The Gatekeeper Balloon Catheter is an over the wire (OTW) triple-lumen catheter with 2 compliant proximal and distal polyurethane balloons having a maximum diameter of 15 mm and 10 mm respectively. The 2 balloon lumens are connected to extension lines with stopcocks and are used to inflate and deflate the proximal and distal balloons. The third lumen is a guidewire lumen. The distance between the proximal and distal balloons is 2 cm. Two (2) radiopaque marker bands are located within the balloons at each end (30mm apart at the proximal balloon and 15mm apart at the distal balloon) to facilitate balloon placement prior to inflation. The catheter can accommodate a 0.014" diameter (or smaller) guidewire and is compatible with 6Fr (or larger) introducer sheath. The device is a single use, sterile device.

AI/ML Overview

The provided text is a 510(k) summary for the Arch Catheter, LLC's Gatekeeper Balloon Catheter. This device is a medical device, not an AI/ML powered device, so many of the requested categories (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, or specific ground truths related to diagnostic accuracy) are not applicable.

However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate its performance against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance values in a single, clear format. Instead, it lists the types of tests performed to demonstrate compliance with recognized standards. The "reported device performance" is implied to meet the standards' requirements, as the conclusion states the device is substantially equivalent based on non-clinical testing.

Here's a summary derived from the text:

Acceptance Criteria Category	Specific Tests Performed	Device Performance (Implied)
Physical/Mechanical	Visual Inspection, Dimensional Inspection, Freedom from Leakage, Luer Syringe Compatibility, Guidewire Compatibility, Introducer Sheath Compatibility, Balloon Compliance (Volume v. Diameter), Inflation Time, Balloon Inflation Characteristics, Freedom from Fragmentation	Complies with standards
Structural Integrity	Balloon Fatigue, Burst or Leak Volume, Tensile Strength (Hub to Shaft), Tensile Strength (Tip to Shaft), Tensile Strength (Extension Tube), Kink Testing, Torque Testing	Complies with standards
Functional	Vessel Occlusion, Simulated Use	Complies with standards
Material & Traceability	Radiopacity	Complies with standards
Storage & Handling	Shipping/Distribution Testing, Shelf Life Testing, Package Integrity, Environmental Conditioning	Complies with standards
Biocompatibility	Biocompatibility testing (in accordance with ISO 10993-1)	Complies with ISO 10993-1

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

Sample Size: Not explicitly stated for each test. The document refers to "non-clinical testing," which typically involves engineering benchtop tests on a representative number of devices, rather than a "test set" in the context of clinical AI/ML studies.
Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective) as the studies were non-clinical benchtop tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: Not applicable. These are engineering and performance tests, not clinical evaluations requiring expert interpretation for ground truth.
Qualifications of Experts: Not applicable.

4. Adjudication Method:

Not applicable as this is not a clinical study involving human assessment of an output, but rather physical performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. This is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance.

6. Standalone (Algorithm only without human-in-the-loop performance) Study:

Not applicable. This is a physical medical device; there is no "algorithm" or standalone AI performance to evaluate.

7. Type of Ground Truth Used:

The "ground truth" for these tests is based on the requirements and specifications outlined in recognized international standards (ISO 10555-1, ISO 10555-4) and internal device specifications. For example, "Freedom from Leakage" would have a defined leakage rate that the device must not exceed. "Biocompatibility" is assessed against the criteria of ISO 10993-1. These are objective engineering criteria rather than clinical expert consensus or pathology.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable as there is no training set for an AI/ML model.

Summary

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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.

April 25, 2020

Arch Catheter, LLC % Mary Vater 510(k) Consultant Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738

Re: K192786

Trade/Device Name: Gatekeeper Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 27, 2019 Received: September 30, 2019

Dear Mary Vater:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 Carmen Gacchina Johnson 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) K192786

Device Name Gatekeeper Balloon Catheter

Indications for Use (Describe)

The Gatekeeper Balloon Catheter is indicated for temporary occlusion of vessels in the peripheral vasculature.

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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Catheter

510(k) SUMMARY K192786

SUBMITTER Arch Catheter, LLC 621 Grand Harbor Boulevard Ninety Six, SC, 29666 USA Tel: 1.864.680.2568 Fax: 1.864.725.7910

Contact Person: Michael Zhadkevich, MD, PhD Date Prepared: Sept. 27, 2019

II. DEVICE
Name of Device:	Gatekeeper Balloon Catheter
Common Name:	Occlusion balloon catheter
Classification Name:	Vascular Clamp
Regulation:	21 CFR § 870.4450
Regulatory Class:	Class II
Product Classification Code:	MJN

III.	PREDICATE DEVICE
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Primary Predicate Manufacturer:Primary Predicate Trade Name:Primary Predicate 510(k):	CoAxia, Inc.FloControl CatheterK090970
Secondary Predicate Manufacturer:Secondary Predicate Trade Name:Secondary Predicate 510(k):	Via Biomedical, Inc.Stent Graft Balloon CatheterK091624
Secondary Predicate Manufacturer:Secondary Predicate Trade Name:Secondary Predicate 510(k):	QXMedical, LLCQ50 PLUS Stent Graft BalloonK120381

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

The Gatekeeper Balloon Catheter is indicated for temporary occlusion of vessels in the peripheral vasculature.

VI. SUMMARY OF SUBSTANTIAL EQUIVALENCE

Compared to the predicate devices of the CoAxia FloControl Catheter (K090970), Via Biomedical Stent Graft Balloon Catheter (K091624), and QXMEDICAL Q50 PLUS Stent Graft Balloon Catheter (K120381). the subject Gatekeeper Balloon Catheter has the same intended use and mechanism of action for temporary occlusion of vessels. The indication statements for the predicate devices describe additional functions for expanding vascular prostheses, controlling blood flow, or occlusion of large vessels; but all devices are intended for temporary occlusion of vessels. The subject device has different technological characteristics of catheter design and materials that do not raise different questions of safety and effectiveness and were evaluated with non-clinical testing.

The subject device is designed to fulfill the requirements of the following recognized standards:

6-301 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters Sterile and single-use intravascular catheters - Part 1: General requirements
6-322 ISO 10555-4 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-use catheters -- | Part 4: Balloon dilatation catheters
6-408 ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]

The following benchtop performance tests were conducted to demonstrate that the Gatekeeper Balloon Catheter performance complies with the standards.

Visual Inspection
-Dimensional Inspection
Freedom from Leakage ー
Luer Syringe Compatibility —
Guidewire Compatibility
Introducer Sheath Compatibility ー
Balloon Compliance (Volume v. Diameter)
-Inflation Time
Balloon Inflation Characteristics —
-Radiopacity
-Shipping/ Distribution Testing
-Vessel Occlusion
Balloon Fatigue
-Burst or Leak Volume
Freedom from Fragmentation
-Tensile Strength (Hub to Shaft)
-Tensile Strength (Tip to Shaft)
-Tensile Strength (Extension Tube)
Shelf Life Testing ー
Package Integrity
-Environmental Conditioning
Kink Testing —
-Torque Testing
-Simulated Use

Biocompatibility testing was conducted in accordance with ISO 10993-1.

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VII. CONCLUSIONS

The Gatekeeper Balloon Catheter has the same intended use as the predicate devices. The technological differences do not raise different questions of safety and effectiveness. Based on the results of non-clinical testing, the data supports the Gatekeeper Balloon Catheter is substantially equivalent to the predicate devices.

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).