(28 days)
Not Found
No
The device description focuses on the physical characteristics and measurement capabilities of a guidewire, with no mention of AI or ML technologies. The performance studies compare it to a predicate device based on traditional performance requirements.
No.
The device acts as a guide for other endoscopic accessories and electrosurgical devices, and helps in visualization and measurement, but it does not directly treat a condition.
No
This device is primarily used to guide and exchange endoscopic accessories and electrosurgical devices, and for selective cannulation of biliary ducts. While it assists in visualizing movement and estimating stricture length, this function is supportive of interventional procedures rather than a standalone diagnostic purpose. Its main role described is operational, not diagnostic.
No
The device description clearly details a physical guidewire made of metal alloy with a PTFE jacket, radiopaque tip, and marker bands. This 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 clearly states the device is used to "guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures" and for "selective cannulation of the biliary ducts." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical guidewire with features for navigation and measurement during a medical procedure. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is entirely mechanical and procedural.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is to facilitate a medical procedure within the body.
N/A
Intended Use / Indications for Use
To be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.
Product codes
78 KOG
Device Description
The FXWire™ Advanced Measurement Guidewire is a kink resistant metal alloy cored guidewire, which is encapsulated in a PTFE jacket. The guidewire has a flexible radiopaque tip, with a hydrophilic coating for enhanced lubricity. At the distal end of the guidewire, there are painted marker bands beginning at 6cm and extending to 30cm from the distal tip of the guidewire, as well as two radiopaque marker bands placed at 10cm and 15 cm from the distal tip of the guidewire. Additionally, at the proximal end of the guidewire, endoscopic marker bands have been placed beginning at 210cm and extending to 270cm from the distal tip of the guidewire. These marker bands enable endoscopic and fluoroscopic visualization of movement, as well as estimation of stricture length. This guidewire meets the recognized standard for high frequency current leakage (Reference ANSI/AAMI Standard HF 18-1993) when used with a sphinctertome and may be left in place during electrosurgical cutting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic and fluoroscopic visualization
Anatomical Site
biliary ducts, including but not limited to the common bile, cystic, pancreatic, and 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)
Design verification data demonstrated that the FXWire™ Advanced Measurement Dosten vermeation asame performance requirements and is as safe and effective as the predicate device.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K050304
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Image /page/0/Picture/1 description: The image shows a date, "MAR 8 - 2005". The month is March, the day is the 8th, and the year is 2005. The text is in a simple, sans-serif font. The image is a close-up of the date.
Image /page/0/Picture/2 description: The image shows the logo for Conmed Endoscopic Technologies. The logo consists of a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" are the words "ENDOSCOPIC TECHNOLOGIES" in a smaller, sans-serif font. The logo is black and white.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| A. | Submitter Information: |
|---|---|
| Submitter's Name: | ConMed Endoscopic Technologies, Inc. |
| Submitter's Address: | 129 Concord Road, |
| Billerica MA 01821-7031 | |
| Contact Person: | Thomas Hirte |
| Contact Person's Telephone Number: | (978) 964-4252 |
| Contact Person's FAX Number: | (978) 964-4250 |
- B. Device Name: FXWire™ Advanced Measurement Guidewire
- C. Predicate Devices: XWire™ Next Generation Guidewire (K011759)
D. Device Description:
The FXWire™ Advanced Measurement Guidewire is a kink resistant metal alloy cored guidewire, which is encapsulated in a PTFE jacket. The guidewire has a flexible radiopaque tip, with a hydrophilic coating for enhanced lubricity. At the distal end of the guidewire, there are painted marker bands beginning at 6cm and extending to 30cm from the distal tip of the guidewire, as well as two radiopaque marker bands placed at 10cm and 15 cm from the distal tip of the guidewire. Additionally, at the proximal end of the guidewire, endoscopic marker bands have been placed beginning at 210cm and extending to 270cm from the distal tip of the guidewire. These marker bands enable endoscopic and fluoroscopic visualization of movement, as well as estimation of stricture length. This guidewire meets the recognized standard for high frequency current leakage (Reference ANSI/AAMI
1
K. Gray
Page 2 of 2
Standard HF 18-1993) when used with a sphinctertome and may be left in place during electrosurgical cutting.
-
Intended Use: E.
The FXWire Advanced Measurement Guidewire is designed to be used to guide I he F X ir no reval.oopic accessories and electrosurgical devices for biliary procedures. -
Technological Characteristics Summary: F.
The FXWire™ Advanced Measurement Guidewire device is a kink resistant metal alloy cored guidewire, which is encapsulated in a PTFE jacket. The mour anto y cored garde radiopaque tip, with a hydrophilic coating. At the distal end of the guidewire, there are painted marker bands beginning at 6cm and extending to 30cm from the distal tip of the guidewire, as well as two radiopaque marker bands placed at 10cm and 15 cm from the distal tip of the guidewire. marker bands proximal end of the guidewire, endoscopic marker bands have Additionally, at the promized on and extending to 270cm from the distal tip of the guidewire. -
Performance Data: G.
Design verification data demonstrated that the FXWire™ Advanced Measurement Dosten vermeation asame performance requirements and is as safe and effective as the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
MAR 8 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas Hirte, P.E. Senior Regulatory Affairs Specialist ConMed® Corporation ConMed® Endoscopic Technologies, Inc. 129 Concord Road, Building 3 BILLERICA MA 01821
Re: K050304
Trade/Device Name: FXWire™ Advanced Measurement Guidewire Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 KOG Dated: February 3, 2005 Received: February 8, 2005
Dear Mr. Hirte:
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FI)A 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to begin manemal equivalence of your device of your device to a legally premarked notheation: "The PDF maning sification 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 If you desire specific active for your as received by 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" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 60 : 77, " Ca may Count Curers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
.
4
Indications for Use Statement
| 510(k) Number (if known): | TBD K050304 |
|---|---|
| Device Name: | FXWire™ Advanced Measurement Guidewire |
| Indications For Use: | To be used to guide and exchange endoscopic accessories |
| and electrosurgical devices for biliary procedures. The | |
| guidewire is indicated for selective cannulation of the | |
| biliary ducts, including but not limited to the common bile, | |
| cystic, pancreatic, and right and left hepatic ducts. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _> (Per 21 CFR 801.109)
ાર
Over-The-Counter Use ________ (Optional Format 1-2-96)
Ervind K. Lypson
(Division Sign-04T
Division of Rape
and Radiolon de
510(k) Number
R050304
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