Patent Hemostasis Band (PH Band)

K201695 · Medical Ingenuities · DXC · Oct 30, 2020 · Cardiovascular

Device Facts

• Record ID: K201695
• Device Name: Patent Hemostasis Band (PH Band)
• Applicant: Medical Ingenuities
• Product Code: DXC · Cardiovascular
• Decision Date: Oct 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PH Band is a compression device used to assist hemostasis of the radial artery after a transradial procedure.

Device Story

PH Band is a compression device for radial artery hemostasis post-transradial procedure; consists of wrist band, 30mL syringe, and two finger cots. Features an Access Site Visualization Window and a secondary Doppler Probe Harnessing band. Designed for use with external ultrasound Doppler system and flat Doppler probe. Physician places probe distal to access site under harness; probe aligned within window. Doppler system provides real-time feedback on patency and antegrade blood flow, guiding physician to apply appropriate pressure to achieve patent hemostasis and avoid over-compression. Used in clinical settings by physicians. Benefits include improved control over compression pressure, confirmation of patent hemostasis, and reduced risk of radial artery over-compression.

Clinical Evidence

No clinical data. Substantial equivalence supported by nonclinical bench testing, including visual inspection, dot detection, Doppler compatibility, bladder leak, pressure decay, Velcro strength, tensile testing, bladder burst, biocompatibility (ISO 10993-1), transit, shelf life, and sterilization validation.

Technological Characteristics

Universal radial compression band (30.5cm, cut-to-fit); includes 30mL syringe and finger cots. Features integrated Doppler probe harness and visualization window. Sterilized via electron beam (ISO 11137-1:2006 +A1:2013, EN ISO 11137-1:2015). Biocompatibility per ISO 10993-1. Mechanical compression principle.

Indications for Use

Indicated for patients undergoing transradial procedures requiring hemostasis of the radial artery.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Medtronic Vascular TRAcelet Compression Device (K162027)

Reference Devices

• Terumo Corporation, TR Band device (K070423)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

October 30, 2020

Medical Ingenuities % Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose. California 95110

Re: K201695

Trade/Device Name: PH Band Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: June 19, 2020 Received: June 22, 2020

Dear Valerie Defiesta-Ng:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Rachel Neubrander 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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## Indications for Use

510(k) Number (if known) K201695

Device Name PH Band

Indications for Use (Describe)

The PH Band is a compression device used to assist hemostasis of the radial artery after a transradial procedure.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Notification K201695

#### GENERAL INFORMATION [807.92(a)(1)]

## Applicant:

Medical Ingenuities 345 Browning Court Wheaton, IL 60189 USA Phone: [phone] FAX: [phone]

#### Contact Person:

Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: [phone] FAX: [phone]

Date Prepared: October 30, 2020

#### DEVICE INFORMATION [807.92(a)(2)]

#### Trade Name:

PH Band

#### Common Name:

Compression Device

#### Classification Name:

Clamp, Vascular

#### Classification:

II

# Product Code:

DXC

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## PREDICATE DEVICE(S) [807.92(a)(3)]

Medtronic Vascular TRAcelet Compression Device (K162027)

### DEVICE DESCRIPTION [807.92(a)(4)]

The PH Band, herein referred to as the "Device," is an compression device consisting of a wrist band (also referred to as the "band"), a syringe, and two finger cots. The Device is used to assist in the hemostasis of the radial artery after a transradial percutaneous procedure.

The Device is similar to the predicate device but differs in that it has been designed to be used in conjunction with an ultrasound doppler system utilizing a flat doppler probe. The PH Band may be used to achieve patent hemostasis when used with the recommended Doppler technology. Located on the Radial Artery Compression Band of the Device is an Access Site Visualization Window used to visualize the hemostasis of the access site. An ultrasound doppler probe is placed immediately distal to the access site and under the Doppler Probe Harnessing band portion of the PH Band. The probe can be viewed and aligned within the access site window. When used with the Doppler probe, the device not only gains hemostasis but allows the physician to confirm patency and confirms antegrade blood flow distal to the access site compression bladder via the ultrasound doppler probe. Use of the doppler system helps guide the physician in applying the appropriate amount of pressure to achieve patent hemostasis and avoid over-compression of the radial artery during wound closure.

#### INDICATIONS FOR USE [807.92(a)(5)]

The PH Band is a compression device used to assist hemostasis of the radial artery after a transradial procedure.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

The PH Band is similar to the predicate device with respect to the intended use and technological characteristics. Medical Ingenuities performed comprehensive testing on the PH Band, including: nonclinical bench testing to demonstrate that the device met all required specifications and performs as intended, e.g., biocompatibility testing, transit testing, shelf life testing, and a sterilization validation. The testing demonstrated that the technological differences do not raise any different questions of safety and effectiveness from the predicate device.

#### SUBSTANTIAL EQUIVALENCE

The PH Band and the predicate device, TRAcelet Compression Device (K162027), are substantially equivalent with regard to intended use, performance, and technological characteristics.

The minor differences in the technological characteristics, and indications for use between the subject Device and the primary predicate device have been evaluated and determined to not raise any different questions of safety and effectiveness. As such, the PH Band is substantially equivalent to the TRAcelet Compression Device (K162027). A comparison table summarizing the specifications and features of the PH Band and the predicate device is included in Table 1.

