(6 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The "Intended Use / Indications for Use" section is not found, and the device description does not indicate a therapeutic function. It describes guidewires used for procedures within "Gastroenterology and Urology," but it's not explicitly stated that device itself delivers treatment.
No
This device is a guidewire, used for navigation within the body. Its description and the performance studies focus on mechanical properties and biocompatibility, not on detecting or identifying medical conditions.
No
The device description clearly describes a physical guidewire made of NiTi core and metal coils, which is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description of the device and its intended use (Gastroenterology and Urology) clearly indicates it is a medical device used in vivo (within the body) for procedures, not for testing samples in vitro (outside the body).
- Device Description: The description of the guidewire's physical characteristics and parameters aligns with a surgical or interventional device, not an IVD.
- No mention of IVD specific activities: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The information provided describes a guidewire used in medical procedures within the body, which falls under the category of a medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
78KOD
Device Description
NiTi core with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. The guidewires are bound by the following parameters: Outside Diameter: .014" - . 045" Length: 20 cm - 500 cm Tip: Straight, Shapable or Preshaped Flexibility: Soft through Stiff Coil Length: 2 cm - 30 cm NOTE: None of these guidewires are for PTCA use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative testing was performed between LRM guidewires and Flexmedics guidewires. A product mix of three groups of LRM manufactured wires and two groups of Flexmedics product was chosen, based on the available Flexmedics products of .014" and .018" configurations. LRM samples were manufactured following current manufacturing processes and procedures. Flexmedics products were purchased by LRM, complete in packaging. All samples were sterilized prior to testing. Within each of the 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 30 samples selected. Some of the tests are destructive in nature which requires the selection of additional sets of 30 samples to perform other tests. The following product qualification tests were performed: Visual, Dimensional Measurement - Outside Diameter, Distal Tip Flexibility, Kink Resistance, Torsional Integrity, Pull Test, 3-Point Bending Test. All test results were within prescribed specification limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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SECTION 2.0 - SUMMARY & CERTIFICATION
- 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
(612) 448-3441 Telephone: (612) 448-5111 Fax:
-
2.1.2 Device Trade Name/Proprietary Name
LRM produces guidewires on an OEM basis for other manufactures, kit assemblers, and distributors. Consequently, there are a large number of trade and proprietary names not included or associated with LRM. LRM has no proprietary names of its own to be included with this submission. -
Device Common Names/Unusual Names, and Classification 2.1.3 Names
These devices are commonly known as guides, guidewires, or spring guidewires.
The current classification name is Gastroenterology and Urology Catheter Accessory (78KOD)
- 2.1.4 LRM Establishment Registration Number: 2126666
- 2.1.5 Classification of Devices
The classification name listed above was originally classified as a Class II device by the Gastroenterology - Urology Review Panel (21CFR 876.5130).
- 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.
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2.2 Labels, Labeling, and Advertising
LRM produces gastroenterology and urology 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 portion of the total production bears LRM controlled labels and labeling.
-
2.3 Summary of Safety and Effectiveness
This summary is being included in the Premarket Notification submission in lieu of a statement of availability. -
2.4 Device Description
2.4.1 Description of CCA Guidewire products
NiTi core with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. The guidewires are bound by the following parameters:
Outside Diameter: .014" - . 045" Length: 20 cm - 500 cm Tip: Straight, Shapable or Preshaped Flexibility: Soft through Stiff Coil Length: 2 cm - 30 cm
NOTE: None of these guidewires are for PTCA use.
- 2.4.2 Engineering Specifications
The design specifications are the same for guidewires manufactured with or without a NiTi core or platinum coil. The finished devices must meet the same design criteria. Section 2.5 contains comparative data to demonstrate equivalency.
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K970994
2.5 Substantial Equivalence Data
2.5.1 Background Information
In order to demonstrate substantial equivalence of guidewires manufactured with a NiTi core and platinum coil, LRM performed comparative testing between LRM guidewires and Flexmedics guidewires.
LRM chose a product mix of three groups of LRM manufactured wires and two groups of Flexmedics product, based on the available Flexmedics products of .014" and .018" configurations. LRM samples were manufactured following current manufacturing processes and procedures. Flexmedics products were purchased by LRM, complete in packaging. All samples were sterilized prior to testing.
- 2.5.2 Comparative Test Data
Within each of the 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 30
samples selected. Some of the tests are destructive in nature which requires the selection of additional sets of 30 samples to perform other tests.
The following product qualification tests were performed:
- 2.5.2.1 Visual: Assess the visual aspects of the product.
- 2.5.2.2 Dimensional Measurement - Outside Diameter: Micrometer measurement of the outside diameter of the product at multiple body points.
- 2.5.2.3 Distal Tip Flexibility: Assess the flexibility of the product's distal tip.
- 2.5.2.4 Kink Resistance: Assess the kink resistance of the core wire.
- 2.5.2.5 Torsional Integrity: Assess the torsional strength of the product.
- 2.5.2.6 Pull Test: Measures the strength of the distal and proximal joints of the product.
- 2.5.2.7 3-Point Bending Test: Assess the product's body stiffness/flexibility.
- All test results were within prescribed specification RESULTS : limits.
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2.6 Qualification and Biocompatibility Test Data
2.6.1 Material/Product/Process Qualification
LRM has formal quality systems in place to assure that each of the products manufactured remain equivalent to the predicate product, and that the change 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 General Program Memorandum #G95-1, Subject: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", dated May 1, 1995.
The following table lists the tests that were performed and the test results.
| TEST PERFORMED | TEST RESULTS |
|---|---|
| Cytotoxicity | The sample evoked no cytotoxic |
| response (Grade 0) | |
| Hemolysis | The sample produced no hemolysis |
| Acute Systemic Toxicity | No signs or symptoms of systemic |
| toxicity were observed | |
| Intracutaneous Test | For all samples, the 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. |
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2.7 Packaging and Sterilization Information
LRM produce guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. A small portion of the production is private label, single packaged to customer specifications, a fraction of that product is provided sterile to the customer.
The single packaged CCA guidewire is placed in a dispenser and then into a Tyvek®/poly pouch. The packaged product may be packaged as five or ten pouches in a shelf carton, which are typical packaging configurations.
There will be no changes to the sterilization process for the portion of the packaged product shipped sterile to the Ocustomer. For the product that is shipped bulk, the packaging design and sterilization process parameters are the customer's responsibility. LRM will not recommend that its customers modify their packaging or sterilization procedures as a result of this submission.