Lake Region's steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.

Device Description

Utilizing a proprietary process, LRM produces a PTFE coated stainless steel steerable core. The proximal portion of the core wire is coated with PTFE to provide lubricity and improve wire handling. A platinum alloy coil provides radiopacity in the distal tip. The coil is secured in its location by solder, which is attached to the core. The proximal end of the coil is attached to the core with solder. Additionally, two sections of PTFE are removed from the proximal end of the core to aid in estimating guidewire positioning. The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are optionally coated with MDX (silicone). The guidewires are bound by the following parameters: Outside Diameter: .018", Lengths: 130cm - 300cm, Tips: Straight or shaped with various tip flexibilities, Flexibility: Floppy to Support.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a guidewire, and the submission emphasizes its substantial equivalence to previously cleared predicate devices (K970376 and K011968), rather than detailing specific numerical performance metrics for acceptance criteria and results. The "performance" is primarily demonstrated through meeting established requirements and the absence of adverse effects due to minor modifications.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (How the device meets the criteria)
Design Specifications	Same basic design criteria as predicate devices (K970376 and K011968).	"The design specifications are the same for the proposed device as they are for the LRM predicate device [reference 510(k) K970376 and K011968]. The finished devices must meet the same basic design criteria." (Section 2.4.2)
Physical Characteristics	Expand overall length from 175cm-300cm to 130cm-300cm. Allow radiopaque coil length from 2cm-30cm (was either 2cm or 30cm).	"No change except to expand the scope of the overall length parameters from: 175cm – 300cm to: 130cm – 300cm and to allow radiopaque coil length ranges from 2 cm to 30 cm (was either 2 cm or 30 cm)." (Table in Section 2.5.1) Testing was done to ensure these changes met predetermined performance criteria.
Material Equivalence	Raw materials (Core, Coil, Extension system) identical to predicate.	"No change" for Core, Coil, Extension system raw materials. (Table in Section 2.5.1). "The materials for the proposed device are identical to the predicate device cleared under K011968 and are identically processed and sterilized." (Section 2.6.3)
Process Equivalence	No significant change to assembly processes.	"No significant change to assembly processes." (Table in Section 2.5.1)
Intended Use	No change to intended use, but to clarify use in renal peripheral vasculature.	"No change to intended use except to clarify the guidewire can be used in the renal peripheral vasculature." (Table in Section 2.5.1). The final "Indications for Use" statement explicitly includes "coronary and peripheral vasculature, including the renal vasculature." (Section 2.8 and 510(k) Letter)
Biocompatibility	No new biocompatibility issues compared to predicate.	"No change" (Table in Section 2.5.1). "Biocompatibility testing for the proposed device is not required" because materials are identical and identically processed/sterilized as the predicate. (Section 2.6.3)
Performance Testing	Meet requirements of FDA guidance "Coronary and Cerebrovascular Guidewire Guidance" (Jan 1995) and ISO 11070. Internally defined protocols for peripheral/renal vasculature. Inspection criteria for visual/tactile, dimensional, and mechanical attributes.	"LRM performed testing to established requirements listed in FDA guidance document entitled Coronary and Cerebrovascular Guidewire Guidance, issued January 1995, and ISO 11070 Sterile Single-use Intravascular Catheter Introducers." (Section 2.5.2) "Additionally, internal test protocol requirements were utilized to verify the guidewire can be used in the peripheral vasculature, including the renal vasculature." (Section 2.5.3) "Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." (Section 2.5.4)
Safety Characteristics	No change from predicate device.	"No change" (Table in Section 2.5.1).
Risk Analysis	No change from predicate device; conformance with design control, FMEA used.	"No change" (Table in Section 2.5.1). "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 criteria could be met." (Section 2.6.1)
Quality Systems	Assurance that proposed product remains equivalent and changes have no adverse effect on safety/effectiveness.	"LRM has formal quality systems in place to assure that the proposed steerable product will 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." (Section 2.6.2)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial or large-scale performance study. It mentions "Test pieces were tested and inspected" (Section 2.5.4) and "testing was done to ensure the changes to the device met the predetermined performance criteria" (Section 2.5.1), but without a number. This submission relies heavily on a "substantial equivalence" argument, meaning much of the "proof" comes from the established performance of the predicate devices combined with verification of the minor changes.
Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be primarily non-clinical bench testing and in-house verification against established standards and internal protocols. There's no mention of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The "ground truth" for guidewire performance in this context would likely be defined by the established engineering specifications and performance standards (FDA guidance, ISO 11070, internal protocols) rather than expert consensus on individual cases. The document refers to "established specific inspection criteria requirements" (Section 2.5.4) which would have been defined by qualified engineers and regulatory specialists during the design control process.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth from clinical data. Since the testing described is primarily non-clinical bench testing and verification against standards, such a method wouldn't typically be used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. This submission pertains to a physical medical device (guidewire), not an AI algorithm. Therefore, there is no mention of human readers, AI assistance, or effect sizes in this context.

