The VASOBand™ Vascular Compression Device is an external compression device to promote patent 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 patent hemostasis at a target vessel's puncture site. Each device is a single-use, sterile, individually pouched inflatable band. The VASOBand™ Vascular Compression 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 materials are 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

The provided text describes a 510(k) premarket notification for the VASOBand™ Vascular Compression Device. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria in the context of a new AI-based diagnostic or imaging device.

Therefore, the requested information regarding acceptance criteria for device performance, clinical study details for proving the device meets these criteria (like sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details), is not directly applicable to this document.

This document describes a device used for physical compression (a vascular clamp), not an AI/software device that generates diagnostic outputs requiring detailed performance metrics such as sensitivity, specificity, or AUC based on a test set and ground truth established by experts.

However, I can extract and structure the information that is present in the document which relates to performance and equivalence:

Acceptance Criteria and Device Performance (in the context of demonstrating substantial equivalence to a predicate device):

The "acceptance criteria" here are implicitly related to demonstrating that changes made from the predicate device do not adversely affect safety or effectiveness, and that the device performs "as well as" the predicate. The performance evaluation is primarily focused on bench testing for material and manufacturing changes, and leveraging publicly available clinical data from an independent study for the indication of patent hemostasis.

1. Table of Acceptance Criteria (as implied by testing) and Reported Device Performance:

Implied Acceptance Criteria (via Testing Performed)	Reported Device Performance
Bench Testing:	Result:
Fastener peel force meets specified criteria	Pass
Fastener slippage meets specified criteria	Pass
Biocompatibility: Cytotoxicity (ISO Elution Method) meets specified criteria	Pass
Biocompatibility: Guinea Pig Skin Sensitization (ISO) meets specified criteria	Pass
Biocompatibility: Intracutaneous Irritation (ISO) meets specified criteria	Pass
Biocompatibility: Material-Mediated Pyrogen (USP Rabbit) meets specified criteria	Pass
Biocompatibility: Acute Systemic Toxicity (ISO) meets specified criteria	Pass
Clinical Performance:	Result:
Ability to assist patent hemostasis of radial artery post-transradial procedure	Met all specified criteria (leveraged from publicly available clinical data)

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (Clinical Data): The document references a clinical study (NCT04002791) listed on www.clinicaltrials.gov and a publication: "Patel G. Shah S. Patel BA. Patel TM. Randomized Comparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: The OPEN-Radial Trial, 2020, J Invasive Cardiol 32(9):Epub".
- Sample Size: Not specified in this 510(k) summary document. It states "Clinical performance data is leveraged from publicly available information of a clinical trial conducted by an independent sponsor investigator." To find the sample size, one would need to refer to the referenced NCT04002791 study or the associated publication.
- Data Provenance: The document does not explicitly state the country of origin. It leverages an independent clinical trial, implying it's prospective, but the specific design (retrospective/prospective) and location would be detailed in the referenced clinical trial documentation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable in the context of this device and 510(k) submission. The clinical data referenced is for demonstrating the device's function (assisting hemostasis), not for validating an AI algorithm's diagnostic accuracy against expert-established ground truth. The "ground truth" for a hemostasis device would be the actual state of hemostasis, determined clinically.

4. Adjudication Method for the Test Set:

Not applicable as this is not an AI diagnostic algorithm requiring expert adjudication of outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is typically performed for AI-assisted diagnostic tools to show how AI assistance impacts human reader performance. This device is a physical compression device, not an imaging or diagnostic AI tool.

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

Not applicable. This isn't an algorithm. The "performance" relates to its physical function as a medical device.

7. The Type of Ground Truth Used:

For the clinical performance, the ground truth would inherently be clinical outcomes data related to patent hemostasis of the radial artery, as determined by the clinical trial methods. This is not "expert consensus" or "pathology" in the sense of an image-based diagnosis.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. This device does not involve machine learning or a "training set."

Summary of what the document does provide regarding "proof" and "acceptance":

The core of this 510(k) submission is to demonstrate substantial equivalence to an existing predicate device (VASOBand™ K190318). The "proof" relies on:

Bench Testing: To show that the material and manufacturing changes (specifically to the hook and loop fasteners and their attachment) do not negatively impact the device's fundamental function. All these tests passed.
Comparison of Technological Characteristics: Highlighting similarities with the predicate device and asserting that the few differences (fastener materials, welding, slightly modified Indications for Use to include "patent hemostasis") do not raise new questions of safety or effectiveness.
Leveraging Existing Clinical Data: Rather than conducting a new clinical trial for this specific 510(k) submission, the applicant refers to publicly available clinical trial data (OPEN-Radial Trial, NCT04002791) to support the device's ability to assist patent hemostasis. The document states that the VASOBand™ Vascular Compression Device "met all specified criteria" based on this leveraged data.

Summary

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January 26, 2021

VASOInnovations, Inc. % Prithul Bom Regulatory Technology Services 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K203803

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: December 23, 2020 Received: December 28, 2020

Dear Prithul Bom:

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

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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/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,

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203803

Device Name

VASOBandTM Vascular Compression Device

Indications for Use (Describe)

The VASOBandTM is a compression device to assist patent 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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510(k) Summary

VASOInnovations, Inc. VASOBand™ Vascular Compression Device

l. 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: October 2, 2020

DEVICE 11.

