(172 days)
No
The device description and performance studies focus on the physical and material properties of a guidewire, with no mention of AI or ML.
No
A therapeutic device is used to treat or cure a disease or medical condition. This device, a guidewire, is explicitly described as facilitating the placement of other devices during diagnostic and interventional procedures, indicating a supportive or enabling role rather than direct treatment.
No
Explanation: The "Intended Use / Indications for Use" states that the device facilitates the placement of other devices during diagnostic and interventional procedures, indicating it is an accessory tool rather than a diagnostic device itself.
No
The device description explicitly details a physical guidewire constructed from metallic and polymer materials, undergoing extensive bench and biocompatibility testing related to its physical properties. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To facilitate the placement of devices during diagnostic and interventional procedures." This describes a tool used within the body to aid in procedures, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a physical guidewire made of metallic and polymer materials, designed for navigation within the body. This is consistent with a medical device used in procedures, not an IVD.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device described is a medical device used to guide other instruments during procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
To facilitate the placement of devices during diagnostic and interventional procedures.
Product codes
DQX
Device Description
Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Nitinol) with a radiopaque polymer (polyurethane) jacket and a hydrophilic coating is applied over the jacket. Guidewires are available up to 260cm length and in diameters from 0.018" to 0.038" depending on specific design requirements. Guidewires may have a straight or angled distal tip.
OUTSIDE DIAMETER: 0.018"-0.038"
LENGTHS: 80cm - 260cm
TIP SHAPE: Straight or Angled
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The conclusions drawn from non-clinical and biocompatibility testing demonstrate the device is substantially equivalent to the claimed predicate device.
BENCH TESTING
Test methods were developed using FDA Coronary and Cerebrovascular Guidance and ISO 11070:1998. The following table lists the applicable bench tests performed at baseline and aging:
- . Dimensional
- FDA Device Compatibility .
- FDA Tensile Strength ●
- FDA Tip Flexibility .
- FDA Coating Adherence/Integrity 0
- FDA Catheter Compatibility .
- FDA Torque Control .
- . FDA Combined Load
- . Packaging Study
- Particulate .
- Kink Resistance .
- Linear Stiffness .
- Lateral Stiffness .
- ISO Visual ●
- ISO Fracture
- ISO Flex .
- ISO Corrosion .
- ISO Strength of Union .
- . ISO Radiopacity
- Body Stiffness .
- Tip Integrity .
- Jacket Durability .
- Tip Puncture Resistance .
- Coating Performance Testing .
- 3 Point Bend .
BIOCOMPATIBILITY TESTING
Biocompatibility testing per ISO 10993 series has been performed on the proposed Hydrophilic Guidewires and has been found to be acceptable:
- ISO Cytotoxicity .
- . ISO Klingman Maximization Test
- ISO Irritation / Intracutaneous Reactivity .
- ISO Systemic Toxicity .
- . ISO Rabbit Pyrogen
- . ASTM Hemolysis
- ISO Complement Activation Assay
- ISO Thrombogenicity
- ISO Lee and White Coagulation
- ISO Prothrombin Time Assay
- ISO Unactivated Partial Thromboplastin Time . Assay
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for Lake Region Medical. The logo consists of a circular symbol on the left, followed by the words "Lake Region" in a bold, serif font. Below "Region" is the word "Medical" in a smaller font size.
PRODUCT: Hydrophilic Coated Guidewires SUBMISSION DATE: September 30, 2013 SUBMISSION TYPE: Traditional 510(k)
K133155, 510(k) Summary Page 1 of 3
SECTION 1.0: 510(k) SUMMARY
1.1 MANUFACTURER / REGISTRATION INFORMATION
| Lake Region Medical | Contact Person: | Tracy Meyer |
|---|---|---|
| 340 Lake Hazeltine Drive | Title: | Regulatory Specialist |
| Chaska, MN 55318-1029 USA | Telephone: | 952-641-8510 |
| FDA REGISTRATION NUMBER: 2126666 | Fax: | 952-448-3441 |
1.2 TRADE NAME (PROPRIETATY NAME)
Hydrophilic Coated Guidewires
1.3 DEVICE COMMON NAMES/USUAL NAMES/CLASSIFICATION NAMES
These devices are commonly known as guidewires, or spring guidewires. The current classification names and product codes are Wire, Guide, Catheter (DQX).
CLASS OF DEVICE 1.4
The classification names listed above were originally classified as Class II devices by the Cardiovascular (74DQX) Review Panel.
IDENTIFICATION OF PREDICATE DEVICE(s) 1.5
| 510(k)
| NUMBER | MANUFACTURER | DEVICE NAME |
|---|---|---|
| K000011 | Lake Region Medical | Hydrophilic Coated Guidewire |
PROPOSED DEVICE DESCRIPTION 1.6
Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Nitinol) with a radiopaque polymer (polyurethane) jacket and a hydrophilic coating is applied over the jacket. Guidewires are available up to 260cm length and in diameters from 0.018" to 0.038" depending on specific design requirements. Guidewires may have a straight or angled distal tip.
