(22 days)
Not Found
Not Found
No
The summary describes a physical medical device (a balloon catheter) and does not mention any software, image processing, AI, or ML capabilities.
Yes
The device is indicated for removing stones from the biliary system, which is a therapeutic intervention.
No
The device is described as a stone retrieval balloon catheter for removing stones and facilitating contrast injection, not for diagnosing conditions.
No
The device description clearly states it is a "stone retrieval balloon catheter," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon." This is a therapeutic and diagnostic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description confirms it's a "stone retrieval balloon catheter used for biliary stone retrieval." This is a medical device used for intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing information about a patient's health status based on in vitro analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Boston Scientific Extractor™ RX Retrieval Balloon is intended to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Product codes
78 FGE
Device Description
The Boston Scientific Extractor™ RX Retrieval Balloon is a stone retrieval balloon catheter used for biliary stone retrieval.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison and functional testing support a determination of substantial equivalence for the modified device when compared to the predicate device. The modified device is substantially equivalent to the currently marketed Boston Scientific Extractor™ RX Retrieval Catheter in terms of performance characteristics, biocompatibility, and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Extractor™ RX Retrieval Balloon
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
JUL - 7 2004
Boston Scientific Corporation June 14, 2004
510 (L) St MMARY
| SPONSOR: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | James McMahon
Senior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name: | Extractor™ RX Retrieval Balloon |
| Common Name: | Catheter, Biliary, Diagnostic |
| Classification: | Class II per 21 CFR Part 876, Section |
| PREDICATE DEVICE: | Extractor™ RX Retrieval Balloon |
| DESCRIPTION: | The Boston Scientific Extractor™ RX Retrieval Balloon is a
stone retrieval balloon catheter used for biliary stone retrieval. |
| INTENDED USE: | The Boston Scientific Extractor™ RX Retrieval Balloon is
intended to remove stones from the biliary system, or to facilitate
injection of contrast medium while occluding the duct with the
balloon. |
| COMPARISON OF
CHARACTERISTICS: | The modified device is substantially equivalent to the predicate
device, as they have the same operating principal and intended
use. In addition, the results of design control activities do not
raise any new issues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",
and the results of physical comparison and functional testing
support a determination of substantial equivalence for the
modified device when compared to the predicate device. The
modified device is substantially equivalent to the currently
marketed Boston Scientific Extractor™ RX Retrieval Catheter in
terms of performance characteristics, biocompatibility, and
intended use. |
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized depiction of a bird or eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
Mr. James D. McMahon Senior Regulatory Affairs Specialist Boston Scientific Corporation, Endoscopy One Boston Scientific Place NATICK MA 01760
Re: K041606
Trade/Device Name: Extractor" RX Retrieval Balloon Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 14, 2004 Received: June 15, 2004
Dear Mr. McMahon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreations of 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) that do not require approval of a premarket approval application (PMA). 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 (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 r loase or note a determination that your device complies with other requirements of the Act that x 12 Pix a 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.
2
This letter will allow you to begin marketing your device as described in your Scellon SIV(k) This letter will allow you to begin marketing of sylvalence of your device to a legally premarket nothication - The F17A momig of anyone 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), please If you desire specific advice for your dones on be of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, Tor questions on the promotion in the regulation entitled, "Misbranding Other of Compliance at (301) 574 1059. Fizes Part 807.97) you may obtain. Other general by reference to premarked notification (2) or Act may be obtained from the Division of Small information on your responsionities uncer at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free main transmin http:/ Manufacturers, International and Collsanter - 2015
(301) 443-6597 or at its Internet address http://www.fda.gov/cdch/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | To be determined K041606 |
|---|---|
| Device Name: | Extractor™ RX Retrieval Balloon |
| Indications For Use: | Indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon. |
Prescription Use __ X (Part 21 CFR 801 subpart D)
AND/OR
Over the Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number