STREERABLE PTCA GUIDEWIRE

• K Number: K011968
• Device Name: STREERABLE PTCA GUIDEWIRE
• Manufacturer: LAKE REGION MFG., INC.
• Date Cleared: 2001-07-25 ( 30 days)
• Product Code: DQX
• Regulation Number: 870.1330

Intended Use

For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral 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, placed within the confines of the outer coil and over-wrapping the ribbon section, provides radiopacity in the distal tip. The coils are secured in their location by solder, which is attached to the core. The proximal end of the outer coil is attached to the core with braze, and the distal end has a mid-point of the outer coil which is attached to the core with solder. On the models with markers, two additional radiopaque markers that are .009" platinum coils in a 5mm length are provided. The distal portion may be either a 30 cm long stainless steel coil with a 2 cm long inner platinum coil to provide radiopacity or a 30 cm long platinum coil (for radiopacity). The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are coated with MDX (silicone).

Predicate Devices

K970376

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of AI or ML technologies.

Therapeutic

No.
The device is a guidewire used to introduce and position other devices, not to directly treat a condition.

Diagnostic

No

The device is a guidewire used to introduce and position catheters and interventional devices, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components such as a PTFE coated stainless steel core, platinum alloy coils, solder, braze, and silicone coating, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
• Device Description: The description details a guidewire with physical components designed for navigation within blood vessels. This aligns with an in vivo medical device.
• Anatomical Site: The anatomical site is "Coronary and peripheral vasculature," which are locations within the human body.
• Input Imaging Modality: Fluoroscopy is an imaging technique used to visualize structures within the body during a procedure.
• Performance Studies: The performance studies focus on the physical and mechanical properties of the guidewire (e.g., lubricity, pull strength, torque control, radiopacity), which are relevant to its function during an in vivo procedure.

IVD devices are typically used to test samples like blood, urine, or tissue to diagnose diseases or conditions. This device's function is entirely different.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

74DQX

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, placed within the confines of the outer coil and over-wrapping the ribbon section, provides radiopacity in the distal tip. The coils are secured in their location by solder, which is attached to the core. The proximal end of the outer coil is attached to the core with braze, and the distal end has a mid-point of the outer coil which is attached to the core with solder. On the models with markers, two additional radiopaque markers that are .009" platinum coils in a 5mm length are provided. The distal portion may be either a 30 cm long stainless steel coil with a 2 cm long inner platinum coil to provide radiopacity or a 30 cm long platinum coil (for radiopacity). The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are coated with MDX (silicone). The guidewires are bound by the following parameters:

Outside Diameter: .014" - .018"
Lengths: 175cm-300cm
Tips: Straight or shaped with various tip flexibilities
Flexibility: Floppy to Support

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. Additionally, internal test protocol requirements were utilized. 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. The following tests were performed: Visual, Dimensional Measurement - Outside Diameter of Core Body with PTFE coating, PTFE Coating Durability, Silicone Adhesion, Lubricity, Pull Test, Torque Control, Linear Stiffness, Lateral Stiffness, Radiopacity, Corrosion Resistance, Tip Shape Memory/Retention, Extension Joint Coupling, Wire Flexure, Wire Fracture Test, Combined Load.

RESULTS: ALL TEST RESULTS WERE WITHIN PRESCRIBED SPECIFICATION LIMITS.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K970376

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS

June 22, 2001

• 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 Telephone: [phone] Fax: [phone]

Contact Name: Jeff Pumper Quality Assurance Engineer

• 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 catheter guidewires. The current classification names and product codes are Wire, Guide, Catheter (74DQX).

• Establishment Registration Number: 2.1.4 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.

• 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.

Statement of Availability 2.3

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, placed within the confines of the outer coil and over-wrapping the ribbon section, provides radiopacity in the distal tip. The coils are secured in their location by solder, which is attached to the core. The proximal end of the outer coil is attached to the core with braze, and the distal end has a mid-point of the outer coil which is attached to the core with solder. On the models with markers, two additional radiopaque markers that are .009" platinum coils in a 5mm length are provided. The distal portion may be either a 30 cm long stainless steel coil with a 2 cm long inner platinum coil to provide radiopacity or a 30 cm long platinum coil (for radiopacity). The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are coated with MDX (silicone). The guidewires are bound by the following parameters:

Outside Diameter:	.014" - .018"
Lengths:	175cm-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 freference 510(k) K970376]. The finished devices must meet the same basic design criteria.

2.5 Substantial Equivalence Data

Background Information 2.5.1

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 acceptance criteria.

