(124 days)
BSC -- PEMT-5 Balloon Dilatation Catheter, BSC -- Courier 1 Balloon Catheter
Not Found
No
The summary describes a mechanical device (balloon catheter) and its intended use for stent deployment. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes.
The device is used to deploy stents for the biliary system, which is a therapeutic intervention.
No
The device, Marshal™ Balloon Dilatation Catheter, is indicated for the deployment of stents, which is a therapeutic rather than a diagnostic function.
No
The device description clearly identifies it as a physical catheter, which is a hardware component. The performance studies also focus on functional and integrity testing of this physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The Marshal™ Balloon Dilatation Catheter is a physical device designed to be inserted into the body (specifically the biliary system) to deploy a stent. It is used in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use is for the deployment of stents within the biliary system, which is a therapeutic procedure performed directly on the patient.
The information provided clearly describes a medical device used for a therapeutic intervention within the body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Marshal™ Balloon Dilatation Cutheter is indicated for deployment of the Palmaz™ and the Palmaz-Shatz™ Balloon-Expanded Stents for the Biliary system
Product codes
78 FGE
Device Description
The Marshal™ Balloon Dilatation catherer is an over-the-wire catherer 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
Biliary System
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
Functional and integrity beach testing and hiocompatibility 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 I: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the Marshall™ Balloon Dilatation Catheter to the Courier and PEMT-5 Balloon Dilatation Catherer.
Key Metrics
Not Found
Predicate Device(s)
BSC -- PEMT-5 Balloon Dilatation Catheter, BSC -- Courier 1 Balloon 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
plansic (2
Medi-toch Marshal™ Balloon Dilatation Cathorer September 12, 1996
ATTACHMENT H
DEC 1 5 1997 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 un " ... adequate summary of aay information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summery of information respection safety and offectiveness. According to §.13(i)(3)(B), "Any summary under subparagraph (A) respecting a dovice shall contain detailed information regarding data concerning adverse health effects ...
The summary regarding the adverse bealth effects of the proposed Marshal™ Balloon Dilatation Catheter is as follows:
Trade Name: | MarshalTM 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 devices are referenced in this premarket notification as predicate devices for the Marshal™ Balloon Dilatation Catheter:
BSC -- PEMT-5 Balloon Dilatation Catheter BSC -- Courier 1 Balloon Catheter
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description:
The Marshal™ Balloon Dilatation catherer is an over-the-wire catherer designed to be placed over guidewires which have outer diameters of .035" or smaller.
Indications for Use:
The Marshal™ Balloon Dilatation Cutheter is indicated for deployment of the Palmaz™ and the Palmaz-Shatz™ Balloon-Expanded Stents for the Biliary system
Safety and Performance:
Functional and integrity beach testing and hiocompatibility testing (according to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-
1
$\leftarrow$ 2/2
K973008
Medi-tech Marshal nu Ralloon Dilation Cather September 12, 1996
10993, "Biological Evaluation of Medical Devices Part I: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the Marshall™ Balloon Dilatation Catheter to the Courier and PEMT-5 Balloon Dilatation Catherer.
Conclusion:
Based on the Indication for Use, technological characteristics and safety and performance testing, the Marshalled Balloon Dilation Catheter has beca shown to be safe und effective for its intended use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 1997
Ms. Mary P. LeGraw Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 Re: K973008
Marshal™ Balloon Dilatation Catheter Dated: November 12, 1997 Received: November 14, 1997 Regulatory class: II 21 CFR §876.5010/Product code: 78 FGE
Dear Ms. LeGraw:
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 misbranion.
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 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 Drue Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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 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/dsmamain.html".
Sincerely yours,
h)liau Yu
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
3
| Page | Ol
Annual Property of Children and Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Chil | |
|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | | Carolina Antario Controllation Company of Children |
510(k) Number lif known)- | K973008 |
---|---|
--------------------------- | --------- |
Courier ST (Marshal) Balloon Dilatation Catheter Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Marshal Balloon Dilatation Catheter is indicated for deployment The Palmaz and the Palmaz-Schatz Balloon-Expanded Stents for the Biliary System.
Marshal Gatheters are not indicated for use in coronary arteries or the neurovasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
i J Concurrence of CDRH, Office of Device Evaluation (ODE) P (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1973008 510(k) Number Prescription Use_ ે.
વિ Over-The-Counter Use__ (Per 21 CFR 201.109) (Optional Format 1-2-96)