(29 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical compression and biocompatibility, with no mention of AI or ML.
Yes.
The device's intended use is to assist patent hemostasis of the radial artery after a transradial procedure, which is a therapeutic intervention aimed at treating or alleviating a medical condition (bleeding at the puncture site).
No
This device is a compression device used to assist patent hemostasis, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly outlines physical components such as an inflatable band, PVC film and tubing, valves, and hook and loop materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide external compression to assist with hemostasis of the radial artery after a procedure. This is a mechanical action applied to the body, not a test performed on a sample of bodily fluid or tissue to diagnose a condition or provide information about a physiological state.
- Device Description: The device is an external compression band. It does not involve reagents, analyzers, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (on the body) to achieve a physical effect (compression for hemostasis).
N/A
Intended Use / Indications for Use
The VASOBandTM is a compression device to assist patent hemostasis of the radial artery after a transradial procedure.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial artery, human arm, vascular access site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Fastener peel force: Pass
- Fastener slippage: Pass
- Cytotoxicity Study Using the ISO Elution Method: 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
Clinical Testing:
- Clinical Study (www.clinicaltrials.gov; NCT04002791)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VASOBand™ (K190318)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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
1
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.
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
4
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 of
Inflatable
Bladders | 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
5
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 Use | |
| Material | 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
6
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 Elution | |
| Method | 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
7
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.