The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.

Device Description

The Lake Region Hydrophilic Guidewire consists of a flexible, tapered core wire that decreases in outer diameter from the proximal to the distal end. The hydrophilic coating reduces friction during use. The radiopaque distal coil facilitates fluoroscopic visualization. The Lake Region Hydrophilic Guidewire will be available in two configuration, with either an outer diameter of 0.010" or 0.014" and 180cm long.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the Lake Region Hydrophilic Guidewire. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (K003084), not to prove that the device meets specific acceptance criteria through new clinical or performance studies.

Therefore, many of the requested sections related to acceptance criteria, device performance, sample sizes, ground truth, and expert adjudication are not applicable to this document as it is a substantial equivalence submission, not a de novo submission or a PMA (Premarket Approval) where new performance data would typically be generated and presented against acceptance criteria.

However, I can extract information related to the device itself and the basis for its substantial equivalence.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

This information is not applicable as this submission is for substantial equivalence to a predicate device, and no new performance acceptance criteria or testing were conducted for the proposed device itself. The document explicitly states: "As there were no changes to the device itself and Lake Region conducted the original design verification testing used to establish safety and effectiveness under Concentric Medical Hydrophilic Guidewire K003084, no further testing has been required."

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 applicable. No new test set data was generated for the proposed device. The submission relies on the data that established the predicate device's safety and effectiveness.

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 information is not applicable. No new ground truth establishment was reported for the proposed device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. No new test set data or adjudication method was reported for the proposed device.

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. This is a medical device for intravascular use (a guidewire), not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. As in point 5, this is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable for the proposed device directly. The "ground truth" for its safety and effectiveness was established through design verification testing conducted for the predicate device (K003084), which involved laboratory and engineering tests to ensure physical and performance specifications were met. This would typically involve objective measurements against predefined specifications, rather than expert consensus on diagnostic outcomes.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. As in point 8, this is not an AI/machine learning device.

Summary of the Device and Substantial Equivalence Claim (as per the document):

The document aims to demonstrate that the Lake Region Hydrophilic Guidewire is substantially equivalent to a predicate device cleared under 510(k) K003084. The basis for this claim is that the proposed device is identical to the predicate device, which Lake Region Manufacturing (LRM) previously manufactured for Concentric Medical. LRM also conducted the original design validation testing for that predicate device.

Key points from the document supporting substantial equivalence:

Proposed Device is the same as the Predicate Device: "The proposed device is the same device as the predicate device."
No Changes to Core Device Attributes: The comparison table explicitly states "No change" for Raw Materials, Assembly Process, Physical Characteristics, Intended Use, Anatomical Sites, Target Population, Performance Testing, Safety Characteristics, and Biocompatibility.
Minimal Labeling Change: "The only change to the IFU will be to the manufacturer information and the omission of the optional introducer information."
Original Testing Suffices: "As there were no changes to the device itself and Lake Region conducted the original design verification testing used to establish safety and effectiveness under Concentric Medical Hydrophilic Guidewire K003084, no further testing has been required."
Design Control and Validation: LRM is in conformance with 21 CFR 820.30 and states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria could be met" for the original design.
Biocompatibility: "The materials for the proposed device are identical to the predicate device cleared under K003084 and are identically processed and sterilized. Therefore, biocompatibility testing for the proposed device is not required."

In essence, the "study" proving the device meets acceptance criteria is the original design verification and validation testing performed for the predicate device K003084, which the current device is identical to.

Summary

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SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

March 26, 2004

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: (952) 448-5111 Fax: (952) 448-3441

Contact Name: Karen Mortensen Senior Regulatory Compliance Specialist

Device Trade Namc/Proprietary Name 2.1.2
LRM produces guidewires 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/Usual Names and Classification Names
These devices are commonly known as coronary and peripheral catheter guidewires. The current classification names and product codes are Wire, Guide, Catheter (74DQX).
2.1.4 Establishment Registration Number: 2126666
Classification of Devices 2.1.5

Catheter guidewires have been classified as Class II devices by the Circulatory Systems Devices Panel (reference 21 CFR 870.1330).

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 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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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 fraction of the total production bears LRM controlled labels and labeling.

2.3 Statement of Availability

This summary is being included in the Premarket Notification submission in lieu of a statement of availability.

Device Description 2-4

The Lake Region Hydrophilic Guidewire consists of a flexible, 2.4.1 tapered core wire that decreases in outer diameter from the The hydrophilic coating reduces proximal to the distal end. The radiopaque distal coil facilitates friction during use. The Lake Region Hydrophilic fluoroscopic visualization. Guidewire will be available in two configuration, with either an outer diameter of 0.010" or 0.014" and 180cm long.
The guidewire dimensions are as follows:

Product Description	Shaft OD(nominal)	Shaft Length(nominal)	Coil Length(nominal)
0.010" Guidewire	.010"	180 cm	10 cm
0.014" Guidewire	.014"	180 cm	10 cm

Engineering Specifications 2.4.2

The design specifications are the same for the proposed device as they are for the predicate device (K003084). The finished devices must meet the same basic design criteria.

