(70 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of AI or ML technology.
No
This device, an endoscopic guidewire, is used for catheter introduction and exchanges, not for treating a disease or condition itself. It's an accessory used in a procedure.
No
The device is an endoscopic guidewire intended for selective cannulation of biliary ducts and for introducing and exchanging catheters during endoscopic biliary procedures. Its function is interventional/procedural, not diagnostic.
No
The device description clearly details physical components like a Nitinol core, PTFE jacket, polyurethane/tungsten loaded jacket, and hydrophilic coating, indicating it is a physical medical 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 clearly describes a device used during endoscopic biliary procedures to facilitate the introduction and exchange of other instruments within the body. This is an in vivo procedure, meaning it takes place within a living organism.
- Device Description: The description details the physical components of a guidewire designed for navigation within anatomical structures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, which is the defining characteristic of an IVD.
Therefore, the Endoscopic Guidewire is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges of catheters, cannulas, and sphincterotomes.
Product codes
OCY
Device Description
The Taxi® Endoscopic Guidewire is a dual colored, spiral patterned guidewire. The quidewire is composed of a Nitinol core with a dual colored PTFE jacket applied over the core to provide endoscopic visualization of wire movement. A polyurethane/lungsten loaded jacket encapsulates the distal end and ensures radiopacity. The distal tip of the guidewire is coated with hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts.
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 the safety and effectiveness of the Taxi® Endoscopic 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. The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices.
BIOCOMPATIBILITY TESTING
Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable.
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
§ 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
K081708
1 of 3
510(k) SUMMARY
MANUFACTURER / REGISTRATION INFORMATION 5.1
| MANUFACTURER NAME / LOCATION | ESTABLISHMENT REGISTRATION NUMBER |
|---|---|
| Lake Region Manufacturing, Inc. | |
| (d/b/a Lake Region Medical) | |
| 340 Lake Hazeltine Drive | |
| Chaska MN 55318-1029 USA | 2126666 |
SUBMITTER / CONTACT PERSON 5.2
| Contact Person: Deep Pal | |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Telephone: | (952) 448-5111, Ext. 6381 |
| Fax: | (952) 448-3441 |
| Email: | dpal@lakergn.com |
5.3 TRADE NAME (PROPRIETATY NAME)
Taxi® Endoscopic Guidewire
5.4 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 Endoscopic Guidewire, Gastroenterology-Urology (OCY).
5.5 CLASS OF DEVICE
This type of Guidewire is listed as a Class II device by the Gastroenterology / Urology Review Panel; OCY, Endoscope and accessories (21 CFR 876.1500).
PREDICATE DEVICE 5.6
| 510(k) NUMBER | MANUFACTURER | DEVICE NAME |
|---|---|---|
| K922302 | lagwire TMT | |
| Recanalization Guidewire |
- 1 4 - 1 11 7 - 1 4 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
II III III III KISHI III III III KE KESHINDAHUAIN BALAMBAN BANK |
사용
DEVICE DESCRIPTION 5.7
The Taxi® Endoscopic Guidewire is a dual colored, spiral patterned guidewire. The quidewire is composed of a Nitinol core with a dual colored PTFE jacket applied over the core to provide endoscopic visualization of wire movement. A polyurethane/lungsten loaded jacket encapsulates the distal end and ensures radiopacity. The distal tip of the guidewire is coated with hydrophilic coating.
The quidewires are bound by the following parameters:
| A the state of the first of the first of the state of
| and the last the state of the comments of the same of the same | IP | COATING | |||
|---|---|---|---|---|---|
| A the state the state of the state the states of the | I FOR SCONFIGURATION I FLEX FLEX I PTFE HYDRO | ||||
| .035" | 260 - 450cm | Straight | Standard | Shaft | in |
(Continues ... )
AUG 2 6 2008
1
Image /page/1/Picture/0 description: The image shows a handwritten note with the text "K081708" on the top line and "2 of 3" on the second line. The handwriting is bold and black, contrasting with the white background. The numbers and letters are clearly written, making them easily readable.
510(k) SUMMARY
(Continued ...)
TECHNOLOGICAL CHARACTERSTICS 5.8
The predicate device is constructed of a nitinol core, which is encapsulated in a stripped PTFE jacket and a polyurethane distal jacket with a hydrophilic radiopaque distal tip. The striped jacket provides endoscopically visible movement markings. The Taxi® Endoscopic Guidewire is constructed of similar materials but employs a gluing process to adhere the polyurethane segment.
APPLICABILITY OF PERFORMANCE STANDARDS 5.9
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.
INTENDED USE STATEMENT 5.10
The Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic billary procedures for catheter introduction and exchanges.
COMPARISION INFORMATION 5.11
| PROPOSED DEVICE | PREDICATE DEVICE |
|---|---|
| TAXI® ENDOSCOPIC GUIDEWIRE | JAGWIRE(TM) RECANALIZATION GUIDEWIRE K922302 |
| CORE | |
| Nitinol | Nitinol |
| JACKET | |
| PROXIMAL - PTFE | PROXIMAL - PTFE |
| DISTAL - Polyurethane | DISTAL - Polyurethane |
| COATING | |
| DISTAL - Hydrophilic | DISTAL - Hydrophilic |
| JOINING AGENTS | |
| Polymer Adhesive / Accelerator | No known adhesives used. |
| VARIOUS TIP FLEXIBILITIES | |
| 5CM Standard | 5CM and 10CM |
| GUIDEWIRE LENGTHS | |
| 260cm to 450cm | 260 and 450CM |
| GUIDEWIRE DIAMETERS | |
| .035" | .025" and .035" |
| STERILIZATION METHOD | |
| ETO | ETO |
(Continues ... )
2
Image /page/2/Picture/0 description: The image shows handwritten text. The text "K081708" is written in large, bold letters on the top line. Below that, the text "3 of 3" is written in a smaller font size.
510(k) SUMMARY
(Continued...)
QUALIFICATION TESTING 5.12
NON-CLINICAL TESTS
In order to demonstrate the safety and effectiveness of the Taxi® Endoscopic 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. The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices.
BIOCOMPATIBILITY TESTING
Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes emanating from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2008
Mr. Deep Pal Regulatory Affairs Specialist Lake Region Medical™ 340 Lake Hazeltine Drive CHASKA MN 55318-1029
Re: K081708
Trade/Device Name: Taxi® Endoscopic Guidewire Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: June 13, 2008 Received: June 17, 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 indice includions 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, Dr ug and Cosmetic act (Act) that do not require approval of any proval 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, isting 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 ean 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
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) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Taxi® Endoscopic Guidewire
Indications for Use:
The Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges of catheters, cannulas, and sphincterotomes.
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)
Ammhhan
(Division Sign-Division of Reproductive. Abdominal and Radiological De 510(k) Number
Page 1 of 1