The VASOBand™ Vascular Compression Device is an external compression device used on a human arm and provides a means for a healthcare professional to apply external compression proximal to and/or over a catheterization puncture site for the purpose of assisting post-procedure hemostasis at a target vessel's puncture site. Each device is a single-use, sterile, individually pouched inflatable band. The VASOBand™ device is available in two different lengths. The strap measures approximately 26 cm or 29 cm in length and is composed of biocompatible multiple-layer PVC film and PVC tubing, and valves made of biocompatible thermoplastics. Hook and loop material is used to secure the strap in position. Only the biocompatible thermoplastic film comes into contact with broken skin. The user can control the compression applied by the device by introducing or removing air in a bladder of the device.

AI/ML Overview

This document is a 510(k) summary for the VASOBand™ Vascular Compression Device. The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process generally relies on non-clinical performance data rather than extensive clinical studies with human participants. Therefore, the information provided below will be based on the type of data typically found in a 510(k) submission for a device of this nature.

The device being cleared is the VASOBand™ Vascular Compression Device.

1. A table of acceptance criteria and the reported device performance

The provided document lists performance data that was submitted to support substantial equivalence. It states that "The VASOBand™ Vascular Compression Device met all specified criteria." However, it does not explicitly state the specific acceptance criteria or the quantitative reported device performance for each test. It only lists the types of tests conducted.

Based on the information provided, a table would look like this, with the understanding that the specific numerical acceptance criteria and performance are not detailed in this public summary. They would typically be in the full 510(k) submission.

Acceptance Criterion (Type of Test)	Reported Device Performance
Band clarity	Met specified criteria
Check valve actuations	Met specified criteria
Bladder inflation/deflation cycles	Met specified criteria
Band deployment time	Met specified criteria
Bladder inflation/deflation time	Met specified criteria
Bladder inflated height	Met specified criteria
Bladder integrity (2h compressive force)	Met specified criteria
Bladder integrity (underwater air leak)	Met specified criteria
Bladder integrity (simulated use testing)	Met specified criteria
Tubing/check valve tensile strength	Met specified criteria
Fastener tensile strength	Met specified criteria
Fastener slippage	Met specified criteria
Cytotoxicity Study (ISO Elution Method)	Met specified criteria
ISO Guinea Pig Skin Sensitization Study	Met specified criteria
ISO Intracutaneous Irritation Study	Met specified criteria
USP Rabbit Material-Mediated Pyrogen Study	Met specified criteria
ISO Acute Systemic Toxicity Study	Met specified criteria
Endotoxin (LAL) Study	Met specified criteria
Shelf Life Testing	Met specified criteria

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each test. For devices like this, the sample size for non-clinical performance and biocompatibility testing is typically determined by industry standards (e.g., ISO, ASTM) and statistical rationale to ensure representative results.

The data provenance is described as "performance data provided in support of the substantial equivalence" by the manufacturer, VASOInnovations, Inc. This is non-clinical, in-vitro, and bench testing, as well as biocompatibility studies (which may involve animal testing as indicated for pyrogen and sensitization studies). The country of origin for the data generation is not explicitly stated, but it would have been conducted by or for VASOInnovations, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is generally not applicable to a 510(k) submission for a physical device like a vascular compression band. The "ground truth" for the performance tests listed are objective, measurable physical and chemical properties and biological responses (e.g., tensile strength, air leak, cytotoxicity). These are assessed against pre-defined engineering specifications and relevant ISO/USP standards, not by expert consensus in a clinical setting.

4. Adjudication method for the test set

Not applicable. As described above, the "test set" here refers to the physical device samples undergoing engineering and biological safety tests, not clinical data requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. An MRMC comparative effectiveness study is typically relevant for diagnostic imaging AI algorithms or similar technologies where human readers interpret medical images or data. The VASOBand™ is a physical medical device (a vascular compression band), and its substantial equivalence is demonstrated through non-clinical performance and safety testing, not human reader studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for the numerous performance data points (e.g., tensile strength, bladder integrity, biocompatibility) are established through objective measurements against predetermined scientific and engineering specifications, and relevant international standards (e.g., ISO, USP). For biocompatibility, this involves specific lab tests following protocols to assess cytotoxicity, irritation, sensitization, pyrogenicity, and systemic toxicity.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this device.

