The SpyGlass Discover Balloon Dilation Catheter is indicated for laparoscopic and open surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.

Device Description

The SpyGlass Discover Balloon Dilation Catheter is a sterile, single use device. The device is a double-lumen catheter manufactured with a nylon copolymer shaft. The distal tip of the catheter consists of a NyBax™ balloon and is available in diameters of 6, 7, and 8 millimeters, and a length of 40 millimeters. The SpyGlass Discover Balloon Dilation Catheter accepts a 0.035-inch diameter guidewire.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "SpyGlass Discover Balloon Dilation Catheter." This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria for an AI/algorithm-driven system. Therefore, most of the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for an AI/algorithm is not applicable or present in this document.

The document primarily focuses on bench testing to demonstrate the physical and mechanical characteristics of the catheter.

Here's a breakdown of what can be extracted from the text in relation to your request, and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document describes tests conducted and generally states "Test results indicated an acceptable..." for each. It does not provide specific quantitative acceptance criteria values or the quantitative reported performance values. The closest it comes to "criteria" are the "pre-defined performance specifications" mentioned vaguely for biocompatibility testing.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Acceptable balloon diameter at nominal pressure	Test results indicated an acceptable balloon diameter at nominal pressure.
Acceptable balloon compliance	Test results indicated an acceptable balloon compliance.
Acceptable balloon failure pressure and burst mode	Test results indicated an acceptable balloon burst pressure and burst mode.
Acceptable balloon stability after multiple inflations	Test results indicated an acceptable balloon stability.
Appropriate bond strength of proximal bond of balloon to catheter shaft	Test results indicated that the bond strength is appropriate.
Appropriate bond strength of the hub to catheter shaft	Test results indicated that the bond strength is appropriate.
Appropriate strength of the catheter shaft	Test results indicated that the catheter shaft strength is appropriate.
Appropriate bond strength of the distal balloon to the catheter shaft	Test results indicated that the bond strength is appropriate.
Appropriate bond strength of the distal tip to the catheter shaft	Test results indicated that the bond strength is appropriate.
Acceptable catheter shaft length	Test results indicated an acceptable catheter shaft length.
Acceptable catheter shaft outer diameter	Test results indicated an acceptable catheter shaft outer diameter.
Acceptable guidewire compatibility	Test results indicated an acceptable guidewire compatibility.
Acceptable introducer sheath compatibility	Test results indicated an acceptable introducer sheath compatibility.
Biocompatible for intended use	Biocompatibility testing demonstrates that the device is biocompatible for its intended use.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: Not specified. The document states "Non-clinical performance bench testing was completed," implying lab-based tests, but no number of samples tested for each criterion is given.
Data Provenance: Not applicable in the context of clinical data for a 510(k) for a physical device. These are bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth. The "ground truth" for these tests would be the measurement results against engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This concept is relevant for clinical studies with human assessors, not for bench testing of a physical device.

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 a physical medical device, not an AI/algorithm-driven system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable in the sense of clinical "ground truth." For bench testing, the "ground truth" is typically defined by engineering principles, industry standards, and the device's design specifications.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

9. How the ground truth for the training set was established:

Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (a balloon dilation catheter), not an AI/algorithm product. Therefore, most of the questions pertaining to acceptance criteria and studies for AI/algorithm performance are not addressed or are irrelevant to this specific submission. The "study that proves the device meets the acceptance criteria" in this context refers to a series of bench tests demonstrating the physical and mechanical performance of the catheter, and the "acceptance criteria" are implied engineering specifications that the device's performance must meet (e.g., "acceptable balloon diameter").

Summary

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May 6, 2022

Boston Scientific Corporation Laura (Kuroski) Meehan Principal Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, MA 01752

K212582 Re:

Trade/Device Name: SpyGlass Discover Balloon Dilation Cathether Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: GCA Dated: April 7, 2022 Received: April 8, 2022

Dear Laura (Kuroski) Meehan:

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. 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

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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-regulatory-information/postmarketing-safety-reportingcombination-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. 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) K212582

Device Name SpyGlass™ Discover Balloon Dilation Catheter

Indications for Use (Describe)

The SpyGlass Discover Balloon Dilation Catheter is indicated for laparoscopic and open surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.

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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K212582 Page 1 of 4

510(k) Summary for SpyGlass™ Discover Balloon Dilation Catheter

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Laura Meehan Principal Regulatory Affairs Specialist Telephone: 508-382-0442 E-Mail: Laura.Meehan@bsci.com

Date Prepared: April 7, 2022

2. Device:

Trade Name:	SpyGlass™ Discover Balloon Dilation Catheter Common
Name:	Biliary catheter for stone removal that may also allow forirrigation and contrast injection
Classification Name:	Biliary catheter and accessories
Product Code:	GCA
Device Class and Panel:	Class II, Gastroenterology/Urology
Classification Number:	21 CFR §876.5010

3. Predicate Device:

Trade Name:	Advance Biliary Balloon Catheter
Manufacturer:	Cook Incorporated
Clearance Number:	K173414
Common Name:	Biliary catheter for stone removal that may also allow forirrigation and contrast injection
Classification Name:	Biliary catheter and accessories
Product Code:	GCA
Device Class and Panel:	Class II, Gastroenterology/Urology
Classification Number:	21 CFR §876.5010

4. Device Description

5. Indications for Use:

The SpyGlass Discover Balloon Dilation Catheter is indicated for laparoscopic and open surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.