2.5 Substantial Equivalence Data

2.5.1 Background Information

The proposed device is the same device as the predicate device. Lake Region manufactured the predicate device for Concentric Medical and Concentric Medical contracted with Lake Region to do the design validation testing. Therefore, the majority of the information supplied in the Concentric Medical 510(k) submission originated with Lake Region Manufacturing.

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Item	Proposed Device Differences from Predicate clearedunder 510(k) K003084
Raw Materials	No change
Assembly Process	No change
Physical Characteristics	No change
Labeling/IFU	The only change to the IFU will be to the manufacturerinformation and the omission of the optional introducerinformation.
Intended Use	No change
Anatomical Sites	No change
Target Population	No change
Performance Testing	No change
Safety Characteristics	No change
Biocompatibility	No change
Risk Analysis	No change

2.5.2 Comparison table of predicate to proposed device

Design Control and Validation Activities 2.6

LRM is in conformance with the design control procedure requirements as specified in 21 CFR 820.30. Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance critcria could be met.

As there were no changes to the device itself and Lake Region conducted the original design verification testing used to establish safety and effectiveness under Concentric Medical Hydrophilic Guidewire K003084, no further testing has been required.

Material/Product/Process Qualification 2.7

LRM has formal quality systems in place to assure that the proposed product will remain equivalent to the predicate product. The quality include Engineering Change Order Review, Material systems Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.

2.8 Biocompatibility Testing

The materials for the proposed device are identical to the predicate device cleared under K003084 and are identically processed and sterilized. Therefore, biocompatibility testing for the proposed device is not required.

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Packaging and Sterilization Information 2.9

LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. A portion of the production is private label, sterile packaged to customer specifications, a fraction of that product is provided sterile to the customer.

The single packaged guidewire is placed in a dispenser and then into a Tyvek®/poly pouch. The packaged product may be packaged singlely or in five or ten pouchs to a shelf carton, which are typical packaging configurations.

There will be no changes to the sterilization process for the portion of 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.

2.10 Intended Use Statement

The intended use statement is the same as the intended use statement for the predicate device cleared under K003084, specifically:

The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.

Conclusion 2.11

The Lake Region Hydrophilic Guidewire is substantially equivalent to the predicate guidcwire cleared under 510(k) K003084. There have been no significant changes to the guidewire design as previously manufactured by Lake Region Manufacturing for Concentric Medical.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three wavy lines representing the body, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the figure. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2004

Lake Region Manufacturing, Inc. c/o Karen Mortensen Senior Regulatory Compliance Specialist 340 Lake Hazeltine Drive Chaska, MN 55318-1029

K040825 Re:

Lake Region Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: March 26, 2004 Received: March 30, 2004

Dear Ms. Mortensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave tevenced your boother of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the enorosaly to regary the enactment date of the Medical Device Amendments, or to commerce provision in May 20, 1978, accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). and Cosmetic (110) therefore, subject to the general controls provisions of the Act. The I ou may, merelove, mains of the Act include requirements for annual registration, listing of general controll provincitive, 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 If your device to such additional controls. Existing major regulations affecting your device can he 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.

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Page 2 – Ms. Karen Mortensen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substitution with other requirements of the Act
that FDA has made a determination that your device Edger League of Soumust that FDA has made a determination and your creases by other Federal agencies. You must
or any Federal statutes and regulations administered by other to: registration and li or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not itements as set comply with all the Act s requirements, mename, surving practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); gractice requirements as set CFR Part 807); labeling (2) CFR Patl 801); good manufacturing platf.applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicab forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Scctions 95 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin makemig your as walnece of your device to a legally
premarket notification. The FDA finding of substantial equivalend thus, permits vour premarket notification. The FDA imalig of substantal equivalies by the subsitive of the to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs (11) 11 (11) (11) (11) (11) (11) - Alles mlesse note the requilation en If you desire specific advice for your uevice on on on nasmile (1) = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = contact the Office of Compliatice at (301) 574 10 107 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarket nontiedation of Set from the Division of Small
other general information on your responsibilities under the Act from worker (900) 638-2 other general information on your responsibilities and con-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

(301)443-0597 or at its mtornol as a smamain. html

Sincerely yours,

Dana R. Vochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vochner

(Division Sign-Off)
Division of Cardiovascular Devices

:0(k) Number Ko40825

Page 1 of 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.