Summary

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March 14, 2019

VASOInnovations. Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K190318

Trade/Device Name: VASOBand™ Vascular Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: DXC Dated: February 11, 2019 Received: February 13, 2019

Dear Mark Job:

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.

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190318

Device Name VASOBand

Indications for Use (Describe)

The VASOBand™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.

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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001. 510(k) Summary

VASOInnovations, Inc. VASOBand™ Vascular Compression Device

I. SUBMITTER

VASOInnovations, Inc. 1260 Huntington Drive, Suite 208 South Pasadena, CA 91030

Contact person: Raj Sardesai, Ph.D., J.D. Phone: 626-688-2568 Fax: 323-999-7562 Date prepared: March 12, 2019

II. DEVICE

Name of the device: VASOBand™ Vascular Compression Device Common or usual name: Vascular compression device Regulation Number: 21 CFR 870.4450 Classification name: Vascular Clamp Classification Panel: Cardiovascular Regulatory Class: 2 Product Code: DXC

III. PREDICATE DEVICE

TR Band™ (K070423)

To the knowledge of the submitter of this 510(k), this predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The VASOBand™ is an external compression device to promote radial artery hemostasis after a transradial procedure. The VASOBand™ Vascular Compression Device is an external compression device used on a human arm and provides a means for a healthcare professional to apply external compression proximal to and/or over a catheterization puncture site for the purpose of assisting post-procedure hemostasis at a target vessel's puncture site. Each device is a single-use, sterile, individually pouched inflatable band. The VASOBand™ device is available in two different lengths. The strap measures approximately 26 cm or 29 cm in length and is composed of biocompatible multiple-layer PVC film and PVC tubing, and valves made of biocompatible thermoplastics. Hook and

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loop material is used to secure the strap in position. Only the biocompatible thermoplastic film comes into contact with broken skin. The user can control the compression applied by the device by introducing or removing air in a bladder of the device.

V. INDICATION FOR USE

The VASOBand™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed VASOInnovations VASOBand™ Vascular Compression Device utilizes substantially equivalent performance attributes and safety components as the predicate device. The subject and predicate devices are based on the following same technological elements:

• Principle of Operation	• Allows Variation in AppliedPressure Allows Gradual Releaseof Pressure
• Target Population
• Intended User
• Anatomical Site	• Pressure can be adjusted WithoutUnfastening Strap
• Packaged Sterile
• Sterilization Method	• Direct Compression
• Clear Adjustable Strap AroundArm	• External Compression
• Air Bladder	• Method of Pressure Adjustment• Quick Release Mechanism• Supporting Plastic Insert in Band

The following technological differences exist between the subject and the predicate device:

The proposed device and its predicate device are both indicated to assist hemostasis of radial artery access sites. As both devices have the same

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indication with respect to radial artery access site use, these differences are not critical to the intended clinical use of the device and do not affect the safety and effectiveness of the proposed device when used as labeled.

VII. PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence.

. Band clarity
트 Check valve actuations
Bladder inflation/deflation cycles
Band deployment time
Bladder inflation/deflation time
트 Bladder inflated height
Bladder integrity including compressive force at 2h, underwater air leak, and simulated use testing
트 Tubing/check valve tensile strength
트 Fastener tensile strength and slippage
Cytotoxicity Study Using the ISO Elution Method
ISO Guinea Pig Skin Sensitization Study
ISO Intracutaneous Irritation Study
USP Rabbit Material-Mediated Pyrogen Study
ISO Acute Systemic Toxicity Study
트 Endotoxin (LAL) Study
Shelf Life Testing

The VASOBand™ Vascular Compression Device met all specified criteria and based on the design verification performance, the conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices.

VIII. SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate device is substantially equivalent to the indications for use for the proposed VASOBand™ Vascular Compression Device. Furthermore, the VASOBand™ Vascular Compression Device has the same intended use, patient population, and anatomical sites as well as similar technological characteristics as the predicate devices. The differences in technological characteristics have been analyzed and addressed through testing. Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, the VASOBand™ Vascular Compression Device is substantially equivalent to the predicate device.

IX. CONCLUSION

The VASOBand™ Vascular Compression Device has the same intended

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use, patient population, and anatomical sites as well as similar technological characteristics as the predicate device. The differences in technological characteristics have been analyzed and addressed through testing. As such, the VASOBand™ Vascular Compression Device is substantially equivalent to the predicate device.

X. SUMMARY

The VASOBand™ Vascular Compression Device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).