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

This document describes the regulatory submission for the Lake Region Manufacturing (LRM) Core and Coil Assembly (CCA) Guidewire. It presents information regarding the device's characteristics, safety, and effectiveness, primarily through comparative testing against a predicate device.

Here's an analysis of the provided text, structured according to your request:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds with specific numerical values for each test. Instead, it describes "prescribed specification limits" which the device met. The reported device performance is that all test results were within these prescribed specification limits.

Test Performed	Acceptance Criteria (Implicit)	Reported Device Performance
Visual	Products must meet visual aspects specifications.	All test results were within prescribed specification limits.
Dimensional Measurement (OD)	Micrometer measurements of OD must be within specifications.	All test results were within prescribed specification limits.
Distal Tip Flexibility	Flexibility of the distal tip must meet specifications.	All test results were within prescribed specification limits.
Kink Resistance	Core wire kink resistance must meet specifications.	All test results were within prescribed specification limits.
Torsional Integrity	Torsional strength must meet specifications.	All test results were within prescribed specification limits.
Pull Test	Strength of distal and proximal joints must meet specifications.	All test results were within prescribed specification limits.
3-Point Bending Test	Body stiffness/flexibility must meet specifications.	All test results were within prescribed specification limits.
Biocompatibility Tests
Cytotoxicity	No cytotoxic response.	No cytotoxic response (Grade 0).
Hemolysis	No hemolysis.	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.	Skin reactions were not significant.
Implantation (7 Day)	Reaction not significant vs. negative control.	Reaction was not significant as compared to the negative control implant.
Sensitization	Non-sensitizer.	Deemed to be a non-sensitizer.
Pyrogen Test	No pyrogenic response.	Did not produce a pyrogenic response.

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Size: For each product qualification test, 30 samples were selected. Since there were three groups of LRM wires and two groups of Flexmedics product, and at least 200 samples of each size were produced (600+ total LRM samples), the 30 samples for each test were drawn from these larger production batches.
- Data Provenance: The study was prospective as LRM samples were manufactured following current processes, and Flexmedics products were purchased (presumably new for the purpose of the study). The country of origin for the data is implicitly the United States, as LRM is based in Chaska, MN, and the submission is to the FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes engineering and biocompatibility testing for a medical device. There is no mention of human "experts" establishing a "ground truth" in the context of clinical or diagnostic performance. Instead, the ground truth for the engineering tests would be established by validated test methods and established engineering specifications. For biocompatibility, the ground truth is determined by the specific laboratory assays and their established pass/fail criteria.
Adjudication method for the test set:
- Not applicable. This is a technical performance and biocompatibility study, not a study involving human interpretation or adjudication of results in the traditional sense of clinical imaging or diagnostics.
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:
- No, an MRMC comparative effectiveness study was not done. This submission is for a guidewire, which is a physical medical device, not an AI or diagnostic system involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the engineering tests (e.g., dimensional, flexibility, kink resistance, torsional integrity, pull test, 3-point bending) is based on established engineering specifications and validated measurement techniques.
- The "ground truth" for biocompatibility tests (e.g., cytotoxicity, hemolysis, systemic toxicity, intracutaneous, implantation, sensitization, pyrogen) is based on standardized laboratory assays and their predetermined pass/fail criteria, as recommended by FDA's General Program Memorandum #G95-1 and ISO-10993.
The sample size for the training set:
- Not applicable. This document describes the manufacturing and testing of a physical medical device. There is no AI component or "training set" in the context of machine learning. The "training" for the device would be the manufacturing processes themselves.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of AI/machine learning. The manufacturing processes and material specifications are the "ground truth" for the device's production.

Summary

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K971322
July 22, 1998
SECTION 2.0 - SUMMARY & CERTIFICATION

General Information 2.1
Company Name, Address, and Telephone Number 2.1.1

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 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
2.1.3 Device Common Names/Usual Names, and Classification Names
These devices are commonly known as guides, guidewires, or spring guidewires.

The current classification names, and product codes are Angiographic Guidewire (74HAP), Catheter Guidewire (74DQx) , and Radiological (71ml) , Catheter Guidewire (74JQX) ,

2.1.4 LRM Establishment Registration Number: 2126666
Classification of Devices 2.1.5

The classification names listed above were originally listed as Class II device by the Neurology (84HAD), Cardiovascular (74DQX), and Radiology (84HAD),
and Radiology (90JA), and Radiology (90JAJ) review panels.

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 Cosmetical Device Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.

2-1

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2.2 Labels, Labeling, and Advertising

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 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 cach 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 Teat: 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.
RESULTS : All test results were within prescribed specification limits.

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2.6 Qualification and Biocompatibilıty Test Data

Material/Product/Process Qualification 2.6.1
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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Packaging and Sterilization Information 2.7

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 customer. 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.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 1998

Ms. Kim Aves Regulatory Affairs Associate Lake Region Manufacturing, Inc. 340 Lake Hazeltine Drive Chaska, MN 55318

Re : K971322 Trade Name: Core and Coil Assembly (CCA) Guidewire Regulatory Class: II Product Code: DQX Dated: April 21, 1998 Received: April 23, 1998

Dear Ms. Aves:

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 accermined the device 13
enclosure) to locall enclosure) to legally marketed predicate devices marketed in the 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 Requiations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 (il verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please note: this response to your device in
notification submission does not effects and notification submission does note. This respons

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Page 2 - Ms. Kim Aves

obligation you might have under sections 531 through 542 of the Act for obligation you might have mider dider Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in inis fected will arew your fication. The FDA finding of substantial your 510(x) premainco nowledged.
equivalence of your device to a legally marketed predicate device results equivalence of your 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) 594-4618. Additionally, for questions on the promotion and advertising of your nadibionale, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on premarket notification" (21CFR 807.97) 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. Callahon

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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Unknown 510(k) Number (if known):

Core and Coil Assembly Guidewire (CCA) Device Name -

Indications for Use:

For percutaneous entry of peripheral vessel using the Seldinger technique.

Tan A. R

(Divisior Sign-Off) Division Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED!

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 32 CFR 801.109)

Over-The Counter Use

8-1

Regulation Number and Section

§ 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.