(12 days)
Not Found
No
The description focuses on the mechanical function of the catheter for guiding optical and accessory devices, with no mention of AI/ML capabilities or image processing beyond basic visualization.
No
The device is described as an "Access and Delivery Catheter" intended to guide other devices for diagnostic and therapeutic applications. Its primary function is to facilitate access and delivery of other tools, rather than directly providing a therapeutic effect itself. While it enables therapeutic procedures, it is not a therapeutic device in its own right.
Yes
The "Intended Use / Indications for Use" section states: "The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications..."
No
The device description clearly states it is a physical catheter with a handle, designed to guide other physical devices. It is a hardware medical device.
Based on the provided information, the SpyScope Access and Delivery Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes guiding devices for diagnostic and therapeutic applications during endoscopic procedures within the body. This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is used to deliver visualization and accessory devices into the body through an endoscope.
- No mention of analyzing samples: IVD devices typically involve analyzing biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information. This device facilitates visualization and intervention within the body.
Therefore, the SpyScope Access and Delivery Catheter is an endoscopic accessory device used for in vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
Product codes (comma separated list FDA assigned to the subject device)
KOG, ODF
Device Description
The SpyScope Access and Delivery Catheter is a sterile, single-use device comprised of two main components: a flexible delivery catheter and a handle. The device is designed to guide the SpyGlass Direct Visualization Probe or other visualization devices and accessory devices. (such as biopsy forceps, cytology brushes, stone retrieval baskets, etc.) during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The SpyScope Access and Delivery Catheter is introduced to the desired anatomical location through a duodenoscope with a minimum working channel diameter of 4.2mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pancreatico-biliary system including the hepatic ducts
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)
As this is a request for an expanded indication and introduces no new materials or design changes, performance testing was not repeated to support this submission. Comparison to predicate devices will be used in support of the proposed indication.
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.
K051504, K990130, K011149, K052194, K051886
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
FEB - 4 2009 0 90170
SECTION 6 510(k) SUMMARY
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4359 Fax: 508-683-5939
Contact: Ashley Pyle Regulatory Affairs Specialist Date Prepared: December 9, 2008
2. Device
Trade Name: SpyScope Access and Delivery Catheter Common Name: Catheter Classification Name: Endoscope and Accessories Regulation Number: 876.1500 Product Code: KOG Classification: Class II
3. Predicate Devices
SpyScope Access and Delivery Catheter, K051504 Wilson-Cook Pancreatic Wedge Stents, K990130 Olympus (SwingTip) Disposable Bending Cannula PR-233Q, K011149 SpyGlass Direct Visualization Probe, K052194 Olympus XCHF-BP160F Choledochoscope, K051886
4. Device Description
The SpyScope Access and Delivery Catheter is a sterile, single-use device comprised of two main components: a flexible delivery catheter and a handle. The device is designed to guide the SpyGlass Direct Visualization Probe or other visualization devices and accessory devices. (such as biopsy forceps, cytology brushes, stone retrieval baskets, etc.) during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The SpyScope Access and Delivery Catheter is introduced to the desired anatomical location through a duodenoscope with a minimum working channel diameter of 4.2mm.
Premarket Notification, SpyScope™ Access and Delivery Catheter Proprietary and Confidential Information of Boston Scientific Corporation
1
K 090/70
pg 282
FEB - 4 2009
5. Indication for Use:
The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
6. Technological Characteristics:
The proposed SpyScope Access and Delivery Catheter has identical technological characteristics (materials, construction, and manufacturing processes) as the currently marketed SpyScope Access and Delivery Catheter.
7. Performance Data:
As this is a request for an expanded indication and introduces no new materials or design changes, performance testing was not repeated to support this submission. Comparison to predicate devices will be used in support of the proposed indication.
8. Conclusion:
Boston Scientific has demonstrated that the proposed SpyScope Access and Delivery Catheter is substantially equivalent to the design of Boston Scientific Corporation's currently marketed SpyScope Access and Delivery Catheter. Boston Scientific is demonstrating substantial equivalence to the proposed anatomical location by comparing the proposed device to BSC SpyGlass Direct Visualization Probe, Wilson Cook's Pancreatic Wedge Stent, the Olymous XCHF-BP160F Choledochoscope, and the Olympus (SwingTip) Disposable Bending Cannula PR-233Q.
Premarket Notification, SpyScope™ Access and Delivery Catheter Proprietary and Confidential Information of Boston Scientific Corporation
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
FEB - 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation % Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Auora Road, Unit B7 TWINSBURG OH 44087
Re: K090170
Trade/Device Name: SpyScope Access and Delivery Catheter Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODF Dated: January 22, 2009 Received: January 23, 2009
Dear Mr. Kogoma:
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 (PMA), 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.
3
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 os 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.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 5 INDICATIONS FOR USE STATEMENT
Indications for Use:
510(k) Number (if known): To Be Determined Kogo170
Device Name: SpyScope Access and Delivery Catheter
Indications for Use:
The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic proceduras in the pancreatico-biliary system including the hepatic ducts.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Part D) |
live
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE, IF NEEDED)
oncurrence of CDRH, Office of Device Evaluation (ODE)
Premarket Notification, SpyScope™ Access and Delivery Catheter (Division Sign-Off) Division of Reproductive, Abdominianprietary and Confidential Information of Boston Scientific Corporation and Radiological Devices
Radiological Devices
510(k) Number K090170