(29 days)
None
No
The summary describes a mechanical compression device with no mention of AI or ML capabilities.
Yes
The device is a compression device used to assist hemostasis after a transradial procedure, which is a therapeutic purpose.
No
The device is described as a "compression device to assist hemostasis" after a procedure, meaning it helps stop bleeding. Its function is to apply external compression, not to diagnose any condition or disease.
No
The device description clearly outlines physical components (inflatable band, strap, PVC film, PVC tubing, valves, hook and loop material) and performance studies related to these physical components (tensile strength, integrity, etc.), indicating it is a hardware device, not software-only.
No, the VASOBand™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- VASOBand™ Function: The VASOBand™ is an external compression device applied to the arm to assist with hemostasis (stopping bleeding) after a procedure. It works by applying physical pressure to the radial artery.
- No Specimen Testing: The VASOBand™ does not involve collecting or testing any specimens from the body. It is a mechanical device used externally.
The information provided in the description clearly indicates its function as a physical compression device, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The VASOBand™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Product codes
DXC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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
Not Found
Summary of Performance Studies
The following performance data was provided in support of the substantial equivalence.
- Band clarity
- Check valve actuations
- Bladder inflation/deflation cycles
- Band deployment time
- Bladder inflation/deflation time
- Bladder inflated height
- Bladder integrity including compressive force at 2h, underwater air leak, and simulated use testing
- Tubing/check valve tensile strength
- 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
- 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.
Key Metrics
Not Found
Predicate Device(s)
TR Band™ (K070423)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo for 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Image /page/3/Picture/2 description: The image shows the logo for VASO Innovations. The logo features the text "VASO Innovations" in a simple, sans-serif font. Below the text is the tagline "Designing for Life" in a smaller font. The logo also includes a stylized graphic element to the left of the text, consisting of lines that form a V shape.
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
4
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 Applied
Pressure Allows Gradual Release
of Pressure |
|----------------------------------------|-----------------------------------------------------------------------------------------------------|
| • Target Population | |
| • Intended User | |
| • Anatomical Site | • Pressure can be adjusted Without
Unfastening Strap |
| • Packaged Sterile | |
| • Sterilization Method | • Direct Compression |
| • Clear Adjustable Strap Around
Arm | • 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
5
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
6
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.