(28 days)
The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
The guide wire is comprised of a stainless steel tapered core with a flexible tip, jacketed by tungsten-loaded polyurethanc on the distal portion and polytetrafluoroethylenc (PTFE) on the proximal portion of the wire. The polyurethane is covered with a hydrophilic coating to increase lubricity. The guide wire is 190 cm long with a maximum outer diameter of 0.0145. The guide wires are available with cither a straight distal tip that is shapeable, or a preformed 'J' distal tip shaped specifically for accessing the coronary sinus.
The provided text describes a 510(k) submission for a medical device, the HI-TORQUE® WHISPER VIEW™ Guide Wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing a separate de novo study with novel acceptance criteria.
Therefore, the information you're requesting regarding explicit acceptance criteria and a detailed study proving the device meets them, especially in the context of AI/ML performance, ground truth, and expert adjudication, is not present in this document. The submission relies on verification testing to show equivalence to the predicate device.
Here's an analysis based on the provided text, addressing your points where possible, and indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The implicit criteria are that the device performs equivalently to the predicate device in terms of safety and effectiveness. | "The results of verification testing demonstrate that the HI-TORQUE® WHISPER VIEW™ Guide Wire meets established acceptance criteria and performs in a manner equivalent to the predicate device." "No new safety or effectiveness issues were raised during testing." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided.
- Data provenance: Not provided (e.g., country of origin, retrospective/prospective). The document describes "verification testing," but details about the test set are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable/not provided. The submission is for a physical medical device (guide wire) and not an AI/ML-based diagnostic system that would typically involve establishing ground truth from expert interpretations of data.
4. Adjudication method for the test set
- This information is not applicable/not provided. As above, this pertains to expert review of data for AI/ML systems.
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
- No. This is a physical device, not an AI/ML application. An MRMC study is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical device, not an AI/ML algorithm.
7. The type of ground truth used
- Not explicitly stated in the sense of 'ground truth' for an AI/ML system. For a physical medical device, "ground truth" would relate to the physical and functional properties of the device meeting engineering specifications and performance expectations. The document refers to "verification testing" comparing the device to its predicate.
8. The sample size for the training set
- Not applicable/not provided. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/not provided. As above, this is for an AI/ML model.
Summary from the document:
The submission focuses on demonstrating substantial equivalence of the HI-TORQUE® WHISPER VIEW™ Guide Wire to the predicate device, HI-TORQUE® WHISPER™ Guide Wire (K030019). The modifications are an increased tungsten load in the polyurethane coating and a change in the tempering method for the stainless steel wire core.
The study (referred to as "verification testing") demonstrated that the modified device:
- "meets established acceptance criteria" (though these criteria are not detailed in the provided text).
- "performs in a manner equivalent to the predicate device."
- Raised "no new safety or effectiveness issues."
This implies that the "acceptance criteria" were primarily related to the physical, mechanical, and functional performance of the guide wire, ensuring it operates safely and effectively in the same way as the predicate device. The evidence for meeting these criteria comes from internal "verification testing" conducted by the manufacturer, rather than external clinical trials or studies involving human experts interpreting diagnostic output.
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JUN 22 2006
Whisper View Special 510(k) Submission Attachment 4
K061453
page 1 of 2
510(K) SUMMARY
ﯩﭗ.
| Submitter: | Guidant Corporation |
|---|---|
| Cardiac Rhythm Management (CRM) | |
| 4100 Hamline Avenue North | |
| St. Paul, Minnesota 55112-5498 | |
| Contact: | Kathleen Vittum |
| Regulatory Affairs Associate | |
| Telephone: | (800) 227-3422 or direct (651) 582-4820 |
| FAX: | (612) 582-5134 |
| Email: | kathleen.vittum@guidant.com |
| Date of Summary: | May 23, 2006 |
| Trade Name: | HI-TORQUE WHISPER VIEW™ Guide Wire, Model #4631-4639 |
| Common Name: | Guide Wire |
| Classification Name: | Catheter Guide Wire, (21 CFR 870.1330, Product Code DQX) |
| Predicate | HI-TORQUE WHISPER™ Guide Wire, K030019 |
Device Description
The guide wire is comprised of a stainless steel tapered core with a flexible tip, jacketed by tungsten-loaded polyurethanc on the distal portion and polytetrafluoroethylenc (PTFE) on the proximal portion of the wire. The polyurethane is covered with a hydrophilic coating to increase lubricity. The guide wire is 190 cm long with a maximum outer diameter of 0.0145. The guide wires are available with cither a straight distal tip that is shapeable, or a preformed 'J' distal tip shaped specifically for accessing the coronary sinus.
Intended Use
The HI-TORQUE® WHISPER VIEW™ Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
Technological Characteristics
The HI-TORQUE® WHISPER VIEW™ Guide Wire is identical to the predicate III-TORQUE® Whisper Wire in all respects with the exception of two modifications -- an
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Whisper View Special 510(k) Submission Attachment 4
061453
page 2 of 2
increased tungsten load in the polyurethane coating and a change in the tempering method for the stainless steel wire core.
Performance data
The results of verification testing demonstrate that the HI-TORQUE® WHISPER VIEW™ Guide Wire meets established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during testing.
Conclusion
The Guidant HI-TORQUE® WHISPER VIEW™ Guide Wire is similar to the predicate WHISPER Guide Wire with respect to intended use, materials, technological characteristics and performance properties, and uses sterilization processes identical to the predicate device. Testing did not identify any new safety or effectiveness concerns. Therefore the HI-TORQUE® WHISPER VIEW™ Guide Wire is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings, stylized in a simple, bold line drawing. The eagle's head is turned to the right, and its wings are depicted with three parallel lines each.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 222 2006
Guidant Corporation c/o Ms. Kathleen Vittum Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K061453
Trade Name: Hi-Torque Whisper View Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: May 24, 2006 Received: May 25, 2006
Dear Ms. Kathleen Vittum:
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 -- Ms. Kathleen Vittum
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 Office of Compliance at (240) 276- 0120 (see bottom for #s). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Bfimmimor for
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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Whisper View Special 510(k) Submission Attachment 2
INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications For Use:
HI-TORQUE WHISPER VIEW™ GUIDE WIRE
The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
Prescription Use: X AND/OR
Over-The-Counter Use:
(Part 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)
Blumena
(División Sign-Off)
Division of Cardiovascular Devices
510(k) Number K06453
§ 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.