(124 days)
The Marshal™ Balloon Dilatation Cutheter is indicated for deployment of the Palmaz™ and the Palmaz-Shatz™ Balloon-Expanded Stents for the Biliary system
Marshal Gatheters are not indicated for use in coronary arteries or the neurovasculature.
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.
This document appears to be a 510(k) premarket notification for the Marshal™ Balloon Dilatation Catheter, filed by Boston Scientific Corporation. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical trials with specific acceptance criteria as you might see for a de novo device or a PMA.
Therefore, the requested information regarding acceptance criteria, specific trial details (sample size, experts, adjudication, MRMC, standalone performance), and ground truth establishment is not present in the provided text, as this type of information is generally not required or included in a 510(k) submission for this class of device.
Here's an analysis based on the information provided, explaining why certain sections are not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document explicitly states: "Functional and integrity bench testing and biocompatibility 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."
- This indicates that the "acceptance criteria" were tied to demonstrating performance comparable to the predicate devices through bench testing and biocompatibility testing, rather than pre-defined clinical performance metrics (e.g., success rates, complication rates) with specific thresholds. No numerical performance data or acceptance criteria are presented.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set data (human or animal studies) is reported. The "testing" mentioned refers to bench and biocompatibility testing. Therefore, there is no information on sample size, data provenance, or study type (retrospective/prospective) for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As no clinical test set is described, there's no mention of experts or ground truth establishment for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set.
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
- Not Applicable. This device is a balloon dilatation catheter. It is a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. For a medical device like a balloon catheter, "ground truth" in the sense of comparing diagnostic accuracy isn't relevant. The "truth" in this context would be the physical properties (e.g., burst pressure, fatigue life) confirmed by engineering tests, and biological response confirmed by biocompatibility tests, all compared against predicate devices.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this device. This is not an AI/machine learning device. The testing describes functional, integrity, and biocompatibility bench tests, not a data-driven training process.
9. How the ground truth for the training set was established
- Not Applicable. No training set.
Summary of what the document does state:
- Device: Marshal™ Balloon Dilatation Catheter
- Indication for Use: For deployment of the Palmaz™ and Palmaz-Shatz™ Balloon-Expanded Stents for the Biliary system.
- Safety and Performance Basis: Functional and integrity bench testing, and biocompatibility testing (according to FDA guidance and ISO-10993).
- Conclusion: The data from these tests "supported the substantial equivalence of the Marshall™ Balloon Dilatation Catheter to the Courier and PEMT-5 Balloon Dilatation Catherer."
- Predicate Devices: BSC -- PEMT-5 Balloon Dilatation Catheter and BSC -- Courier 1 Balloon Catheter.
- Regulatory Outcome: FDA found the device "substantially equivalent" to predicate devices, allowing it to proceed to market.
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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 CorporationOne Boston Scientific PlaceNatick, MA 01760 |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, thedevice 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-
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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.
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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
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| Page | OlAnnual 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)
§ 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.