(195 days)
No
The description focuses on the mechanical design and function of a retrieval basket and its compatibility with a digital catheter. There is no mention of AI, ML, or any computational analysis of the endoscopic visualization data.
No
The device is described as an endoscopic retrieval basket for removing stones, which is a surgical tool rather than a therapeutic device that treats a condition.
No
The device is indicated for the endoscopic removal of stones and stone fragments, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines a physical, mechanical device (nitinol wire basket, flexible sheath, thumb slide, handle) used for stone retrieval, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "endoscopic removal of stones and stone fragments in the biliary system." This describes a procedure performed within the body to remove physical objects.
- Device Description: The device is a physical retrieval basket designed to be used with an endoscope. It physically interacts with the stones.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis or testing of biological samples.
The device is a surgical tool used for a therapeutic procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The SpyGlass™ Discover Retrieval Basket is indicated for the endoscopic removal of stones and stone fragments in the biliary system.
Product codes
LQR
Device Description
The SpyGlass Discover Retrieval Basket is designed to be used with the SpyGlass Discover Digital Catheter (K200483), which is a single-use endoscope. The SpyGlass Discover Retrieval Basket is a self-expanding nitinol wire basket that is housed within a flexible sheath. The basket is extended from the sheath (opened) and retracted into the sheath (closed) using a thumb slide on the proximal handle. The basket cage is made of four nitinol wire legs. The basket wires are looped at the distal end featuring a tipless design with no exposed wire ends.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visualization
Anatomical Site
biliary system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Non-clinical performance bench testing and simulated use testing were completed to evaluate the design of the SpyGlass Discover Retrieval Basket for its intended use. Testing includes:
- Sheath Outer Diameter
- Working Length
- Basket Outer Diameter
- Basket Wire Spacing
- Tensile Pull Testing
- Simulated-Use Functionality & Durability
- Stone Capture
- Deflection Testing
Comparative stone retention testing was conducted on the SpyGlass Discover Retrieval Basket and the predicate Cook NCompass Nitinol Stone Extractor (K173009).
Testing was conducted per the requirements of ISO 10993-1 based on the biocompatibility classification of the device (category: externally communicating, contact duration: limited (
§ 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
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May 26, 2021
Boston Scientific Corporation Lindsay Forys Regulatory Affairs Manager 100 Boston Scientific Wav Marlborough, MA 01752
Re: K203322
Trade/Device Name: SpyGlass™ Discover Retrieval Basket Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: LQR Dated: May 3, 2021 Received: May 4, 2021
Dear Lindsay Forys:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Je Hi An, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203322
Device Name SpyGlass™ Discover Retrieval Basket
Indications for Use (Describe)
The SpyGlass Discover Retrieval Basket is indicated for the endoscopic removal of stones and stone fragments in the biliary system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Primary Contact: Lindsay Forys Regulatory Affairs Manager Telephone: 508-382-0498 E-Mail: Lindsay.Forys@bsci.com
Date Prepared: 26 May 2021
2. Device:
| Trade Name: | SpyGlass™ Discover Retrieval Basket |
|---|---|
| Device Common Name: | Dislodger, Stone, Biliary |
| Regulation Name: | Biliary Catheter and Accessories |
| Regulation Number: | 21 CFR 876.5010 |
| Product Code: | LQR |
| Regulatory Class: | Class II |
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3. Predicate Device:
| Trade Name: | Cook NCompass Nitinol Stone Extractor |
|---|---|
| 510(k) Number: | K173009 |
| Device Common Name: | Dislodger, Stone, Biliary |
| Regulation Name: | Biliary Catheter and Accessories |
| Regulation Number: | 21 CFR 876.5010 |
| Product Code: | LQR |
| Regulatory Class: | Class II |
4. Device Description
The SpyGlass Discover Retrieval Basket is designed to be used with the SpyGlass Discover Digital Catheter (K200483), which is a single-use endoscope. The SpyGlass Discover Retrieval Basket is a self-expanding nitinol wire basket that is housed within a flexible sheath. The basket is extended from the sheath (opened) and retracted into the sheath (closed) using a thumb slide on the proximal handle. The basket cage is made of four nitinol wire legs. The basket wires are looped at the distal end featuring a tipless design with no exposed wire ends.
5. Indications for Use:
The SpyGlass Discover Retrieval Basket is indicated for the endoscopic removal of stones and stone fragments in the biliary system.
Technological Characteristics 6.
The SpyGlass Discover Retrieval Basket is substantially equivalent to the Cook NCompass Stone Extractor in terms of technological characteristics. The baskets are designed to be viewed under endoscopic visualization, feature a thumb slide operating mechanism, and consist of a nitinol wire basket that self-expands in a 360° configuration once extended from the outer sheath.
The SpyGlass Discover Retrieval Basket features a 4-wire basket configuration while the Cook NCompass Nitinol Stone Extractor (K173009) features a 12 or 16-wire basket configuration. Comparative stone retention testing was conducted to demonstrate substantial equivalence.
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7. Performance Data
Non-clinical performance bench testing and simulated use testing were completed to evaluate the design of the SpyGlass Discover Retrieval Basket for its intended use. Testing includes:
- Sheath Outer Diameter
- Working Length ●
- Basket Outer Diameter ●
- Basket Wire Spacing ●
- . Tensile Pull Testing
- Simulated-Use Functionality & Durability ●
- Stone Capture ●
- Deflection Testing ●
Comparative stone retention testing was conducted on the SpyGlass Discover Retrieval Basket and the predicate Cook NCompass Nitinol Stone Extractor (K173009).
Testing was conducted per the requirements of ISO 10993-1 based on the biocompatibility classification of the device (category: externally communicating, contact duration: limited (