(26 days)
To dilate strictures of the GI tract including the colon, pylorus and esophagus.
The Bard® ELIMINATOR® PET Balloon Dilators are comprised of a radioopaque polyurethanc catheter with an internally fixed guide wire and a high-pressure nondistending PET balloon.
The provided text is a 510(k) summary for the Bard® ELIMINATOR® PET Balloon Dilators. It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.
The document states:
- No new biocompatibility testing was performed because there were no material changes.
- Functionality testing, Failure Pressure and Inflation/Deflation testing were completed and demonstrated substantial equivalence to the current device and safety for intended use.
This suggests that the "acceptance criteria" were related to these functional and pressure tests, and the "study" was the performance of these tests, but the specific metrics, thresholds, and detailed results are not provided in this summary.
Therefore, I cannot fill out the requested table or provide details for the study in the format specified because the necessary information is not present in the provided text. The document acts as a summary of the 510(k) application, not the full testing report.
Here's a breakdown of what can be extracted and what cannot based on your request and the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document mentions "Functionality testing, Failure Pressure and Inflation/Deflation testing were completed," and "demonstrated that the modified Bard® ELIMINATOR® PET Balloon Dilators are substantially equivalent to the current Bard® ELIMINATOR® PET Balloon Dilators and that the device is safe for its intended use and patient population." However, it does not specify the numerical acceptance criteria (e.g., "Failure Pressure > X psi") or the actual reported performance values (e.g., "Failure Pressure was Y psi").
2. Sample sized used for the test set and the data provenance
- Cannot be provided. The document does not specify sample sizes for any of the hinted-at functional or pressure tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned, as these are engineering tests, not clinical studies in humans.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Cannot be provided. This information pertains to studies where expert opinion or clinical assessment forms a ground truth, typically in AI/imaging diagnostics or clinical trials. The tests mentioned (functionality, pressure, inflation/deflation) are engineering performance tests, where ground truth is typically measured against established physical properties or engineering standards.
4. Adjudication method for the test set
- Not applicable / Cannot be provided. Similar to point 3, adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human experts in clinical studies, not for objective engineering tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical medical device (balloon dilator), not an AI algorithm or diagnostic tool that would be used by human "readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Implied ground truth (engineering specifications/predicate device performance). While not explicitly stated, for "Functionality testing, Failure Pressure and Inflation/Deflation testing," the ground truth would be the pre-defined engineering specifications for the device's performance, or the performance of the legally marketed predicate device (as stated, "substantially equivalent to the current Bard® ELIMINATOR® PET Balloon Dilators"). The document does not provide details on these specifications.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set."
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BARD ENDOSCOPIC TECHNOLOGIES C.R. Bard, Inc. 129 Concord Road
Page 1 of 2
BARD
P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989
VI 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows.
| A. Submitter Information | ||
|---|---|---|
| Submitter's Name: | Bard Endoscopic TechnologiesC.R. Bard, Inc. | |
| Address: | 129 Concord Road, Bldg. #3Billerica, MA 01821 | |
| Phone: | (978) 262 - 4868 | |
| Fax: | (978) 262 - 4878 | |
| Contact Person: | Michael A. Patz | |
| Date of Preparation: | December 18, 2003 | |
| B. Device Name | ||
| Trade Name: | Bard® ELIMINATOR® PET Balloon Dilators | |
| Common/Usual Name: | Dilator, Esophageal, Biliary | |
| Classification Name: | Biliary Catheter/Accessories, Esophageal Dilator | |
| C. Predicate Device Name(s) | ||
| Trade Name: | Bard® ELIMINATOR® PET Balloon Dilators |
- D. Device Description:
The Bard® ELIMINATOR® PET Balloon Dilators are comprised of a radioopaque polyurethanc catheter with an internally fixed guide wire and a high-pressure nondistending PET balloon.
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KC33936
Page 2 of 2
-
E. Intended Use:
The Bard® ELIMINATOR® PET Balloon Dilators are used to dilate strictures of the GI tract including the colon, pylorus and esophagus. -
F. Technological Characteristics Summary:
The modified Bard® ELIMINATOR® PET Balloon Dilators is comprised of the same medical grade plastics, stainless steels and balloon material as the current device. -
G. Performance Data:
Biocompatibility testing was not conducted for this product line extension, as there were no material changes. The only design change was the addition of a 20 mm balloon dilator size. Functionality testing, Failure Pressure and Inflation/Deflation testing were completed and demonstrated that the modified Bard® ELIMINATOR® PET Balloon Dilators are substantially equivalent to the current Bard® ELIMINATOR® PET Balloon Dilators and that the device is safe for its intended use and patient population.
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Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2004
Mr. Michael A. Patz Bard Endoscopic Technologies C. R. Bard, Inc. 129 Concord Road P.O. Box 7031 BILLERICA MA 01821-7031
Re: K033936
Trade/Device Name: Bard® ELIMINATOR PET® Balloon Dilators Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: 78 KNQ Dated: December 18, 2003 Received: December 19, 2003
Dear Mr. Patz:
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 classificd (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); 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.
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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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. I roodon 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 Statement
510(k) Number (if known):
TBD K033936
Device Name:
Indications For Use:
Bard® ELIMINATOR® PET Balloon Dilators
To dilate strictures of the GI tract including the colon, pylorus and esophagus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use U (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Daniel B. Hyman
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
§ 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.