(189 days)
The New Microvasive® Biliary Stent and Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
The New Microvasive® Biliary Stent and Delivery System is a device intended for delivery of a stent to the biliary tract. The stent is of the Amsterdam type, made of Flexima material, and is available in diameters from 7 to 11.5 Fr and lengths from 5 to 15 cm. The delivery system has a preloaded stent, a working length of 200 cm, and is compatible with a 0.035 inch guidewire.
The provided document is a 510(k) summary for a medical device, the New Microvasive® Biliary Stent and Delivery System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study for a new AI/software-as-a-medical-device (SaMD) product.
Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for a performance study is not applicable or not present in this type of submission.
Here's a breakdown of the information that can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not present acceptance criteria for a performance study in the way an AI/SaMD submission would. Instead, it demonstrates "substantial equivalence" based on descriptive and technological characteristics compared to predicate devices. The "performance characteristics" mentioned refer to laboratory testing for safety and basic function, not clinical efficacy or diagnostic accuracy.
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 or data provenance is mentioned as this is a device based on substantial equivalence, not a new performance evaluation study.
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. No ground truth establishment by experts is mentioned in the context of a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set is mentioned.
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 is not a comparative effectiveness study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm, so "standalone performance" in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is established in the context of a performance study. For this device, "ground truth" for its design and safety is implicitly based on established engineering principles and biocompatibility standards for similar devices already on the market.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
Information that is available from the document related to "performance" in the context of this 510(k) submission:
The document states:
- Performance Characteristics: "Laboratory testing regarding characteristics was performed on New Microvasive® Biliary Stent and Delivery System to verify its safety and performance."
- Biocompatibility: "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the New Microvasive® Biliary Stent and Delivery System with satisfactory results."
- Sterilization & Pyrogenicity: "The New Microvasive® Biliary Stent and Delivery System will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels."
The "study" that "proves" the device meets acceptance criteria in this 510(k) context is primarily through:
- Bench Testing/Laboratory Testing: Mentioned for "characteristics" relating to safety and performance (specific details not provided in the summary).
- Biocompatibility Assessment: To ensure the materials are safe for patient contact.
- Sterilization Validation: Using the AAMI protocol for ethylene oxide sterilization.
- Pyrogenicity Testing: To monitor bacterial endotoxin levels.
- Substantial Equivalence Argument: The core of the 510(k) is the comparison in design, materials, and intended use to the predicate devices (Solopas™ Percuflex Biliary Stent and Flexima™ Biliary Drainage Catheter), implying that because the predicate devices are safe and effective, and the new device is substantially similar, it too will be safe and effective.
The provided document is a regulatory submission for a physical medical device (a biliary stent) seeking clearance based on substantial equivalence, not a clinical study report for an AI/SaMD product. Therefore, the specific questions about AI/SaMD study design are not addressed.
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SECTION 9 510(K) SUMMARY
JUN 30 1997
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "…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.
- Biliary Stent, Biliary Stent System, Biliary Endoprosthesis > Common/Usual Names:
-
TRADE/PROPRIETARY NAME: The trade name has not yet been finalized.
| > CLASSIFICATION NAME & | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ------------------------- | -- |
| DEVICE CLASSIFICATION: | Class II | ||
|---|---|---|---|
| Name | Number | 21 CFR Ref. | |
| Biliary Catheter and Accessories | 78 FGE | 876.5010 | |
| ➤ DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU)Gastro-Renal (GRDB) | ||
| ➤ OWNER/OPERATOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760Owner/Operator No. 9912058 | ||
| ➤ CONTACT PERSON: | Daniel J. Dillon, Senior Regulatory Affairs Specialist |
INDICATIONS FOR USE
The New Microvasive® Biliary Stent and Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
CONTRAINDICATIONS
None known.
POTENTIAL COMPLICATIONS
Potential complications that may result from a biliary stent procedure include, but may not be limited to, perforation of bile ducts; liver and/or duodenum; hemorrhage; hematoma; septicemia/infection; bile peritonitis; allergic reaction to contrast medium.
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DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the New Microvasive® Biliary Stent and Delivery System is substantially equivalent to the currently-marketed Solopas™4 Percuflex Biliary Stent and Flexima™ Biliary Drainage Catheter. Table 9-1 compares the descriptive characteristics of these products.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on New Microvasive® Biliary Stent and Delivery System to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the New Microvasive® Biliary Stent and Delivery System with satisfactory results.
PACKAGING, STERILIZATION, AND PYROGENICITY
The New Microvasive® Biliary Stent and Delivery System will be packaged using Twek/Mylar. The New Microvasive® Biliary Stent and Delivery System will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.
CONCLUSION
Boston Scientific Corporation believes that New Microvasive® Biliary Stent and Delivery System is substantially equivalent to the currently-marketed Solopass™ Percuflex Biliary Stent and Flexima™ Biliary Drainage Catheter. Table 9-1 compares the descriptive characteristics of these products. As demonstrated in Table 9-1, the New Microvasive® Biliary Stent and Delivery System is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the New Microvasive® Biliary Stent and Delivery System will meet the minimum requirements that are considered acceptable for its intended use.
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Table 9-1: Comparison of New Microvasive® Biliary Stent and Delivery System, Solopass™ Percuflex Biliary Stent, and Flexima™ Billary Drainage Catheter
| New Microvasive® BiliaryStent and Delivery System | Solopass™ PercuflexBiliary Stent | Flexima™ BiliaryDrainage Catheter |
|---|---|---|
| (This 510(k)) | (K834468) | (K944290) |
USE
1
| Indication | Biliary Drainage | ← Same | ← Same |
|---|---|---|---|
| Route of Administration | Endoscopic | ← Same | PercutaneousTranshepatic |
STENT
| Type | Amsterdam | ← Same | Pigtail |
|---|---|---|---|
| Material | Flexima | Percuflex | Flexima |
| Dissolvable Tip | No | Yes | Yes |
| Available Diameters (Fr) | 7 - 11.5 | 7 - 12 | 8 - 14 |
| Available Lengths (cm) | 5 - 15 | 5 - 15 | 35 |
DELIVERY SYSTEM
| Preloaded Stent? | Yes | Yes | Not Applicable |
|---|---|---|---|
| Working Length (cm) | 200 | 195 | Not Applicable |
| Compatible Guidewire (in) | 0.035 | 0.035 | 0.018/0.038 |
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest the bird's head, body, and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 30 1997
Mr. Daniel J. Dillon --Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re: K965147 ……… New Microvasive® Biliary Stent and Delivery System Dated: April 29, 1997 Received: May 1, 1997 Regulatory class: II 21 CFR §876.5010/Product code: 78 FGE
Dear Mr. Dillon:
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 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 might have under sections 53 1 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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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,
Lillian Yin, Ph.D.
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
Enclosure
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SECTION 1 INDICATIONS FOR USE
510(k) Number:
To Be Determined
Device Name:
New Microvasive® Biliary Stent and Delivery System™
Indication for Use:
.
The New Microvasive® Biliary Stent and Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Rolar D. Rathung
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use_
§ 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.