(145 days)
This device is used for motility studies in the common bile duct, pancreatic duct, Sphincter of Oddi and duodenum.
The Lehman Manometry Catheter is a modification to the Wilson-Cook Biliary Motility Catheter currently cleared to market via 510k K900058 by Wilson-Cook Medical, Inc. The modified manometry catheter is compatible with a .018" inch wire guide and available in a 200 cm length with a 5 mm short tip or 15 mm long tip configuration. The catheter features include 1 mm marks at the distal end that provide reference points to the .023" inch perfusion and aspiration side ports and to indicate movement of the catheter while in use. The proximal end consists of three lumen color coded leads that provide access to the side ports and wire guide lumen. The red is designated to the proximal side perfusion port, the yellow is for the distal side perfusion port and the green leads to the middle aspiration or through the end of catheter wire guide ports.
I apologize, but this document does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study that proves a device meets those criteria.
The provided text is a 510(k) clearance letter from the FDA for a device called the "Lehman Manometry Catheter." It primarily focuses on the regulatory determination of substantial equivalence to a predicate device.
Here's a breakdown of why I cannot extract the requested information from this document:
- No specific acceptance criteria are listed. The document mentions that the device is substantially equivalent and that design validation/verification testing was performed, but it does not specify what those acceptance criteria were (e.g., specific performance thresholds, accuracy metrics, etc.).
- No detailed study results or methodology are provided. While it states that "Design verification and/or validation testing was performed," it does not include any information about the study design, sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for either training or test sets. It also doesn't mention MRMC comparative effectiveness studies or standalone algorithm performance.
In summary, this document is an FDA clearance letter, not a detailed technical report or study publication that would contain the specific performance data and study design details you are asking for. It confirms that the manufacturer performed testing and the FDA found the device substantially equivalent, but it does not disclose the specifics of that testing or the performance metrics against acceptance criteria.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2016
Wilson-Cook Medical, Inc. Doris A. Hawks Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K160170
Trade/Device Name: Lehman Manometry Catheter Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: II Product Code: FFX Dated: June 6, 2016 Received: June 8, 2016
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.
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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 contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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
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Indications for Use
510(k) Number (if known) K160170
Device Name Lehman Manometry Catheter
Indications for Use (Describe)
This device is used for motility studies in the common bile duct, pancreatic duct, Sphincter of Oddi and duodenum.
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 word "COOK" is in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The logo is simple and clean, and the red and white colors are eye-catching.
COOK ENDOSCOPY 900 RETHANIA STATION ROAD
510(k) Summary
| Name: | Wilson-Cook Medical, Inc. / Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station RoadWinston-Salem, North Carolina 27105 |
| Phone: | (336) 744-0157 ext. 6293 |
| Fax: | (336) 201-5994 |
| Contact: | Doris A. Hawks, Global Regulatory Affairs Specialist |
| Date: | February 12, 2016 |
Device Name
| Trade Name: | Lehman Manometry Catheter |
|---|---|
| Common Name: | Motility Catheter |
| Classification Name: | System, Gastrointestinal Motility (Electrical) |
| 21 CFR 876.1725, FFX, Class II |
Predicate Device
Wilson-Cook Biliary Motility Catheter, K900058, cleared July 27, 1990
Intended Use
This device is used for motility studies in the common bile duct, pancreatic duct, Sphincter of Oddi and duodenum.
Device Description
The Lehman Manometry Catheter is a modification to the Wilson-Cook Biliary Motility Catheter currently cleared to market via 510k K900058 by Wilson-Cook Medical, Inc. The modified manometry catheter is compatible with a .018" inch wire guide and available in a 200 cm length with a 5 mm short tip or 15 mm long tip configuration. The catheter features include 1 mm marks at the distal end that provide reference points to the .023" inch perfusion and aspiration side ports and to indicate movement of the catheter while in use. The proximal end consists of three lumen color coded leads that provide access to the side ports and wire guide lumen. The red is designated to the proximal side perfusion port, the yellow is for the distal side perfusion port and the green leads to the middle aspiration or through the end of catheter wire guide ports.
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Substantial Equivalence
Minor design changes were made to the predicate device cleared to market via k90058. These changes include modifications as follows: side port diameter, lead colors, additional (center) side ports; additional print marks, proximal and distal side port ink color; reusable to disposable; wire guide compatible and catheter tip length. The modified device is substantially equivalent to the predicate with respect to the intended use, key 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, Effects and Criticality Analysis (DFMECA) 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 provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.
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.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).