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.

AI/ML Overview

The provided text describes comparative testing for guidewires, focusing on their substantial equivalence to predicate devices and biocompatibility. However, it does not describe a device that uses an AI algorithm or a study that utilizes features like experts, ground truth, or MRMC studies typically associated with AI/ML medical devices.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: While various tests were performed, specific acceptance criteria values are not provided, only that "All test results were within prescribed specification limits."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "For each test, there were 30 samples selected" for comparative testing, and "at least two hundred (200) samples of each size (600+ total samples)" were produced. Data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The ground truth for the physical tests would be the measurement results against engineering specifications.
8. The sample size for the training set: Not applicable as this is not an AI/ML device study.
9. How the ground truth for the training set was established: Not applicable.

Information that can be extracted from the provided text regarding the closest equivalent to acceptance criteria and study findings:

The document describes product qualification tests and biocompatibility tests performed to demonstrate substantial equivalence of new guidewires (with NiTi core and platinum coil) to predicate guidewires (Flexmedics products).

Acceptance Criteria and Device Performance (Summary based on text):

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Product Qualification	Within prescribed specification limits for equivalence to predicate.	All test results were within prescribed specification limits.
Visual	Acceptable visual aspects.	(Implied: Acceptable)
Dimensional Measurement (OD)	Within specified diameter range.	(Implied: Within range)
Distal Tip Flexibility	Acceptable flexibility.	(Implied: Acceptable)
Kink Resistance	Acceptable kink resistance.	(Implied: Acceptable)
Torsional Integrity	Acceptable torsional strength.	(Implied: Acceptable)
Pull Test	Acceptable strength of joints.	(Implied: Acceptable)
3-Point Bending Test	Acceptable body stiffness/flexibility.	(Implied: Acceptable)
Biocompatibility	No adverse biological response as per ISO-10993.
Cytotoxicity	No cytotoxic response.	The sample evoked no cytotoxic response (Grade 0).
Hemolysis	No hemolysis.	The sample produced no hemolysis.
Acute Systemic Toxicity	No signs/symptoms of systemic toxicity.	No signs or symptoms of systemic toxicity were observed.
Intracutaneous Test	Skin reactions not significant.	For all samples, the skin reactions were not significant.
Implantation (7 Day)	Reaction not significant compared to negative control.	The reaction was not significant as compared to the negative control implant, for any of the samples.
Sensitization	Non-sensitizer.	The samples were deemed to be a non-sensitizer.
Pyrogen Test	No pyrogenic response.	The samples did not produce a pyrogenic response.

Study Information:

Study Purpose: To demonstrate substantial equivalence of guidewires with NiTi core and platinum coil to predicate Flexmedics guidewires and assess biocompatibility.
Test Set Description:
- Comparative Test Data: LRM guidewires (produced following current manufacturing processes) and Flexmedics guidewires (purchased complete in packaging). Both were sterilized prior to testing.
- Biocompatibility Testing: Samples of the new guidewire type.
Sample Size for Test Set:
- Comparative Test Data: "at least two hundred (200) samples of each size (600+ total samples)" were produced. For each specific test, "30 samples selected."
- Biocompatibility Testing: Not explicitly stated, but implies sufficient samples for each of the listed tests.
Data Provenance (Comparative Test Data): LRM samples were manufactured, and Flexmedics products were purchased. No country of origin or explicit retrospective/prospective status stated, but based on the context of premarket notification, it is prospective testing for regulatory submission.
Type of Ground Truth Used (Comparative Test Data): Engineering specifications/design criteria and comparison to predicate device performance.
Type of Ground Truth Used (Biocompatibility): Standardized biological evaluation methods (ISO-10993) and established criteria for biological responses (e.g., Grade 0 for cytotoxicity, no hemolysis, etc.).

Summary

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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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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 cytotoxicresponse (Grade 0)
Hemolysis	The sample produced no hemolysis
Acute Systemic Toxicity	No signs or symptoms of systemictoxicity were observed
Intracutaneous Test	For all samples, the skinreactions were not significant.
Implantation (7 Day)	The reaction was not significantas compared to the negativecontrol implant, for any of thesamples.
Sensitization	The samples were deemed to be anon-sensitizer.
Pyrogen Test	The samples did not produce apyrogenic 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.

Regulation Number and Section

§ 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.