The Xcess guiding catheter is available in many different curve shapes and two sizes (5F and 6F). Each device consists of a catheter shaft, soft extension, soft tip, strain relief and luer. The catheter shaft is constructed with 3 layers: an outer layer of radiopaque Nylon/Pebax material, a middle layer of braided stainless steel, and an inner layer of PTFE tubing. The soft extension and soft tip consist of 2 layers: an outer layer of a radiopaque Nylon/Pebax material of differing hardness than the layer in the catheter shaft and an inner layer of PTFE. The strain relief at the proximal end of the catheter prevents kinking during catheter manipulation, and the luer is used to connect with either a hemostasis valve-linked accessory or 3-way connector. The distal ends of the guiding catheters are formed into a variety of shapes required to access differing vasculatures. The guiding catheters are provided with a hydrophilic coating on the catheter body. The guiding catheters are designed to accept a maximum of 0.038" (0.97mm) diameter guide wire.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Xcess Guiding Catheter), not an AI/ML-enabled medical device. Therefore, the questions related to AI/ML specific acceptance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e., algorithm only) performance," "sample size for the training set," and "how ground truth for the training set was established," are not applicable.

This document describes the process of demonstrating substantial equivalence for a physical medical device. The acceptance criteria focus on bench testing performance and biocompatibility in comparison to a predicate device.

Here's an analysis of the provided text in the context of the requested information, while acknowledging the non-AI nature of the device:

Device Name: Xcess Guiding Catheter
Device Type: Percutaneous Catheter (Class II)
Predicate Device: VISTA BRITE TIP Guiding Catheter (K962830)

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests confirmed the products met the pre-defined acceptance criteria." However, it does not provide a quantitative table of the specific acceptance criteria (e.g., maximum force for tensile strength, specific values for torquability) or the specific numerical results of the tests. It only lists the types of tests performed.

Acceptance Criteria Category	Reported Device Performance Statement
Performance Testing	"The results of these tests demonstrate that the technological characteristics and performance criteria of the Xcess Guiding Catheter are adequate for its intended use, and that is substantially equivalent to the predicate device." All tests confirmed the products met the pre-defined acceptance criteria.
Biocompatibility Testing	"The results from these tests demonstrate that the Xcess Guiding Catheter is biocompatible for its intended use."

Specific Performance Tests Conducted (without quantitative criteria/results):

Visual and dimension inspection
Coating integrity and particulate evaluation
Catheter usability
Catheter shape retention
Catheter freedom from leakage
Catheter torque
Catheter pressure integrity
Catheter flexibility and kink
Catheter joints tensile strength
Corrosion resistance
Radio-detectability

Specific Biocompatibility Tests Conducted:

Cytotoxicity
Sensitization
Irritation or Intracutaneous Reactivity
Acute Systemic Toxicity
Material-Mediated Pyrogenicity
Hemocompatibility (Hemolysis, Thrombogenicity, and Complement Activation)

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

Sample Size: The document does not specify the sample sizes used for any of the performance or biocompatibility tests.
Data Provenance: The document implies the testing was conducted internally by Curatia Medical Co. (Santa Clara, CA, USA) or its designated testing facilities, as it states, "Curatia Medical has determined that the Xcess Guiding Catheters are substantially equivalent." The data is prospective in the sense that the tests were performed specifically for this 510(k) submission, not gathered retrospectively from existing data. The country of origin for the data is implicitly USA (California).

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

Not Applicable: For a physical medical device like a guiding catheter, "ground truth" as it would be understood for an AI/ML model (e.g., disease diagnosis) is not established by human experts in the same way. The "ground truth" or acceptance criteria for mechanical and biological performance are established by engineering standards (e.g., ISO 10555-1, ISO 10993 series) and risk analysis, not by expert interpretation of images or clinical cases. Testing against these standards determines performance.

4. Adjudication Method for the Test Set

Not Applicable: As this is verification testing of a physical device against engineering and biological standards, there is no "adjudication method" involving multiple human readers/experts in the way there would be for, say, an AI diagnostic tool. Test results are objective measurements compared against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Not Applicable: This type of study is relevant for AI/ML-enabled diagnostic or assistive devices where human reader performance is being evaluated. The Xcess Guiding Catheter is a physical interventional device, not an AI or diagnostic tool.

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

Not Applicable: This question pertains specifically to AI/ML algorithms. The Xcess Guiding Catheter is a physical device, and therefore does not have an "algorithm-only" mode.

7. The Type of Ground Truth Used

The "ground truth" for the Xcess Guiding Catheter's performance is based on established international standards (ISO 10555-1 for performance, ISO 10993 series for biocompatibility) and the specific design requirements derived from a risk analysis for a percutaneous catheter. This is a scientific/engineering ground truth based on accepted practices for medical device design and testing, rather than an expert consensus on clinical data, pathology, or outcomes data in the context of an AI model.
The comparison to the predicate device (VISTA BRITE TIP Guiding Catheters) also serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable: This question applies to AI/ML algorithms where a "training set" of data is used to develop the model. For a physical medical device, there is no training set in this context. Device design and manufacturing processes are developed and refined through engineering iterations, but not via "training" on a data set.

