(195 days)
The SpyGlass Discover Retrieval Basket is indicated for the endoscopic removal of stones and stone fragments in the biliary system.
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.
The provided text is a 510(k) summary for the Boston Scientific SpyGlass™ Discover Retrieval Basket. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on demonstrating equivalence through comparison of technical characteristics and performance data, rather than detailing a clinical study with human subjects, acceptance criteria for an AI/algorithm, or MRMC studies that would be typical for an AI-powered diagnostic device.
Therefore, the information requested in your prompt regarding acceptance criteria for an algorithm, study design elements like sample size for training/test sets, expert adjudication, or MRMC studies, and ground truth establishment is not present in this document. This document describes a physical medical device (a retrieval basket), not a software or AI-based diagnostic tool.
However, I can extract the acceptance criteria and performance data for the physical device's bench testing, as described in Section 7, "Performance Data."
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
The document describes various bench tests conducted to evaluate the device. The specific acceptance criteria values and the quantitative results are not explicitly stated in a table format with numerical values within this summary. However, the types of tests and the implicit acceptance criteria (that the device performs acceptably for its intended use and is comparable to the predicate) are listed.
| Acceptance Criteria (Implicit from Tests) | Reported Device Performance (Implicit) |
|---|---|
| Sheath Outer Diameter: (Must be within specifications for compatibility with SpyGlass Discover Digital Catheter) | Device met specifications; details not quantified in summary. |
| Working Length: (Must be appropriate for endoscopic procedures in the biliary system) | Device met specifications; details not quantified in summary. |
| Basket Outer Diameter: (Must be suitable for stone capture without causing tissue damage) | Device met specifications; details not quantified in summary. |
| Basket Wire Spacing: (Must be optimized for stone capture and retention) | Device met specifications; details not quantified in summary. |
| Tensile Pull Testing: (Must withstand forces during use without breaking) | Device met specifications; details not quantified in summary. |
| Simulated-Use Functionality & Durability: (Must function correctly and withstand repeated use cycles) | Device demonstrated functionality and durability without significant issues. |
| Stone Capture: (Must effectively capture stones and stone fragments) | Conducted ("Comparative stone retention testing was conducted"); results explicitly state "demonstrate substantial equivalence." |
| Deflection Testing: (Must demonstrate appropriate flexibility and steerability) | Device met specifications; details not quantified in summary. |
| Biocompatibility (ISO 10993-1): (Must not cause adverse biological reactions) | "Testing performed per ISO 10993-1 confirms that the SpyGlass Discover Retrieval Basket is biocompatible for its intended use." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual bench tests. The document generically states "Testing includes:" and then lists the tests.
- Data Provenance: The testing was "Non-clinical performance bench testing and simulated use testing" performed by Boston Scientific Corporation. This is laboratory bench data, not human patient data. Therefore, questions of country of origin or retrospective/prospective do not apply in the context of human data studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as this document solely describes bench testing of a physical device. There is no concept of "ground truth" derived from expert interpretation in this context, nor human subject data requiring expert review.
4. Adjudication method for the test set:
- Not applicable, as there are no human interpretations or judgments to adjudicate in bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/software device, nor is it a diagnostic device that would involve human "readers" interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For bench testing of a physical device, "ground truth" refers to the engineering specifications and measurable physical properties of the device, assessed through specific testing methodologies (e.g., measuring dimensions, tensile strength, successful stone capture in a simulated environment). This is not equivalent to clinical ground truth from patient data.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or "ground truth" in the AI/ML sense.
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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 (<24 hours), and body contact: tissue). Testing performed per ISO 10993-1 confirms that the SpyGlass Discover Retrieval Basket is biocompatible for its intended use.
8. Conclusion
The information provided in this submission demonstrates that the proposed SpyGlass Discover Retrieval Basket is substantially equivalent to the Cook NCompass Nitinol Stone Extractor (K173009) in terms of performance, technological characteristics, and intended use.
§ 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.