(143 days)
The SilverSpeed guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the mural, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
The SilverSpeed™ Hydrophilic Guidewire is a .010" diameter stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated from the shapeable platinum coil up to the proximal 30cm of the guidewire. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introduction of the guidewire into the catheter hub and or hemostasis valve.
The provided text describes the regulatory submission for the "SilverSpeed™ Hydrophilic Guidewire" and focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and proving performance against them through extensive clinical studies.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the information that is present.
Acceptance Criteria and Device Performance Study for SilverSpeed™ Hydrophilic Guidewire
This submission focuses on demonstrating substantial equivalence to predicate devices rather than setting and proving new acceptance criteria through a large-scale clinical study with specific performance metrics. The testing performed aimed to show that the new device performs as well as or similarly to existing legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for external communicating, blood contact, short duration (<24 hrs.) device. | Test results confirmed biocompatibility. |
| In-vitro Performance | Substantially equivalent to predicate devices for: - Dimensional inspection - Tensile strength - Flexibility - Trackability - Particulate compatibility | All testing yielded acceptable results substantially equivalent to the predicate devices. |
| In-vivo Performance | Substantially equivalent to predicate devices in animal models. | Studies demonstrated that the guidewire is substantially equivalent to the predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size (In-vitro): Not explicitly stated, but implies a sufficient number of devices were tested for each performance characteristic to demonstrate substantial equivalence to predicate devices.
- Sample Size (In-vivo): Not explicitly stated, but included testing in "rabbit and swine models." The exact number of animals or guidewires used per animal is not provided.
- Data Provenance: The studies were conducted by Micro Therapeutics, Inc. (the manufacturer). The text does not specify the country of origin for the data beyond being part of the manufacturer's internal testing program. The studies were likely prospective for the specific purpose of this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of submission (510(k) for substantial equivalence) does not typically involve external experts establishing ground truth in the way a diagnostic AI study would. The "ground truth" for proving substantial equivalence relies on established engineering principles, recognized standards (like ISO 10993-1), and comparative testing against predicate devices. The internal teams at Micro Therapeutics, Inc. and potentially external contract labs (for biocompatibility) would have performed and analyzed these tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This concept is typically relevant to studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need expert resolution. The testing described here is primarily physical, chemical, and animal model performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This study type is highly specific to assessing the impact of a diagnostic aid (like AI) on human reader performance, which is not the nature of this guidewire submission.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Study: Yes, in a sense, the in-vitro and in-vivo animal studies represent "standalone" device performance evaluations without human intervention influencing the device's inherent physical properties or biological interactions. However, this is not an "algorithm-only" study as the device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
- Ground Truth (Biocompatibility): Compliance with recognized international standard ISO 10993-1.
- Ground Truth (In-vitro Performance): Engineering specifications, validated test methods, and performance characteristics established for the predicate devices.
- Ground Truth (In-vivo Performance): Observational outcomes and measurements in animal models against the established performance of predicate devices.
- The overall "ground truth" for the submission is the demonstration of substantial equivalence to previously cleared predicate devices, meaning the new device is as safe and effective as the predicate.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical medical instrument, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable, as there is no "training set" for this type of device submission.
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Micro Therapeutics, Inc.
6254.3
DEC 1 1 1998
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510(k) Summary of Safety and Effectiveness
SilverSpeed™ Hydrophilic Guidewire
Prepared December 9, 1998
| Trade Name: | SilverSpeed™ Hydrophilic Guidewire | ||
|---|---|---|---|
| Generic Name: | Guidewire, Catheter | Classification: | Class II |
| Submitted By: | Micro Therapeutics, Inc.1062-F Calle NegocioSan Clemente, CA 92673 | Contact: | Tom DaughtersRegulatory Affairs(949) 361-0616 |
| Predicate Devices |
Target Therapeutics, Inc. Dasher-10 Guidewire Target Therapeutics, Inc (BSC). Transend-10 Guidewire B. Braun Guidewire Introducer B. Braun Guidewire Torque Device
Device Description
The SilverSpeed™ Hydrophilic Guidewire is a .010" diameter stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated from the shapeable platinum coil up to the proximal 30cm of the guidewire. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introduction of the guidewire into the catheter hub and or hemostasis valve.
Intended Use
The guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Testing
Biocompatibility of the guidewire has been verified in accordance with ISO 10993-1, Biological Eyaluation of Medical Devices. Test results confirmed biocompatibility of the guidewire when tested as an external communicating, blood contact, short duration (<24 hrs.) device.
In-vitro performance testing of the guidewire included dimensional inspection, tensile strength, flexibility, trackability, particulate compatibility tests. All testing of the product yelded acceptable results substantially equivalent to the predicate devices.
In-vivo animal studies were performed to assess the performance of the guidewire of rabbit and swine models. The studies demonstrated that the guidewire is substantially equivalent to the predicate devices.
Summary of Substantial Equivalence
The SilverSpecd Hydrophilic Guidewire and accessories are substantially equivalent to the predicate devices in intended use and principles of operation.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing the body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Mr. Tom Daughters Regulatory Affairs Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, CA 92673
Re : K982543 SilverSpeed™ Hydrophilic Guidewire Trade Name: Regulatory Class: II Product Code: DOX November 5, 1998 Dated: November 9, 1998 Received:
Dear Mr. Daughters:
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 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). 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 (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 A substantially equivalent determination assumes compliance with 895. 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices
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Page 2 - Mr. Tom Daughters
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4586. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
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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510(k) Number (if known): K982543
SilverSpeed™ Hydrophilic Guidewire Device Name:
Indications for Use: The SilverSpeed guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the mural, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
A.D. Grantt
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over the Counter Use _ OR Prescription Use (Per 21 CFR 801.109)
Exhibit 7 Page 4
§ 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.