(69 days)
The CrossCath Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
CrossCath Support Catheters with hydrophilic coating are single lumen intravascular catheters, designed to support a wire guide during access of vasculature, allow for exchange of wire guides, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
CrossCath Support Catheters are available in nine different configurations. All models have three radiopaque markers spaced equally along the distal shaft to aid in estimating lengths within the vascular system. The distal radiopaque maker is positioned approximately 3 mm from the catheter tip. Each model has a smaller distal portion for passing through smaller vasculature and a larger proximal portion for additional support. The models with 0.014" and 0.018" end holes have hydrophilic coating at the distal 40 cm portion. The models with 0.035" end holes have hydrophilic coating at the distal 60 cm portion.
Here's an analysis of the provided text regarding the CrossCath Support Catheter, outlining the acceptance criteria and study details based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tensile Testing | Device maintains structural integrity under tension. (Implied for safe use) | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." |
| Leakage Testing | Device does not leak fluids during operation. (Implied for safe and effective fluid delivery) | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." |
| Burst Pressure Testing | Device withstands specified internal pressures without bursting. (Implied for safe fluid delivery) | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." |
| Flow Rate Testing | Device allows for adequate flow of saline solutions or contrast agents. (Implied for effective diagnostic/interventional procedures) | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." |
| Accelerated Aged Testing | Device maintains performance characteristics after simulated aging. (Implied for shelf-life and long-term stability) | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." |
| Biocompatibility Testing | Device materials are compatible with biological systems and do not elicit adverse reactions. (Implied for patient safety) | Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." |
Note: The provided text does not explicitly state quantitative acceptance criteria for each test. Instead, it offers a general statement that the results of these tests "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." This is typical for a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting detailed test reports. The implied criteria are derived from the nature of the tests and the intended use of the device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for the Test Set: Not specified. The document lists the types of tests performed but does not provide details on the number of units tested for each.
- Data Provenance: Not explicitly stated. The tests were performed by "Cook Incorporated," indicating they were likely internal tests; however, the country of origin of the data (e.g., in terms of where the samples were manufactured or tested) is not mentioned beyond the company's location in Bloomington, IN, USA. The study appears to be retrospective in the sense that the testing was performed on a completed device design to demonstrate its performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This device is a medical instrument (catheter), not a diagnostic algorithm that requires expert human interpretation for ground truth establishment. The "ground truth" for these tests would be objective measurements and adherence to established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is not a diagnostic device requiring human interpretation, there's no "adjudication method" in the sense of expert consensus on image or data interpretations. The tests performed are objective, measurable, and evaluated against predetermined specifications by engineers or technicians.
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 is a physical medical device (catheter), not an AI diagnostic tool. Therefore, an MRMC study or a study involving human readers with/without AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. As mentioned above, this is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used:
- For the physical tests (Tensile, Leakage, Burst Pressure, Flow Rate, Accelerated Aged): The "ground truth" is defined by engineering specifications and validated testing methodologies that ensure the device meets its functional requirements.
- For Biocompatibility Testing: The "ground truth" is established through recognized industry standards (e.g., ISO 10993) and testing protocols designed to assess biological responses to materials.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would involve iterative development and testing, analogous to "training" in a broad sense, but not a distinct dataset for algorithm training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no "training set" for an algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to quality systems (e.g., ISO 13485), engineering principles, and regulatory requirements (e.g., 21 CFR Part 820 for good manufacturing practices), which guide the development and production of medical devices.
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K093052 page lot 2
Special 510(k): Device Modification CXC Support Catheter Cook Incorporated 29 September 2009
DEC - 8 2009
510(k) SUMMARY
Submitted By:
Molly Busenbark Cook Incorporated 750 Daniels Way Bloomington, IN 47404
Device:
Trade Name: Proposed Classification: CrossCath Support Catheter Catheter, Continuous Flush KRA (21 CFR §870.1210)
Indications for Use:
The CrossCath Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
Predicate Device:
The CrossCath Support Catheter is similar in terms of intended use, principles of operation, materials of construction, and technological characteristics to the predicate device reviewed as a device for use in small vessel or superselective anatomy for diagnostic and interventional procedures.
Device Description:
CrossCath Support Catheters with hydrophilic coating are single lumen intravascular catheters, designed to support a wire guide during access of vasculature, allow for exchange of wire guides, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
CrossCath Support Catheters are available in nine different configurations. All models have three radiopaque markers spaced equally along the distal shaft to aid in estimating lengths within the vascular system. The distal radiopaque maker is positioned approximately 3 mm from the catheter tip. Each model has a smaller distal portion for passing through smaller vasculature and a larger proximal portion for additional support. The models with 0.014" and 0.018" end holes have hydrophilic coating at the distal 40 cm portion. The models with 0.035" end holes have hydrophilic coating at the distal 60 cm portion.
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K093052 page 262
Special 510(k): Device Modification CXC Support Catheter Cook Incorporated 29 September 2009
Substantial Equivalence:
Cook Incorporated currently markets the predicate CXI Support Catheter, cleared for marketing on November 9, 2007 (D.C. #K072724). The similar indications for use, principals of operation, and technological characteristics of the CrossCath Support Catheter as compared to the predicate device support a determination of substantial equivalency.
Test Data:
The proposed CrossCath Support Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- Tensile Testing
- 트 Leakage Testing
- Burst Pressure Testing
- 트 Flow Rate Testing
- Accelerated Aged Testing
- 트 Biocompatibility Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Cook Incorporated c/o Ms. Molly Busenbark Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402-0489
Re: K093052
Trade/Device Name: CrossCath Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II (two) Product Code: KRA Dated: November 3, 2009 Received: November 4, 2009
Dear Ms. Busenbark:
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.
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.
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Page 2 - Ms. Molly Busenbark
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
pmua R.V.V.hmer
A 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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Special 510(k): Device Modification CrossCath Support Catheter Cook Incorporated 29 September 2009
Indications for Use
510(k) Number (if known):
Device Name: CrossCath Support Catheter
Indications for Use for the CrossCath Support Catheter:
The CrossCath Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
Prescription Use XX (Part 21 CFR 801 Subpart D) i OR Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vic hnes
(Division Sign-Off) Division of Cardiovascular Devices
510/k) Numbiar K09 3052
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).