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.

AI/ML Overview

This document, K201695, is a 510(k) premarket notification for a medical device called the "PH Band," a compression device used to assist hemostasis of the radial artery after a transradial procedure. The FDA has determined the device is substantially equivalent to a legally marketed predicate device (Medtronic Vascular TRAcelet Compression Device, K162027).

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several non-clinical bench tests performed on the PH Band. While it lists the types of tests, it does not provide specific numerical acceptance criteria or quantitative performance results for each test. Instead, it states that the device "met all required specifications and performs as intended" and that 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."

Here's a table summarizing the tests, noting the absence of specific criteria/results in this document:

Test Name	Acceptance Criteria (as reported in document)	Reported Device Performance (as reported in document)
Nonclinical Bench Testing	Met all required specifications	Designed to meet established specifications necessary for consistent performance during its intended use. Does not raise new or different questions of safety or effectiveness compared to the predicate device.
Visual Inspection	(Not explicitly stated, implied to meet quality standards)	(Implied to have passed, as part of overall nonclinical testing success)
Dot Detection Test	(Not explicitly stated, implied to meet quality standards)	(Implied to have passed)
Doppler Compatibility	(Not explicitly stated, implied to ensure proper function with Doppler)	Designed for use with an ultrasound Doppler system and flat Doppler probe. Secondary strap incorporated to hold the Doppler probe in place. Functionality is implied to be acceptable.
Bladder Leak Test	(Not explicitly stated, implied to ensure bladder integrity)	(Implied to have passed)
Pressure Decay Test	(Not explicitly stated, implied to ensure pressure retention)	(Implied to have passed)
Velcro Peel/Shear Strength Test	(Not explicitly stated, implied to ensure secure fastening)	(Implied to have passed)
Luer Valve/Tubing Tensile Test	(Not explicitly stated, implied to ensure structural integrity)	(Implied to have passed)
Sterilization Validation	Sterility Assurance Level of 10⁻⁶ (for Radiation Electron Beam, ISO 11137-1:2006 +A1:2013 and EN ISO 11137-1:2015)	Met the Sterility Assurance Level of 10⁻⁶. Demonstrated that the difference in sterilization method does not raise different questions of safety or effectiveness.
Biocompatibility Testing	Performed in accordance with ISO 10993-1.	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Material Mediated Pyrogenicity testing were performed and implied to have passed, demonstrating no different questions of safety or effectiveness.
Transit Testing	(Not explicitly stated, implied to ensure device integrity during transport)	(Implied to have passed)
Shelf Life Validation	(Not explicitly stated, implied to ensure device integrity over its shelf life)	(Implied to have passed)
Bladder Burst Testing	(Not explicitly stated, implied to ensure bladder can withstand anticipated pressures)	(Implied to have passed)

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

The document states that clinical data was not required to demonstrate substantial equivalence (Page 8, [807.92(b)(2)] Clinical Testing Summary). Therefore, there is no "test set" in the context of human subjects or clinical data mentioned in this document. The testing described is entirely non-clinical bench testing. The data provenance is internal testing performed by Medical Ingenuities.

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

Not applicable, as no clinical test set or human-derived ground truth was established for this submission. The ground truth for bench testing is derived from engineering specifications and industry standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical compression band, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical bench testing, the ground truth used would be engineering specifications, industry standards (e.g., ISO standards for biocompatibility and sterilization), and design requirements established by the manufacturer. These are derived from established scientific and engineering principles.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device and 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 no training set was used.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 630-258-2042 FAX: 630-665-0546

Contact Person:

Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-400-0856 FAX: 408-400-0865

Date Prepared: October 30, 2020

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

PH Band

Common Name:

Compression Device

Classification Name:

Clamp, Vascular

Classification:

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)]

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(Subject Device)	TRAcelet Compression Device(Primary Predicate)	Rationale forSubstantialEquivalence
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 assisthemostasis of the radial artery after a transradial procedure.	The compression device is used to assist patenthemostasis of the radial artery after a transradialprocedure.	Same
Single Use	Intended for single use only.	Intended for single use only.	Same
Prescription/Over-the-Counter	Prescription Use	Prescription Use	Same
Components	Compression Band•Syringe (30mL)•2 Finger Cots•	Compression Band•Customized Syringe•	Similar. Thedifferences in thecomponents do notraise differentquestions of safety oreffectiveness, asdemonstrated byperformance testing.
DopplerCompatibility	Designed for use with an ultrasound doppler system•and flat doppler probe.Designed with a secondary strap incorporated to holdthe doppler probe in place.•	Does not include a strap to hold a Doppler•in place.	These differences donot raise any differentquestions of safety oreffectiveness, asdemonstrated byperformance testing.
			Rationale for
Device Name	PH Band(Subject Device)	TRAcelet Compression Device(Primary Predicate)	SubstantialEquivalence
Sizing	The PH Band is a Universal Radial Compression Band(Right or Left) that is 30.5cm in length. The Velcro loopside of the band can be cut to fit a smaller wrist by firstwrapping the band around the patient's wrist and thencutting off any excess. Up to 10.8cm of length can be cut offthe Velcro loop bands.	Band length available in two sizes (19.2cm or25.2cm).	Similar. Thedifference indimensions does notraise differentquestions of safety oreffectiveness, asdemonstrated byinspection andperformance testing.
Sterility	Radiation (Electron Beam) Sterilized(ISO 11137-1:2006 +A1:2013 and EN ISO 11137-1:2015 toprovide a Sterility Assurance Level of 10-6.)	Ethylene Oxide Sterilized(ANSI/AAMI/ISO 11135:1994 to provide aSterility Assurance Level of 10-6.)Similar to predicate (Terumo Corporation, TRBand device (K070423)).	The difference insterilization methoddoes not raisedifferent questions ofsafety oreffectiveness, asdemonstrated by thesterilizationvalidation.
Nonclinical BenchTesting/In VitroBench 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. Thedifferences in testingperformed do notraise differentquestions of safety oreffectiveness.
Device Name	PH Band(Subject Device)	TRAcelet Compression Device(Primary Predicate)	Rationale forSubstantialEquivalence
BiocompatibilityTesting	• Cytotoxicity Testing• Sensitization Testing• Intracutaneous Reactivity Testing• Acute Systemic Toxicity Testing• Material Medicated Pyrogenicity Testing	• Cytotoxicity Testing• Sensitization Testing• Intracutaneous Reactivity Testing• Acute Systemic Toxicity Testing	Similar. Thedifferences in testingperformed do notraise differentquestions of safety oreffectiveness. Alltesting wasperformed inaccordance with ISO10993-1.

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.

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).