(179 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI, ML, or data processing for decision-making or analysis.
No
The device is described as an accessory used during ERCP procedures to control wire guides and prevent fluid reflux, rather than directly treating a condition or disease.
No.
The device is described as an accessory used with endoscopic devices to lock wire guides, prevent reflux of bodily fluids, and control wire guides during ERCP procedures. Its purpose is mechanical assistance, not the diagnosis of a medical condition.
No
The device description clearly describes a physical accessory that clips onto a duodenoscope and contains molded components and a silicone seal. It is a hardware device.
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 an accessory to be used with endoscopic devices during ERCP procedures to manage wire guides and prevent fluid reflux. This is a procedural accessory, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a mechanical accessory that clips onto an endoscope to aid in wire control and prevent leakage. It does not describe any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or analytes
The device's function is purely mechanical and procedural, supporting the delivery and manipulation of other devices during an endoscopic procedure.
N/A
Intended Use / Indications for Use
This device is an accessory to be used with endoscopic biliary and pancreatic devices to lock the wire guide(s) in place and to prevent reflux of bodily fluids during ERCP
Product codes
ODC
Device Description
The SnapLoc Wire Lock device is an accessory that is clipped onto the outside of a Duodenoscope during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. Its purpose is to help control the wire guides during a procedure, to enable ERCP devices (catheters, baskets, balloons, stents, etc) to pass through the device and to prevent the backflow of bodily fluids during procedures. The SnapLoc wire lock contains features to aid in wire control. The wire is locked into place by simply sliding the wire into one of the locking notches located on the left and right sides of the wire is unlocked by lifting the wire out of the wire locking notch. For control, the proximal end of the wire can be secured by inserting it into one of the docking channels. A silicone seal located between the molded components helps reduce leakage from the duodenoscope. For ease of connection, the wire lock attaches to the duodenoscope by sliding laterally onto the port until secure. The SnapLoc will be sold in three sizes to be compatible with the most commonly used endoscopes from Olympus. Fuji, and Pentax.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary and pancreatic devices
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)
Performance testing was conducted to demonstrate that the SnapLoc Wire Guide Lock meets the design input requirements identified based on the intended use of the device, and where appropriate, applicable standards. Where applicable, each test was performed on each variant of the SnapLoc device based on endoscope compatibility (Olympus, Fuji, Pentax).
Verification testing was conducted on final, finished devices to demonstrate the subject devices meet their design requirements. The following tests were performed to demonstrate conformance to their design input requirements as well as substantial equivalence to the predicate Fusion Wire Locking Device:
- Force to Connect to Duodenoscope
- Leakage Rate At Scope Seal
- Force to Advance Device Through Wirelock
- Ability to Lock Wireguide
- Leakage Rate at Accessory Seal
- Force to Remove Catheter During Short Wire Exchange
- Translation Distance of Wire in Locked Position
- Force to Detach from Duodenoscope
- Joint Strength during Short Wire Exchange/Stent Use
Applicable testing was conducted on representative devices at time zero and accelerated aging to a real-time equivalency of one year where appropriate to support the subject SnapLoc Wire Locks for their labeled shelf-life. Material assessments following accelerated aging demonstrated no significant change in the polycarbonate material composing the majority of the device, therefore, verification endpoints related to this material (e.g. joint strength) evaluated at time zero are also representative of aged devices. Successful functional testing of the subject SmapLoc Wire Lock supports a determination of substantial equivalence to the predicate device.
Non-clinical testing on the SnapLoc Wire Lock on all critical performance characteristics (compatibility with scopes, ability to lock wires in place, leakage, etc.) and biocompatibility demonstrates that the subject device does not raise any new questions of safety or effectiveness compared to the predicate, Fusion Wire Lock.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 26, 2022
Wilson Cook Medical Paul Meyer, Ph.D. Regulatory Scientist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K213483
Trade/Device Name: SnapLoc Wire Lock Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: March 10, 2022 Received: March 22, 2022
Dear Paul Meyer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213483
Device Name SnapLoc Wire Lock
Indications for Use (Describe)
This device is an accessory to be used with endoscopic biliary and pancreatic devices to lock the wire guide(s) in place and to prevent reflux of bodily fluids during ERCP
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
SnapLoc Wire Lock 21 CFR 8876.1500 Date Prepared: December 17, 2021
| Submitted By: |
|---|
| Submission: |
| Applicant: |
| Applicant Address: |
Contact: Email: Contact Phone Number: Contact Fax number:
Traditional 510(k) Premarket Notification Wilson Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem NC 27105 Paul Meyer paul.meyer(a)cookmedical.com (812) 335-3575 x105299 (812) 332-0281
Device Information:
Trade Name: Device Common Name: Classification Regulation: Classification Panel:
SnapLoc Wire Lock Endoscope and accessories 21 CFR 8876.1500, Product Code ODC Gastroenterology/Urology
Predicate Device:
The SnapLoc Wire Lock is substantially equivalent to the following device: Fusion Wire Guide Locking Device (K040137, Wilson Cook Medical).
