(144 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Cook Endoscopy Esophageal Dilation Balloon. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, indications for use, performance characteristics, available diameters/lengths, and biocompatibility.
Here's an analysis based on the information provided, highlighting what is present and what is missing in relation to your request:
1. Table of acceptance criteria and reported device performance:
The document mentions "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." However, it does not provide a specific table of acceptance criteria (e.g., burst pressure, inflation/deflation times, material integrity) nor the detailed reported performance results against those criteria.
2. Sample size used for the test set and data provenance:
This information is not present in the provided text. The document refers to "Non-Clinical Testing," which implies laboratory or bench testing rather than a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and qualifications:
This information is not present. As the testing appears to be non-clinical, the concept of "ground truth" established by experts in a clinical context (e.g., for diagnostic accuracy) does not apply here.
4. Adjudication method for the test set:
This information is not present. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:
This information is not present. An MRMC study compares human readers' performance with and without AI assistance, which is not applicable to a non-clinical device like an esophageal dilation balloon.
6. If a standalone (algorithm only without human-in-the-loop performance) was done:
This information is not present. This applies to AI algorithms, not to a physical medical device like a balloon dilator.
7. The type of ground truth used:
Given that "Non-Clinical Testing" was performed, the "ground truth" would likely refer to engineering specifications and performance standards established by FDA guidance (e.g., "FDA Guidance for Urological Balloons") and internal Cook Endoscopy requirements. However, the exact type of ground truth (e.g., specific measurement tolerances, physical properties verified by calibrated instruments) is not explicitly detailed.
8. The sample size for the training set:
This information is not present. This concept applies to machine learning models, which are not relevant to the described device.
9. How the ground truth for the training set was established:
This information is not present, for the same reason as point 8.
Summary of what's available and what's missing:
The provided text from K061937 describes the Cook Endoscopy Esophageal Dilation Balloon and its 510(k) submission for substantial equivalence.
- Acceptance Criteria & Performance: The document states that "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." However, specific quantitative acceptance criteria or detailed performance results (e.g., burst pressure values, diameter consistency, material strength) are not provided.
- Study Design: The study mentioned is "Non-Clinical Testing," indicating laboratory or bench testing rather than a clinical trial with human subjects.
- Missing Information: Crucially, the document does not contain information regarding:
- Specific quantitative acceptance criteria.
- Detailed reported performance data.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type or establishment method of ground truth in a clinical or AI context.
The 510(k) summary focuses on demonstrating equivalence to predicate devices (Wilson-Cook Quantum T.T.C. Dilation Balloon and Microvasive RX Biliary Balloon Dilation Catheter) based on intended use, indications, and general performance characteristics, rather than detailing a specific study with defined acceptance criteria for a novel AI or diagnostic device.
{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 .
{2}------------------------------------------------
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
§ 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.