(90 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and performance of a guidewire, with no mention of AI or ML.
No.
The device description and performance studies indicate it is a guidewire used for navigation, not for treating a condition or performing therapy.
No
The device description indicates it is a guidewire, which is a tool used to guide catheters or other devices within the body for treatment, not for diagnosing conditions. The performance studies focus on mechanical and physical properties of the guidewire itself, not its ability to detect or identify diseases.
No
The device description clearly describes a physical guidewire made of stainless steel with a coating, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on the physical characteristics and performance of a guidewire used within the body (in vivo). There is no indication that this device is used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description of a "Steerable stainless steel core with radiopaque marker; a jacket, and polymer/hydrophilic coating" is consistent with a medical device used for navigation within blood vessels or other body lumens.
- Performance Studies: The performance studies described (Lubricity, Coating Durability, Dimensional Measurement, etc.) are all related to the physical and functional performance of a device used in vivo.
- Lack of IVD-specific information: There is no mention of intended use for diagnosis, analysis of biological samples, or any other activity typically associated with IVD devices.
Therefore, based on the provided text, this device is a medical device intended for use within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
74HAP, 74DQX, 74JAJ
Device Description
Steerable stainless steel core with radiopaque marker; a jacket, and polymer/hydrophilic coating is applied over the core/coil. The quidewires are bound by the following parameters: Outside Diameter: .016" - .045" 20 cm -- 400 cm Lengths: Straight, Shapable with standard Tips: and stiff tip flexibility. None of these guidew.res are for PTCA use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Testing: In order to demonstrate equivalence of guidewires manufactured with polymer/hydrophilic, LRM performed comparative testing between LRM polymer/hydrophilic guidewire and Terumo guidewires. LRM chose a product mix of three groups of wires, based on the available Terumo products of .018" standard, .035" standard and .038" stiff configurations. LRM samples were manufactured following current manufacturing processes and procedures. Terumo product was purchased by LRM, complete in packaging. All samples were sterilized prior to testing. Within each of the three groups, production samples were made; at least two hundred (200+) samples of each size (600+ total samples) were produced per standard manufacturing procedures. For each test, there were either twenty (20) or thirty (30) samples selected. Some of the tests are destructive in nature which required the selection of additional sets of twenty (20) or thirty (30) samples to perform other tests. The following product qualification tests were performed: Lubricity, Coating Durability, Dimensional Measurement - Outside Diameter, Distal Tip Flexibility, 3-Point Bending Test, Rotational Control, Torsional Integrity, Radiopacity, Tracking, Pull Test. RESULTS : All test results were within prescribed specification limits.
Biocompatibility Testing: LRM has adapted the biocompatibility testing recommendations in the FDA's draft "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993. The following tests were performed and results obtained: Cytotoxicity (The samples evoked a mild cytotoxic response (Grade 2) when tested at a 48 hour exposure period. The test material passed the assay.), Hemolysis (The samples did not produce hemolysis.), Acute Systemic Toxicity (No signs or symptoms of Systemic Toxicity were observed for any of the samples.), Intracutaneous Test (For all samples, skin reactions were not significant.), Implantation (7 Day) (The reaction was not significant as compared to the negative control implant, for any of the samples.), Sensitization (The samples were deemed to be a non-sensitizer.), Pyrogen Test (The samples did not produce a pyrogenic response.).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
SECTION 2.0 - SUMMARY & CERTIFICATION
MAY 2 | 1996
2.1 General Information
- 2.1.1 Company Name, Address, and Telephone Number
Lake Region Manufacturing, Inc., (LRM) 340 Lake Hazeltine Drive Chaska, MN 55318
Telephone: (612) 448-5111 Fax: (612) 448-3441
-
2.1.2 Device Trade Name/Proprietary Name
LRM produces quidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission. -
2.1.3 Device Common Names/Unusual Names, and Classification Names
These devices are commonly known as quides, guidewires, or spring guidewires.
The current classification names, and product codes are Angiographic Guidewire (74HAP), Catheter Guidewire (74DQX), and Radiological Catheter Guidewire (74JAJ)
- 2.1.4 LRM Establishment Registration Number: 2126666
- 2.1.5 Classification of Devices
The classification names listed above were originally classified as Class II devices by the Neurology (84HAD), Cardiovascular (74DQX), and Radiology (90JAJ) Review Panels respectively.
- 2.1.6 Applicability of Performance Standards
LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.
1
- Labels, Labeling, and Advertising 2.2
LRM produces cardiovascular and vascular guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. Changes to the customer controlled labels, labeling, or promotional material are at their discretion, including the resolution of any resulting regulatory obligations.
