(31 days)
Not Found
No
The device description and summary of performance studies focus on the physical components and mechanical performance of a stent system, with no mention of AI or ML.
Yes
The device is indicated for "palliation of malignant neoplasms in the biliary tree," which describes a therapeutic purpose to alleviate symptoms or reduce the severity of a disease.
No
This device is a stent system used for palliation of malignant neoplasms, indicating it is a therapeutic device rather than one used for diagnosing a condition.
No
The device description clearly outlines physical components like a stent, delivery system, balloon, and catheter, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "palliation of malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed within the body to alleviate symptoms caused by a disease.
- Device Description: The device is a stent and a delivery system, designed to be implanted in the biliary tree. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such testing.
Therefore, based on the provided information, the Medtronic, Inc. RACER Biliary Stent System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The RACER Biliary Stent System is indicated for use in the palliation of malignant neoplasm in the biliary tree.
Product codes
78FGE
Device Description
The RACER Biliary Stent System consists of a MP35N (Cobalt, Nickel, Chromium, Molybdenum Alloy) stent mounted on an over-the-wire delivery system. The device is equipped with an AV100 balloon mounted on the distal portion of the catheter. Diameters of the device include 4.0, 5.0, 6.0, and 7.0mm and the lengths are either 12mm or 18mm, all premounted on 80cm or 130cm catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
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
Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device.
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.
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Image /page/0/Picture/0 description: The image shows the Medtronic logo along with the date October 9, 2003. The logo consists of a circular emblem with three figures in motion, followed by the company name "Medtronic" in a bold, sans-serif font. The date is positioned above the logo, indicating a specific time reference associated with the image.
: 上一篇:
510(k) Summary for the Medtronic, Inc. RACER Biliary Stent System
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|---|---|
| Submitter | Medtronic, Inc. |
| Peripheral Technologies | |
| 3576 Unocal Place | |
| Santa Rosa, California 95407 | |
| Contact Person | Sarah Sheppard |
| Regulatory Affairs Manager | |
| Peripheral Technologies | |
| Phone: (707) 591-7465 | |
| FAX: (707) 591-7406 | |
| e-mail: sarah.sheppard@medtronic.com | |
| Date Prepared | September 5, 2003 |
| Trade Name | Medtronic, Inc. RACER Biliary Stent System ("RACER") |
| Common Name | Biliary Stent and Delivery System |
| Classification Name | Biliary Catheter and Accessories |
| Device Classification | Classification: Class II |
| Classification Panel: 78FGE | |
| Regulation Number: 21 C.F.R. §876.5010 | |
| Predicate Device | Bridge Constant Biliary Stent System (K030633) |
| (Previously named Bridge Symbiant) | |
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act |
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510(k) Summary for the Medtronic, Inc. RACER Biliary Stent System
| Device Description | The RACER Biliary Stent System consists of a MP35N (Cobalt, Nickel, Chromium, Molybdenum Alloy) stent mounted on an over-the-wire delivery system. The device is equipped with an AV100 balloon mounted on the distal portion of the catheter. Diameters of the device include 4.0, 5.0, 6.0, and 7.0mm and the lengths are either 12mm or 18mm, all premounted on 80cm or 130cm catheters. |
|---|---|
| Indications for Use | The RACER Biliary Stent System is indicated for use in the palliation of malignant neoplasm in the biliary tree. |
| Technological | |
| Characteristics | The RACER Biliary Stent System is substantially equivalent to the currently cleared Bridge Constant Biliary Stent System (K030633). The subject and predicate stents are identical both in material and technology and are intended for palliation of malignant neoplasms in the biliary tree. The subject and predicate stents are constructed from identical biocompatible materials. The subject and predicate stents are both balloon expandable and premounted on a sheathless delivery system. The subject device offers a lower crossing profile. The subject and predicate stents are both intended to meet clinical needs. The difference between the subject and predicate devices are minor and are not relevant to the ability of the subject device to palliate malignant neoplasms in the biliary tree. |
| Nonclinical | |
| Performance | Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device. |
| Sterilization | The RACER Biliary Stent System is provided sterile. The device is not intended for reuse or resterilization. |
| Conclusion | The RACER Biliary Stent System is substantially equivalent to the currently cleared Bridge Constant device (K030633) and meets the clinical needs of the physicians. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 9 2003
Ms. Sarah Sheppard Regulatory Affairs Manager Peripheral Technologies Medtronic AVE 3576 Unocal Place SANTA ROSA CA 95403
Re: K032768
Trade/Device Name: Medtronic, Inc. RACER Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: September 5, 2003 Received: September 9, 2003
Dear Ms. Sheppard:
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 legally marketed predicate 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 and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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Page 2 - Ms. Sarah Sheppard
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Daniel G. Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K032768
Device Name: Medtronic, Inc. RACER Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Medtronic, Inc. RACER Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use OR
(Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy C Brogdon