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## 510(k) SUMMARY

| Device Name | PH Band<br>(Subject Device) | TRAcelet Compression Device<br>(Primary Predicate) | Rationale for<br>Substantial<br>Equivalence |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | - | K162027 | N/A |
| Company | Medical Ingenuities | Medtronic Vascular | N/A |
| Classification | 21 CFR§870.4450 (Class II) | 21 CFR§870.4450 (Class II) | Same |
| Product Code | DXC - Clamp, Vascular | DXC - Clamp, Vascular | Same |
| Indications for Use | The PH Band is a compression device used to assist<br>hemostasis of the radial artery after a transradial procedure. | The compression device is used to assist patent<br>hemostasis of the radial artery after a transradial<br>procedure. | Same |
| Single Use | Intended for single use only. | Intended for single use only. | Same |
| Prescription/<br>Over-the-Counter | Prescription Use | Prescription Use | Same |
| Components | Compression Band<br>•<br>Syringe (30mL)<br>•<br>2 Finger Cots<br>• | Compression Band<br>•<br>Customized Syringe<br>• | Similar. The<br>differences in the<br>components do not<br>raise different<br>questions of safety or<br>effectiveness, as<br>demonstrated by<br>performance testing. |
| Doppler<br>Compatibility | Designed for use with an ultrasound doppler system<br>•<br>and flat doppler probe.<br>Designed with a secondary strap incorporated to hold<br>the doppler probe in place.<br>• | Does not include a strap to hold a Doppler<br>•<br>in place. | These differences do<br>not raise any different<br>questions of safety or<br>effectiveness, as<br>demonstrated by<br>performance testing. |
| | | | Rationale for |
| Device Name | PH Band<br>(Subject Device) | TRAcelet Compression Device<br>(Primary Predicate) | Substantial<br>Equivalence |
| Sizing | The PH Band is a Universal Radial Compression Band<br>(Right or Left) that is 30.5cm in length. The Velcro loop<br>side of the band can be cut to fit a smaller wrist by first<br>wrapping the band around the patient's wrist and then<br>cutting off any excess. Up to 10.8cm of length can be cut off<br>the Velcro loop bands. | Band length available in two sizes (19.2cm or<br>25.2cm). | Similar. The<br>difference in<br>dimensions does not<br>raise different<br>questions of safety or<br>effectiveness, as<br>demonstrated by<br>inspection and<br>performance testing. |
| Sterility | Radiation (Electron Beam) Sterilized<br>(ISO 11137-1:2006 +A1:2013 and EN ISO 11137-1:2015 to<br>provide a Sterility Assurance Level of 10-6.) | Ethylene Oxide Sterilized<br>(ANSI/AAMI/ISO 11135:1994 to provide a<br>Sterility Assurance Level of 10-6.)<br>Similar to predicate (Terumo Corporation, TR<br>Band device (K070423)). | The difference in<br>sterilization method<br>does not raise<br>different questions of<br>safety or<br>effectiveness, as<br>demonstrated by the<br>sterilization<br>validation. |
| Nonclinical Bench<br>Testing/In Vitro<br>Bench Testing | Visual InspectionDot DetectionDoppler CompatibilityBladder LeakPressure DecayVelcro Peel StrengthVelcro Shear StrengthLuer Valve/Tubing TensileBladder Burst | Effective Strap LengthSyringe to Anti-Lock Cap TensileBalloon RuptureSide-Tube to Balloon TensileSide-Tube to Check Valve TensileVelcro to Lay Flat Tubing Weld TensileRivet Joint Tensile RegularDial Removal TorqueDial to Threaded Window Shear StrengthInitial Balloon Inflations PressureBalloon Internal Pressure Over TimeDial TorqueDial Lock Disengagement Force | Similar. The<br>differences in testing<br>performed do not<br>raise different<br>questions of safety or<br>effectiveness. |
| Device Name | PH Band<br>(Subject Device) | TRAcelet Compression Device<br>(Primary Predicate) | Rationale for<br>Substantial<br>Equivalence |
| Biocompatibility<br>Testing | • Cytotoxicity Testing<br>• Sensitization Testing<br>• Intracutaneous Reactivity Testing<br>• Acute Systemic Toxicity Testing<br>• Material Medicated Pyrogenicity Testing | • Cytotoxicity Testing<br>• Sensitization Testing<br>• Intracutaneous Reactivity Testing<br>• Acute Systemic Toxicity Testing | Similar. The<br>differences in testing<br>performed do not<br>raise different<br>questions of safety or<br>effectiveness. All<br>testing was<br>performed in<br>accordance with ISO<br>10993-1. |

# Table 1: Substantial Equivalence Table – Regulatory Information

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## 510(k) SUMMARY

## Table 1: Substantial Equivalence Table – Regulatory Information (cont.)

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## 510(k) SUMMARY

## Table 1: Substantial Equivalence Table – Regulatory Information (cont.)

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#### PERFORMANCE DATA [807.92(b)]

All necessary bench testing was conducted on the PH Band to support a determination of substantial equivalence to the predicate device.

#### [807.92(b)(1)] Nonclinical Testing Summary:

Testing included:

- . Nonclinical Bench Testing
- Visual Inspection O
- Dot Detection Test O
- Doppler Compatibility O
- Bladder Leak Test O
- Pressure Decay Test O
- Velcro Peel/Shear Strength Test O
- Luer Valve/Tubing Tensile Test o
- Sterilization Validation ●
- Biocompatibility Testing ●
- Transit Testing ●
- Shelf Life Validation ●
- Bladder Burst Testing .

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the PH Band meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the PH Band does not raise new or different questions of safety or effectiveness when compared to the predicate device.

#### [807.92(b)(2)| Clinical Testing Summary:

Clinical data was not required to demonstrate substantial equivalence.

#### CONCLUSIONS [807.92(b)(3)]

Extensive performance testing has been performed on the PH Band to evaluate the overall performance of the device. The collective results confirm that the Device meets its specifications and exhibits the required medical and functional characteristics for its intended use to compress/close and assist in hemostasis of the radial artery and as such, is substantially equivalent to the predicate device.