(189 days)
No
The summary describes a mechanical device (stent and delivery system) and its physical characteristics, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is intended for clinical use in patients (delivery of a stent to the biliary tract for drainage, splinting, or maintaining patency of bile ducts), which aligns with the definition of a therapeutic device.
No
The device is a stent delivery system intended for therapeutic purposes like drainage, splinting, and maintaining patency of bile ducts, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Biliary Stent and Delivery System," which includes physical components (stent, delivery system) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of a stent to the biliary tract for drainage, splinting, or providing patency. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The device is a physical stent and delivery system designed to be implanted or placed within the biliary tract.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens for diagnostic purposes.
The device is a medical device used for treatment and intervention within the body, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
78 FGE
Device Description
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.
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.
The device is described as an Amsterdam type stent made of Flexima material. It does not have a dissolvable tip. Available diameters for the stent range from 7 to 11.5 French, and available lengths range from 5 to 15 cm. The delivery system comes with a preloaded stent, has a working length of 200 cm, and is compatible with a 0.035 inch guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tract, bile ducts
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
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
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 Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| Owner/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.
1
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.
2
Table 9-1: Comparison of New Microvasive® Biliary Stent and Delivery System, Solopass™ Percuflex Biliary Stent, and Flexima™ Billary Drainage Catheter
| New Microvasive® Biliary
Stent and Delivery System | Solopass™ Percuflex
Biliary Stent | Flexima™ Biliary
Drainage Catheter |
|-------------------------------------------------------|--------------------------------------|---------------------------------------|
| (This 510(k)) | (K834468) | (K944290) |
USE
1
| Indication | Biliary Drainage | ← Same | ← Same |
|---|---|---|---|
| Route of Administration | Endoscopic | ← Same | Percutaneous |
| Transhepatic |
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 |
3
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
4
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_