(25 days)
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: A therapeutic device is designed to treat a medical condition. This device, a guidewire, is described as facilitating the introduction of other diagnostic and treatment devices, meaning its primary function is not to treat but to aid in the delivery of treatment.
No
The provided information states that the device's intended use is "To facilitate the introduction of other diagnostic and treatment devices," not to perform a diagnosis itself.
No
The device description clearly details physical components (Nitinol or Stainless Steel core wire, Palladium coil, PTFE coating, silicone fluid) and physical parameters (diameter, length, tips, coil length), indicating it is a hardware device, not software-only.
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 introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures." This describes a device used in vivo (within the body) to aid in procedures, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a physical guidewire with specific materials, dimensions, and features designed for insertion into the body. This is consistent with a medical device used in procedures, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device is a medical device used for procedural guidance, not an IVD.
N/A
Intended Use / Indications for Use
To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
Product codes
KOD, KNY, FGE, KOG, OCY
Device Description
Nitinol or Stainless Steel core wire with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetrafluoroethylene). 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: 60 cm - 500 cm
TIPS: Straight or shaped with various tip flexibilities.
COIL LENGTH: 2cm - 30 cm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastroenterology and urology
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
Non-clinical tests were performed to demonstrate equivalence of the Mandrel Guidewire iterations. 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. Biocompatibility testing per ISO 10993 series has been performed on the Mandrel device and has been found to be acceptable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
P6. 1 or ?
SECTION 2.0 - SUMMARY OF SAFETY AND EFFECTIVENESS
March 05, 2008
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
Chaska, MN 55318
| PRIMARY CONTACT PERSON | ALTERNATE CONTACT PERSON | |
|---|---|---|
| Telephone: | (952) 448-5111, Ext. 6381 | (952) 448-5111, Ext. 6727 |
| Fax: | (952) 448-3441 | (952) 448-3441 |
| Email: | dpal@lakergn.com | kmortensen@lakergn.com |
| Contact Person: | Deep Pal | Karen Mortensen |
| Title: | Regulatory Affairs Specialist | Manager, Regulatory Affairs |
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 Urological Catheter and Accessories, Biliary Catheter and Accessories and Endoscope and Accessories.
CLASSIFICATION OF DEVICES
This type of Guidewire was originally listed as a Class II device by the Gastroenterology/Urology Review Panel; Urological Catheter and Accessories (21 CFR 876.5130) - KOD, Urological Catheter and Accessories (21 CFR 876.5130, which is now Exempt) - KNY, Biliary Catheter and Accessories (21 CFR 876.5010) - FGE and Endoscope and Accessories (21 CFR 876.1500) - KOG 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 wire with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetrafluoroethylene). 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: | 60 cm - 500 cm |
| TIPS: | Straight or shaped with various tip flexibilities. |
| COIL LENGTH: | 2cm - 30 cm |
2-1
1
K-080503 PG. 2 of 3
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
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 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.
BIOCOMPATIBILITY TESTING
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) K970994. All non-clinical test results support the claim of substantial equivalence to the predicate devices.
INTENDED USE STATEMENT
To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
NOTE: The modification of this device does not alter its intended use.
2
SECTION 3.0 - PROPOSED LABELING
3.1 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 Lake Region.
An example of a typical single pack label is included in this section.
INTENDED USE STATEMENT 3.2
To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
NOTE: The modification of this device does not alter its intended use.
3.3 | INSTRUCTIONS FOR USE
A draft example of a typical "Instructions for Use" for the Mandrel Guidewires is included in this section.
3.4 | ADVERTISING/PROMOTIONAL MATERIALS
LRM has no advertising or promotional materials intended for distribution to the end-users of this product.
The following pages contain labeling information including;
- . Sample label for proposed device
- 트 Sample IFU for proposed device
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 2 1 2008
Mr. Deep Pal Regulatory Affairs Specialist Lake Region Medical 340 Lake Hazeltine Drive CHASKA MN 55318-1029
Re: K080508
Trade/Device Name: Mandrel Guidewire or M-Wire™ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: February 22, 2008 Received: February 25, 2008
Dear Mr. Pal:
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 (Premarket Approval), 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.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. There are stars at the bottom of the logo.
Protesting and Promoting Public Health
4
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 one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-011 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-011 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-012 |
| Other | 240-276-010 |
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 Biometric's (OSB's) 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.
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications for Use:
To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
Prescription Use _ X (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)
Y. Nancy C. Brogdon
Page 1 of
(Division Sign-Division of Reproductive, Abdominal, and Radiological D 510(k) Number
9-1