(51 days)
BD-3 Catheters are intended for urological dilatation; ureteral and urethral.
Urological Balloon Dilatation Catheter
The provided document is a 510(k) premarket notification for a medical device, specifically the BD-3 Urological Balloon Dilatation Catheters. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data that would establish novel safety and effectiveness.
Therefore, the document does NOT contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria in the way a clinical trial might. It explicitly states: "The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested." This implies that the device's performance is being benchmarked against existing devices rather than a new set of predefined acceptance criteria for novel claims.
However, I can extract the information available from the document that is relevant to your request, indicating where information is missing for a full answer to your questions.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" for the BD-3 Catheters are implicitly tied to demonstrating Substantial Equivalence to legally marketed predicate devices. The performance reported is that it meets this equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices for indications of use (urological dilatation; ureteral and urethral). | "The proposed modified devices are Substantially Equivalent to devices previously cleared by the FDA via the 510(k) Notification process and indicated for dilatation of the urinary tract." |
| Substantial Equivalence to predicate devices in terms of performance characteristics tested. | "The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a prospective clinical study with human subjects or a defined dataset for algorithm evaluation. The "performance characteristics tested" would typically refer to bench testing or animal studies demonstrating the physical and functional properties of the catheter (e.g., burst pressure, durability, guidewire compatibility), but the specific details (sample sizes, results, and provenance) are not included in this summary.
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document. Given the nature of a 510(k) for a well-established device type, it's likely to involve internal bench testing or possibly data from previous 510(k) clearances for similar predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. A 510(k) notification for a physical device like a catheter typically relies on engineering specifications, bench testing, and potentially animal studies to demonstrate safety and performance equivalent to existing devices, not expert human assessment of a "test set" to establish ground truth in the way it would for an AI diagnostic device.
4. Adjudication Method for the Test Set
Not applicable and not provided. See explanation for point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC study. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of a 510(k) for a physical medical catheter.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used
The concept of "ground truth" as it applies to diagnostic algorithms is not directly applicable here. For this device, "truth" would involve demonstrating that the catheter can withstand intended pressures, navigate the urinary tract, and perform its dilatation function as expected and without causing undue harm, similar to predicate devices. This is typically established through:
- Engineering specifications and design verification.
- Bench testing (e.g., burst pressure, tensile strength, fatigue testing).
- Biocompatibility testing.
- Potentially animal studies for in-vivo performance.
- Comparison to the known performance and safety profiles of the predicate devices.
The document states the device is "Substantially Equivalent to the predicate devices in terms of performance characteristics tested," implying that the "truth" is established by matching the performance of already-approved devices, rather than establishing a completely new medical "ground truth."
8. Sample Size for the Training Set
Not applicable and not provided. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable and not provided. This is a physical device, not an AI model.
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K980795 plofl
APR 22 1998
ATTACHMENT H
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate summary of any information respecting to submit "rith this remaintent will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects..."
The summary regarding the adverse health effects of the proposed BD-3 Catheters is as follows:
| Sponsor: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760-1537 |
|---|---|
| Contact Person: | Linda S. PollitzSenior Regulatory Affairs SpecialistorLorraine M. HanleyManager, Regulatory Affairs |
| Submission Date: | February 24, 1998 |
| Common/Usual Names: | Urological Balloon Dilatation Catheter |
| Trade/Proprietary Name: | To Be Determined |
| Device Classification and Name: | According to Section 13 of the Federal Food, Drug and Cosmetic Act,the device classification is Class II, Performance StandardsProduct Code: 78 EZN and 78 KOE |
| Substantial Equivalence: | The proposed modified devices are Substantially Equivalent to devicespreviously cleared by the FDA via the 510(k) Notification process andindicated for dilatation of the urinary tract. |
| Performance: | The proposed modified device is Substantially Equivalent to the predicatedevices in terms of performance characteristics tested. |
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Image /page/1/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 1998
Ms. Linda S. Pollitz Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re: K980795 BD-3 Urological Balloon Dilatation Catheters Dated: February 27, 1998 Received: March 2, 1998 Regulatory class: II 21 CFR §876.5470/Product code 78 EZN 21 CFR §876.5520/Product code 78 KOE
Dear Ms. Pollitz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976; the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
William Yu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | T ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------มมากที่ 1977 เป็นที่มีสินค้ามา |
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Device Name:
To Be Determined
Indications For Use:
BD-3 Catheters are intended for urological dilatation; ureteral and urethral.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
Robert D Mathing/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
(Optional Format
510(k) Number K980795
(Optional Format 1-2-96)
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).