(15 days)
Not Found
No
The device description and performance studies focus on fiberoptic technology and optical performance, with no mention of AI, ML, or image processing beyond basic visualization.
No
The device is described as providing "direct visualization for diagnostic and therapeutic applications," but the description of the device itself and its function focuses on visualization, not on active therapeutic intervention. The performance studies also relate to optical performance and image quality.
Yes
The device's "Intended Use / Indications for Use" explicitly states it is "intended to provide direct visualization for diagnostic and therapeutic applications".
No
The device description clearly states it is a fiberoptic endoscope with physical components like a lens, adapter, and connections for an ocular lens and light source, indicating it is a hardware device.
Based on the provided information, the SpyGlass™ Direct Visualization Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system". This describes a device used in vivo (within the body) for direct observation and potentially guiding therapeutic interventions.
- Device Description: The description details a fiberoptic endoscope used for visualization within the body. It doesn't mention any components or processes related to analyzing samples of human origin in vitro (outside the body).
- Lack of IVD Characteristics: IVD devices typically involve the examination of biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status. The SpyGlass probe is used for direct visual inspection of internal anatomy.
Therefore, the SpyGlass™ Direct Visualization Probe is a medical device used for visualization during endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization 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
Device Description
The proposed SpyGlass™ Direct Visualization Probe a fiberoptic endoscope. There is a glass fens at the distal end of the probe, and an adapter at the proximal end. The adapter has a bayonet fitting and a light post. An ocular lens connects to the bayonet fitting and the light post provides a connection for a light source. The proposed device is used with an ERCP cannula that provides stability for steering the device. The canula/probe is inserted into the working channel of a duodenoscope for entry into the duodenum and access to the pancreatico-biliary system.
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)
A comparison of the optical performance and image quality specifications was made between the proposed and predicate Visicath Imaging Catheter. Electrical safety testing was performed in accordance with industry standards.
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.
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
KOSd403
MAR 4 - 2005
SECTION 11 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation One Boston Scientific Place Natick. MA 01760-1537
Contact: Kathleen Morahan Regulatory Affairs Manager Date Prepared: January 7, 2005
2. Device:
Trade Name: SpyGlass™ Direct Visualization Probe Common Name: Mini-Endoscope Classification Name: Flexible Endoscope
3. Predicate Devices:
Boston Scientific, Visicath Imaging Catheter - K850393 5 Star Medical, Saratoga Modular Miniature Endoscope - K963354
4. Device Description:
The proposed SpyGlass™ Direct Visualization Probe a fiberoptic endoscope. There is a glass fens at the distal end of the probe, and an adapter at the proximal end. The adapter has a bayonet fitting and a light post. An ocular lens connects to the bayonet fitting and the light post provides a connection for a light source. The proposed device is used with an ERCP cannula that provides stability for steering the device. The canula/probe is inserted into the working channel of a duodenoscope for entry into the duodenum and access to the pancreatico-biliary system.
5. Intended Use:
The proposed SpyGlass™ Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
6. Technological Characteristics:
Essentially. the SpyGlass™ Direct Visualization Probe has the same technological characteristics as the predicate devices. The proposed device and both predicate devices are fiberoptic miniscopes used in conjunction with a mother scope to access and visualize an indicated location.
1
7. Performance Data:
A comparison of the optical performance and image quality specifications was made between the proposed and predicate Visicath Imaging Catheter. Electrical safety testing was performed in accordance with industry standards.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed SpyGlass™ Direct 170ston Scientifie Corporation to the Boston Scientific Visicath Imaging Catheter and in terms of the proposed indication, to the 5 Star Medical Saratoga Modular Miniature Endoscope.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle or bird with three stylized wings or feathers.
Public Health Service
MAR 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Mr. Daniel W. Lehtonen Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779
Re: K050403
K050405
Trade/Device Name: SpyGlass Direct Visualization Probe Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: February 15, 2005 Received: February 17, 2005
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premaince is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivale referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed prodicate device Amendments for use stated in the enclosure) to legally manced provice Amendical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Eederal Food. Drug commerce prior to May 28, 1970, the chacanent with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with spersonal application (PMA devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval assured assuredicoss of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The Act. The
You may, therefore, market the device, subject to the generation, li You may, therefore, market the device, subject or the general morements for annual registration, listing of general controls provisions of the rectments.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into ether class II (Special Controls) or class III (PMA), it If your device is classified (See above) mito caso i percentations affecting your device can
may be subject to such additional controls. Existing may on 808 - In addition F may be subject to such additional controls. Extrong may --------------------------------------------------------------------------------------------------------------------be found in the Code on Pederal Regarations, our device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decermination that your accred by other Federal agencies. You must on or any Federal statutes and regulations administered or registration and listing (21
comply with all the Act's requirements, including, but not is set comply with an the Act s requirements, n.c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CFR Part 807), labeling (21 CFR Part 801), good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 (1050 forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
3
Page 2 - Mr. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k)
Children and contraction TRA to for lies of unstance of your device to a legally This letter will allow you to begin marketing your device of your device of your device of your device to a legally
premarket notification. The FDA inding of substantial cap premarket notification. The FDA Inding of substantial equive 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 If you desire specific advice for your device on our nasemato the regulation cuitiled,
contact the Office of Compliance at (240) 276-0115. Also, please note 207-07. You ma contact the Office of Compliance at (240) 270 - 19. 13. FR Part 807.97). You nay obtain
"Misbranding by reference to premarket notification of Single of Small "Misbranding by reference to premiers nonitication " (270) At then the Division of Small
other general information on your responsibilities under the Act from the Division of other general information on your responsibility of the envires mumber (800) 638-2041 or 1988)
Manufacturers, International and Consumer Assistance at iss toll-free/support/i Manufacturers, International and Consumer Assistance at les con Products/Jsupport/index.html.
Sincerely yours,
Mark A. Millbern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 INDICATIONS FOR USE
510(k) Number:
To Be Determined
KUFO403
SpyGlass Direct Visualization Probe Device Name:
Indication for Use:
The proposed SpyGlass Direct Visualization Probe is intended to provide direct I he proposed Dpy Stato Direct + sexapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
Prescription Use X (Per 21 CFR 801.1091) (Optional Format 1-2-96) OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (
vision of General, Restorative
& Neurological Devices
050403
Premarket Notification, SpyGlass™ Direct Visualization Probe, January 7, 2005 Proprietary and Confidential Information of Boston Scientific Corporation
000010