(74 days)
Not Found
No
The summary describes a mechanical stone retrieval basket and does not mention any AI or ML components or functionalities.
Yes
The device is identified as a "stone retrieval basket" used to "entrap and remove stones from the biliary system," which directly addresses and treats a medical condition.
No
The device is a stone retrieval basket, used for entrapping and removing stones, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "stone retrieval device" and a "basket," which are physical, hardware components used endoscopically.
Based on the provided information, the SpyCatch™ Stone Retrieval Basket is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- SpyCatch Function: The SpyCatch is a physical device used within the body (endoscopically) to retrieve stones from the biliary system. It is a surgical/interventional tool, not a device that analyzes biological samples in vitro.
The description clearly indicates its use as a retrieval tool during an endoscopic procedure, which is an in vivo (within the living body) application.
N/A
Intended Use / Indications for Use
The SpyCatch™ Stone Retrieval Basket is used endoscopically to entrap and remove stones from the Biliary system. The SpyCatch Stone Retrieval Basket is designed to be used through the working channel of a delivery device accessing the Biliary system.
Product codes (comma separated list FDA assigned to the subject device)
LQR
Device Description
The proposed SpyCatch is a stone retrieval device designed to pass through the working channel of a scope with a working channel of >1.1mm and retrieve stones inside the biliary duct.
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)
Design Verification testing has been conducted to confirm that the proposed basket meets its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary - SpyCatch™ Stone Retrieval Basket
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Neil Kelly Regulatory Affairs Specialist Date Prepared: March 19, 2007
2. Device:
Trade Name: SpyCatch™ Stone Retrieval Basket Common Name: Dislodger, Stone, Biliary Regulation Number: 876.5010 Regulation Name: Biliary catheter and accessories Classification: Class II Product Code: LQR
3. Predicate Device:
Boston Scientific Corporation's Biliary Flat Wire Baskets, K925879
4. Device Description:
The proposed SpyCatch is a stone retrieval device designed to pass through the working channel of a scope with a working channel of >1.1mm and retrieve stones inside the biliary duct.
5. Indications for Use:
The SpyCatch Stone Retrieval Basket is used endoscopically to entrap and remove stones from the Biliary system. The SpyCatch Stone Retrieval Basket is designed to be used through the working channel of a delivery device accessing the Biliary system.
JUN 2 9 2007
1
6. Technological Characteristics:
The SpyCatch™ Stone Retrieval Basket represents the same fundamental scientific technology as the currently marketed Biliary Flat Wire Baskets, K925879.
7. Performance Data:
Design Verification testing has been conducted to confirm that the proposed basket meets its intended use.
8. Conclusion:
Boston Scientific Corporation has demonstrated that proposed SpyCatch Stone Retrieval Basket is substantially equivalent to the currently marketed Biliary Flat Wire Baskets, K925879.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 2 9 2007
Mr. Neil Kelly Regulatory Affairs Specialist Endoscopy Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K071066
Trade/Device Name: SpyCatch™ Stone Retrieval Basket Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: LQR Dated: May 25, 2007 Received: May 29, 2007
Dear Mr. Kelly:
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.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular seal with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is written in a cursive font. The seal is surrounded by stars and text, which appears to be the full name of the organization. The seal is black and white and has a slightly distressed look.
Promoting and Promoting Public Health
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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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
21 CFR 876.xxxxx 21 CFR 884.xxxx 21 CFR 892 xxxxx Other
(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
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
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INDICATIONS FOR USE
510(k) Number (if known): _ Ko 7 / 066
Device Names:
SpyCatch Stone Retrieval Basket
Indications for Use:
The SpyCatch™ Stone Retrieval Basket is used endoscopically to entrap and remove stones from the biliary system. The SpyCatch Stone Retrieval Basket is designed to be used through the working channel of a delivery device accessing the biliary system.
노사
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K071046 |
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