OUTSIDE DIAMETER: 0.018"-0.038"
LENGTHS: 80cm - 260cm TIP SHAPE: Straight or Angled
1.7 COMPLIANCE WITH APPLICABLE STANDARDS
The proposed Hydrophilic Coated Guidewires is in compliance with ISO 10993, ISO 11070, ISO 15223, EN 980, ISO 594.
1
Image /page/1/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a circular symbol to the left of the words "Lake Region" in a bold, sans-serif font. Below "Region" is the word "Medical" in a smaller font size.
PRODUCT: Hydrophilic Coated Guidewires SUBMISSION DATE: September 30, 2013 SUBMISSION TYPE: Traditional 510(k)
SECTION 1.0: 510(k) SUMMARY
INTENDED USE STATEMENT 1.8
To facilitate the placement of devices during diagnostic and interventional procedures.
1.9 CONTRAINDICATIONS
None Known
1.10 COMPARISON
The proposed Hydrophilic Coated Guidewire is substantially equivalent to the predicate Hydrophilic Coated Guidewire with 510(k) number K000011.
QUALIFICATION TESTING 1.11
The conclusions drawn from non-clinical and biocompatibility testing demonstrate the device is substantially equivalent to the claimed predicate device.
BENCH TESTING
In order to demonstrate equivalence of the proposed hydrophilic guidewire, Lake Region Medical performed testing to establish requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional attributes. Test methods were developed using FDA Coronary and Cerebrovascular Guidance and ISO 11070:1998. The following table lists the applicable bench tests performed at baseline and aging:
- . Dimensional
- FDA Device Compatibility .
- FDA Tensile Strength ●
- FDA Tip Flexibility .
- FDA Coating Adherence/Integrity 0
- FDA Catheter Compatibility .
- FDA Torque Control .
- . FDA Combined Load
- . Packaging Study
- Particulate .
- Kink Resistance .
- Linear Stiffness .
- Lateral Stiffness .
- ISO Visual ●
- ISO Fracture
- ISO Flex .
- ISO Corrosion .
- ISO Strength of Union .
- . ISO Radiopacity
- Body Stiffness .
- Tip Integrity .
- Jacket Durability .
- Tip Puncture Resistance .
- Coating Performance Testing .
- 3 Point Bend .
2
Image /page/2/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a circular graphic on the left, followed by the words "Lake Region" in a bold, serif font. The word "Medical" is written in a smaller font below "Region."
PRODUCT: Hydrophilic Coated Guidewires SUBMISSION DATE: September 30, 2013 SUBMISSION TYPE: Special 510(k)
K133155, 510(k) Summary Page 3 of 3
8 | P a g e
1 , 1 1 QUALIFICATION TESTING Continued
BIOCOMPATIBILITY TESTING
Biocompatibility testing per ISO 10993 series has been performed on the proposed Hydrophilic Guidewires and has been found to be acceptable:
- ISO Cytotoxicity .
- . ISO Klingman Maximization Test
- ISO Irritation / Intracutaneous Reactivity .
- ISO Systemic Toxicity .
- . ISO Rabbit Pyrogen
- . ASTM Hemolysis
- ISO Complement Activation Assay
- ISO Thrombogenicity
- ISO Lee and White Coagulation �
- ISO Prothrombin Time Assay ◆
- ISO Unactivated Partial Thromboplastin Time . Assay
1.12 SUBSTANTIAL EQUIVALENCE DATA
The proposed Hydrophilic Coated Guidewire has the same intended use as predicate Hydrophilic Coated Guidewires legally marketed by Lake Region Medical and cleared by 510(k) K000011.
The proposed Hydrophilic Coated Guidewires have the same physical characteristics as the predicate device with the exception of the change to the hydrophilic coating. All required tests results support the claim of substantial equivalence.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2014
Lake Region Medical % Tracy Meyer, Regulatory Specialist 340 Lake Hazeltine Drive Chaska, MN 55318-1029
Re: K133155
Trade/Device Name: Hydrophilic Coated Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire Catheter Regulatory Class: Class II Product Code: DQX Dated: March 5, 2014 Received: March 6, 2014
Dear Tracy Meyer,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Tracy Meyer
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Image /page/4/Picture/5 description: The image shows the name "Bram D. Zuckerman" in bold, black font. Below the name is the letter "S" in a similar font. To the right of the name and the letter is the acronym "FDA" in a stylized, outlined font.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
C Lak
PRODUCT: Hydrophilic Coated Guidewires SU8MISSION DATE: September 30, 2013 SUBMISSION TYPE: Traditional 510(k)
INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): K133155
DEVICE NAME: Hydrophilic Coated Guidewire
INDICATIONS FOR USE:
To facilitate the placement of devices during diagnostic and interventional procedures.
PRESCRIPTION × USE
OVER-THE-.4ND/OR
COUNTER USE (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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