(26 days)
Not Found
No
The description focuses on mechanical features and modifications to an existing device, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device description indicates it is a wire guide intended to assist in cannulation and bridging strictures, which are procedural aids rather than a direct treatment for a disease or condition.
No
The device is described as assisting in cannulation and aiding in bridging strictures, which are procedural functions, not diagnostic ones. Its features and intended use indicate it is an interventional device.
No
The device description clearly outlines a physical wire guide with specific dimensions, materials (hydrophilic slip-coating), and markings, indicating it is a hardware device. The performance studies also mention design verification and validation testing, which are typical for hardware modifications.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP." This describes a device used within the body for a procedural purpose (guiding instruments), not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical wire guide with specific features for navigation within anatomical structures. This is consistent with a surgical or interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
This device is clearly an interventional medical device used during an endoscopic procedure (ERCP).
N/A
Intended Use / Indications for Use
This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.
Product codes
OCY
Device Description
The Acrobat Calibrated Tip Wire Guide is a modification to the existing Endoscopic Wire Guides currently marketed by Wilson-Cook Medical, Inc. The modified wire guide is compatible with a .025", .035" inch or larger inner diameter accessory and available in 205cm, 260cm and 450cm lengths. The wire guide features include marks at 5cm to 25cm at the distal end that provide reference points to indicate movement of wire guide while in use. The distal tip consists of an 11.5cm or 27cm hydrophilic slip-coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary and pancreatic 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)
The Risk Analysis was completed to access the impact of modifications to the cleared device using the Design Failure Modes and Effects Analysis (DFMEA) method. Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provided reasonable assurance that the modified device 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
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the figure in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2014
Wilson-Cook Medical, Inc. Doris A. Hawks Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K142950
Trade/Device Name: Acrobat Wire Guide Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: October 14, 2014 Received: October 15, 2014
Dear Doris A. Hawks,
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 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.
1
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
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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
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Indications for Use
510(k) Number (if known)
K142950
Device Name Acrobat Wire Guide
Indications for Use (Describe)
This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures 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)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif letters at the top, with a registered trademark symbol next to it. Below "COOK", the word "MEDICAL" is written in smaller, white, sans-serif letters.
COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. HONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
510(k) Summary
| Name: | Wilson-Cook Medical, Inc. / Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station Road |
| Winston-Salem, North Carolina 27105 | |
| Phone: | (336) 744-0157 ext. 6293 |
| Fax: | (336) 201-5994 |
| Contact: | Doris A. Hawks, Global Regulatory Affairs Specialist |
| Date: | October 6, 2014 |
Device Name
| Trade Name: | Acrobat Calibrated Tip Wire Guide |
|---|---|
| Common Name: | Wire Guide |
| Classification Name: | Endoscope Guidewire, Gastroenterology-Urology, |
| 21 CFR 876.1500, OCY, Class II |
Predicate Device
Endoscopic Wire Guide, K122816, cleared October 9, 2012
Intended Use
This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.
Device Description
The Acrobat Calibrated Tip Wire Guide is a modification to the existing Endoscopic Wire Guides currently marketed by Wilson-Cook Medical, Inc. The modified wire guide is compatible with a .025", .035" inch or larger inner diameter accessory and available in 205cm, 260cm and 450cm lengths. The wire guide features include marks at 5cm to 25cm at the distal end that provide reference points to indicate movement of wire guide while in use. The distal tip consists of an 11.5cm or 27cm hydrophilic slip-coating.
4
Substantial Equivalence
Minor design changes were made to the predicate device cleared to market via K122816. These changes include modifications to the diameter, core wire, print marks and coated tip length. The modified device is substantially equivalent to the predicate with respect to the intended use, operating mechanics, materials and the technological characteristics.
Performance Data
The Risk Analysis was completed to access the impact of modifications to the cleared device using the Design Failure Modes and Effects Analysis (DFMEA) method. Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provided reasonable assurance that the modified device is as safe and effective as the predicate device.
Conclusion
We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Processes. We believe the proposed device to be substantially equivalent to the named predicate in terms of its intended use, performance characteristics tested.