The Houdini Cross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

Device Description

The Houdini® Cross Support Catheter is a single use, bi-lumen intravascular catheter intended for percutaneous use. The Houdini® Cross Support Catheter is intended for use in the iliac. femoral, ilio-femoral and popliteal arteries. It is designed for use in conjunction with a standard commercially available off the shelf (OTS) 0.014" - 0.018" quidewire (not included) to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the Houdini® Cross Support Catheter provides the option of distal anchoring as well as physician-controlled extension of the inner shaft (up to 2 cm) to support the OTS guidewire during advancement.

The effective length of the Houdini® Cross Support Catheter is a nominal 100 cm. The inner lumen accommodates an OTS 0.014" - 0.018" spring-tipped guidewire. The inner lumen shaft allows for visualization under fluoroscopy due to the radiopague stainlesssteel design and additionally allows for continuous clinician control of the OTS guidewire for appropriate positioning.

If distal anchoring is desired, the Houdini® Cross Support Catheter requires the use of a commercially available OTS manual inflation device (not included). Once positioned within 2 cm of the user's target location, the catheter is inflated to 6 atm using diluted radiopaque contrast media to anchor the distal end of the catheter in the blood vessel. For additional support of the quidewire, the clinician may extend the location of the inner lumen shaft up to 2 cm distally without the need to reposition the anchoring balloon.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Houdini Cross Support Catheter." It focuses on demonstrating the device's substantial equivalence to previously cleared predicate devices.

Based on the provided text, the document describes the acceptance criteria and study proving the device meets those criteria primarily through a comparison to a predicate device and extensive bench/simulated use testing, rather than a clinical study involving human patients or AI performance metrics.

Therefore, I will extract relevant information where available and state "Not Applicable" or "Information not provided in the document" for aspects that are typically found in studies for AI/diagnostic devices but not for a catheter's 510(k) submission focused on substantial equivalence.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in a quantitative, tabular format as one might find for a diagnostic or AI device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device and satisfying functional and safety requirements through engineering bench testing and simulated use.

The "criteria" are implicitly tied to meeting the performance characteristics of the predicate device and established international standards (e.g., ISO 10555-1, ISO 10993-1). The "reported performance" is a general statement that the device "satisfies" these requirements.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Biocompatibility (ISO 10993-1)	Satisfies requirements for Cytotoxicity, Sensitization, Irritation, Material-mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility (Hemolysis, Partial Thromboplastin Time, Platelet and Leukocyte Count, Complement Activation), and Material characterization.
Simulated Use Performance	"Test results indicate that the device satisfies simulated use testing requirements when used as indicated." (Ability to access discrete regions of peripheral vasculature and for guidewire exchange).
Performance Bench Testing (ISO 10555-1)	"Test results indicate that the device satisfies functional performance requirements when used as indicated." (Includes: Dimensional verification, Crossing profile, Radiopacity, Corrosion resistance, Tensile strength, Pressurization performance, Freedom from leakage, Inflation fatigue, Torque load, Kink resistance, Particulate testing).
Substantial Equivalence to Predicate Device	Comparison table shows similar Indications for Use, Sterilization Method, and close ranges for physical characteristics (Guidewire Compatibility, Sheath Compatibility, Catheter Outer Diameter, Catheter Effective Length, Labeled Balloon Diameter, Balloon Length, Anchoring Inflation Pressure, Maximum Working Pressure). Deviations are justified and supported by testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or clinical images, as this is a 510(k) for a medical catheter based on engineering and simulated use testing. For bench testing, samples of the physical device were used, but the exact number of units tested for each specific test is not provided.
Data Provenance: The data provenance is from laboratory bench testing and simulated use. No patient data (retrospective or prospective) from specific countries or populations is mentioned because a clinical study with patients was not required for this type of device and submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This document pertains to a medical catheter, not a diagnostic device or AI algorithm requiring expert interpretation of medical images or patient data to establish ground truth. Ground truth for device performance is established through engineering specifications, validated test methods (e.g., ISO standards), and comparative performance with predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As there is no clinical test set requiring expert interpretation for ground truth, there is no adjudication method described.

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 document is for a medical catheter, not an AI algorithm or a diagnostic device that would involve human readers or AI assistance.

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

Not Applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established through:
- Engineering Specifications: The device is designed to meet specific physical and performance parameters (e.g., diameter, length, pressure resistance, guide wire compatibility).
- International Standards: Compliance with ISO standards (e.g., ISO 10555-1 for intravascular catheters, ISO 10993-1 for biocompatibility) where the "ground truth" is adherence to these established safety and performance benchmarks.
- Predicate Device Performance: The predicate device serves as a benchmark for "ground truth" in terms of expected functionality and safety. The new device must demonstrate that its performance characteristics are substantially equivalent.

8. The sample size for the training set

Not Applicable. This document does not describe the development of an AI algorithm thus there is no "training set" in the machine learning sense.

9. How the ground truth for the training set was established

Not Applicable. As there is no AI training set, this question is not applicable.

