(242 days)
Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.
The modified Hercules 3 Stage Wire Guided Balloon consists of coaxial catheter with a dilation balloon mounted on the distal tip. The balloon is inflatable with fluid to three distinct and progressively larger size diameters to exert pressure on strictures and affect dilation of the stricture. It is offered in a variety of balloon diameters. Supplied sterile and Intended for Single Use. Inflation device sold separately.
The provided text is a 510(k) summary for the Cook Endoscopy Hercules 3 Stage Wire Guided Balloon, dated January 23, 2009. This document is a regulatory submission to the FDA, not a study report detailing performance data and acceptance criteria for a device that uses an algorithm or AI.
Therefore, the requested information cannot be extracted from the provided text as it does not contain:
- A table of acceptance criteria and reported device performance: The document states, "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process," but provides no specific performance data or acceptance criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance: These concepts are relevant to studies involving algorithms or AI, which are not mentioned in this 510(k) summary for a medical device.
- Type of ground truth used: Not applicable as no study involving ground truth assessment is described.
- Sample size for the training set and how ground truth for the training set was established: These relate to AI/ML model development, which is not discussed.
The document is a declaration of substantial equivalence to a predicate device (Quantum T.T.C Balloon Dilation Catheter, K935094) based on similar intended use, fundamental design, operational principle, and scientific technology. It briefly describes the device, its intended use (to dilate strictures of the gastrointestinal tract), and its comparison to a legally marketed device. It does not include performance data in the format of a clinical study with acceptance criteria.
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SEP 2 5 2009
510(k) Summary
Name: Address: Cook Endoscopy 4900 Bethania Station Road Winston-Salem. NC 27105
Phone: Fax: Contact Person: 336-744-0157 336-201-5994 Tiffanny A. Thomas, Global Regulatory Affairs Specialist
Date:
January 23, 2009
separately.
and colon.
Balloon Dilation Catheter
Trade Name:
Common Name:
Classification Name:
Esophageal Dilator (21 CFR 876.5365, Product Code 78 KNQ)
Quantum T.T.C Balloon Dilation Catheter (K935094)
The modified Hercules 3 Stage Wire Guided Balloon
and Intended for Single Use. Inflation device sold
Used to dilate strictures of the gastrointestinal tract,
including strictures of the esophagus, pylorus, duodenum
consists of coaxial catheter with a dilation balloon mounted
on the distal tip. The balloon is inflatable with fluid to three distinct and progressively larger size diameters to exert pressure on strictures and affect dilation of the stricture. It is offered in a variety of balloon diameters. Supplied sterile
Hercules 3 Stage Wire Guided Balloon
Legally Marketed Devices:
Description of the Device:
Intended Use:
Comparison of Characteristics: We believe the proposed device to be substantially equivalent to currently marketed predicate device. We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, the same fundamental design and operational principle and fundamental scientific technology.
Performance Data:
We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 5 2009
Ms. Tiffanny Thomas Global Regulatory Affairs Specialist Cook Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K090183
Trade/Device Name: Hercules 3 Stage Wire Guided Balloon Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Codes: KNQ Dated: August 26, 2009 Received: August 27, 2009
Dear Ms. Thomas:
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 (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 801); medical device reporting (reporting of medical
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Page 2 -
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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K090183
Device Name: Hercules 3 Stage Wire Guided Balloon
Indications for Use:
Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Device 54016 510(k) Number,
of 1 Page 1
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.