(133 days)
K 930011, K 900894, K 923996
K 930011, K 900894, K 923996
No
The device description explicitly states it consists of commercially available, previously cleared components and the only difference is a single Instructions for Use document. There is no mention of AI/ML in the description or the "Mentions AI, DNN, or ML" section.
Yes
The device is described as an "angioscopic valvulotome kit" intended for "venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass," which involves surgical intervention for a medical condition.
No
The device is described as an "angioscopic valvulotome kit" intended for "venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass." Its function is interventional (incision) and observational (identification of tributaries), not diagnostic in the sense of detecting or characterizing a disease or condition for medical diagnosis. While it helps identify anatomical features, this is for surgical planning and execution rather than a medical diagnosis.
No
The device description explicitly states that the kit consists of commercially available hardware components (valvulotome, angioscope, irrigation system). The only new element is a single Instructions for Use document, which is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The angioscopic valvulotome kit is used directly within the body (intravascularly) for surgical procedures (venous valve incision and tributary identification). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes a surgical intervention, not a diagnostic test performed on a sample.
- Components: The components (valvulotome, angioscope, irrigation system) are all tools used for direct surgical manipulation and visualization within the body.
Therefore, based on the provided information, this device falls under the category of a surgical device used for in-situ procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The angioscopic valvulotome kit is intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass.
Product codes
Not Found
Device Description
The angioscopic valvulotome kit, intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass, consists of commercially available components cleared under previous and/or separate 510k premarket notifications: the GORE EZE-Sit Valvulotome, an angioscope, and an irrigation system. All kit components will be used within their labeled and FDA-cleared indications; the only difference is that GORE will write a single Instructions for Use document to facilitate surgical use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 930011, K 900894, K 923996
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
FEB 20 1997
PREMARKET NOTIFICATION SUMMARY
- W. L. Gore and Associates, Inc. 1. Applicant : 1505 N. Fourth St. P.O. Box 3000 Flagstaff, Arizona 86003-3000 Phone : 800 - 528-1866 FAX : 520 - 527-0584
- Contact : Dawn Lopez Associate
- GORE EZE-Sit Angioscopic Valvulotome Kit Applicant Device : 2.
Common Name : Angioscopic valvulotome
Kit components have the following Classification Name : classification names:
Valvulotome Angioscope Intravascular administration set
3. Predicate Device :
For the purpose of determining substantial equivalence, GORE cites the following as predicate devices :
URESIL Valvulotome (marketed under contract as the "GORE EZE-Sit Valvulotome") - K 930011 CLARUS Angioscope - K 900894 NEURONAVIGATIONAL Angioscope - K 923996 NOTE: One of these two, or any other FDA-cleared, commercially marketed, angioscopes will be used in the angioscopic valvulotome
kit.
GORE Irrigation System - Premarket notification submitted to General Hospital/Personal Use Division; number and clearance documentation to be supplemented to this submission upon receipt.
1
Applicant Device Description : 4.
The angioscopic valvulotome kit, intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass, consists of commercially available components cleared under previous and/or separate 510k premarket notifications: the GORE EZE-Sit Valvulotome, an angioscope, and an irrigation system. All kit components will be used within their labeled and FDA-cleared indications; the only difference is that GORE will write a single Instructions for Use document to facilitate surgical use.
- Intended Use : The angioscopic valvulotome kit is intended to be 5. used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass.
Technological Characteristics : 6.
As all components of the GORE EZE-Sit Angioscopic Valvulotome will be used within their labeled and FDA-cleared indications. with the only difference being that GORE will write a single Instructions for Use document to facilitate surgical use, there are no changes in technological characteristics. The applicant GORE kit and the predicate devices have the same intended uses, the same classifications, are reviewed by the same panels and utilize the same technological characteristics to achieve equivalent clinical results. No new safety and effectiveness questions arise when using the angioscopic valvulotome kit as intended.