Summary

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October 20, 2022

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Cruzar Medsystems Inc Adrienne Foller Consultant Strategic Quality Solutions LLC 1594 E Monaco Ave Salt Lake City, Utah 84121

Re: K213466

Trade/Device Name: Houdini Cross Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 13, 2022 Received: January 18, 2022

Dear Adrienne Foller:

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 5 10(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 (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 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 Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention 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) K213466

Device Name Houdini Cross Support Catheter

Indications for Use (Describe)

The Houdini Cross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

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

Cruzar Medsystems, Inc. Houdini® Cross Support Catheter

1. MANUFACTURER AND SUBMITTER

Company Name: Cruzar Medsystems, Inc. Company Address: 50 Braintree Hill Office Park, Suite 301 Braintree, MA 02184
Contact Person: Adrienne von Foller, Strategic Quality Solutions, LLC Regulatory Consultant Telephone: 801-916-8188 Email: Adrienne@device2market.com

Telephone: 781-223-0508

26 October 2021 Date Prepared:

2. DEVICE NAME AND CLASSIFICATION

Trade Name:	Houdini® Cross Support Catheter
Common Name:	Percutaneous catheter
Model Numbers:	CM-3502, CM-3602
Classification Name:	Percutaneous catheter
Regulation Number:	21 CFR 870.1250
Regulatory Class:	II
Product Code:	DQY

3. PREDICATE DEVICE

Device Name: Houdini® Catheter 510(k) Applicant: Cruzar Medsystems, Inc. 510(k): K151896 There has been no recall on the Cruzar Medsystems Houdini® Catheter device.

4. REFERENCE DEVICE

Device Name:	XO Cross Support Catheter
510(k) Applicant:	Transit Scientific
510(k):	K193420
:	There has been no recall on the Transit Scientific XO Cross Support Catheter.

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5. DEVICE DESCRIPTION

6. INDICATIONS FOR USE

The Houdini® Cross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for quidewire exchange.

The intended use and indications for use of the modified device are the same as the cleared, leqally marketed predicate device (K151896) and reference device (K193420).

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Houdini® Cross Support Catheter and the predicate Houdini® Catheter (K151896) are both sterile, single-use devices designed to access discrete regions of the peripheral vasculature. A comparison of the technological characteristics of the subject device, the predicate Houdini® Catheter (K151896), and the reference XO Cross Support Catheter (K193420) is described below in Table 1.

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	Subject Device	Predicate Device	Reference Device
Characteristic	Houdini CrossSupport Catheter	Houdini Catheter(K151896)	XO Cross SupportCatheter (K193420)
Indications for Use	Intended to be used inconjunction with asteerable guidewire toaccess discreteregions of theperipheral vasculatureand for guidewireexchange.	Intended to be used inconjunction with asteerable guidewire toaccess discreteregions of theperipheral vasculatureand for guidewireexchange.	Intended to guide andsupport a guidewireduring access of theperipheral vasculature,allow for wireexchanges and providea conduit for thedelivery of salinesolutions or diagnosticcontrast agents.
GuidewireCompatibility	0.014" - 0.018"	0.014" - 0.035"	0.014" - 0.035"
Sheath Compatibility	6 Fr	6 Fr	4 Fr
Catheter OuterDiameter	5 Fr	5 Fr	2 Fr - 4 Fr
Catheter EffectiveLength	100 cm	100 cm	90, 135, 150, 175 cm
Labeled BalloonDiameter	5mm6mm	4mm5mm6mm7mm8mm	No balloon component
Balloon Length	2 cm	2 cm	No balloon component
Anchoring InflationPressure	6 atm	6 atm
Maximum WorkingPressure	9 atm	12 atm
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

8. PERFORMANCE DATA

The following performance testing has been completed in support of the substantial equivalence determination, including bench testing, biocompatibility, and simulated use testing.

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Biocompatibility Testing

The biocompatibility evaluation for the Houdini® Cross Support Catheter was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" dated September 04, 2020. The biological evaluation included the following:

Material characterization .
Cytotoxicity ●
Sensitization ●
Irritation ●
Material-mediated Pyrogenicity ●
Acute Systemic Toxicity
Hemocompatibility: Hemolysis, Direct and Extract Methods ●
Hemocompatibility: Partial Thromboplastin Time
Hemocompatibility: Platelet and Leukocyte Count ●
Hemocompatibility: Complement Activation .

Simulated Use Testing

The Houdini® Cross Support Catheter was subjected to simulated use testing to verify ability to access discrete regions of the peripheral vasculature and for guidewire exchange. Test results indicate that the device satisfies simulated use testing requirements when used as indicated.

Performance Bench Testing

The Houdini® Cross Support Catheter has completed the following performance bench tests per ISO 10555-1. Test results indicate that the device satisfies functional performance requirements when used as indicated.

Dimensional verification ●
Crossing profile ●
Radiopacity ●
Corrosion resistance ●
Tensile strength
Pressurization performance
Freedom from leakage
Inflation fatigue
Torque load ●
Kink resistance ●
Particulate testing ●

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9. CONCLUSIONS

A comparison of the design and technological characteristics between the Houdini® Cross Support Catheter and the predicate Houdini® Catheter demonstrates substantial equivalence. The performance data for the subject device, including biological evaluation, bench testing, and simulated use, further supports the substantial equivalence of the Houdini® Cross Support Catheter.

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).