(88 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a guidewire used to introduce and position catheters, which are diagnostic or interventional tools, but the guidewire itself does not provide therapy.
No
The device, a guidewire, is intended for introducing and positioning catheters and other interventional devices within the left heart. It is a tool for facilitating procedures, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of a stainless steel core wire and coil, indicating it is a physical medical device, not software. The performance studies also focus on physical and material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in percutaneous transseptal procedures to introduce and position catheters and other interventional devices within the left heart." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical guidewire used for navigation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a medical procedure.
N/A
Intended Use / Indications for Use
The ANCHORWIRE™ guidewires are intended for use in percutaneous transseptal procedures to introduce and position catheters and other interventional devices within the left heart. The device is not intended for use in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Lake Region Anchorwire™ guidewires are comprised of a stainless steel core wire with a flexible, spiral shaped stainless steel coil on the distal end. The guidewire is offered in several lengths including 175cm, 203cm, and 230cm. The product is supplied sterile for single use only.
MAX OD: .025"
LENGTHS: 175cm - 230 cm
TIPS: Spiral
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left heart
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)
NON-CLINICAL TESTS
In order to demonstrate equivalence of the Anchorwire™ guidewire, 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. A list of applicable non-clinical tests included performed at baseline and aging include:
- Dimensional
- Kink Resistance
- Device Compatibility
- Pull Strength
- Pouch Peel
- Spiral Compression
- Dye Penetration
- Visual
- Radiopacity
- Fracture
- Flex
- Corrosion
- Strength of Union
- Body Stiffness
- Particulate
- Spiral Memory
- Coil Free Play
BIOCOMPATIBILITY TESTING
Biocompatibility testing per ISO 10993 series has been performed on the Anchorwire™ devices and has been found to be acceptable.
- Cytotoxicity
- Kligman Maximization Test
- Systemic Toxicity
- Rabbit Pyrogen
- Hemolysis
- Complement Activation Assay
- Thrombogenicity
- Lee & White Coagulation
- Unactivated Thromboplastin Time Assay
- USP Physicochemical Test
- Inhibition and Enhancement
GLP ANIMAL STUDY
An animal study was completed evaluating the clinical safety and performance of the Anchorwire™ to the currently marketed device. The study proved the Anchorwire™ is as safe as effective and performs at least as safely and effectively as the legally marketed device.
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.
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
§ 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 Healthcare. The logo consists of a stylized symbol on the left, resembling interconnected circles or a medical symbol. To the right of the symbol, the words "Lake Region" are written in a serif font, with the word "Medical" appearing in a smaller font size below "Region."
PRODUCT: ANCHORWIRE™ GUIDEWIRES SUBMISSION DATE: August 1, 2011 SUBMISSION TYPE: TRADITIONAL
AUG - 2 2011
510(k) SUMMARY SECTION 5.0:
MANUFACTURER / REGISTRATION INFORMATION 5.1
| Lake Region Medical | Contact Person: | Mathew Pexa |
|---|---|---|
| 340 Lake Hazeltine Drive | Title: | Regulatory Specialist I |
| Chaska, MN 55318-1029 USA | Telephone: | (952) 641-8511 |
| FDA REGISTRATION NUMBER: 2126666 | Fax: | (952) 448-3441 |
TRADE NAME (PROPRIETATY NAME) 5.2
Anchorwire™ Guidewire
Lake Region Medical (LRM) produces Guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors.
5.3 DEVICE COMMON NAMES/USUAL NAMES/CLASSIFICATION NAMES
These devices are commonly known as Guides, Guidewires, or spring Guidewires. The current classification name and product code is Wire, Guide, Catheter (DQX) and regulation number 870.1330.
5.4 CLASS OF DEVICE
This type of Guidewire was originally listed as a Class II device by the Cardiovascular (DQX) Review Panel.
