(88 days)
The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires).
Here's an analysis of the provided text regarding the SCIMED® Luge™ Guide Wire, focusing on the requested information.
It's important to note that the provided documents are a 510(k) summary and FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study reports with detailed performance metrics against pre-defined acceptance criteria. Therefore, some of the requested information, particularly regarding specific performance metrics, sample sizes for training/test sets, ground truth establishment for AI/ML models, and detailed adjudication methods, is not present in these documents. The device cleared is a guide wire, which is a medical device, not an AI/ML diagnostic tool, thus many of the AI/ML specific questions are not applicable.
Acceptance Criteria and Study for SCIMED® Luge™ Guide Wire
The SCIMED Luge Guide Wire's acceptance criteria and proven performance are based on its substantial equivalence to previously marketed SCIMED Guide Wires (ChoICE, Sceptor, and ChoICE PT Families). The study primarily involved non-clinical testing and comparison of design and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Benchmark | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | Facilitate placement/exchange of balloon catheters/therapeutic devices during PTCA or other intravascular interventional procedures. Not for cerebral vasculature. Single procedure use. | Met: Device has the same intended use as predicate devices. |
| Technological Characteristics Equivalence | Utilize same materials and methods of construction as predicate devices (ChoICE, Sceptor, ChoICE PT Families). | Met: Utilizes the same materials and methods of construction. |
| Non-Clinical Testing & Evaluation (Overall) | Performance comparable to predicate devices in relevant non-clinical tests. | Met: Considered substantially equivalent based on testing and evaluations performed. |
| Substantial Equivalence (Overall) | Demonstrated substantial equivalence to a legally marketed predicate device. | Met: FDA determined the device is substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a clinical trial demonstrating new performance metrics. The comparison is based on the design, materials, manufacturing processes, and non-clinical testing results against existing predicate devices.
- Data Provenance: The data provenance is from non-clinical testing of the Luge Guide Wire and comparison with the design specifications and known performance characteristics of the predicate SCIMED Guide Wires. This is retrospective in the sense that it relies on established data and designs of existing products. The country of origin for the data is implied to be within the US, where SCIMED Life Systems, Inc. is located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This device clearance is based on substantial equivalence to predicate devices through non-clinical testing and design comparison, not on establishing a "ground truth" for diagnostic accuracy by a panel of experts.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no clinical "test set" requiring expert judgment for ground truth, no adjudication method is described. The review process is handled by the FDA based on the submitted non-clinical data and comparisons.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is not mentioned as part of this 510(k) submission. These studies are typically for AI/ML diagnostic devices where the performance of human readers with and without AI assistance is evaluated. This device is a guide wire, not a diagnostic AI/ML system.
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 (guide wire), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" here is the established safety and effectiveness profile of the predicate devices (ChoICE, Sceptor, and ChoICE PT Families of Guide Wires) in their intended use. The Luge Guide Wire's equivalence is demonstrated against this established standard through physical and engineering comparisons.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the conventional sense for model development. The design and manufacturing processes are likely informed by years of experience and testing with previous guide wire designs, but not in the format of a discrete "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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510(k) Notification SCIMED® Luge™ Guide Wire
| Summary of Safety and Effectiveness, cont. | Section 4 | |
|---|---|---|
| JAN 12 1998 | ||
| Intended Use | The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only. | |
| Summary ofTechnologicalCharacteristics | The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires). | |
| Non-Clinical TestSummary | The Luge Guide Wire is considered to be substantially equivalent to the currently marketed ChoICE, Sceptor and ChoICE PT Families of Guide Wires based on a comparison of the intended uses and designs and results of the testing and evaluations performed. |
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized symbol of three human profiles facing right, stacked on top of each other, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Ms. Jill Townsend Regulatory Affairs Associate SCIMED Life Systems, Inc. One Scimed Place Maple Grove, MN 55311-1566
Re : K973945 SCIMED® Luge™ Guide Wire Requlatory Class: II (two) Product Code: DQX October 15, 1997 Dated: Received: October 16, 1997
Dear Ms. Townsend:
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 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 reqistration, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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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) 594-4648. 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" (21 CFR 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K973926
n/a
510(k) Number (if known):
Dental Implant Endosseous Device Name:
Indications For Use:
"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Ewald Shipp
(Division Sian-Off and Ga 510k) Nu
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.