(150 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML. The device is manually controlled by the physician.
No.
The device is a catheter used for accessing and exchanging guidewires in the peripheral vasculature; it does not directly treat a disease or condition, but rather facilitates a diagnostic or interventional procedure.
No
Explanation: The device is described as a catheter used for accessing regions of the peripheral vasculature and for guidewire exchange, as well as providing distal anchoring and supporting guidewire advancement. Its function is to facilitate interventional procedures, not to diagnose a condition.
No
The device description clearly details a physical catheter with lumens, a radiopaque marker, and a balloon that is inflated with contrast media. It also mentions requiring manual inflation devices. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the Houdini Catheter is an intravascular catheter intended for percutaneous use within the peripheral vasculature. It is used to access and exchange guidewires within blood vessels. This is an in vivo procedure (performed within the living body), not an in vitro procedure (performed outside the living body).
- Lack of Mention of Samples or Testing: The description focuses on the physical manipulation and placement of the catheter within the body and does not mention any collection or analysis of biological samples.
Therefore, the Houdini Catheter is a medical device used for interventional procedures within the body, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Illac, femoral, ilio-femoral and popliteal arteries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
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.
1
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
2
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 301 |
| Braintree, MA 02184 | |
| Telephone: 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 PART
NUMBER: 1160 |
|-------------------|----------------------------------------------------------|
| 510(k) Applicant: | ENDOCROSS, LTD |
| 510(k): | K083833 |
There has been no recall on the Endocross Enabler-P device.
4. 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
4
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).
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: 4mm | |
| Model CM-3500: 5mm | ||
| Model CM-3600: 6mm | 6mm |
A comparison the technological characteristics of the Houdini Catheter and the predicate Endocross Enabler-P Catheter (K083833) is tabulated below.
5
| Characteristic | Houdini Catheter – Subject
Device | Predicate Device Endocross,
Enabler-P Catheter (K083833) |
|-----------------------------------|------------------------------------------|-------------------------------------------------------------|
| | Model CM-3700: 7mm
Model CM-3800: 8mm | |
| Catheter Effective
Length | 100cm | 103cm |
| Maximum Balloon
Working Length | 2cm | 2cm |
| Anchoring Inflation
Pressure | 6atm | 1.5atm |
| Maximum Working
Pressure | 12atm | 6atm |
| Rated Burst
Pressure | 16atm | 10atm |
| Catheter Shaft
Diameter | 5Fr | 5Fr |
| Guidewire Size | 0.014 - 0.035 inches | 0.035 inches |
| Introducer Sheath
Size | 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.
6
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.