(133 days)
The Cordis AGILITY™ Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.
The hydrophilically coated AGILITY Steerable Guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the AGILITY Guidewire.
The provided 510(k) summary (K991646) describes the Cordis AGILITY™ Steerable Guidewires, a Class II device intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.
However, it is important to note that this document does not contain specific acceptance criteria for performance metrics in a numerical form nor does it present a detailed study proving the device meets said criteria in the way typically expected for AI/ML medical devices.
Instead, for this type of medical device (guidewire), "acceptance criteria" are implied by the comparative testing against predicate devices to establish substantial equivalence. The "study" in this context refers to the in-vitro and animal testing performed to demonstrate that the AGILITY Guidewire performs "as well or better than" the predicate devices.
Here's an attempt to structure the information based on the provided text, acknowledging the limitations for an AI/ML context:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Implied Acceptance Criteria: Perform "as well or better than predicate devices") | Reported Device Performance (Summary) |
|---|---|
| Tensile Strength | Performed "as well or better than predicate devices" |
| Torque Strength | Performed "as well or better than predicate devices" |
| Torque Response | Performed "as well or better than predicate devices" |
| Tip Flexibility | Performed "as well or better than predicate devices" |
| Lubricity | Performed "as well or better than predicate devices" |
| Kink Resistance | Performed "as well or better than predicate devices" |
| Biocompatibility (materials) | All appropriate tests successfully performed |
| Functionality in-vivo (animal study) | Device works as intended |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the in-vitro comparative tests (e.g., number of guidewires tested for tensile strength).
For the animal study, the sample size is not mentioned.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated, but these are typically prospective laboratory and animal studies conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable in the context of this device and study type. Ground truth for mechanical and biological performance of a guidewire is established by standardized testing methods, not expert consensus on images or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. Mechanical and biocompatibility tests have objective pass/fail or quantitative measurements, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a medical device (guidewire), not an AI/ML system for image interpretation, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way relevant to this device type. The in-vitro and animal studies assess the device's inherent performance and safety characteristics independently of a human operator's specific skill set beyond standard surgical handling. The performance is of the physical device itself.
7. The Type of Ground Truth Used
- For in-vitro tests: The "ground truth" is based on objective, quantifiable measurements of physical properties (e.g., force required for tensile break, torque applied, coefficient of friction for lubricity) as defined by established engineering and material science standards and compared against predicate devices.
- For biocompatibility: Ground truth is established by adherence to recognized standards for material safety, often involving cell culture tests, sensitization tests, and toxicity tests.
- For animal study: The "ground truth" for intended function (e.g., steerability, ability to navigate vasculature, lack of adverse tissue reaction) is observed and assessed in a live biological system.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this device does not utilize a "training set" in the context of AI/ML.
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SEP 2 3 1999
K991646
0-000032
510(k) Summary of Safety and Effectiveness
| Submitter's Name/Contact Person | Alina CaraballoRegulatory Affairs ManagerCordis Endovascular Systems14000 NW 57 CourtMiami Lakes, FL 33014Tel: (305) 512-6518 |
|---|---|
| Trade Name | The trade name is :AGILITY™ Steerable Guidewires. |
| Classification | This is a Class II Device. |
| Performance Standard | The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this device. |
| Device Description | The hydrophilically coated AGILITY Steerable Guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the AGILITY Guidewire. |
| Intended Use | The Cordis AGILITY™ Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature. |
Continued on next page
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510(k) Summary of Safety and Effectiveness, Continued
| Device | Company | Product Code | Predicate for: |
|---|---|---|---|
| Dasher® - 10 | Target Therapeutics | DQX | • Intended use• Sterilization• method• Design• Corewire and coil• material• Performance |
| TRANSEND™Guidewire | Target Therapeutics(BSC) | DQX | • Hydrophilic• coating |
| INSTINCT™Guidewire | Cordis Corporation | DQX | • Intended Use• Sterilization• Packaging |
| ESSENCE™Guidewire | Cordis EndovascularSystems, Inc. (CES) | DQX | • Intended Use• Sterilization• Manufacturing |
The predicate devices are listed in the table below: Predicate Devices
In-vitro testing showed that the Agility Guidewire performs as well or better than the Summary of predicate devices tested. No new questions of safety and effectiveness were raised. Studies Comparative testing included:
- Tensile Test
- Torque Strength .
- . Torque Response
- . Tip Flexibility
- . Lubricity Testing
- Kink Resistance .
Animal study testing indicated that the device works as intended.
All appropriate biocompatibility tests were successfully performed on the materials used to manufacture the AGILITY™ Guidewire.
The AGILITY™ Steerable Guidewire is similar in its basic design, construction, indication Summary of for use, and performance characteristics to the predicate devices. Substantial Equivalence
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract caduceus symbol with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
Public Health Service
SEP 2 3 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Alina Caraballo Manager, Regulatory Affairs Cordis Endovascular Systems P.O. Box 025700 Miami, FL 33102-5700
K991646 Re : AGILITY™ Steerable Guidewires Trade Name: Requlatory Class: II Product Code: DOX September 13, 1999 Dated: Received: September 14, 1999
Dear Ms. Caraballo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices
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Page 2 - Ms. Alina Caraballo
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number: K991646
Indications for Use Statement
The Cordis Endovascular AGILITY™ Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use /
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Chtopm. A
Division Sign-Off)
ISIR Intravascular Respiratory,
S No & Devices
PMK Number K991646
§ 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.