(144 days)
No
The description focuses on the mechanical function of a balloon dilator and does not mention any AI/ML components or capabilities.
Yes
The device is used to dilate strictures of the esophagus, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is described as a dilator, which is a therapeutic device used to treat strictures by physical dilation, not to diagnose a condition.
No
The device description clearly states it is a physical catheter with a balloon, which is a hardware component.
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 (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Esophageal Balloon Dilator is a device used directly within the body (endoscopically) to physically dilate a stricture. It does not analyze any biological specimens.
- Intended Use: The intended use is to "endoscopically dilate strictures of the esophagus," which is a therapeutic procedure, not a diagnostic test performed on a sample.
The device description and intended use clearly indicate it's a therapeutic device used for a physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Cook Endoscopy's Esophageal Dilation Balloon is intended to endoscopically dilate strictures of the esophagus. The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.
Product codes
KNQ
Device Description
The proposed Cook Endoscopy Dilation Balloon is a single lumen catheter with a balloon mounted on the distal tip. The balloon is inflatable with water to three distinct and progressively larger size diameters to exert force on esophageal strictures resulting in stricture dilation. It is offered in a variety of diameters to accommodate a range of esophageal strictures This device is supplied sterile and intended for single use. This balloon is not sold with inflation device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
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)
Non-Clinical Testing was performed on characteristics of the balloon with respect to The FDA Guidance for Urological Balloons and additional tests as needed to verify safety and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wilson-Cook Quantum T.T.C.Dilation Balloon (K935094), Microvasive RX Biliary Balloon Dilation Catheter (K001338)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC = ] 2006
ATTACHMENT G : 510(k) Summary
Cook Endoscopy SPONSOR: 4900 Bethania Station Road Winston-Salem, NC 27105 Mabel L. Hunter CONTACT/SUBMITTER: Global Regulatory Affairs Specialist [336] -744-0157 Ex.6292 July 6, 2006 DATE OF SUBMISSION: Esophageal Dilation Balloon DEVICE: Cook Endoscopy Esophageal Dilation Balloon Trade Name: Esophageal Balloon Dilator Common Name: Dilator, Esophageal, Class II 78 KNQ Classification: 21 CFR § 876.5365 PREDICATE DEVICES: Wilson-Cook Quantum T.T.C.Dilation Balloon (K935094) Microvasive RX Biliary Balloon Dilation Catheter (K001338) Cook Endoscopy's Esophageal Dilation Balloon INTENDED USE: is intended to endoscopically dilate strictures of the esophagus. The proposed Cook Endoscopy Dilation Balloon DEVICE DESCRIPTION: is a single lumen catheter with a balloon mounted on the distal tip. The balloon is inflatable with water to three distinct and progressively larger size diameters to exert force on esophageal strictures resulting in stricture dilation. It is offered in a variety of diameters to accommodate a range of esophageal strictures This device is supplied sterile and intended for single use. This balloon is not sold with inflation device. We believe the proposed device to be COMPARISON OF CHARACTERISTICS: substantially equivalent to the named predicates in terms of Intended Use, Indications for Use, performance characteristics tested, balloon diameter and length available and biocompatibility. Non-Clinical Testing was performed on characteristics of the balloon with respect to The PERFORMANCE DATA: FDA Guidance for Urological Balloons and additional tests as needed to verify safety and performance.
1
Image /page/1/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 an eagle or other bird-like figure, with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
DEC - 1 2006
Ms. Mabel L. Hunter Global Regulatory Affairs Specialist Cook Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K061937
Trade/Device Name: Cook Endoscopy Esophageal Dilation Balloon Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: October 30, 2006 Received: November 1, 2006
Dear Ms. Hunter:
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 (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in cursive. There are three stars at the bottom of the logo.
noting Public .
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Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K06/937
Indications for Use
510(k) Number (if known): __KD(@1937
Device Name: Cook Endoscopy Esophageal Dilation Balloon
Indications for Use:
The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Leger
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Prescription Use Only
(Per 21 CFR § 801.109
OR
Over-the-Counter