SpyGlass Discover Balloon Dilation Catheter
Device Facts
| Record ID | K212582 |
|---|---|
| Device Name | SpyGlass Discover Balloon Dilation Catheter |
| Applicant | Boston Scientific Corporation |
| Product Code | GCA · Gastroenterology, Urology |
| Decision Date | May 6, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Sterile, single-use, double-lumen balloon dilation catheter; used in laparoscopic or open surgical procedures. Device features NyBax balloon at distal tip; available in 6, 7, 8 mm diameters; 40 mm length. Operates via over-the-wire delivery system; physician inflates balloon to dilate cystic duct; facilitates common bile duct exploration. Visualized via fluoroscopy or laparoscopic imaging. Benefits patient by enabling access to bile duct for exploration during surgery.
Clinical Evidence
Bench testing only. Evaluated balloon diameter at nominal pressure, compliance, rated burst pressure, multiple inflation stability, bond tensile strengths (proximal, manifold, distal, tip), shaft dimensions, guidewire compatibility, and sheath insertion/withdrawal forces. All tests met pre-defined acceptance criteria.
Technological Characteristics
Double-lumen catheter; nylon copolymer shaft; NyBax balloon material. Dimensions: 6, 7, 8 mm diameter; 40 mm length. Compatible with 0.035-inch guidewire and 6-12 Fr introducer sheaths. Sterilized via Ethylene Oxide. Mechanical dilation principle.
Indications for Use
Indicated for patients undergoing laparoscopic or open surgical procedures requiring dilation of the cystic duct to facilitate common bile duct exploration.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Advance Biliary Balloon Catheter (K173414)
Submission Summary (Full Text)
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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 for<br>irrigation 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 for<br>irrigation 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
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.
## 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 Device<br>Cook Incorporated Advance<br>Biliary Balloon Catheter<br>(K173414) | Proposed Device<br>Boston Scientific Corporation<br>SpyGlass Discover Balloon<br>Dilation Catheter<br>(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 Balloon<br>Catheter is indicated for<br>laparoscopic and general<br>surgical procedures for the<br>dilation of the cystic duct to<br>facilitate common bile duct<br>exploration. | The SpyGlass Discover Balloon<br>Dilation Catheter is indicated for<br>laparoscopic and open surgical<br>procedures for the dilation of the<br>cystic duct to facilitate common<br>bile duct exploration. |
| | Single Use | Yes | Identical to Predicate |
| | Duration of Use | Limited (≤ 24 hours) | Identical to Predicate |
| | Imaging Technique to<br>Visualize Device | Fluoroscopy, Laparoscopic<br>Imaging | Identical to Predicate |
| | Principles of Operation | Balloon inflation to open or<br>widen biliary lumen | Identical to Predicate |
| | Delivery System | Over-the-wire | Identical to Predicate |
| Balloon of Catheter | Inflated Outer<br>Diameter (mm) | 6, 8 | 6, 7, 8 |
| | Nominal<br>Pressure | PTA 6 mm - 10 atm<br>PTA 8 mm - 8 atm<br>ATB 8 mm - 5 atm | 6 mm - 10 atm<br>7 mm - 10 atm<br>8 mm - 10 atm |
| | Rated Burst<br>Pressure | PTA 6 mm - 15 atm<br>PTA 8 mm - 11 atm<br>ATB 8 mm - 15 atm | 6 mm - 15 atm<br>7 mm - 15 atm<br>8 mm - 15 atm |
| | Length (mm) | 40 | Identical to Predicate |
| | Material | Nylon | NyBaxTM |
| Shaft of Catheter | Outer Diameter<br>(Fr) | 5 | 5.3 |
| | Length (cm) | 40, 80 | 40 |
| | Material | Nylon copolymer | Identical to Predicate |
| | Marker Bands | Yes | Identical to Predicate |
| | Number of<br>Lumens | 2 | Identical to Predicate |
| | Guidewire<br>Compatibility (in) | 0.035 | Identical to Predicate |
| | Introducer Sheath<br>Compatibility (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.
