The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

Device Description

The RePort™ Guide Catheter System is a two-catheter system comprised of the RePort™ Sheath and the RePort™ Dilator. The RePort™ Sheath has a distal region which expands when the RePort™ Dilator is advanced. The RePort™ Guide Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy. The proximal ends of the RePort™ Sheath and the RePort™ Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the RePort™ Sheath's distal expandable region into the catheter introducer sheath. The System is provided sterile, non-pyrogenic, and is intended for single use only.

AI/ML Overview

The provided document describes the RePort™ Guide Catheter System and its substantial equivalence to predicate devices, rather than an AI/ML device. Therefore, the questions related to AI/ML specific aspects like AI assistance effect size, standalone algorithm performance, training set, and AI specific ground truth are not applicable.

However, the document does contain information about the acceptance criteria and the studies performed to demonstrate the device meets these criteria in the context of a medical device submission.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device "Met established criteria" for all tests, indicating that the acceptance criteria for each test were successfully achieved. The specific numerical values or ranges for these criteria are not provided, only the outcome.

Bench Tests	Acceptance Criteria (Implied)	Reported Device Performance
Dimensional and Visual Inspection	Established criteria	Met established criteria
Guidewire Compatibility	Established criteria	Met established criteria
Torque Response	Established criteria	Met established criteria
Torque Strength	Established criteria	Met established criteria
System Deployment Cycle Test	Established criteria	Met established criteria
Kink Resistance	Established criteria	Met established criteria
Flexibility Test	Established criteria	Met established criteria
Tensile Strength	Established criteria	Met established criteria
Catheter Leak Test (Liquid Leakage)	Established criteria	Met established criteria
Catheter Leak Test (Air Leakage)	Established criteria	Met established criteria
Dynamic Pressure Test	Established criteria	Met established criteria
Static Burst Test	Established criteria	Met established criteria
Aspiration Test	Established criteria	Met established criteria
Hub Gauging	Established criteria	Met established criteria
Corrosion Resistance	Established criteria	Met established criteria
USP Particulate Test	Established criteria	Met established criteria
Navigation and Accessibility Capabilities in vitro	Established criteria	Met established criteria
In vivo Tests	Acceptance Criteria (Implied)	Reported Device Performance
System Deliverability, Compatibility, Visibility and Aspiration Performance	Established criteria	Met established criteria
Acute histopathology of treated vessels	Established criteria	Met established criteria
Biocompatibility testing	Established criteria	Met established criteria

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

Test Set Sample Size: The document does not explicitly state the specific number of units or samples used for each test. It generally states that "All testing was performed on units which were twice sterilized."
Data Provenance: The tests are described as "bench-top testing" and "in vivo tests," implying some animal or cadaveric testing for the in vivo portion. There is no mention of human clinical trial data for this 510(k) submission for the RePort™ Guide Catheter System. The document focuses on demonstrating substantial equivalence through non-clinical data. The country of origin for the data is not specified, but the applicant is Reverse Medical Corporation, Irvine, CA, suggesting the testing was likely conducted in the US or by US-based contractors/labs. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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

This question is not applicable as the document describes physical, mechanical, and biological testing of a medical device, not an AI/ML system requiring expert-established ground truth from images or other data. The "ground truth" for these tests would be the measured physical properties or biological responses against established engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device testing. Adjudication methods like 2+1 or 3+1 are used for reviewing ambiguous cases or discrepancies in image interpretation or diagnosis, which is not relevant here. The results of the tests were compared against "established criteria."

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 describes a non-AI/ML medical device. No human reader studies with or without AI assistance are mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This pertains to an AI/ML algorithm, which is not the subject of this document.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" was defined by established engineering standards and specifications (e.g., dimensional tolerances, strength requirements, leak rates).
For the biocompatibility tests, the "ground truth" was established by international biological evaluation standards (ISO 10993-1), with the results compared against acceptable biological responses.
For the in vivo tests, the "ground truth" would be direct observation of performance (e.g., deliverability, compatibility, visibility, aspiration performance) and histopathological examination of treated vessels, assessed against pre-defined safety and performance parameters.

