(230 days)
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.
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.
The provided text describes the VenAir Sequential Compression System (K213577) and its substantial equivalence determination to the predicate device, Kendall SCD 700 Sequential Compression Controller (K120944). Based on the text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence through non-clinical testing against pre-defined acceptance criteria derived from relevant standards and device performance requirements. Specific numerical acceptance criteria are not explicitly detailed in a consolidated table, but the results are stated as meeting the requirements.
| Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| General Safety & Performance | Meeting requirements of pre-defined acceptance criteria and intended use | "All the test results demonstrate that subject device meets the requirements of its pre-defined acceptance criteria and intended use." |
| Biocompatibility | Compliance 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 (for Cytotoxicity, Skin Irritation, Skin Sensitization) | "Test results performed in biocompatibility test reports demonstrated that subject device complies with..." (listed standards). |
| Software Validation | (Implicit: Functionality, safety, and performance as per intended use) | "Software Validation" completed; "All the test results demonstrate VenAir Sequential Compression System meets the requirements..." |
| Electromagnetic Compatibility & Electrical Safety | (Implicit: Compliance with relevant standards for EMC and electrical safety) | "Electromagnetic compatibility and electrical safety" completed; "All the test results demonstrate VenAir Sequential Compression System meets the requirements..." |
| Performance Tests | (Implicit: Functionality of alarm, battery, cycle time, pressure resistance, accuracy, air tightness, pull force, venous refill detection) | "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" all completed, meeting requirements. |
| Usability | (Implicit: Device is safe and effective for end-users) | "Usability test" completed; "All the test results demonstrate VenAir Sequential Compression System meets the requirements..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for individual non-clinical tests (e.g., how many units were tested for shelf life, how many samples for biocompatibility). The testing described is non-clinical, involving the device itself rather than human or patient data. Therefore, concepts like country of origin for patient data or retrospective/prospective studies are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since this is a non-clinical device performance study (testing the physical device and its software), there is no mention of "ground truth" derived from expert interpretation of medical images or patient outcomes. The "ground truth" is established by the specifications, standards, and engineering requirements for the device's functionality.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like '2+1' are typically used when comparing multiple human interpretations or human interpretations against AI outputs in clinical studies. This document describes non-clinical engineering and performance testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This type of study would fall under clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
While software validation was performed, the device is a physical medical device (Sequential Compression System) with integrated hardware and software. The "standalone" performance described refers to the device itself operating according to its design specifications, not an algorithm's isolated performance on a dataset in a diagnostic context. The performance tests (e.g., pressure accuracy, cycle time) represent the device's standalone operation.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is based on:
- Industry Standards: ISO 10993 series, USP <87>, OECD404, OECD406 for biocompatibility.
- Device Specifications and Requirements: Internal engineering specifications for pressure, timing, alarms, battery performance, shelf-life, electrical safety, EMC, and usability.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. The "training set" concept is relevant for AI/ML algorithms that learn from data. While the device contains software, there is no indication that it utilizes a learning algorithm that requires a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of AI/ML for this device.
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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 (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 TaipeiCity, 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 productCode: | 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 CompressionController |
|---|---|
| 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 | Substantialequivalencedetermination |
|---|---|---|---|
| Proprietary name | VenAir SequentialCompression System | Kendall SCD 700 SequentialCompression 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 VenAirSequential Compression System(hereby referenced as “VenAirsystem”) is to help prevent DeepVein Thrombosis (DVT) andpulmonary embolism. The | The Kendall SCD TM 700 SequentialCompression System (herebyreferenced as "Kendall SCD TM 700Series") is designed to applyintermittent pneumatic compressionto increase venous blood flow in | |
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
| Proprietary name510(k) No. | VenAir SequentialCompression SystemK213577 | Kendall SCD 700 SequentialCompression ControllerK120944 | |
| garments are single patient use - donot reuse. The VenAir system isintended for use only inprofessional healthcare facilityenvironment by trained medicalstaff. It is not for use in the homehealthcare environment. TheVenAir system should be used aspart of a prescribed plan of care. | at-risk patients in order to helpprevent deep vein thrombosis andpulmonary embolism. The KendallSCD ™ 700 Series is a prescriptiondevice for use in a clinical setting orin the home. | pulmonary embolism. Itdoesn't raise any newissues of substantialequivalence. | |
| Type of useMechanism ofaction | Prescription UseThe device is a sequentialpneumatic compression system byapplying sequential and gradientpressure to increase venous bloodflow and circulation in at-riskpatients that aids in the preventionof deep vein thrombosis (DVT) apotentially life threateningcondition which can lead topulmonary embolism. | Prescription UseThe device is a sequential pneumaticcompression system by applyingsequential and gradient pressure toincrease venous blood flow andcirculation in at-risk patients thataids in the prevention of deep veinthrombosis (DVT) a potentially lifethreatening condition which can leadto pulmonary embolism. | EquivalenceEquivalence |
| Intended useenvironment | Healthcare facilities. | Clinical, home use | Similar.It does not raise new issueof 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 | Substantialequivalencedetermination |
| Proprietary name | VenAir SequentialCompression System | Kendall SCD 700 SequentialCompression Controller | |
| 510(k) No. | K213577 | K120944 | |
| Dimension ofpump (mm) | 195×178×186 | 196x173x185 (free standing)196x173x114 (place on foot board) | Different.It does not raise new issueof substantial equivalence. |
| Weight | 2.765 kg2.977 kg (Inc. Battery) | 2.3 kg | Different.It does not raise new issueof 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 |
| Electricalclassification | Class I, Type BF | Class I, Type BF | Equivalence |
| Ingress of waterprotection | IP23 | IP23 | Equivalence |
| Control panel | Yes | Yes | Equivalence |
| Mode of operation | Continuous | Continuous | Equivalence |
| Set pressure | Calf, thigh: 45 mmHgFoot: 130 mmHg | Leg (calf and thigh): 45 mmHgFoot: 130 mmHg | Equivalence |
| Inflation time | Calf / thigh: 11 secFoot: 5 sec | Leg (calf and thigh): 11 secFoot: 5 sec | Equivalence |
| Deflation time | Calf / thigh:Based on Venous Reflux SensingTechnologyFoot: 60 sec | Leg (calf and thigh):Based on Vascular refill detectionmeasurement technologyFoot: 60 sec | Both devices compliedwith the IEC 62304.Differences do not raisenew issue of substantialequivalence. |
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
| Proprietary name | VenAir SequentialCompression System | Kendall SCD 700 SequentialCompression Controller | |
| 510(k) No. | K213577 | K120944 | |
| Applied part | Calf garment,Thigh garment,Foot garment | Leg (calf and thigh) sleeves,Foot cuff | SimilarIt does not raise new issueof substantial equivalence. |
| Main material ofapplied part | Polyester, Polyvinyl Chloride,Polyamide, Nylon, Polyurethane | Meet ISO10993-1 requirement | SimilarBoth devices compliedwith the ISO10993. It doesnot raise new issue ofsubstantial equivalence. |
| Appliedpartchamber | Calf, thigh: 3Foot: 1 | Leg (calf and thigh): 3Foot: 1 | Equivalence |
| Operatingconditions | - | - | |
| Temperature | 5° C to 40° C | 10°C to 40°C | Different.It does not raise new issueof substantial equivalence. |
| Relative humidity | 30% to 75% non-condensing | 85% Maximum, non-condensing | |
| Atmosphericpressure | 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.
§ 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).