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 Surgical Devices Requlatory Class: II Product Code: DXC

PREDICATE DEVICE III.

VASOBand™ (K190318)

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.

DEVICE DESCRIPTION IV.

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target vessel's puncture site. Each device is a single-use, sterile, individually pouched inflatable band. The VASOBand™ Vascular Compression 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 materials are 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.

The proposed device trade name is VASOBand™ Vascular Compression Device ("VASOBand"). A list of VASOBand™ Vascular Compression Device configurations is provided in Table 3.1.

Model	SKU	Number ofInflatableBladders	Band Size[Length]
VB-2600-AR	Right	2	26 cm
VB-2900-AR	Right	2	29 cm
VB-2600-AL	Left	2	26 cm
VB-2900-AL	Left	2	29 cm

Table 3.1 - VASOBand™ Product List

V. INDICATION FOR USE

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

This difference in the indications for use between the proposed and predicate devices does not raise different questions of safety and effectiveness.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Characteristics of the proposed device have been evaluated using established scientific methodology such as design verification, biocompatibility testing and clinical testing. No significant differences between the proposed and the predicate device were found that would adversely affect the use of the device, and the differences do not raise any new issues of safety or effectiveness. The differences in the technological characteristics between the proposed and predicate devices are the hook and loop fastener

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materials and the welding of the fasteners to the band. VASOInnovations, Inc. believes that any difference in the technological characteristics between the proposed and predicate devices does not raise different questions of safety and effectiveness.

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

• Product Code	• Labeling
• Device Classification Name	• Biocompatibility Test Results
• 21 CFR Regulation Number	• Method of compression
• Indications for Use (vs. primary predicate)	• Clear Adjustable Strap Around Arm
• Principle of Operation	• Air injection ports
• Target Population	• Air Bladder
• Intended User	• Allows Variation in Applied Pressure
• Anatomical Site	• Allows Gradual Release of Pressure
• Where Used	• Pressure can be adjusted Without Unfastening Strap
• Human Factors	• Direct Compression
• Packaged Sterile	• External Compression
• Sterile Barrier System	• Method of Pressure Adjustment
• Primary Packaging Barrier	• Quick Release Mechanism
• Shelf Carton	• Supporting Plastic Insert in Band
• Not Re-sterilized
• Sterilization Method
• Shelf Life
• Pouch/Shelf Box Label
• Shipper Box Label
• Shipping Carton

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

• Patent hemostasis	• Hook material
indication	• Loop material
• Instructions For Use	• Hook and loop attachment
• Instructions For UseMaterial	to band (RF welding)

The proposed and predicate devices are identical in appearance and have adjustable bands that surround the arm having an area of the band that compresses the arm over a vascular access site to assist in hemostasis. The differences, as noted above, are the hook and

VASOInnovations, Inc. 510(k) Traditional Premarket Notification VASOBand™ Vascular Compression Device

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loop fastener materials and the welding of the fasteners to the band. The hook and loop used in the predicate device were applied to the band solely with adhesive backing. In the proposed device, the hook fastener has changed to nylon (with a corresponding change to the loop fastener of a compatible family). The hook and loop fasteners used in the proposed device are compatible with the RF welding to secure the fasteners to the base band material. No other technological difference exists between the proposed and predicate devices.

The predicate device has a similar indication for use:

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

VII. PERFORMANCE TESTING - BENCH

The manufacturing and material change of the fastener mechanism does not impact the ability of the band to assist patent hemostasis. The following performance testing was performed in support of substantial equivalence based on the minor differences between hook and loop fastener materials and production methods:

Test	Results
Fastener peel force	Pass
Fastener slippage	Pass
Cytotoxicity Study Using the ISO ElutionMethod	Pass
ISO Guinea Pig Skin Sensitization Study	Pass
ISO Intracutaneous Irritation Study	Pass
USP Rabbit Material-Mediated Pyrogen Study	Pass
ISO Acute Systemic Toxicity Study	Pass

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

VIII. PERFORMANCE TESTING - CLINICAL

Clinical performance data is leveraged from publicly available information of a clinical trial conducted by an independent sponsor

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investigator. The following publicly available performance data is provided in support of the indication for patent hemostasis:

. Clinical Study (www.clinicaltrials.gov; NCT04002791) including the study protocol that is available on this website.
트 Patel G. Shah S. Patel BA. Patel TM. Randomized Comparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: The OPEN-Radial Trial, 2020, J Invasive Cardiol 32(9):Epub

The VASOBand™ Vascular Compression Device met all specified criteria.

VIII. EQUIVALENCE

The indications for use for the predicate devices are similar 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 device. The differences in technological characteristics have been analyzed and addressed through performance testing, and clinical testing results support use of VASOBand ™ Vascular Compression Device to assist patent hemostasis. Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness.

IX. CONCLUSION

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. As such, the nonclinical and clinical tests demonstrated that the device is as safe, as effective, and performs as well as the predicate device.

SUMMARY X.

The VASOBand™ Vascular Compression Device is as safe, as effective, and performs as well as 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).