(238 days)
K929224/A
Not Found
No
The summary describes a mechanical balloon dilating catheter and does not mention any AI or ML components or functionalities.
Yes
The device is intended for "dilating narrowed or obstructed ducts in the biliary tree," which is a treatment for a physiological condition.
No.
Explanation: The device is described as a dilating catheter used to open narrowed ducts, which is a therapeutic function, not a diagnostic one. Its indicated use is to "allow access for diagnostic or surgical procedures," implying it facilitates diagnosis rather than performing it.
No
The device description clearly states it is a "Cystic Duct Balloon Dilating Catheter" and describes a physical balloon and catheter, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to dilate ducts within the body (biliary tree) for diagnostic or surgical procedures. This is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The device is a balloon catheter designed for mechanical dilation, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, urine, tissue, or other biological specimens, which are characteristic of IVDs.
Therefore, the Applied Medical Cystic Duct Balloon Dilating Catheter is a medical device used for a therapeutic or procedural purpose within the body, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The Applied Cystic Duct Dilator consists of a non-distensible dilating balloon with a inflation profile of 15 French.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K929224/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY り いず
K983154
Page 1 of 1
510(k) SUMMARY
| 510(k) NUMBER: | K983154 |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 26051 Merit Circle, Unit # 103 | |
| Laguna 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.
1
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
2
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
3
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 |
|---|---|
| --------------- | -------------- |