(26 days)
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
The Safe-Steer™ Guide Wire System consists of the following:
- Safe-Steer™ 0.014" Guide Wire ●
- Safe-Steer™ OCR Unit with Display Monitor .
The Safe-Steer™ Guide Wire is similar to a conventional 0.014" coronary guide wire, except that it incorporates an optic fiber, which runs the length of the guide wire. The Safe-Steer™ Guide Wire is connected to the OCR Unit, providing information on the Display Monitor of the location of the distal tip relative to the vessel wall.
The provided text is related to a 510(k) submission for a medical device called the Safe-Steer™ Guide Wire System. This submission describes a modification to an existing cleared device and asserts substantial equivalence to its predicate device. This type of submission relies on demonstrating that the modified device performs as safely and effectively as the predicate, often through performance testing and biocompatibility.
However, the provided document does not contain the detailed information required to answer all parts of your request, especially regarding clinical study specifics like sample size, reader qualifications, or ground truth establishment in the context of diagnostic or prognostic performance. The device is a guide wire, which is an interventional tool, not an AI/ML diagnostic algorithm.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "The Safe-Steer Guide Wire has been subjected to performance testing to verify conformance to the requirements of the product specification." and "On the basis of the testing conducted on the Safe-Steer™ Guide Wire it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population."
However, specific acceptance criteria values and reported performance metrics are NOT provided in this summary. For a guide wire, performance criteria would typically include:
- Mechanical Properties: Tensile strength, torque response, pushability, trackability, flexibility, kink resistance, tip integrity.
- Biocompatibility: Confirmation of non-toxic, non-irritating, non-sensitizing properties, often tested according to ISO 10993 standards.
- Dimensional Accuracy: Outer diameter, length, and other critical dimensions as per specifications.
- Integrity of Components: E.g., for this device, the integrity of the optic fiber within the guide wire.
- Connection/System Functionality: For the Safe-Steer™ system, this would include the OCR Unit's ability to accurately display the distal tip's location relative to the vessel wall.
Due to the lack of specific data in the provided text, a table can only indicate the types of testing performed, not quantitative results or acceptance thresholds.
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Biocompatibility | Conforms to ISO 10993-1 and FDA Guidance for biological safety |
| Mechanical Performance | Conforms to product specifications |
| Design Requirements | Conforms to Design Control Procedures (21 CFR 820) |
| Safety and Efficacy (Overall) | Satisfies safety and performance requirements for intended use |
| Substantial Equivalence to Predicate | Deemed substantially equivalent to the predicate device (K011986) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The text mentions "performance testing" and "biocompatibility testing" but does not detail the sample sizes for these tests, nor does it specify if any human clinical data (which implies provenance) was used for this particular modification. Given it's a device modification and a special 510(k), the primary focus would be on bench and possibly pre-clinical (animal) testing to confirm the changes don't adversely affect performance.
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)
This is not applicable or provided. The device is an interventional guide wire, not an AI diagnostic tool requiring expert interpretation for ground truth establishment. The performance testing would involve engineering and laboratory methods, not expert clinical readers interpreting outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable or provided. Since the device is a medical instrument (guide wire), not a diagnostic algorithm where human interpretation and adjudication are involved in a test set, this concept doesn't apply.
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
This information is not applicable or provided. The device is an interventional guide wire with an optical coherence reflectometry (OCR) unit to help locate its tip. It's not an AI-powered diagnostic tool, and therefore, an MRMC study and AI assistance effect size are not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable or provided. The Safe-Steer™ Guide Wire System is a physical medical device, not a standalone algorithm. While the OCR unit processes data, its functionality is integrated into the guide wire's use by a clinician, meaning there is always a "human-in-the-loop."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for cancer detection) does not directly apply here. For a guide wire, the "truth" would be established through:
- Bench Test Standards: Adherence to engineering specifications and performance benchmarks (e.g., does it meet specified torque, trackability, or tensile strength values under defined conditions?).