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| Item | Proposed Device Differences from LRM Predicate cleared
under 510(k) K970376 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Raw Materials | Core:
No change
Outer Coil:
No change
Inner Coil:
No change
Marker coil bands:
Addition of marker coil bands. However the raw
material used is the same as the raw material used
to manufacture the inner coil.
Extension system:
No change |
| Assembly Process | No significant change to assembly processes |
| Physical
Characteristics | The guidewire will have two sections of PTFE removed to
aid in positioning. |
| Labeling/IFU | The only change to the label or IFU will be to reference
the slight design modifications that aid the physician in
determining placement of the guidewire {marker band
coils and proximal marker (PTFE removed sections)}. |
| Intended Use | No change to intended use |
| Anatomical Sites | No change |
| Target Population | No change |
| Performance Testing | No change |
| Safety Characteristics | No change |
| Biocompatibility | No change |
| Risk Analysis | No change |

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. Additionally, internal test protocol requirements were utilized. Configurations, including straight and shaped distal tips were inspected to established criteria. These parts were produced following current manufacturing processes and procedures.

• 2.5.2 Test Data
  Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes.

The following tests were performed:

• 2.5.2.1 Visual: Assess the product for visual appearance per established criteria.
• 2.5.2.2 Dimensional Measurement - Outside Diameter of Core Body with PTFE coating: Micrometer measurement of the outside diameter of the product at multiple body points.

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• 2.5.2.3 PTFE Coating Durability: Measures the ability of the coating to adhere to the core wire material.
• 2.5.2.4 Silicone Adhesion: Assess coating adherence when wire is subjected to wire flexure and tested in a powder.
• 2.5.2.5 Lubricity: Measures the force required to insert and withdraw the guidewire from a shaped catheter lumen.
• Pull Test: Measures the strength of materials and joints in the 2.5.2.6 guidewire.
• 2.5.2.7 Torque Control: Assess guidewire rotational control (clockwise or counter clockwise) to allow placement of the distal tip at a desired location in a 360° radius when controlled from the proximal end of the guidewire.
• Linear Stiffness: Assess the flexibility of the distal tip form 2.5.2.8 of the product.
• Lateral Stiffness: Measures stiffness / flexibility of the guidewire 2.5.2.9 from distal tip through to the guidewire body.
• 2.5.2.10 Radiopacity: Assess the ability of the device to be seen under fluoroscopy, when simulating a density of body mass.
• 2.5.2.11 Corrosion Resistance: Assess the material against resistance to oxidation over a period of time.
• 2.5.2.12 Tip Shape Memory/Retention: Assess the tip form after repeated exposure to a tortuous path.
• 2.5.2.13 Extension Joint Coupling: Assess ease of joint connection.
• 2.5.2.14 Wire Flexure: Assess the distal section and guidewire body for coating damage and guidewire breakage after repeated flexure of the product.
• 2.5.2.15 Wire Fracture Test: Assess the guidewire for breakage after wrapping the distal portion of the guidewire around a mandrel 10X the diameter of the product.
• 2.5.2.16 Combined Load: Assess the torsional integrity of the guidewire by applying a load on one end of the guidewire and torque to the opposite end of the guidewire.

RESULTS: ALL TEST RESULTS WERE WITHIN PRESCRIBED SPECIFICATION LIMITS.

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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 were met.

2.6.2 Material/Product/Process Qualification

LRM has formal quality systems in place to assure that the proposed PTCA 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

Biocompatibility testing has been performed on the material components of this device. This testing, along with a market history of proven biocompatibility establishes acceptable biocompatibility for this device.

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 PTCA 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

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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Image /page/5/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 eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2001

Mr. Jeff Pumper Lake Region Manufacturing, Inc. 340 Lake Hazeltine Drive Chaska, MN 55318-1029

K011968 Re:

Steerable PTCA Guidewire Regulation Number: 870.1330 Regulatory Class: II (two) Product Code: DQX Dated: June 22, 2001 Received: June 25, 2001

Dear Mr. Pumper:

We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your Section Pro(t) fiotely its substantially equivalent (for the indications for use stated in and we have deletinmed the devices is successfaritially interstate commerce prior to the enclosure) to regally marketed productions access or to devices that have been
May 28, 1976, the enactment date of the Medical Device Amending Ant Antone May 28, 1976, the enactinent date of the Federal Food, Drug, and Cosmetic Act (Act).
reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Ac reclassified in accordance with the provisions of the general controls provisions of the Act. The You may, merefore, market the devices, belyer to the of annual registration, listing of general Controls provisions of the Processor and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into crass . Existing major regulations affecting your Approval), It thay be subject to such additions, Title 21, Parts 800 to 895. A substantially device can be found in the Code of Fedeliance with the Current Good Manufacturing Practice equirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General Deva requirents, as set form in the Quality by seen and seen and one of the Food and Drug
regulation (21 CFR Part 820) and that, through periodic QS inspections, the AM prove regulation (21 CFR rail 620) and that, through post. Failure to comply with the GMP regulation Administration (1 DA) will vertify such assumplation announcements concerning may result in the Federal Register. Please note: this response to your premarket notification your device in the Federal Register. Thou you might have under sections 531 through 542 of the

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Page 2 - Mr. Jeff Pumper

Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Donk Telle

James E. Dillard III Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Unknown

Device Name: PTCA Steerable Guidewires

Indications for Use:

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

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