Device Description:
The SnapLoc Wire Lock device is an accessory that is clipped onto the outside of a Duodenoscope during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. Its purpose is to help control the wire guides during a procedure, to enable ERCP devices (catheters, baskets, balloons, stents, etc) to pass through the device and to prevent the backflow of bodily fluids during procedures. The SnapLoc wire lock contains features to aid in wire control. The wire is locked into place by simply sliding the wire into one of the locking notches located on the left and right sides of the wire is unlocked by lifting the wire out of the wire locking notch. For control, the proximal end of the wire can be secured by inserting it into one of the docking channels. A silicone seal located between the molded components helps reduce leakage from the duodenoscope. For ease of connection, the wire lock attaches to the duodenoscope by sliding laterally onto the port until secure. The SnapLoc will be sold in three sizes to be compatible with the most commonly used endoscopes from Olympus. Fuji, and Pentax.
4
Indications for Use:
This device is an accessory to be used with endoscopic biliary and pancreatic devices to lock the wire guide(s) in place and to prevent reflux of bodily fluids during ERCP
Substantial Equivalence:
Nearly all technological characteristics between the subject and predicate device are similar, however, there are some minor differences in indications for use, product code, seal material, and shelf-life as described in the following table.
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| Fusion Wire Guide Locking Device | ||
| (K040137) | SnapLoc Wire Lock | |
| Product Code | OCY | ODC |
| Indications for Use | This device is an accessory to be | |
| used with endoscopic biliary devices | ||
| to lock the wire guide(s) in place | ||
| during ERCP procedures. | This device is an accessory to be used | |
| with endoscopic biliary and pancreatic | ||
| devices to lock the wire guide(s) in | ||
| place and to prevent reflux of bodily | ||
| fluids during ERCP | ||
| Shelf Life | 3 years | 1 year |
| Seal Material | Chlorinated synthetic polyisoprene | |
| and polyurethane foam | Silicone |
Indications for Use Comparison:
The predicate, Fusion Wire Lock, is intended to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedures. The SnapLoc device has the same indication with the addition indications of use with pancreatic devices and the ability to prevent fluid reflux during the procedure. ERCP procedures enable access to the common bile duct which includes pancreatic and biliary access and therapies (e.g. stent placement, stone removal, etc). During the course of ERCP treatments, a physician often has to place a pancreatic stent in the patient for the prevention of post-ERCP pancreatitis. This determination is only made during the procedure, and so both the Fusion Wire Guide Locking Device and the SnapLoc Wire Lock support both biliary and pancreatic devices during ERCP, despite pancreatic devices not being explicitly stated in the predicate indications for use. The ability to prevent reflux is also a feature of the predicate, Fusion Wire Lock, however it is not captured explicitly in the indications for use. Therefore, these differences do not constitute a new intended use.
Technological Characteristics:
Performance testing was conducted to demonstrate that the SnapLoc Wire Guide Lock meets the design input requirements identified based on the intended use of the device, and where
5
appropriate, applicable standards. Where applicable, each test was performed on each variant of the SnapLoc device based on endoscope compatibility (Olympus, Fuji, Pentax).
Verification testing was conducted on final, finished devices to demonstrate the subject devices meet their design requirements. The following tests were performed to demonstrate conformance to their design input requirements as well as substantial equivalence to the predicate Fusion Wire Locking Device:
- Force to Connect to Duodenoscope .
- Leakage Rate At Scope Seal .
- . Force to Advance Device Through Wirelock
- Ability to Lock Wireguide .
- . Leakage Rate at Accessory Seal
- . Force to Remove Catheter During Short Wire Exchange
- . Translation Distance of Wire in Locked Position
- Force to Detach from Duodenoscope ●
- Joint Strength during Short Wire Exchange/Stent Use ●
Applicable testing was conducted on representative devices at time zero and accelerated aging to a real-time equivalency of one year where appropriate to support the subject SnapLoc Wire Locks for their labeled shelf-life. Material assessments following accelerated aging demonstrated no significant change in the polycarbonate material composing the majority of the device, therefore, verification endpoints related to this material (e.g. joint strength) evaluated at time zero are also representative of aged devices. Successful functional testing of the subject SmapLoc Wire Lock supports a determination of substantial equivalence to the predicate device.
Non-clinical testing on the SnapLoc Wire Lock on all critical performance characteristics (compatibility with scopes, ability to lock wires in place, leakage, etc.) and biocompatibility demonstrates that the subject device does not raise any new questions of safety or effectiveness compared to the predicate, Fusion Wire Lock. A full comparison between the subject and predicate devices is presented in the Substantial Equivalence section of this submission.