A small fraction of the total production bears LRM controlled labels and labeling. Summary of Safety and Effectiveness
This summary is being included in the Premarket Notification submission in lieu of a statement of availability.
- Device Description 2.4
2.3
- Description of Guidewires Produced With Polymer/ 2.4.1 Hydrophilic Coating
Steerable stainless steel core with radiopaque marker; a jacket, and polymer/hydrophilic coating is applied over the core/coil. The quidewires are bound by the following parameters:
Outside Diameter: .016" - .045" 20 cm -- 400 cm Lengths: Straight, Shapable with standard Tips: and stiff tip flexibility
None of these guidew.res are for PTCA use. Note:
-
2.4.2 Engineering Specifications
The design specifications are the same for guidewires manufactured with or without the polymer/hydrophilic coating. The finished devices must meet the same design criteria. Section 2.5 contains comparative data to demonstrate equivalency. -
2.5 Substantial Equivalence Data
-
2.5.1 Background Information
In order to demonstrate equivalence of guidewires manufactured with polymer/hydrophilic, LRM performed comparative testing between LRM polymer/hydrophilic guidewire and Terumo guidewires.
LRM chose a product mix of three groups of wires, based on the available Terumo products of .018" standard, .035" standard and .038" stiff configurations. LRM samples were manufactured following current manufacturing processes and procedures. Terumo product was purchased by LRM, complete in packaging. All samples were sterilized prior to testing.
2
Comparative Test Data 2.5.2
Within each of the three groups, production samples
were made; at least two hundred (200+) samples of each size (600+ total samples) were produced per standard manufacturing procedures. For each test, there were either twenty (20) or thirty (30) samples selected. Some of the tests are destructive in nature which required the selection of additional sets of twenty (20) or thirty (30) samples to perform other tests.
The following product qualification tests were performed:
- Measures the force required to insert Lubricity: 2.5.2.1 and withdraw the guidewire within a catheter lumen standardized to each guidewire diameter.
- Coating Durability: Measures the lubricity before 2.5.2.2 and after multiple catheter insertions and withdrawals.
- 2.5.2.3 Dimensional Measurement - Outside Diameter, Dry and after 10 minutes soak and after 40 minute soak in normal saline : Micrometer measurement of the outside diameter of the guidewire at multiple body points.
- Distal Tip Flexibility: Assess the flexibility of 2.5.2.4 the distal tip.
- 3-Point Bending Test: Assess guidewire body 2.5.2.5 stiffness/flexibility.
- Rotational Control: Assess guidewire rotational 2.5.2.6 control to allow placement of the distal tip at a desired location in a 360 degree circle when controlled from the proximal end of the guidewire. Control may be clockwise or counter-clockwise.
- 2.5.2.7 Torsional Integrity: Assess the torqueable strength of a guidewire.
- Assess the radiopacity of the distal 2.5.2.8 Radiopacity: tip, to establish equivalency to currently marketed hydrophilic guidewires.
- 2.5.2.9 Tracking: Assess the tractability of Lake Region's hydrophilic quidewire.
- 2.5.2.10 Measures the strength of welded joint Pull Test: points in the guidewire.
- RESULTS : All test results were within prescribed specification limits.
3
Qualification and Biocompatibility Test Data 2.6
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Material/Product/Process Qualifications 2.6.1
LRM has formal quality systems in place to assure that each of the products manufactured with the polymer/hydrophilic coating remain equivalent to the predicate product, and that the changes will not have an adverse affect on the safe and effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group. -
2.6.2 Biocompatibility Testing
LRM has adapted the biocompatibility testing recommendations in the FDA's draft "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993.
The following table lists the test that were performed and the test results.
| TEST PERFORMED | TEST RESULTS |
|---|---|
| Cytotoxicity | The samples evoked a mild |
| cytotoxic response (Grade 2) | |
| when tested at a 48 hour | |
| exposure period. The test | |
| material passed the assay. | |
| Hemolysis | The samples did not produce |
| hemolysis. | |
| Acute Systemic Toxicity | No signs or symptoms of |
| Systemic Toxicity were | |
| observed for any of the | |
| samples. | |
| Intracutaneous Test | For all samples, skin |
| reactions were not | |
| significant. | |
| Implantation (7 Day) | The reaction was not |
| significant as compared to | |
| the negative control | |
| implant, for any of the | |
| samples. | |
| Sensitization | The samples were deemed to be |
| a non-sensitizer. | |
| Pyrogen Test | The samples did not produce a |
| pyrogenic response. |