(263 days)
The CiTop™ Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
The CiTop™ Guidewire has an outside diameter of 0.014" (0.36 mm) and a length of 280 cm. The CiTop™ 0.014" Guidewire can be torqued to facilitate navigation through the vasculature. A handle control is supplied with the guidewire to facilitate torque and tip shaping for deployment and positioning according to standard practices. The distal tip can be momentarily shaped into an arched formation by the operator to aid in releasing a wedged guidewire and allow its advancement through difficult occlusions. A platinum marker coil at the distal tip aids visualization under fluoroscopy. The CiTop™ Guidewire is supported by a stainless steel helical cut accessory shaft with an outside diameter of 0.023" and length of 126cm. The support accessory may be independently torqued and its distal end shaped. The support accessory operates as an aid in the advancement of the CiTop™ Guidewire and as an adjustment to the flexibility of the distal end of the CiTop™ Guidewire . The CiTop™ 0.014" Guidewire is supplied in a protective dispenser, that is packaged in a single-use sterilizeable pouch. The Pouch is labeled, and placed in an individual protective carton for sterilization. The CiTop™ 0.014" Guidewire is a single use/disposable product with a nitinol shaped tip. The Guidewire is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small-diameter, tortuous vasculature.
Here's a breakdown of the acceptance criteria and the study information for the CiTop™ 0.014" Guidewire, based on the provided text:
Preamble: This document describes a traditional medical device (guidewire), not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study aspects related to AI (like standalone performance, MRMC studies, training set data, etc.) are not applicable or explicitly stated in this type of 510(k) summary. The evaluation focuses on physical characteristics, biocompatibility, and substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a physical medical device and not an AI algorithm, the "acceptance criteria" are not reported as specific performance metrics with numerical thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, they are framed as compliance with recognized standards and established performance expectations for guidewires. The reported device performance confirms these general criteria were met.
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 (external communicating, blood contact, short duration) | Materials test results confirmed biocompatibility. |
| Safety and effectiveness as confirmed by design analysis, in vitro, and in vivo data | Design analysis, in vitro and in vivo data confirm the safety and effectiveness, and substantial equivalence to predicate devices. |
| Compliance with FDA's Coronary and Cerebrovascular Guidewire Guidance Document (January 1995) | Device evaluation included in vitro tensile, torque strength, torqueability, tip flexibility, biocompatibility, and catheter compatibility tests (as specified in the guidance document). All data was within device specification requirements, standard requirements, and predicate performance expectations. |
| Substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to predicate devices | The CiTop™ Guidewire is substantially equivalent to predicate devices (Asahi PTCA & PTA guidewire Confianza Pro K041531, Cordis STEER-IT Guidewire K040592, LuMend Frontrunner CTO Catheter and Accessories K013284) based on indications for use, technological characteristics, and safety and performance testing. The components are similar in basic materials, design, construction, and performance. The distal tip is designed to improve performance in passing total occlusions (tip flexibility, shaping, retention/relaxation). |
| Yielding acceptable safety & performance outcomes | Subject product testing yielded acceptable safety & performance outcomes. Verification performance testing also yielded acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a number of guidewires or test repetitions. The document refers to "in vitro" and "in vivo" data, and "subject product testing" and "verification performance testing," implying various tests were conducted. However, specific sample sizes for these tests are not provided.
- Data Provenance: The study was conducted by OVALUM Ltd. based in Rehovot, Israel. The studies involved "in vitro" and "in vivo" data. Whether the "in vivo" data involved human subjects, and if so, their country of origin or whether it was retrospective/prospective, is not detailed in this summary. Given the context of a 510(k) for a physical device, "in vivo" might refer to animal studies or limited human trials, but this is not clarified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as this is a physical medical device. The "ground truth" for guidewire performance is typically based on objective physical measurements (e.g., tensile strength, torqueability values) and observed functional performance, not human expert consensus on interpretations as would be the case for an imaging AI.
4. Adjudication Method for the Test Set
This information is not applicable for a physical guidewire. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic tasks, not for evaluating the physical properties and performance of a device like a guidewire.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic imaging AI algorithms and their impact on human reading performance. It is not applicable to a physical medical device like a guidewire.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not Applicable. This concept applies to AI algorithms. The CiTop™ Guidewire is a physical device used by a human operator; it does not have a standalone "algorithm-only" mode.
7. The Type of Ground Truth Used
The "ground truth" for the CiTop™ Guidewire was established through:
- Objective physical measurements: In vitro tests of tensile strength, torque strength, torqueability, tip flexibility, and catheter compatibility.
- Biocompatibility testing: Adherence to ISO 10993-1 standards.