5.5 IDENTIFICATION OF PREDICATE DEVICE(s)
| 510(k) NUMBER | MANUFACTURER | DEVICE NAME |
|---|---|---|
| K042370 | Toray Industries (America), Inc | Torayguide® |
5.6 DEVICE DESCRIPTION
The Lake Region Anchorwire™ guidewires are comprised of a stainless steel core wire with a flexible, spiral shaped stainless steel coil on the distal end. The guidewire is offered in several lengths including 175cm, 203cm, and 230cm. The product is supplied sterile for single use only.
| MAX OD: | .025" |
|---|---|
| LENGTHS: | 175cm - 230 cm |
| TIPS: | Spiral |
5.7 TECHNOLOGICAL CHARACTERSTICS
The primary modifications between the Toray Industries (America), Inc. Torayguide® and the Lake Region Anchorwire™ is the intended use statement, shorter taper length, joining method of distal tip and dimension of the spiral diameter. The table below shows the technological differences between the proposed Anchorwire™ and predicate Torayguide® guidewires.
| PREDICATE DEVICE - TORAYGUIDE® | PROPOSED DEVICE - ANCHORWIRE™ |
|---|---|
| SPIRAL DIAMETER | |
| 39-45mm | 36-46mm |
| DISTAL TIP JOINING METHOD | |
| Solder | Weld |
| TAPER LENGTH | |
| 29cm | 26cm |
5.8 COMPLIANCE WITH APPLICABLE STANDARDS
The Lake Region Anchorwire™ is in compliance with ISO 10993, ISO 11070, ISO 15223, EN 980 and 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 on the left, followed by the words "Lake Region" in a larger font. Below "Region" is the word "Medical" in a smaller font. The logo is simple and professional.
PRODUCT: ANCHORWIRE™ GUIDEWIRES SUBMISSION DATE: August 1, 2011 SUBMISSION TYPE: TRADITIONAL
SECTION 5.0: 510(k) SUMMARY
5.9 INTENDED USE STATEMENT
The ANCHORWIRE™ guidewires are intended for use in percutaneous transseptal procedures to introduce and position catheters and other interventional devices within the left heart. The device is not intended for use in the coronary arteries.
COMPARISON 15.10
The Anchorwire™ Guidewires are substantially equivalent to the Torayguide® Guidewires (K042370).
5.11 QUALIFICATION TESTING
The conclusions drawn from nonclinical, biocompatibility and GLP animal study demonstrate the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device.
NON-CLINICAL TESTS
In order to demonstrate equivalence of the Anchorwire™ guidewire, 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. A list of applicable non-clinical tests included performed at baseline and aging include:
- · Dimensional
- Kink Resistance .
- Device Compatibility .
- · Pull Strength
- Pouch Peel
- · Spiral Compression
- · Dye Penetration · · ·
- Visual
- · Radiopacity
- Fracture
- Flex
- · Corrosion
- Strength of Union
- · Body Stiffness
- · Particulate
- · Spiral Memory
- · Coil Free Play
BIOCOMPATIBILITY TESTING
Biocompatibility testing per ISO 10993 series has been performed on the Anchorwire™ devices and has been found to be acceptable.
- · Cytotoxicity
- · Kligman Maximization Test
- · Systemic Toxicity · Systemic ·
- · Rabbit Pyrogen
- · Hemolysis
- · Complement Activation Assay
- · Thrombogenicity
- · Lee & White Coagulation
- · Unactivated Thromboplastin Time Assay
- · USP Physicochemical Test
- Inhibition and Enhancement
GLP ANIMAL STUDY
An animal study was completed evaluating the clinical safety and performance of the Anchorwire™ to the currently marketed device. The study proved the Anchorwire™ is as safe as effective and performs at least as safely and effectively as the legally marketed device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Lake Regional Medical c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
AUG - 2 2011
Re: K111288
Device Name: Anchorwire Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: July 20, 2011 Received: July 21, 2011
Dear Mr. Job:
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 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.
3
Page 2 - Mr. Mark Job
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,
Sincerely yours,
Bram D. Zuckerman
Bram D. Žuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Lake Region
INDICATIONS FOR USE
510(k) NUMBER (if KNOWN): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME: ANCHORWIRE™ Guidewires
INDICATIONS FOR USE:
The ANCHORWIRE™ guidewires are intended for use in percutaneous transseptal procedures to introduce and position catheters and other interventional devices within the left heart. The device is not intended for use in the coronary arteries.
.
| PRESCRIPTION USE
(Part 21 CFR 801 Subpart D) | X | 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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K111288 |
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