(87 days)
The Approach CTO Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
The Approach CTO Wire Guide is manufactured using a stainless steel wire with a PTFE coating and a stainless steel and platinum distal tip. The maximum outside diameter is 0.0142-inch and will be available in 135, 190 and 300 cm lengths. It will be supplied sterile, intended for one-time use.
The provided text describes a 510(k) premarket notification for the "Approach CTO Wire Guide." This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, rather than conducting a detailed clinical study with human readers and AI. Therefore, many of the requested elements pertaining to AI performance metrics, expert reviews, and large-scale clinical trials are not applicable to this type of regulatory submission.
Here's an analysis of the provided information in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission lists several tests performed. The "acceptance criteria" are implied by the successful completion of these tests as stated: "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide." Specific quantitative acceptance criteria or detailed results are not provided in this summary document.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device integrity under tensile stress | Tensile Test (Successfully performed; specific results not provided) |
| Ability to withstand tip loads | Tip Load Test (Successfully performed; specific results not provided) |
| Resistance to fracture | Fracture Test (Successfully performed; specific results not provided) |
| Durability under flexing | Flexing Test (Successfully performed; specific results not provided) |
| Resistance to bending | Bending Test (Successfully performed; specific results not provided) |
| Strength under torsional forces | Torque Strength Test (Successfully performed; specific results not provided) |
| Responsive to torque input | Torque Response Test (Successfully performed; specific results not provided) |
| Resistance to corrosion | Corrosion Resistance Test (Successfully performed; specific results not provided) |
| Biocompatibility with biological systems | Biocompatibility Testing (Successfully performed; specific results not provided) |
| Microbial load within acceptable limits | Bioburden Testing (Successfully performed; specific results not provided) |
| Endotoxin levels within acceptable limits | Endotoxin Testing (Successfully performed; specific results not provided) |
| EtO residuals within acceptable limits | EtO Residual Testing (Successfully performed; specific results not provided) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The tests performed are likely engineering bench tests on a sample of devices, not clinical trials with human subjects.
- Data Provenance: The tests were conducted internally by Cook Incorporated. This is not a clinical study, so concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the "test set" here refers to physical device testing, not a clinical dataset requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the "test set" here refers to physical device testing. Adjudication methods are relevant for clinical studies or image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Approach CTO Wire Guide is a physical medical device, not an AI diagnostic tool.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable for the reasons stated above.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? No. This is not an AI algorithm. The device is evaluated for its physical performance and safety characteristics.
7. Type of Ground Truth Used
- The "ground truth" for the device's performance is established by engineering specifications and recognized standards for wire guides. The device is expected to meet predefined physical and biological characteristics (e.g., tensile strength, corrosion resistance, biocompatibility). Successful completion of the listed tests confirms adherence to these engineering "ground truths."
8. Sample Size for the Training Set
This is not applicable. There is no AI model being trained for this device. The "training" for a physical device involves its design, manufacturing processes, and quality control, not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
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Specia =510(k) Premarket Notification Approach CTO Wire Guide COOK INCORPORATED
510(k) Summary
Submitted By:
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235
K08/337
AUG - 8 2008
Device:
Trade Name: Proposed Classification: Approach CTO Wire Guide Wire, Guide, Catheter 21 CFR §870.1330
Indications for Use:
The Approach CTO Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
Predicate Devices:
The Approach CTO Wire Guide is similar in terms of intended use, materials of construction and technological characteristics to predicate devices reviewed as devices for facilitating delivery of percutaneous catheters into the cardiovascular system.
Device Description:
The Approach CTO Wire Guide is manufactured using a stainless steel wire with a PTFE coating and a stainless steel and platinum distal tip. The maximum outside diameter is 0.0142-inch and will be available in 135, 190 and 300 cm lengths. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
The Approach CTO Wire Guide is similar to many devices in commercial distribution for facilitating delivery of percutaneous catheters into the cardiovascular system. The identical indications for use, principles of operations, similar materials of construction and technological characteristics of the wire guide support a determination of substantial equivalency.
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Test Data:
The Approach CTO Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
-
- Tensile Test
-
- Tip Load Test
-
- Fracture Test
-
- Flexing Test
-
- Bending Test
-
- Torque Strength Test
-
- Torque Response Test
-
- Corrosion Resistance Test
-
- Biocompatibility Testing
- Bioburden Testing 10.
-
- Endotoxin Testing
-
- EtO Residual 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 use as a wire guide.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
AUG - 8 2008
Re: K081337
Trade/Device Name: Approach CTO Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Dated: July 10, 2008 Received: July 11, 2008
Dear Ms. Bradburn:
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.
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
Image /page/2/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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Page 2 - Ms. Karen Bradburn
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) 276-3150. 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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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,
Donna R. Kuchner
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) Premarket Notification Cook MicroWire Wire Guide COOK INCORPORATED
510(k) Number (if known): K081337
Device Name: Approach CTO Wire Guide
Indications for Use:
Indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) annon a p to desse
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Ko8133
§ 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.