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

The Houdini Catheter is indicated for use in the illac, femoral, ilio-femoral and popliteal arteries.

Device Description

The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.014" - 0.035" quide wire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, quide wires may be exchanged within the catheter. In addition, the Houdini Catheter can provide distal anchoring and supports the advancement of the guidewire.

The effective length of the Houdini Catheter is a nominal 100cm. The distal tip incorporates a radiopaque marker to aid in visualization under fluoroscopy. The inner diameter of the Houdini Catheter shaft will accommodate a standard commercially available 0.014" - 0.035" guidewire.

The balloon catheter is inflated to 6atm with radiopaque contrast media with a standard manual inflator to anchor the catheter. Internal forces are placed on the inner lumen to the point that it grips and stabilizes the guidewire. Once pressurized to 6 atm, the guidewire is advanced by manual control of the proximal Y-connector by the physician.

The Houdini Catheter requires the use of traditional manual inflation devices (not included).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:

Acceptance Criteria and Study Details for the Houdini Catheter

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail manner with specific numerical thresholds. Instead, it describes various performance tests and states that the device "satisfies functional performance requirements." For some characteristics, it provides specific values for the Houdini Catheter and compares them to the predicate device.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Houdini Catheter)
Biocompatibility	Compliant with ISO 10993 and FDA G95-1	Biocompatible (based on cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and thrombogenicity testing)
Simulated Use (Insertion, Deployment, Removal)	Functional and as intended	Device insertion, deployment, and removal were assessed and found satisfactory ("satisfies functional performance requirements").
Radio-detectability	Compliant with ASTM F640-12	Satisfies functional performance requirements
Peak Tensile Force	Compliant with ISO 10555-1 Annex B	Satisfies functional performance requirements
Freedom from Fluid Leakage	Compliant with ISO 10555-1 Annex C	Satisfies functional performance requirements
Freedom from Air Leakage (Hubs)	Compliant with ISO 10555-1 Annex D	Satisfies functional performance requirements
Burst Pressure	Compliant with ISO 10555-1 Annex F	16 atm (compared to predicate's 10 atm)
Inflation Pressure vs. Diameter	As specified	Satisfies functional performance requirements
Peak Delivery Force vs. Inflation Pressure	As specified	Satisfies functional performance requirements
Dimensional Verification	Within specified tolerances	Satisfies functional performance requirements
Tensile Strength	As specified	Satisfies functional performance requirements
Torque Load	As specified	Satisfies functional performance requirements
Crossing Profile	As specified	Satisfies functional performance requirements
Kink Resistance	As specified	Satisfies functional performance requirements
Nominal Balloon Diameter	As specified for each model	CM-3400: 4mm; CM-3500: 5mm; CM-3600: 6mm; CM-3700: 7mm; CM-3800: 8mm
Catheter Effective Length	100cm	100cm
Maximum Balloon Working Length	2cm	2cm
Anchoring Inflation Pressure	6atm	6atm (compared to predicate's 1.5 atm)
Maximum Working Pressure	12atm	12atm (compared to predicate's 6 atm)
Catheter Shaft Diameter	5Fr	5Fr
Guidewire Size	0.014 - 0.035 inches	0.014 - 0.035 inches
Introducer Sheath Size	6Fr	6Fr (compared to predicate's 7 Fr)
Peak Force Delivery	0.35kgf to 0.71kgf	0.35kgf to 0.71kgf (compared to predicate's 0.026Kgf to 0.185)
Sterilization Method	Ethylene Oxide	Ethylene Oxide

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

The document does not specify the sample sizes used for any of the performance bench tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The testing conducted appears to be primarily in vitro (bench testing) and in silico (simulated use) rather than involving human or animal subjects that would typically have country of origin relevance.

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

This information is not applicable and not provided. The testing described is primarily physical and mechanical performance testing, with ground truth established by adherence to recognized standards (e.g., ISO, ASTM, FDA Blue Book Memorandum) and measurement/engineering best practices, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This is not applicable as the testing involves objective measurements against engineering specifications and international standards, not subjective interpretations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is typical for diagnostic AI devices involving human readers and interpretations of medical images. The Houdini Catheter is a physical medical device (catheter) and the performance data provided relates to its mechanical and biocompatible properties.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not directly applicable in the context of the Houdini Catheter as it is a physical medical device, not an algorithm or AI. The performance studies described are "standalone" in the sense that they evaluate the device's physical and functional characteristics in a bench setting without a human operator's performance being studied, but it's not "algorithm only" as there's no algorithm involved.

7. The Type of Ground Truth Used

The "ground truth" for the performance data is established by:

Adherence to International Standards: For biocompatibility (ISO-10993), radio-detectability (ASTM F640-12), peak tensile force (ISO 10555-1 Annex B), fluid/air leakage (ISO 10555-1 Annex C/D), and burst pressure (ISO 10555-1 Annex F).
Engineering Specifications: For dimensional verification, inflation pressure vs. diameter, peak delivery force, tensile strength, torque load, crossing profile, and kink resistance.
Functional Assessment: For simulated use (insertion, deployment, removal).

8. The Sample Size for the Training Set

This is not applicable and not provided. The Houdini Catheter is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This is not applicable as there is no training set for a physical medical device.