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	Device Characteristic	Predicate DeviceCook Incorporated AdvanceBiliary Balloon Catheter(K173414)	Proposed DeviceBoston Scientific CorporationSpyGlass Discover BalloonDilation Catheter(K212582)
	Classification Number	21 CFR §876.5010	Identical to Predicate
	Product Code	GCA	Identical to Predicate
	Classification	II	Identical to Predicate
	Indications for Use	The Advance Biliary BalloonCatheter is indicated forlaparoscopic and generalsurgical procedures for thedilation of the cystic duct tofacilitate common bile ductexploration.	The SpyGlass Discover BalloonDilation Catheter is indicated forlaparoscopic and open surgicalprocedures for the dilation of thecystic duct to facilitate commonbile duct exploration.
	Single Use	Yes	Identical to Predicate
	Duration of Use	Limited (≤ 24 hours)	Identical to Predicate
	Imaging Technique toVisualize Device	Fluoroscopy, LaparoscopicImaging	Identical to Predicate
	Principles of Operation	Balloon inflation to open orwiden biliary lumen	Identical to Predicate
	Delivery System	Over-the-wire	Identical to Predicate
Balloon of Catheter	Inflated OuterDiameter (mm)	6, 8	6, 7, 8
	NominalPressure	PTA 6 mm - 10 atmPTA 8 mm - 8 atmATB 8 mm - 5 atm	6 mm - 10 atm7 mm - 10 atm8 mm - 10 atm
	Rated BurstPressure	PTA 6 mm - 15 atmPTA 8 mm - 11 atmATB 8 mm - 15 atm	6 mm - 15 atm7 mm - 15 atm8 mm - 15 atm
	Length (mm)	40	Identical to Predicate
	Material	Nylon	NyBaxTM
Shaft of Catheter	Outer Diameter(Fr)	5	5.3
	Length (cm)	40, 80	40
	Material	Nylon copolymer	Identical to Predicate
	Marker Bands	Yes	Identical to Predicate
	Number ofLumens	2	Identical to Predicate
	GuidewireCompatibility (in)	0.035	Identical to Predicate
	Introducer SheathCompatibility (Fr)	6	6 - 12
	Sterilization Method	Ethylene Oxide	Identical to Predicate

6. Proposed Device and Predicate Device Technological Characteristics

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The SpyGlass Discover Balloon Dilation Catheter is substantially equivalent to the Cook Incorporated Advance Biliary Balloon Catheter in terms of technological characteristics. The proposed device and the predicate device have the same principal of operation and fundamental duallumen balloon dilation catheter design. The differences in balloon materials, shaft outer diameter, and introducer sheath compatibility do not raise different questions of safety or effectiveness because:

. Balloon materials - Biocompatibility testing for the proposed device demonstrates that the device is biocompatible for its intended use and bench testing demonstrates that the material used allows the device to meet all pre-defined performance specifications.
. Shaft outer diameter - Both the proposed device and the predicate device are designed to be compatibility with a minimum 6Fr sheath.
. Introducer Sheath Compatibility - Bench testing demonstrates that the proposed device is compatible with an introducer sheath size from 6 Fr to 12 Fr.

7. Performance Data

Non-clinical performance bench testing was completed to evaluate the design of the SpyGlass Discover Balloon Dilation Catheter for its intended use. Testing includes:

. Balloon Diameter at Nominal Pressure – testing was conducted to evaluate the balloon diameter at nominal pressure of the subject device. Test results indicated an acceptable balloon diameter at nominal pressure.
Balloon Compliance - testing was conducted to evaluate the balloon compliance of the subject device. Test results indicated an acceptable balloon compliance.
Rated Burst Pressure / Burst Mode - testing was conducted to evaluate the balloon failure pressure and burst mode of the subject device. Test results indicated an acceptable balloon burst pressure and burst mode.
Balloon Multiple Inflation - testing was conducted to evaluate the balloon stability after multiple inflations of the subject device. Test results indicated an acceptable balloonstability.
. Proximal Balloon Bond Tensile Strength - testing was conducted to ensure the appropriate bond strength of the proximal bond of balloon to catheter shaft. Test results indicated that the bond strength is appropriate.
Manifold Bond Tensile Strength - testing was conducted to ensure the appropriate bond strength of the hub to catheter shaft. Test results indicated that the bond strength is appropriate.
Catheter Shaft Tensile Strength - testing was conducted to ensure the appropriate strength of the catheter shaft. Test results indicated that the catheter shaft strength is appropriate.

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Distal Balloon Bond Tensile Strength - testing was conducted to ensure the appropriate bond strength of the distal balloon to the catheter shaft. Test results indicated that the bond strength is appropriate.
Distal Tip Bond Tensile Strength testing was conducted testing to ensure the appropriate . bond strength of the distal tip to the catheter shaft. Test results indicated that the bond strength is appropriate.
Catheter Shaft Length - testing was conducted to evaluate the catheter shaft length of the subject device. Test results indicated an acceptable catheter shaft length.
. Catheter Shaft Outer Diameter – testing was conducted to evaluate the catheter shaft outer diameter of the subject device. Test results indicated an acceptable catheter shaft outer diameter.
Guidewire Compatibility - testing was conducted to evaluate the guidewire compatibility of the subject device. Test results indicated an acceptable guidewire compatibility.
. Initial Sheath Insertion and Withdrawal Force – testing was conducted to evaluate the introducer sheath compatibility of the subject device. Test results indicated an acceptable introducer sheath compatibility.

8. Conclusion

The information provided in this submission demonstrates that the proposed SpyGlass Discover Balloon Dilation Catheter is substantially equivalent to the Cook Incorporated Advance Biliary Balloon Catheter (K173414) in terms of performance, technological characteristics, and intended use.

Regulation Number and Section

§ 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.