(28 days)
Not Found
No
The summary describes a mechanical device for stone retrieval and contrast injection, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is used to remove stones from the biliary system, which is a therapeutic intervention.
No
The device is used for stone retrieval and injection of contrast medium, which are therapeutic and procedural functions, not diagnostic.
No
The device description clearly describes a physical catheter with a balloon, injection ports, and the ability to accept a guidewire. This is a hardware medical device, not software-only.
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 facilitate contrast injection endoscopically. This is a procedure performed in vivo (within the living body).
- Device Description: The description details a physical catheter used for a medical procedure within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a surgical tool used directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The Extractor™ Pro Retrieval Balloon Catheters are 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
FGE
Device Description
Extractor™ Pro Retrieval Balloon Catheters are a stone retrieval balloon catheter used for biliary stone retrieval.
. The catheter may be placed with or without the aid of a guidewire.
. The catheter is capable of accepting a 0.035 in. (0.89 mm) guidewire
Injection ports for contrast are set either below or above the retrieval balloon. .
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)
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K102082
SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4872 Fax: 508-683-5939
Contact: Laurie Pannella, RAC Regulatory Affairs Specialist Date Prepared: July 23, 2010
2. Proposed Device:
Trade Name: Extractor™ Pro RX Retrieval Balloon, Extractor™ Pro XL Retrieval Balloon, and Extractor™ Pro DL Retrieval Balloon Classification Name: Endoscopic Biliary Stone Retrieval Balloon Catheter (Catheter, Biliary, Diagnostic) Regulation Number: 876.5010 Product Code: FGE Classification: Class II
3. Predicate Device:
1
Trade Name: Extractor™ RX Retrieval Balloon Manufacturer and Clearance Number: Boston Scientific Corporation, K041606 Classification Name: Endoscopic Biliary Stone Retrieval Balloon Catheter Regulation Number: 876.5010 Product Code: FGE Classification: Class II
Trade Name: Endoscopic Biliary Stone Retrieval Catheter Manufacturer and Clearance Number: Boston Scientific Corporation, K931619 Classification Name: Catheter, Biliary, Surgical Regulation Number: 876.5010 Product Code: GCA Classification: Class II
Trade Name: Tri-Ex Extraction Balloon with Multiple Sizing Manufacturer and Clearance Number: Wilson-Cook Medical, K040129 Classification Name: Catheter, Biliary, Surgical Regulation Number: 876.5010 Product Code: GCA . . Classification: Class II
AUG 2 3 2010
000013
Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters
1
4. Proposed Device Description:
Extractor™ Pro Retrieval Balloon Catheters are a stone retrieval balloon catheter used for biliary stone retrieval.
- . The catheter may be placed with or without the aid of a guidewire.
- . The catheter is capable of accepting a 0.035 in. (0.89 mm) guidewire
- Injection ports for contrast are set either below or above the retrieval balloon. .
5. Intended Use:
The Extractor™ Pro Retrieval Balloon Catheters are 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.
6. Technological Characteristics:
The proposed Extractor™ Pro Retrieval Balloon Catheters are similar in design, materials, and manufacturing processes to the predicate Extractor™ RX Retrieval Balloon (K041606) and Endoscopic Biliary Stone Retrieval Catheter (K931619).
7. Performance Data:
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Extractor™ Pro Retrieval Balloon Catheters are substantially equivalent to Boston Scientific Corporation's currently marketed Extractor™ RX Retrieval Balloon (K041606) and Endoscopic Biliary Stone Retrieval Catheter (K931619).
000014
Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters
2
SECTION 6 TRUTHFUL AND ACCURACY STATMENT
Premarket Notification Truthful and Accurate Statement (As Required by 21 CFR 807.87(k))
I certify that, in my capacity as a Regulatory Affairs Specialist at Boston Scientific Corporation, I believe to the best of my knowledge that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.
$\lim_{x \to \infty} \frac{x^2}{e^x} = 0$
$\lim_{x \to \infty} \frac{x^n}{e^x} = 0$
$\lim_{x \to \infty} \frac{\ln x}{x} = 0$
$\lim_{x \to 0^+} x \ln x = 0$
$\lim_{x \to \infty} x^{1/x} = 1$
$\lim_{x \to 0} (1+x)^{1/x} = e$
$\lim_{x \to \infty} (1+\frac{1}{x})^x = e$
$\lim_{n \to \infty} \sqrt[n]{n} = 1$
$\lim_{n \to \infty} \frac{x^n}{n!} = 0$
$\lim_{n \to \infty} (1-\frac{1}{n})^n = \frac{1}{e}$
Laurie Pannella, RAC Regulatory Affairs Specialist Boston Scientific Corporation
July 23, 2010 Date
000015
Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters Proprietary and Confidential Information of Boston Scientific Corporation
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Laurie Pannella Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
AUG 2 3 2010
Re: K102082
Trade/Device Name: Extractor™ Pro Retrieval Balloon Catheter Regulation Number: 21 CFR& 876,5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 23, 2010 Received: July 26, 2010
Dear Ms. Pannella:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
4
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Hubert Lenoir MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
To Be Determined
Device Name:
Indications For Use:
Extractor™ Pro Retrieval Balloon Catheter
The Extractor™ Pro Retrieval Balloon Catheters are 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.
102002
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)
1
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
000012
Special 510(k) Premarket Notification, Extractor™ Pro Retrieval Balloon Catheters