigh: 11 sec<br>Foot: 5 sec | Leg (calf and thigh): 11 sec<br>Foot: 5 sec | Equivalence |
| Deflation time | Calf / thigh:<br>Based on Venous Reflux Sensing<br>Technology<br>Foot: 60 sec | Leg (calf and thigh):<br>Based on Vascular refill detection<br>measurement technology<br>Foot: 60 sec | Both devices complied<br>with the IEC 62304.<br>Differences do not raise<br>new issue of substantial<br>equivalence. |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Proprietary name | VenAir Sequential<br>Compression System | Kendall SCD 700 Sequential<br>Compression Controller | |
| 510(k) No. | K213577 | K120944 | |
| Applied part | Calf garment,<br>Thigh garment,<br>Foot garment | Leg (calf and thigh) sleeves,<br>Foot cuff | Similar<br>It does not raise new issue<br>of substantial equivalence. |
| Main material of<br>applied part | Polyester, Polyvinyl Chloride,<br>Polyamide, Nylon, Polyurethane | Meet ISO10993-1 requirement | Similar<br>Both devices complied<br>with the ISO10993. It does<br>not raise new issue of<br>substantial equivalence. |
| Applied<br>part<br>chamber | Calf, thigh: 3<br>Foot: 1 | Leg (calf and thigh): 3<br>Foot: 1 | Equivalence |
| Operating<br>conditions | - | - | |
| Temperature | 5° C to 40° C | 10°C to 40°C | Different.<br>It does not raise new issue<br>of substantial equivalence. |
| Relative humidity | 30% to 75% non-condensing | 85% Maximum, non-condensing | |
| Atmospheric<br>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

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# VenAir Sequential Compression System

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#### 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.