(238 days)
The Applied Medical Cystic Duct Balloon Dilating Catheter is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures.
The Applied Cystic Duct Dilator consists of a non-distensible dilating balloon with a inflation profile of 15 French.
The provided text describes a 510(k) submission for the Applied Medical Cystic Duct Balloon Dilating Catheter (K983154). This document focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving the device meets explicit acceptance criteria in the manner one might find for a novel Artificial Intelligence or software-driven medical device.
Therefore, the requested information categories related to AI/software performance, such as sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable or available in this submission. This is a traditional medical device submission for a physical catheter.
Below is an attempt to address the request based on the available information regarding the device.
Acceptance Criteria and Device Performance Study for K983154: Applied Medical Cystic Duct Balloon Dilating Catheter
This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing performance against pre-defined quantitative acceptance criteria through a clinical study with human readers or AI.
The "acceptance criteria" in this context refer to passing all required tests to prove the device's safety and effectiveness are equivalent to the predicate devices and that it introduces no new safety or effectiveness issues.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence | The device passed all testing to demonstrate substantial equivalence to the predicate devices: Applied Medical Obturator (part of Cystic Duct Access Kit K929224/A) and Cook Guided Biliary Dilator Set. |
| Safety and Effectiveness | The device introduces no new safety and effectiveness issues when used as instructed. (Implicitly, this means safety and effectiveness are comparable to the predicates for the stated indications). |
| Inflation Profile | The device has an inflation profile of 15 French. This is a characteristic feature and presumed to meet design specifications, contributing to its equivalence with predicate devices designed for similar purposes. |
| Intended Use | The device is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures. This matches the intended use of predicate devices, supporting equivalence. |
| Regulatory Compliance | The device complies with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, and labeling), and thus was cleared by the FDA. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. This submission does not detail a clinical "test set" with specific cases or patient data in the manner of an AI or diagnostic imaging device. The "testing" referred to is likely a series of engineering, biocompatibility, and performance bench tests to ensure the physical catheter meets design specifications and is equivalent to the predicate. No information on data provenance (country of origin, retrospective/prospective) is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. This type of expert review to establish ground truth is typical for diagnostic algorithms; it is not relevant for a physical device like a balloon dilating catheter in a 510(k) submission focused on substantial equivalence.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods are not described as this is not a diagnostic or AI performance study requiring such an approach.
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
- No. An MRMC study was not done. This device is a physical medical instrument, not an AI or software-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or software device, so "standalone" performance in that context is not relevant.
7. The type of ground truth used
- Not applicable for a clinical "ground truth" derived from patient outcomes or pathology. The "ground truth" in this context would be derived from engineering specifications, material testing standards, and established performance characteristics of the predicate devices. For instance, burst pressure, inflation/deflation times, material compatibility, and dimensional accuracy would be verified against engineering standards assumed to be met by the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. This is not a machine learning device and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set (as defined in machine learning), there is no ground truth established for one.
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MAY り いず
K983154
Page 1 of 1
510(k) SUMMARY
| 510(k) NUMBER: | K983154 |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation26051 Merit Circle, Unit # 103Laguna Hills, California 92653(949) 582-6120 |
| CONTACT PERSON: | Anil Bhalani |
| DATE OF PREPARATION: | February 1 1999 |
| NAME OF DEVICE: | Applied Medical Cystic Duct Balloon Dilating Catheter |
| CLASSIFICATION NAME: | Endoscope and Accessories, 21 CFR 876.1500 |
| TRADE NAME: | Not Determined |
SUMMARY STATEMENT: The Applied Medical Cystic Duct Balloon Dilating Catheter is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures. The Applied Medical Cystic Duct Balloon Dilating Catheter is substantially equivalent to predicate devices cleared for marketing inclusive of the Applied Medical Obturator (dilator) which is a component of the Cystic Duct Access Kit K929224/A and the Cook Guided Biliary Dilator Set which is a preamendment device. The Applied Cystic Duct Dilator consists of a non-distensible dilating balloon with a inflation profile of 15 French.
The Applied Medical Cystic Duct Balloon Dilating Catheter passed all testing to demonstrate substantial equivalence to the predicate devices and introduces no new safety and effectiveness issues when used as instructed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, with three profiles merging to form a single, abstract shape.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 5 1999
Mr. Anil Bhalani Director of Regulatory Affairs and Clinical Programs Applied Medical Resources 26051 Merit Circle, Building 104 Laguna Hills, California 92653
Re: K983154
Cystic Duct Balloon Dilating Catheter Regulatory Class: II 21 CFR 876.5010/Product Code: 78 FGE Dated: February 3, 1999 Received: February 4, 1999
Dear Mr. Bhalani:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish
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Page 2 - Mr. Anil Bhalani
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 the Electronic Product 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 the 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 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" (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/dsma/dsmamain.html".
Sincerely yours,
[signature]
CAPT Daniel G. Schultz, M.D. Acting 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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INDICATIONS FOR USE
Applied Medical Resources is providing this revised separate cover page for the Applied Medical Cystic Duct Balloon Dilating Catheter "Indications for Use" as required.
510(k) Number: K983154
Applied Medical Cystic Duct Balloon Dilating Catheter Device Name:
Indications for Use: The Applied Medical Cystic Duct Balloon Dilating Catheter is indicated for dilating narrowed or obstructed ducts in the biliary tree to allow access for diagnostic or surgical procedures.
Signature:
ANIL BHALANI
Title: Director of RA
and Clinical Programs
Date: 2-3-99
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 | |
|---|---|
| ------------------------ | -- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K983154/S001 |
|---|---|
| --------------- | -------------- |
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.