Summary

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

December 7, 2015

Cruzar Medsystems, Inc. Ms. Gina To Regulatory Consultant 50 Braintree Hill Office Park, Suite 301 Braintree, MA 02184

Re: K151896

Trade/Device Name: Houdini Catheter Regulation Number: 21 CFR 870.1250 Regulatory Class: Class II Product Code: DQY Dated: October 19, 2015 Received: October 22, 2015

Dear Ms. To:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kenneth J. Cavanaugh -S

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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510(k) Number (if known) K151896

Device Name

Houdini Catheter

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Cruzar Medsystems Houdini™ Catheter

1. MANUFACTURER AND SUBMITTER

Company Name:	Cruzar Medsystems, Inc.
Company Address:	50 Braintree Hill Office Park, Suite 301Braintree, MA 02184Telephone: 781-223-0508
Contact Person:	Gina To, Regulatory Consultant
Date Prepared:	November 23, 2015

2. DEVICE NAME AND CLASSIFICATION

Trade Name:	Houdini™ Catheter
Model Numbers:	CM-3400, CM-3500, CM-3600, CM-3700, CM-3800
Classification Name:	Percutaneous catheter
Regulation Number:	21 CFR 870.1250
Regulatory Class:	II
Product Code:	DQY

3. PREDICATE DEVICE

Device Name:	ENDOCROSS, ENABLER-P CATHETER, 1000 PARTNUMBER: 1160
510(k) Applicant:	ENDOCROSS, LTD
510(k):	K083833

There has been no recall on the Endocross Enabler-P device.

4. DEVICE DESCRIPTION

The effective length of the Houdini Catheter is a nominal 100cm. The distal tip incorporates a radiopaque marker to aid in visualization under fluoroscopy. The inner

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diameter of the Houdini Catheter shaft will accommodate a standard commercially available 0.014" - 0.035" guidewire.

The Houdini Catheter requires the use of traditional manual inflation devices (not included).

5. INTENDED USE/INDICATIONS FOR USE

The Houdini 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 Houdini Catheter is indicated for use in the illac, femoral, ilio-femoral and popliteal arteries.

The intended use and indications for use for the subject device are the same as the predicate device.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Houdini Catheter and the predicate Endocross Enabler-P Catheter (K083833) are both sterile, single-use devices designed to access discrete regions of the peripheral vasculature. The mechanism of operation of the non-therapeutic inflatable balloon elements at the distal tip of the Houdini Catheter is similar to the Enabler and facilitates stability, visual orientation and placement of the central quidewire. The Houdini Catheter has the same intended use and indication for use as the Enabler.

Characteristic	Houdini Catheter – Subject Device	Predicate Device Endocross, Enabler-P Catheter (K083833)
Intended Use	Intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.	Intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange
Nominal Balloon Diameter	Model CM-3400: 4mmModel CM-3500: 5mmModel CM-3600: 6mm	6mm

A comparison the technological characteristics of the Houdini Catheter and the predicate Endocross Enabler-P Catheter (K083833) is tabulated below.

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Characteristic	Houdini Catheter – SubjectDevice	Predicate Device Endocross,Enabler-P Catheter (K083833)
	Model CM-3700: 7mmModel CM-3800: 8mm
Catheter EffectiveLength	100cm	103cm
Maximum BalloonWorking Length	2cm	2cm
Anchoring InflationPressure	6atm	1.5atm
Maximum WorkingPressure	12atm	6atm
Rated BurstPressure	16atm	10atm
Catheter ShaftDiameter	5Fr	5Fr
Guidewire Size	0.014 - 0.035 inches	0.035 inches
Introducer SheathSize	6Fr	7Fr
Peak Force Delivery	0.35kgf to 0.71kgf	0.026Kgf to 0.185
Sterilization Method	Ethylene Oxide	Ethylene Oxide

7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the Houdini Catheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and thrombogenicity. Biocompatibility test results indicate that the device materials are biocompatible.

Simulated Use Testing

The Houdini Catheter was subjected to simulated use testing to assess device insertion, deployment and device removal.

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Performance Bench Testing

The Houdini Catheter has completed the performance bench tests as listed below. Test results indicate that the device satisfies functional performance requirements when used as indicated.

Simulated use validation ●
- Device insertion, deployment, removal
- o Surface, Distal Tip, ISO 10555-1
- o Introducer sheath sizing
Radio-detectability, ASTM F640-12 ●
Peak tensile force, ISO 10555-1 Annex B ●
. Pressurization Performance
- Freedom from fluid leakage, ISO 10555-1 Annex C
- o Freedom from Air leakage, Hubs, ISO 10555-1 Annex D
- Burst pressure, ISO 10555-1 Annex F o
- o Inflation pressure vs. diameter
- Peak delivery force versus inflation pressure
Dimensional verification ●
Tensile strength
Torque load ●
. Crossing Profile
Kink Resistance

8. CONCLUSIONS

A comparison of the technological characteristics between the Houdini Catheter and the predicate Endocross, Enabler-P Catheter shows that they are largely similar. While there are some differences in technological characteristics between the subject device and the predicate device, these differences do not raise new questions of safety or effectiveness. The performance data for the Houdini Catheter demonstrate that it should perform as intended for the indicated use, the same indicated use as the predicate device. Therefore, the subject device is substantially equivalent.

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).