(37 days)
The Approach Pro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
The Approach Pro ST Wire Guide consists of a stainless steel core wire coated with polytetrafluoroethylene (PTFE). The outside diameter of the Approach Pro ST Wire Guide is 0.014 inches and the device will be available in 135 cm, 190 cm, and 300 cm lengths. It will be supplied sterile and intended for one-time use.
The provided document describes a 510(k) premarket notification for a medical device, the Approach Pro ST Wire Guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy studies with predefined acceptance criteria and performance metrics typically associated with AI/ML devices or novel therapies.
Therefore, many of the requested categories related to acceptance criteria, study design for performance, ground truth establishment, expert adjudication, and AI/MRMC studies are not applicable to this document as it pertains to a traditional medical device demonstrating substantial equivalence through non-clinical bench testing.
Here's an breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable in the sense of clinical performance metrics, accuracy, sensitivity, or specificity. The acceptance criteria are implicit in the success of the various bench tests, demonstrating that the device meets engineering and safety standards. The "reported device performance" is that it successfully passed these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical integrity (bend, torque, tensile, fracture) | Successfully withstood specified mechanical stresses. |
| Biocompatibility | Passed biocompatibility testing. |
| Radiopacity | Demonstrated appropriate radiopacity. |
| Corrosion resistance | Passed corrosion resistance testing. |
| Sterility and safety (pyrogen, bioburden, endotoxin, EtO residuals) | Passed testing for pyrogens, bioburden, endotoxins, and EtO residuals. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified quantitatively in terms of individual device units tested for each test, but standard test methods would dictate appropriate sample sizes for each type of bench test (e.g., n=3, n=5, n=10 per batch, etc., as per ISO or ASTM standards).
- Data Provenance: The tests were performed internally by Cook Incorporated, a US-based company, as part of their premarket notification process. This is retrospective in the sense that the tests were completed before the submission to FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. For traditional medical devices undergoing bench testing for mechanical properties and biocompatibility, "ground truth" is established by adherence to recognized engineering standards, laboratory protocols, and validated analytical methods, not by expert medical consensus in the same way it would be for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" are relevant for clinical trials or diagnostic accuracy studies where there's a need to resolve discrepancies in expert opinions or clinical outcomes. For bench testing, results are typically objective measurements against a defined standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) for a traditional medical device (wire guide), not an AI/ML diagnostic tool. Therefore, MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical instrument, not an algorithm or software. Its performance is always in conjunction with a human operator.
7. The Type of Ground Truth Used
For the bench tests: Engineering standards, validated test methods, and material specifications. For example, a "Three Point Bend Test" would have an established maximum deflection or force requirement based on the expected mechanical properties of a functional wire guide. Biocompatibility would be determined against established ISO standards (e.g., ISO 10993).
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant.
In summary: The provided document is for a traditional medical device seeking 510(k) clearance by demonstrating substantial equivalence through non-clinical bench testing, not through clinical or AI/ML performance studies. Therefore, many of the requested details related to "acceptance criteria" and "ground truth" in the context of diagnostic accuracy or AI performance are not present or applicable. The "study" proving it meets "acceptance criteria" refers to a series of specific, enumerated bench tests that demonstrated the device's physical and biological properties are suitable for its intended use and comparable to the predicate device.
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Special 510(K) Premarket Notification Approach Pro ST Wire Guide COOK INCORPORATED January 18, 2011
510(k) Summary
Submitted By:
Aaron Santner, PhD Regulatory Science Associate Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402
Device:
Trade Name: Proposed Classification: Approach Pro ST Wire Guide Wire, Guide, Catheter 21 CFR §870.1330
Indications for Use:
The Approach Pro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Predicate Devices:
The Approach Pro ST Wire Guide is a modification of the Approach Pro LT Wire Guide, D.C. #K070410, which was cleared for commercial distribution on April 27, 2007.
Device Description:
The Approach Pro ST Wire Guide consists of a stainless steel core wire coated with polytetrafluoroethylene (PTFE). The outside diameter of the Approach Pro ST Wire Guide is 0.014 inches and the device will be available in 135 cm, 190 cm, and 300 cm lengths. It will be supplied sterile and intended for one-time use.
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FEB 2 5 2011
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Substantial Equivalence:
The Approach Pro ST Wire Guide is similar to many devices in commercial distribution for facilitating delivery of percutaneous catheters into the peripheral vascular system. The Approach Pro ST Wire Guide is a modification of the Approach Pro LT Wire Guide, D.C. #K070410, which was cleared for commercial distribution on April 27, 2007. The Approach Pro LT and Approach Pro ST Wire guides share identical indications for use, principles of operation, technological characteristics, and similar materials of construction, supporting a determination of substantial equivalence.
Test Data:
The Approach Pro ST Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests included:
- Three Point Bend Test 1.
-
- Corrosion Resistance Test
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- Radiopacity Evaluation
-
- Evaluation of Torque Response and Torque Strength
-
- Tensile Evaluation of the Distal Tip
- Q. Characterization of Loads Required to Deflect the Distal Tip
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- Evaluation of Resistance to Fracture
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- Evaluation of Resistance to Fracture after 3-Year Accelerated Aging
- Evaluation of Resistance to Damage by Flexing 9.
- Evaluation of Resistance to Damage by Flexing after 3-Year Accelerated Aging 10.
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- Biocompatibility Testing
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- Pyrogen Testing
- Bioburden Testing 13.
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- Endotoxin Testing
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- 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cook Incorporated c/o Aaron Santner, PhD Regulatory Science Associate 750 Daniels Way, PO Box 489 Bloomington, IN 47402
FEB 2 5 2011
Re: K110163
Trade/Device Name: Approach Pro ST Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 18, 2011 Received: January 27, 2011
Dear Dr. Santner:
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 - Aaron Santner, PhD
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
D. Zuckerman, M.D. Bra 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 Approach Pro ST Wire Guide
COOK INCORPORATED January 18, 2011
..
510(k) Number (if known): D.C. #K110163
Device Name: Approach Pro ST Wire Guide
Prescription Use __ X
Indications for Use: For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
1
(Per 21 CFR 801 Subpart D) (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number: | K110 163 |
OR
Over–the-Counter Use
(21 CFR 807 Subpart C)
§ 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.