- Performance observations: In vivo data and subject product testing to assess functional characteristics and comparison against predicate device performance expectations.
8. The Sample Size for the Training Set
Not Applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles, material science, and iterative testing, not by training a model on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no "training set" ground truth in the AI sense for this device. The design and development of the guidewire rely on established engineering principles, material science knowledge, and adherence to regulatory guidance documents (like the FDA's Coronary and Cerebrovascular Guidewire Guidance Document).
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510(k) Summary CiTop™ 0.014" Guidewire
Date: August 29, 2007
Submitter Information:
JCI 1 2 /007
OVALUM Ltd. 10. Plaut St. Rabin Industrial Park, Rehovot Israel 76706 Tel: (972)-8-9315679 Fax: (972)-8-9318107
Contact Person:
Naáma Oren Director of QA and Regulatory Affairs
Device Identification
| Trade Name: | CiTop™ 0.014" Guidewire |
|---|---|
| Device Common Name: | Catheter Guide Wire |
| Classification Name: | Catheter Guide Wire |
| Classification: | Class II (74 DQX/21CFR 870.1330) |
Predicate devices:
The CiTop™ 0.014" Guidewire is substantially equivalent to the following predicate devices:
- · Asahi PTCA & PTA guidewire Confianza Pro cleared under K041531
- · Cordis STEER-IT Guidewire cleared under K040592;
- · LuMend Frontrunner CTO Catheter and Accessories K013284
Device Description:
The CiTop™ Guidewire has an outside diameter of 0.014" (0.36 mm) and a length of 280 cm.
The CiTop™ 0.014" Guidewire can be torqued to facilitate navigation through the vasculature. A handle control is supplied with the guidewire to facilitate torque and tip shaping for deployment and positioning according to standard practices. The distal tip can be momentarily shaped into an arched formation by the operator to aid in releasing a wedged guidewire and allow its advancement through difficult occlusions. A platinum marker coil at the distal tip aids visualization under fluoroscopy.
The CiTop™ Guidewire is supported by a stainless steel helical cut accessory shaft with an outside diameter of 0.023" and length of 126cm. The support accessory may be independently torqued and its distal end shaped. The support accessory operates
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as an aid in the advancement of the CiTop™ Guidewire and as an adjustment to the flexibility of the distal end of the CiTop™ Guidewire .
The CiTop™ 0.014" Guidewire is supplied in a protective dispenser, that is packaged in a single-use sterilizeable pouch. The Pouch is labeled, and placed in an individual protective carton for sterilization.
The CiTop™ 0.014" Guidewire is a single use/disposable product with a nitinol shaped tip. The Guidewire is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small-diameter, tortuous vasculature.
Intended Use
The CiTop™ Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
Technological Characteristics
The components of the CiTop™ 0.014" Guidewire are similar in basic materials. design, construction and performance to the predicate devices. The distal tip has been designed to improve performance characteristics in passing total occlusions (i.e. tip flexibility, tip shaping and shape retention / relaxation).
Safety and Performance Testing
Biocompatibility of the CiTop™ 0.014" Guidewire materials has been verified in accordance with ISO 10993-1. Biological evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) device.
Design analysis, in vitro and in vivo data confirm the safety and effectiveness of the device and that the basic functional characteristics are substantially equivalent to the predicate devices cited. Device evaluation based on testing specified in the FDA's Coronary and Cerebrovascular Guidewire Guidance Document (January 1995) and included in vitro tensile, torque strength, torqueability, tip flexibility, biocompatibility and catheter compatibility tests. All data was within device specification requirements, as well as standard requirements and predicate performance expectations. Subject product testing has yielded acceptable safety & performance outcomes.
In addition, verification performance testing also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate that the CiTop™ 0.014" Guidewire is substantially equivalent to the cited predicate devices.
Summary of Substantial Equivalence
Based on the indications for use, technological characteristics, and safety and performance testing, the subject CiTop™ 0.014" Guidewire meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available guidewires/cited predicates.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
307 1 2 2007
Ovalum, Ltd. c/o Mr. Jonathan Kahan Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004
Re: K070212
Trade/Device Name: CiTop Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: August 31, 2007 Received: August 31, 2007
Dear Mr. Kahan:
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 such 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 – Mr. Jonathan Kahan
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Directo Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number(if known): | K070212 | ||
|---|---|---|---|
| Device Name: | CiTop™ 0.014" Guidewire | ||
| Indications for Use: | The CiTop™ Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. | ||
| Prescription Use | X | OR | Over the Counter Use |
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109 subpart
D)
IF NEEDED)
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(Division Sign-Off) Division of Cardiovasculur Des 510(k) Number_for 0212
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.