8. The Sample Size for the Training Set

Not applicable. This refers to an AI/ML device. The RePort™ Guide Catheter System is a physical medical device and does not involve a training set.

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

Not applicable. This refers to an AI/ML device.

Summary

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APR 1 5 2011

4. 510(k) Summary according to 807.92

Pursuant to Section 12, Part (a){i)(3A) of the Safe Medical Devices Act of 1990, Reverse Medical Corporation is providing the summary of Substantial Equivalence for the RePort™ Guide Catheter System.

4.1 Sponsor /Applicant Name and Address

Reverse Medical Corporation 13900 Alton Parkway Suite 123 Irvine, CA 92618

4.2 Sponsor Contact Information

Amy Éskina Vice President, Regulatory Quality & Clinical Affairs Phone: 949-215-0660 x234 949-215-0661 Fax: email: aeskina@reversemed.com

4.3 Date of Preparation of 510(k) Summary

August 13, 2010

4.4 Device Trade or Proprietary Name

RePort™ Guide Catheter System

4.5 Device Common/Usual or Classification Name

Catheter, Percutaneous (Product Code: DQY)

4.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:

Name of Predicate Device	Name of Manufacturer(Town, State)	510(k) Number
Penumbra Neuron™Intracranial Access System	Penumbra, Inc.Alameda, CA	K070970
ENVOY® Guiding Catheter	Codman & Shurtleff, IncRaynham, MA	K093184
Chaperon™ Guiding CatheterSystem	Microvention, Inc.Aliso Viejo, CA	K082385

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4.7 Device Description

The proximal ends of the RePort™ Sheath and the RePort™ Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the RePort™ Sheath's distal expandable region into the catheter introducer sheath. The System is provided sterile, non-pyrogenic, and is intended for single use only.

4.8 Intended Use

The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

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4.9 Comparison to Predicate Devices

	Penumbra		Chaperon™	RePort™ Guide
	Neuron™	ENVOY® Guiding	Guiding Catheter	Catheter
	Intracranial Access	Catheter;	System
	System
510(k) Number	K070970	K093184	K082385	TBD
Classification	Class II, DQY	Class II, DQY	Class II, DQY	Class II, DQY
Indication	The ... is indicated forthe introduction ofinterventional devicesinto the peripheral,coronary, and neurovasculature.	The ... is intended for usein the peripheral,coronary, andneurovasculature for theintravascularintroduction ofinterventional/diagnosticdevices.	The ...is intended forgeneral intravascularuse, including theneuro andperipheralvasculature.The... can be used tofacilitate ·introduction ofdiagnostic ortherapeutic devices.The... are notintended for use incoronary arteries.	The ... is indicated forthe introduction ofinterventional /diagnostic devices intothe peripheral,coronary, and neurovasculature.
Materials
- Shaft Materials	PTFE linednylon/polyurethanewith stainless steelbraid support	PTFE linednylon/polyurethanewith stainless steelbraid support	PTFE linedpolymeric catheterwith braid support	PTFE linednylon/polyurethanewith stainless steel andnitinol braid support
- Proximal EndConfiguration	Luer Hub	Luer Hub	Luer Hub	Luer Hub
- Radiographic markers /Radiopacity	• Delivery Catheter:Platinum reinforceddistal shaft forradiopacity• Select Catheter:shaft is radiopaquethroughout	Radiopaque distal tip	Radiopaque distal tip	• Sheath:Platinum/tungstenbands embedded atjunction ofexpandable section;gold marker at tip ofexpandable section;• Dilator: shaft isradiopaquethroughout
- Packaging	Catheterin polyethylene hoopinsidePET/PE/Tyvek pouchinside SBS carton	Catheterattached topackaging cardinsidePET/PE/Tyvek pouchinside SBS carton	Catheterattached topackaging cardinsidePET/PE/Tyvek pouchinside SBS carton	Catheterin polyethylene hoopattached topackaging cardinsidePET/PE/Tyvek pouchinside SBS carton
Sterilization	EtO	EtO	EtO	EtO