- Biocompatibility Testing Standards: Compliance with ISO 10993 series through laboratory assays.
- Physical Measurement: Actual measurements (e.g., diameter, length) compared to design specifications.
- Functional Verification: For the OCR unit, verifying that the display accurately reflects the physical location of the guide wire tip as measured by other independent means (e.g., visual inspection in phantoms, specialized sensors).
8. The sample size for the training set
This information is not applicable or provided. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
This information is not applicable or provided. As above, it is not an AI/ML device.
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510 (K) #: KO21323
Special 510(k): Device Modification Safe-Steer™ Guide Wire System
510(K) SUMMARY
SUBMITTER INFORMATION 10.1
| A. | Company Name: | IntraLuminal Therapeutics, Inc. |
|---|---|---|
| B. | Company Address: | 6354 Corte Del Abeto – Suite ACarlsbad, CA 92009 |
| C. | Company Phone: | (760) 918-1820 |
| D. | Company Facsimile: | (760) 603-9615 |
| E. | Contact Person: | Pamela MisajonVice President of Regulatory Affairs and Quality Assurance |
10.2 DEVICE IDENTIFICATION
| A. | Device Trade Name: | Safe-Steer™ Guide Wire System |
|---|---|---|
| C. | Device Common Name: | Catheter Guide Wire |
| D. | Classification Name: | Catheter Guide Wire |
| E. | Device Class: | Class II (per 21 CFR 870.1330) |
IDENTIFICATION OF PREDICATE DEVICE 10.3
The predicate device is the Safe-Steer™ Guidewire System, manufactured by IntraLuminal Therapeutics and cleared under Premarket Notification 510(k) K011986.
10.4 DEVICE DESCRIPTION
The Safe-Steer™ Guide Wire System consists of the following:
- Safe-Steer™ 0.014" Guide Wire ●
- Safe-Steer™ OCR Unit with Display Monitor .
The Safe-Steer™ Guide Wire is similar to a conventional 0.014" coronary guide wire, except that it incorporates an optic fiber, which runs the length of the guide wire. The Safe-Steer™ Guide Wire is connected to the OCR Unit, providing information on the Display Monitor of the location of the distal tip relative to the vessel wall.
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10.5 INTENDED USE
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
TECHNOLOGICAL CHARACTERISTICS 10.5
The Safe-Steer™ Guide Wire is similar in basic materials, design, construction and mechanical performance to the predicate device.
BIOCOMPATIBILITY AND PERFORMANCE DATA 10.6
The materials used to manufacture the patient components of the Safe-Steer Guide Wire have been subjected to biocompatibility testing in accordance with ISO 10993-1 and relevant FDA Guidance to ensure biological safety for the intended use.
The Safe-Steer Guide Wire has been subjected to performance testing to verify conformance to the requirements of the product specification.
Testing has been conducted in accordance with the Design Control Procedures of the company as required by the Quality System Regulation (21 CFR 820).
10.7 CONCLUSIONS DRAWN FROM STUDIES
On the basis of the testing conducted on the Safe-Steer™ Guide Wire it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population. The Safe-Steer™ Guide Wire is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces merging into one, suggesting unity and collaboration.
Public Health Servic
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
AY 2 2 2002
Ms. Pamela Misajon IntraLuminal Therapeutics, Inc. 6354 Corte Del Abeto, Suite A Carlsbad, CA 92009
Re: K021323
SAFE-STEER™ Guide Wire System Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: April 25, 2002 Received: April 26, 2002
Dear Ms. Misajon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neve reviewed your be 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
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Page 2 - Ms. Pamela Misajon
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
N. Daghlian
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) #: K021323
Special 510(k): Device Modification Safe-Steer™ Guide Wire System
INDICATIONS FOR USE
KOHISS KOZI323 510(k) Number:
Device Name:
Safe-Steer™ Guide Wire System
Indications For Use:
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K021323 |
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
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§ 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.