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

Not Applicable: As there is no "training set" for a physical device, there is no ground truth established for it.

Summary

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December 14, 2018

Curatia Medical Co. % Breanne Butler Regulatory Affairs Consultant JCO Consulting 11218 Zest Court NE Blaine, Minnesota 55449

Re: K180797

Trade/Device Name: Xcess Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 15, 2018 Received: November 15, 2018

Dear Breanne Butler:

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Lydia S. Digitally signed by Lydia S. Glaw -S Date: 2018.12.14 Glaw -S 15:12:17 -05'00'

for 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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Indications for Use

510(k) Number (if known) K180797

Device Name Xcess Guiding Catheter

Indications for Use (Describe)

The guiding catheter is intended to use for introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

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) Summary

510(k) SUMMARY K180797

Submitter:	Curatia Medical Co.3227 Kifer RoadSanta Clara, CA 95051Establishment Number: 3008361782
Company Contact Person:Phone:Fax:Email:	Jessica Chiu, VP(408) 414-2188(408) 413-3000jchiu@curatiamed.com
Submission Correspondent:Address:Phone:Email:	Breanne Butler, Regulatory Affairs Consultant11218 Zest Ct. NE, Blaine, MN 55449(860)-810-5594breanne.sm.butler@gmail.com
Date Prepared:	December 13, 2018
Proprietary Name:	Xcess Guiding Catheter
Common Name:	Percutaneous catheter
Product Code:	DQY
Device Classification:	Class II, 21 CFR 870.1250 - Percutaneous Catheter
Predicate Devices:	VISTA BRITE TIP Guiding Catheter (K962830)

Device Description:

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Indications for Use:

The guiding catheter is intended to use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Comparison to Predicate Devices:

The Xcess Guiding Catheter is substantially equivalent in design, construction, and performance characteristics to the following commercially available product: VISTA BRITE TIP Guiding Catheters (CORDIS - FDA registration No: K962830, 1996). Based on comparison and testing of the predicated device and the Xcess Guiding Catheter, the specifications of the Xcess Guiding Catheter (Curatia) are substantially equivalent to the predicate device, VISTA BRITE TIP Guiding Catheter (Cordis). The clinical, technical, material, and biological specifications of the Xcess Guiding Catheter are substantially equivalent to the predicate device.

Summary of Performance Data and Substantial Equivalence:

The Xcess Guiding Catheters were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre-defined acceptance criteria. Curatia Medical has determined that the Xcess Guiding Catheters are substantially equivalent. The Xcess Guiding Catheters have been tested and shown to be compliant with the following standards documents:

. ISO 10555-1:2013- Intravascular catheters – Sterile, single-use intravascular catheters – Part 1: General requirements
ISO 10993-1:2009- Biological evaluation of medical devices – Part 1: Evaluation and testing
ISO 10993-3:2014- Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
. ISO 10993-4:2002+AMD1:2006-Biological testing of medical and dental materials and devices -Part 4: Selection of tests for interactions with blood
ISO 10993-5: 2009- Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin ● sensitization
ISO 10993-11:2006- Biological testing of medical and dental materials and devices – Part 11: Tests for systemic toxicity
. ISO 10993-12:2012- Biological testing of medical and dental materials and devices – Part 12: Sample Preparation And Reference Materials
. ISO 11135: 2014 Sterilization of health-care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 11607-1: 2009(R2014)- Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

Performance Testing:

To demonstrate substantial equivalence of the Xcess Guiding Catheter to the predicate device, the technological characteristics and performance criteria were evaluated using the bench testing recommendations outlined in the ISO 10555-1 Sterile, single-use intravascular catheters-Part 1: General requirement. The following performance tests were completed:

. Visual and dimension inspection
Coating integrity and particulate evaluation ●
. Catheter usability

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Catheter shape retention ●
Catheter freedom from leakage ●
Catheter torque
. Catheter pressure integrity
Catheter flexibility and kink ●
Catheter joints tensile strength ●
Corrosion resistance
. Radio-detectability

The results of these tests demonstrate that the technological characteristics and performance criteria of the Xcess Guiding Catheter are adequate for its intended use, and that is substantially equivalent to the predicate device.

Biocompatibility:

To demonstrate the biocompatibility of the materials in contact with the body and substantial equivalence of the Xcess Guiding Catheter to its predicate device, the following biocompatibility testing was performed in accordance with ISO 10993 and the FDA Guidance Document "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"" dated June 2016:

. Cytotoxicity
. Sensitization
Irritation or Intracutaneous Reactivity ●
Acute Systemic Toxicity ●
Material-Mediated Pyrogenicity
Hemocompatibility (Hemolysis, Thrombogenicity, and Complement Activation)

The results from these tests demonstrate that the Xcess Guiding Catheter is biocompatible for its intended use.

Conclusion:

Based on comparison of indications for use, technological characteristics, performance testing, biocompatibility testing, the Xcess Guiding Catheter has been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate device.

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).