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4.10 Summary of Non-clinical Data

4.10.1 Biocompatibility and Sterilization

The RePort™ Guide Catheter System is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (≤ 24 hours). Results of the testing demonstrate that the blood contacting materials are biocompatible.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1 guidelines "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The RePort™ Guide Catheter System successfully passed all of the following biocompatibility tests:

Test	Method
Cytotoxicity	L929 MEM Elution Test
Sensitization	Kligman Maximization
Intracutaneous Reactivity (Irritation)	Intracutaneous Injection Test
Systemic Toxicity (Acute)	ISO Acute Systemic Injection Test
Haemocompatibility	Complement ActivationHemolysisInactivated Partial Thromboplastin Time TestIn vivo thrombogenicity
Pyrogenicity	USP Material Mediated Rabbit Pyrogen Test

Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, Sterilization of Health Care Products-Part 1: Requirement, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10 °.

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4.10.2 Design Verification (Bench-Top Testing)

The physical, mechanical and performance testing of the RePort™ Guide Catheter System demonstrates that the product is substantially equivalent to the currently marketed predicate devices. Design Verification testing was conducted to evaluate the physical and mechanical properties of the RePort™ Guide Catheter System. All studies were conducted in accordance with Reverse Medical Design Control procedures. All testing was performed on units which were twice sterilized and met all inspection criteria. Tests on the the RePort™ Guide Catheter System included:

Verification and Test Summary

Bench Tests	Result
Dimensional and Visual Inspection	Met established criteria
Guidewire Compatibility	Met established criteria
Torque Response	Met established criteria
Torque Strength	Met established criteria
System Deployment Cycle Test	Met established criteria
Kink Resistance	Met established criteria
Flexibility Test	Met established criteria
Tensile Strength	Met established criteria
Catheter Leak Test (Liquid Leakage)	Met established criteria
Catheter Leak Test (Air Leakage)	Met established criteria
Dynamic Pressure Test	Met established criteria
Static Burst Test	Met established criteria
Aspiration Test	Met established criteria
Hub Gauging	Met established criteria
Corrosion Resistance	Met established criteria
USP Particulate Test	Met established criteria
Navigation and Accessibility Capabilities in vitro	Met established criteria
In vivo Tests	Result
System Deliverability, Compatibility, Visibility and Aspiration Performance	Met established criteria
Acute histopathology of treated vessels	Met established criteria
Biocompatibility testing	Met established criteria

The physical, mechanical and performance testing of the subject RePort™ Guide Catheter System demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.

4.11 Substantial Equivalence

The performance of the RePort™ Guide Catheter System in this submission demonstrates that the product is substantially equivalent to the performance of the predicate devices. The equivalence was shown through comparison of component materials and specification, performance and biocompatibility testing and sterilization validation.

The RePort™ Guide Catheter System is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate devices. Differences between the devices do not raise any significant issues of safety or effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wing. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 1 5, 2011

Reverse Medical Corporation c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K102418

Trade/Device Name: RePort Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 31, 2011 Received: April 1, 2011

Dear Mr. 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. 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 requirements, including, but not limited to: registration and listing (21

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CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Duma R. Vi. Luner

Image /page/6/Picture/7 description: The image shows a black and white drawing of a symbol. The symbol is abstract and appears to be a stylized letter or character. It has a curved line at the top and a sharp angle at the bottom, with a wavy line connecting them. The symbol is simple and minimalist in design.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Indications for Use

510(k) Number (if known):_K(02418

Device Name: Reverse Medical RePort™ Guide Catheter System

Indications for Use:

The Reverse Medical RePort™ Guide Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ea R. h. mmm
(Plaintiff's Signature)

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_K102418

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).