(14 days)
Roll-X Coronary Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during intended to faoilitate the procedures. The Guidewire is not to be used in the cerebral blood vessels.
Roll-X™ Guidewire is a steerable guide wire constructed of a stainless steel core wire and a colled wire design at the distal end. The core wire is PTFE coated. The Roll-X Guidewire has a unique distal end design to enhance torque response and control. The distal end of the guidewire is shapeable and is radiopaque. The guide wire is provided sterile and non-pyrogenic.
The provided document describes the St. Jude Medical Roll-X™ Guidewire and its 510(k) premarket notification. This submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than a standalone clinical study with acceptance criteria and device performance metrics against those criteria.
Therefore, many of the requested elements (1, 2, 3, 4, 5, 6, 7, 8, 9) are not applicable or not extractable from this type of regulatory document.
However, I can extract information related to the overall regulatory strategy and non-clinical testing.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided: The document does not present specific acceptance criteria or quantitative performance metrics in a study-like format. Instead, it relies on demonstrating that the new device's technological characteristics are substantially equivalent to predicate devices. The "Summary of Non-Clinical Testing" broadly states that "Results of the testing demonstrate that the guidewire design meets product specifications and intended uses," but no specific criteria or performance data are listed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This document details non-clinical bench testing and animal evaluations, not human clinical trials. Therefore, a "test set" in the context of human data or origin is not relevant here. The non-clinical tests would have involved various samples of the guidewire itself, but the specific numbers are not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As this is a 510(k) submission based on substantial equivalence and non-clinical testing, there is no mention of experts establishing ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical test set requiring adjudication is described.
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 / Not Provided: This document describes a medical device (guidewire), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a guidewire, a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: For a medical device like a guidewire in a 510(k) submission, "ground truth" in the clinical sense is typically not established through these methods. Instead, the "truth" is established through engineering and performance testing against design specifications, recognized standards, and comparison to predicate devices, ensuring it performs as intended and safely.
8. The sample size for the training set
- Not Applicable / Not Provided: No mention of a training set as this is not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No mention of a training set.
Summary of the Study and Regulatory Strategy Presented in the Document:
The St. Jude Medical Roll-X™ Guidewire received 510(k) clearance based on demonstrating substantial equivalence to two predicate devices:
- ASAHI Prowater PTCA Coronary Guidewire (K052339)
- Hi-Torque Balanced Middleweight Universal Guidewire (K013833)
The "study" or evidence provided to meet this regulatory pathway consisted of:
- Non-clinical testing: This included in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life and package testing, and sterilization evaluation.
- Conclusion: The results of these non-clinical tests demonstrated that the guidewire design meets product specifications and intended uses, and that its intended use, design, material types, technology, and performance are equivalent to the predicate devices.
- Absence of New Safety/Effectiveness Issues: The submission concluded that there were "no differences between devices which would raise issues of safety or effectiveness."
This type of submission focuses on proving that a new device is "as safe and effective" as a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive standalone clinical trials with predefined acceptance criteria.
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082304
Image /page/0/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of squares on the left and the text "ST. JUDE MEDICAL" on the right. Below the text is the tagline "MORE CONTROL. LESS RISK."
AUG 2 7 2008
510(K) SUMMARY
1. Administrative Information
| Name: | St. Jude Medical |
|---|---|
| Address: | 14901 DeVeau PlaceMinnetonka, MN 55345 |
| Phone: | 763-383-2640 |
| Fax: | 763-383-2556 |
| Contact Person: | Jeff SturmPrincipal Regulatory Affairs Specialist |
| Date: | August 6, 2008 |
2. DEVICE INFORMATION
Name of Device: Common Name: Classification Name: Product Code:
Roll-X™ Guidewire Coronary Guidewire Catheter Guide Wire (870.1330) DOX
3. Predicate Device Information
Asahi Prowater PTCA Coronary Guidewire (Abbott)- K052339 cleared Nov 2005 Hi-Torque Balanced Middleweight Universal (Abbott)- K013833 cleared Jan 2002
Device Description ব
Roll-X™ Guidewire is a steerable guide wire constructed of a stainless steel core wire and a colled wire design at the distal end. The core wire is PTFE coated. The Roll-X Guidewire has a unique distal end design to enhance torque response and control. The distal end of the guidewire is shapeable and is radiopaque. The guide wire is provided sterile and non-pyrogenic.
ട്. INTENDED USE
The Roll-X Guidewire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures. The guidewire is not to be used in the cerebral blood vessels.
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Image /page/1/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of nine squares, with the center square rotated. To the right of the grid is the text "ST. Jude Medical" in a serif font. Below the text is the tagline "More control Less risk."
6. TECHNOLOGICAL CHARACTERISTICS
Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices.
7. SUMMARY OF NON-CLINICAL TESTING
Non-clinical testing of the Roll-X™ Guidewire includes in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life and package testing and sterilization evaluation. Results of the testing demonstrate that the guidewire design meets product specifications and intended uses.
8. SUBSTANTIAL EQUIVALENCE CONCLUSION
The Roll-X™ Guidewire described in this 510(k) is substantially equivalent to the ASAHI Prowater PTCA Coronary Guidewire (K052339) and Hi-Torque Balanced Middleweight Universal Guidewire (K013833). The intended use, design, material types, technology, and performance of the Roll-X™ Guidewire is equivalent to the predicate devices. There are no differences between devices which would raise issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or other bird-like figure. The emblem is stylized and composed of thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2008
St. Jude Medical c/o Mr. Jeff Sturm Principal Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345
Re: K082304
Trade/Device Name: Roll-X™M Coronary Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: August 12, 2008 Received: August 13, 2008
Dear Mr. Sturm:
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 forth in the quality
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Page 2 - Mr. Jeff Sturm
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 Biometrics' (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.
Duna R. Holmes
ABram D. Zuckerman, M.D. Director 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):
Device Name: Roll-X™ Coronary Guidewire
Indications for Use:
Roll-X Coronary Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during intended to faoilitate the procedures. The Guidewire is not to be used in the cerebral blood vessels.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
suma R.vo. Annes
(Division Sign-Off) (Division Sign of Cardiovascular Devices
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510(k) Number_K082304
§ 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.