(171 days)
Not Found
Not Found
No
The summary describes a mechanical device (balloon catheter) and its intended use for stent deployment and stricture treatment. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on bench testing and biocompatibility, not algorithmic performance.
Yes
The device is indicated for "treatment of biliary strictures," which is a therapeutic purpose.
No
The device is a Balloon Dilatation Catheter used for treatment (stent deployment/optimization and treatment of strictures), not for diagnosis.
No
The device description clearly identifies it as a physical catheter, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stent deployment/optimization of the J&J Palmaz Biliary Stent and for the treatment of biliary strictures." This describes a therapeutic and interventional procedure performed directly on a patient's body.
- Device Description: The description of an "over-the-wire catheter designed to be placed over guidewires" further confirms its use in a medical procedure within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to test samples taken from the body, while this device is used to perform a procedure within the body.
N/A
Intended Use / Indications for Use
The SC 35 Balloon Dilatation Catheter is indicated for stent deployment/optimization of the J&J Palmaz Biliary Stent and for the treatment of biliary strictures.
The Semi Compliant 35 Balloon Dilatation Catheter is indicated for stent deployment/optimization of the J&J Palmaz Biliary Stent and for the treatment of biliary strictures.
Product codes
78 FGE
Device Description
The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheter designed to be placed over guidewires which have outer diameters of .035" or smaller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Functional and integrity bench testing and biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the SC 35 Balloon Dilatation Catheter to the Ultra-thin Diamond Balloon Dilatation Catheter and the Courier ST Balloon Dilatation Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Boston Scientific - Ultra-thin Diamond Dilatation Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SC 35 Balloon Dilatation Catheter
K993303
Page 1 of 2 September 2, 1999
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 safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses 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 SC 35 Balloon Dilatation Catheter is as follows:
| Trade Name: | SC 35 Balloon Dilatation Catheter |
|---|---|
| Manufacturer: | Boston Scientific Corporation |
| One Boston Scientific Place | |
| Natick, MA 01760 | |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the |
| device classification is Class II, Performance Standards. | |
| Predicate Devices: | The following device is referenced in this premarket notification as predicate |
| devices for the SC 35 Balloon Dilatation Catheter: |
Boston Scientific - Ultra-thin Diamond Dilatation Catheter
The devices mentioned above has been determined substantially equivalent by
FDA. |
| Device Description: | The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheter
designed to be placed over guidewires which have outer diameters of .035" or
smaller. |
| Indications for Use: | The SC 35 Balloon Dilatation Catheter is indicated for stent
deployment/optimization of the J&J Palmaz Biliary Stent and for the treatment
of biliary strictures. |
1
MAR 23
SC 35 Balloon Dilatation Catheter
K993303
Page 2 of 2 September 2, 1999
Safety and Performance:
Functional and integrity bench testing and biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the SC 35 Balloon Dilatation Catheter to the Ultra-thin Diamond Balloon Dilatation Catheter and the Courier ST Balloon Dilatation Catheter.
Conclusion:
Based on the Indication for Use, technological characteristics and safety and performance testing, the SC 35 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that appears to be a stylized bird or eagle with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2000
Ms. Terry A. McGovern Senior Regulatory Affairs Specialist Boston Scientific Corporation MEDI-TECH One Boston Scientific Place Natick, MA 01760-1537
Re: K993303 Semi Compliant (SC) 35 Balloon Dilatation Catheter Dated: January 6, 2000 Received: January 11, 2000 Regulatory Class: II 21 CFR §876.5010/Procode: 78 FGE
Dear Ms. McGovern:
We have reviewed your Section 510(k) notification of intent to market the device 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 pror 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 (Act, 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Aproval), 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, 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 micht 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 predication 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 Compiance at (301) 594-4591. 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 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
510(k) Number (if known):__K993303
Device Name:__Semi Compliant 35 Balloon Dilatation Catheter
Indications For Use:
The Semi Compliant 35 Balloon Dilatation Catheter is indicated for stent deployment/optimization of the J&J Palmaz Biliary Stent and for the treatment of biliary strictures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
. '
H
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_1993303