Nitinol or Stainless Steel core with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetratlyoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters: Outside Diameter: .014" - .035" Lengths: Straight or shaped with various tip flexibilities. Tips: Coil Length: 2cm - 30 cm

AI/ML Overview

The provided text describes a 510(k) premarket notification for Mandrel Guidewires (M-Wires), seeking substantial equivalence to existing predicate devices. However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document states that "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 were met." It also mentions "LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visualitactile, dimensional and mechanical attributes." And "Biocompatibility testing per ISO 10993 series has been performed on the Mandrel device and has been found to be acceptable."

However, it does not explicitly list the predetermined acceptance criteria themselves or the detailed results of the tests against these criteria in a quantitative manner. It only states that the results "demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices" and "support the claim of substantial equivalence to the predicate devices."

Therefore, much of the requested information cannot be extracted from this specific filing.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Visual/Tactile Attributes (Established specific inspection criteria)	"Supported the claim of substantial equivalence to the predicate devices." "Functionality and performance characteristics... are comparable to the currently marketed devices."
Dimensional Attributes (Established specific inspection criteria)	"Supported the claim of substantial equivalence to the predicate devices." "Functionality and performance characteristics... are comparable to the currently marketed devices."
Mechanical Attributes (Established specific inspection criteria)	"Supported the claim of substantial equivalence to the predicate devices." "Functionality and performance characteristics... are comparable to the currently marketed devices."
Biocompatibility (Per ISO 10993 series)	"Found to be acceptable."
Risk analysis (FMEA)	Predetermined acceptance criteria were met.

Note: The document states that the predetermined acceptance criteria were met, but it does not specify the quantitative values for these criteria. The "Reported Device Performance" is a summary statement of comparability and acceptability, rather than specific performance metrics against defined thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided text. The document only mentions "Test pieces were tested and inspected."
Data Provenance: Not specified, but likely internal testing conducted by Lake Region Manufacturing, Inc. in Chaska, MN, USA. There is no mention of external data or patient data.
Retrospective/Prospective: The testing described is prospective, in the sense that the new Mandrel Guidewire iterations were specifically tested to demonstrate equivalence.

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 and not provided. The "ground truth" for this type of device (guidewire) is typically established through engineering specifications, material science, and performance testing against established physical and biological standards, not through expert clinical consensus on images or patient outcomes in the context of a diagnostic AI.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data where consensus is needed for ground truth. This filing discusses non-clinical engineering and bench testing.

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

No, an MRMC comparative effectiveness study was not done. This is a medical device (guidewire), not a diagnostic AI algorithm that assists human readers.

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

This is not applicable. The device is a physical medical guidewire, not an algorithm. The testing described is "standalone" in the sense that it evaluates the physical device's properties (visual/tactile, dimensional, mechanical attributes, biocompatibility).

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

The ground truth for the non-clinical tests appears to be based on established engineering specifications, material standards, and performance requirements relevant to guidewires, as well as the ISO 10993 series for biocompatibility. This is considered objective, measurable physical properties and material safety standards rather than expert clinical consensus or pathology.

8. The sample size for the training set

This is not applicable. The Mandrel Guidewires are physical medical devices, not an AI algorithm that requires a "training set."

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

This is not applicable as there is no training set for a physical medical device.

Summary

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SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

January 18, 2007

K080144

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

COMPANY NAME, ADDRESS AND TELEPHONE NUMBER

Lake Region Manufacturing, Inc. d/b/a Lake Region Medical (LRM) 340 Lake Hazeltine Drive Chaska, MN 55318 (952) 448-5111 Telephone: (952) 448-3441 Fax: Contact Person: Deep Pal Regulatory Affairs Specialist

ESTABLISHMENT REGISTRATION NUMBER

2126666

DEVICE TRADE NAME/PROPRIETARY NAME

Mandrel Guidewire Or M-Wires

DEVICE COMMON NAMES/USUAL NAMES/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 Catheter Guidewire (74JAJ).

GLASSIFICATION OF DEVICES OF CHICLES OF CHARACT CHEAR OF The classification names listed above were originally classified as Class II devices by the Neurology (84HAD), Cardiovascular (74DQX), and Radiology (90JAJ) Review Panels, respectively.

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.

DEVICE DESCRIPTION

Nitinol or Stainless Steel core with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetraflyoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters:

Outside Diameter: .014" - .035" Lengths: Straight or shaped with various tip flexibilities. Tips: Coil Length: 2cm - 30 cm

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SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS (continued...)

TECHNOLOGICAL CHARACTERSTICS

The design specifications are substantially similar to the existing Mandrel Guidewires. Material used for the coil of the Guidewire will be Palladium.

QUALITY SYSTEM CONTROLS

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 were met.

MATERIAL/SUPPLIER/PRODUCT/PROCESS CONTROLS = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = LRM has formal quality systems in place to assure that each product manufactured remains equivalent to the predicate products, 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, Supplier Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.

QUALIFICATION TESTING

NON-CLINICAL TESTS THE FIRE FOR THE FOR SHOW FOR WARRET WE WARRE WE WAR In order to demonstrate equivalence of the Mandrel Guidewire iterations, LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visualitactile, dimensional and mechanical attributes. The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices.

BIOGOMPATIBILITY TESTING COUNTY CONTROLLER OF THE CONNECT CONSULTION Biocompatibility testing per ISO 10993 series has been performed on the Mandrel device and has been found to be acceptable.

SUBSTANTIAL EQUIVALENCE DATA

Lake Region believes the Mandrel Guidewire iterations are substantially equivalent to the predicate devices cleared under 510(k) K011084. All non-clinical test results support the claim of substantial equivalence to the predicate devices.

INTENDED USE STATEMENT

Mandrel Guidewires are intended for use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. NOTE: The modification of this device does not alter its intended use.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

FEB 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lake Region Manufacturing, Inc. DBA Lake Region Medical c/o Mr. Deep Pal Regulatory Affairs Specialist 340 Lake Hazeltine Drive Chaska, MN 55318

Re: K080144

Mandrel Guidewires Regulation Number: 21 CFR §870.1330 Regulation Name: Vascular clamp Regulatory Class: II Product Code: DQX Dated: January 18, 2008 Received: January 22, 2008

Dear Mr. Pal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of 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, de necs that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may , necess , sisions 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 (PMA), it If your de ho ho ho hadditional 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 - Mr. Deep Pal

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Dmna R. Vorhner

( 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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INDICATIONS FOR USE

080 510(k) Number (if known):

Device Name: Mandrel Guidewires

Indications for Use:

For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Prescription Use × (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)

uma R. Vuchner
(Division Sign-Off)

Page 1 of

Division of Cardiovascular Devices

510(k) Number_

9-1

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.