(114 days)
Not Found
No
The device description and intended use are purely mechanical, describing a guidewire for endoscopic procedures. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is a guidewire intended for selective cannulization during endoscopic biliary procedures, facilitating other tools, rather than directly treating a disease or condition.
No
Explanation: The device is described as a guidewire for "selective cannulization of the biliary ducts" during endoscopic procedures, facilitating catheter introduction and exchanges. Its function is procedural assistance, not diagnosis.
No
The device description clearly details physical components like wires, core materials (nitinol, stainless steel), coatings (PTFE, hydrophilic), and a radiopaque tip, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential transfusions, or to monitor therapeutic measures.
- Device Description and Intended Use: The description and intended use of the Endo-Glide Guidewire clearly indicate it is a device used within the body during a medical procedure (endoscopic biliary procedures) to facilitate the introduction and exchange of other catheters. It is a tool for navigating and accessing anatomical structures, not for analyzing biological specimens outside the body.
The information provided aligns with a surgical or interventional device, not an IVD.
N/A
Intended Use / Indications for Use
Endo-Glide Guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
Product codes
OCY, GCA
Device Description
The Endo-Glide Guidewire has a range of diameters from 0.025" to 0.035" and lengths from 250cm to 450cm. The wires are offered with and without a 50mm radiopaque platinum distal tip (curved and straight). The wires are assembled with a solid nitinol or stainless steel core wire, which can be tapered at the distal tip. A lubricious coating (PTFE or hydrophilic) surrounds the entire core and/or tip, which also provides insulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary ducts, 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Jagwire™ Guidewire (K922302), Flex Finder® Guidewire (K964955), Next Generation Guidewire (K011759)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Endo-Therapeutics. Inc. Mr. Todd Adkisson 1183 Cedar Street Safety Harbor, FL 34695
JUL 2 7 2015
K023603 Re: Trade/Device Name: Endo-Glide Guidwire Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY, GCA Dated (Date on orig SE Itr): January 23, 2003 Received (Date on orig SE ltr): January 27, 2003
Dear Mr. Adkisson,
This letter corrects our substantially equivalent letter of February 19, 2003.
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
1
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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); medical device reporting of medical device-related 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 toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K 023603
510(k) INDICATIONS FOR USE STATEMENT
KU23603 510(k) Number (If KNOWN):
Device Name: Endo-Glide Guidewire
Applicant Name: Endo-Therapeutics, Inc
Indications for Use: Endo-Glide Guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
Signature: President
Date: 9/2/02
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David Lee Ingram
(Division Sign-Off)
Division of Reproductive and Radiological De 510(k) Numbe
3
510(k) Summary: Endo-Therapeutics Endo-Glide Guidewires
| (1) | Endo-Therapeutics Inc.
1183 Cedar st.
Safety Harbor, FL 34695 | FEB 1 9 2003 |
|--------------------------------|---------------------------------------------------------------------|--------------|
| Contact Person: | Todd Adkisson | |
| Date Prepared: | 9/2/02 | |
| 510(k) #: | K | |
| (2) Trade or Proprietary Name: | Endo-Glide Guidewire | |
| Common Name: | Guidewire | |
| Classified Name: | Gastrointestinal Guidewire | |
(3) Equivalent Predicate Devices:
Jagwire™ Guidewire (K922302), Flex Finder® Guidewire (K964955), Next Generation Guidewire (K011759)
(4) Description of Device:
The Endo-Glide Guidewire has a range of diameters from 0.025" to 0.035" and lengths from 250cm to 450cm. The wires are offered with and without a 50mm radiopaque platinum distal tip (curved and straight). The wires are assembled with a solid nitinol or stainless steel core wire, which can be tapered at the distal tip. A lubricious coating (PTFE or hydrophilic) surrounds the entire core and/or tip, which also provides insulation.
Intended Use: (5)
Endo-Glide Guidewire is used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
Technological Characteristics: (6)
The Endo-Therapeutics Endo-Glide Guidewires have essentially the same technological characteristics as the predicate device. The intended use, design, materials and method of operation are all substantially similar to the before mentioned guidewires.