(357 days)
No
The device description and performance studies focus on the mechanical and material properties of a catheter and do not mention any computational or data-driven features indicative of AI/ML.
No
The device is described as a catheter used to access and exchange guidewires within the peripheral vasculature, which are procedural steps, not a direct treatment for a disease or condition. While it aids in procedures that might be therapeutic, the device itself is a tool for access and support rather than a therapeutic agent.
No
The device is described as a catheter used for guidewire exchange and to access discrete regions of the peripheral vasculature. Its purpose is to facilitate the placement or exchange of guidewires, not to diagnose a medical condition.
No
The device description clearly outlines a physical, single-use intravascular catheter with lumens, shafts, and an anchoring balloon, requiring physical manipulation and interaction with other hardware (guidewire, inflation device). This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access discrete regions of the peripheral vasculature and for guidewire exchange. This is a procedural device used within the body for mechanical purposes.
- Device Description: The description details a catheter used for navigating blood vessels, supporting guidewires, and potentially anchoring. This is consistent with an interventional medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
- Anatomical Site: The device is used directly within the peripheral vasculature. IVDs typically analyze samples taken from the body.
In summary, the Houdini Cross Support Catheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device used for testing biological samples.
N/A
Intended Use / 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 guidewire exchange.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
peripheral vasculature, iliac. femoral, ilio-femoral and popliteal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 testing has been completed in support of the substantial equivalence determination, including bench testing, biocompatibility, and simulated use testing.
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
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.
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
October 20, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The logo is simple and professional, reflecting the organization's role in regulating food and drugs.
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
1
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
2
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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3
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. |
4
5. 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.
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.
5
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Characteristic | Houdini Cross | ||
| Support Catheter | Houdini Catheter | ||
| (K151896) | XO Cross Support | ||
| Catheter (K193420) | |||
| Indications for 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. | Intended to guide and | ||
| support a guidewire | |||
| during access of the | |||
| peripheral vasculature, | |||
| allow for wire | |||
| exchanges and provide | |||
| a conduit for the | |||
| delivery of saline | |||
| solutions or diagnostic | |||
| contrast agents. | |||
| Guidewire | |||
| Compatibility | 0.014" - 0.018" | 0.014" - 0.035" | 0.014" - 0.035" |
| Sheath Compatibility | 6 Fr | 6 Fr | 4 Fr |
| Catheter Outer | |||
| Diameter | 5 Fr | 5 Fr | 2 Fr - 4 Fr |
| Catheter Effective | |||
| Length | 100 cm | 100 cm | 90, 135, 150, 175 cm |
| Labeled Balloon | |||
| Diameter | 5mm | ||
| 6mm | 4mm | ||
| 5mm | |||
| 6mm | |||
| 7mm | |||
| 8mm | No balloon component | ||
| Balloon Length | 2 cm | 2 cm | No balloon component |
| Anchoring Inflation | |||
| Pressure | 6 atm | 6 atm | |
| Maximum Working | |||
| Pressure | 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.
6
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 ●
7
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.