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

No. This is a submission for a physical medical device (guidewire), not a standalone AI algorithm. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Engineering Specifications: Conformance to the design and performance criteria set for guidewires, identical to the predicate device.
Regulatory Standards: Compliance with requirements of the FDA guidance document "Coronary and Cerebrovascular Guidewire Guidance, issued January 1995," and ISO 11070 "Sterile Single-use Intravascular Catheter Introducers."
Internal Protocol Requirements: Verification against LRM's own internal test protocols, especially for verifying use in peripheral and renal vasculature.
Visual/Tactile, Dimensional, and Mechanical Attributes: Established specific inspection criteria for these physical properties. (Section 2.5.4)

Essentially, the ground truth is a combination of validated engineering requirements and compliance with recognized industry and regulatory standards.

8. The Sample Size for the Training Set

This information is not applicable/provided. The concept of a "training set" is relevant for machine learning or AI algorithms. This submission is for a physical medical device (guidewire), which does not involve a training set in this context. The "training" for the device's design would be the extensive R&D and manufacturing experience of LRM that led to the predicate devices.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided for the reasons stated in point 8.

Summary

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SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

August 21, 2002

2.1 General Information
FEB 1 4 2003
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 Regulatory Compliance Specialist

2.1.2 Device Trade Name/Proprietary Name
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
2.1.5 Classification of Devices

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.
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

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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.
2.4 Device Description
- Utilizing a proprietary process, LRM produces a PTFE coated stainless 2.4.1 steel steerable core. The proximal portion of the core wire is coated with PTFE to provide lubricity and improve wire handling. A platinum alloy coil provides radiopacity in the distal tip. The coil is secured in its location by solder, which is attached to the core. The proximal end of the coil is attached to the core with solder. Additionally, two sections of PTFE are removed from the proximal end of the core to aid in estimating guidewire positioning. The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are optionally coated with MDX (silicone). The guidewires are bound by the following parameters:

Outside Diameter:	.018"
Lengths:	130cm - 300cm
Tips:	Straight or shaped with various tip flexibilities
Flexibility:	Floppy to Support

2.4.2 Engineering Specifications

The design specifications are the same for the proposed device as they are for the LRM predicate device [reference 510(k) K970376 and K011968]. The finished devices must meet the same basic design criteria.

2.5 Substantial Equivalence Data
- 2.5.1 Background Information

The table below lists the differences between the predicate device and the proposed device. Testing was done to ensure the changes to the device met the predetermined performance criteria.

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Item	Proposed Device Differences from LRM Predicate clearedunder 510(k) K970376 and K011968
Raw Materials	Core:No changeCoil:No changeExtension system:No change
Assembly Process	No significant change to assembly processes
PhysicalCharacteristics	No change except to expand the scope of the overall lengthparameters from:175cm – 300cmto:130cm – 300cmand to allow radiopaque coil length ranges from 2 cm to30 cm (was either 2 cm or 30 cm).
Labeling/IFU	The only change to the IFU will be to reference thespecific use regarding renal vasculature in addition to thealready stated coronary and peripheral vasculature use.
Intended Use	No change to intended use except to clarify the guidewirecan be used in the renal peripheral vasculature.
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 In order to demonstrate equivalence of the proposed device, LRM performed testing to established requirements listed in FDA guidance document entitled Coronary and Cerebrovascular Guidewire Guidance, issued January 1995, and ISO 11070 Sterile Single-use Intravascular Catheter Introducers.
2.5.3 Additionally, internal test protocol requirements were utilized to verify the guidewire can be used in the peripheral vasculature, including the renal vasculature.
2.5.4 Configurations, including straight and shaped distal tips were inspected to established criteria. These parts were produced following current manufacturing processes and procedures. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes.

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2.6 Qualification and Biocompatibility Test Data

2.6.1 Design Control

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 criteria could be met.

2.6.2 Material/Product/Process Qualification

LRM has formal quality systems in place to assure that the proposed steerable product will 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.

2.6.3 Biocompatibility Testing

The materials for the proposed device are identical to the predicate device cleared under K011968 and are identically processed and sterilized. Therefore, biocompatibility testing for the proposed device is not required.

2.7 Packaging and Sterilization Information

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 steerable guidewire is placed in a dispenser and then into a Tyvek®/poly pouch. The packaged product may be packaged as five or ten pouchs in 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.

2.8 Intended Use Statement

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three faces overlapping to represent the department's focus on health and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K022813

Trade Name: Coronary Peripheral and Renal Steerable Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: December 16, 2002 Received: December 17, 2002

Dear Ms. Mortensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 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) that do not require approval of a premarket approval application (PMA). 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.

FEB 1 4 2003

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

VDeila Tuller

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

Enclosure

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510(k) Number (if known): Unknown

Device Name: Steerable Guidewires

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X Or Over-The-Counter Use __
(PER 21 CFR 801.109)
PREMARKET NOTIFICATION
(Division Sign-Off)
9-Division of Cardiovascular Devices
510(k) Number K022813

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.