(17 days)
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of AI or ML.
No.
The device description and intended use indicate that this guidewire facilitates the placement of other devices, rather than directly treating a condition itself.
No
The device, a guidewire, is used to facilitate the placement of other devices during diagnostic and interventional procedures, not to perform diagnosis itself.
No
The device description clearly outlines physical components (nitinol or stainless steel core wire, coil, coating) and physical parameters (diameter, length, tips), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To facilitate the placement of devices used during diagnostic and interventional procedures." This describes a tool used during a medical procedure, not a test performed on a sample (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description details a physical guidewire used to navigate within the body. This is consistent with a surgical or interventional tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the guidewire, not on the accuracy or reliability of a diagnostic test.
In summary, the device is a medical tool used to assist in procedures, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
To facilitate the placement of devices used during diagnostic and interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
74HAP, 74DQX, 74JAJ, DQX
Device Description
Nitinol or stainless steel core wire with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. Additionally, the proximal end of the coil is secured to the core either at the proximal end of the core (where the entire core is enclosed in the coil as in K779077 design) or at a design-driven location on the core (where a portion of the core is exposed as in K011084 design). A portion of the guidewire is coated with hydrophilic coating. The guidewires are bound by the following parameters: .014" - . 018" Outside Diameter: Lengths: 40cm - 150cm Tips: Straight or shaped with various tip flexibilities. NOTE: None of these guidewires are for PTCA use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
No change
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. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, 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.
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.
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.
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
§ 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.
0
SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS
December 1, 2003
- 2.1 General Information
- 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 Name/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. -
Device Common Names/Usual Names and Classification Names 2.1.3
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). -
Establishment Registration Number: 2126666 2.1.4
-
Classification of Devices 2.1.5
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 2.1.6
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.
1
-
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. -
2.4 Device Description
- Nitinol or stainless steel core wire with stainless steel or platinum coil 2.4.1 secured to the ground, flexible (distal) end of the core. Additionally, the proximal end of the coil is secured to the core either at the proximal end of the core (where the entire core is enclosed in the coil as in K779077 design) or at a design-driven location on the core (where a portion of the core is exposed as in K011084 design). A portion of the guidewire is coated with hydrophilic coating. The guidewires are bound by the following parameters:
.014" - . 018" Outside Diameter: Lengths: 40cm - 150cm Tips: Straight or shaped with various tip flexibilities
NOTE: None of these guidewires are for PTCA use.
Engincering Specifications 2.4.2
The design specifications are the same for the proposed device as they are for the LRM predicate devices {reference 510(k) K770977 and K011084]. The finished device with hydrophilic coating must meet the same basic design criteria and also meet the criteria established for the hydrophilic properties of the guidewire.
- 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 acceptance criteria.
2
| Item | Proposed Device Differences from LRM Predicate cleared under
510(k) K770977 and K011084 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Raw Materials | Core:
No change to raw material
Coil:
No change to raw material
Coating:
Addition of hydrophilic coating as alternate coating
(reference K991898 Microvena Corporation HyTekTM
Guidewire for predicate of a legally marketed device within
the same classification for the same intended use that
employs the hydrophilic coating in its design.) |
| Assembly Process | No change to assembly processes |
| Physical Characteristics | No change |
| Labeling/IFU | The only change to the label or IFU will be wording specific to the
hydrophilic properties of the guidewire. |
| 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 |
2.5.2 Non-Clinical Tests
In order to demonstrate equivalence of the proposed device, LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, 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.
Qualification and Biocompatibility Test Data 2.6
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 Fffect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.
Material/Product/Process Qualification 2.6.2
LRM has formal quality systems in place to assure that each product manufactured with the hydrophilic coating 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, Product Qualification, and Process Qualification. These controls are applied to each product size/group.
3
-
Biocompatibility Testing 2.6.3
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 hydrophilic coated 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
To facilitate the placement of devices used during diagnostic and interventional procedures. NOTE: The modification of this device does not alter its intended use.
4
Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Lake Region Manafacturing, Inc. c/o Ms. Karen Mortensen Senior Regulatory Compliance Specialist 340 Lake Hazeltine Drive Chaska, MN 55318-1029
Re: K033758
Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: December 1, 2003 Received: December 2, 2003
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.
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.
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
5
Page 2 – Ms. Karen Mortensen
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QS) regular (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decirons of I device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device to locar device to a I his letter will anow you to begin manisang your and equivalence of your device to a legally premarket nothleadon. The PDA miding of backand is plan
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 If you desire specific advice for your ac (301) 594-4648. Also, please note the regulation entitled, Colliact the Office of Compullier as (est notification" (21CFR Part 807.97). You may obtain Misoraliums by reference to premantonitiities under the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(901)445 657 fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Alison Hag Jr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): Unknown
Device Name: Hydrophilic Guidewire
Indications for Use:
: "
To facilitate the placement of devices for diagnostic and interventional procedures.
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)
(Division Sign-off) for BraPREMARKET NOTIFICATU
Division of Cardiovascular Devices
510(K) Number_K033758 (SM.K
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