(13 days)
No
The summary describes a fiberoptic endoscope for direct visualization and does not mention any AI or ML capabilities, image processing, or data analysis beyond basic optical performance comparison.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended for "diagnostic and therapeutic applications."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications".
No
The device description explicitly states it is a "fiberoptic endoscope" and is used with a "delivery catheter/probe," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system". This describes a device used in vivo (within the body) for direct observation.
- Device Description: The device is described as a "fiberoptic endoscope" used through a catheter inserted into a duodenoscope. This is a classic description of an endoscopic device used for internal examination.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to diagnose conditions. The provided information does not mention any analysis of specimens or use outside the body.
Therefore, the SpyGlass Direct Visualization Probe is an endoscopic device used for direct visualization within the body, not an IVD.
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
KOG
Device Description
The proposed SpyGlass Direct Visualization Probe a fiberoptic endoscope. The proposed device is used through the SpyScope Access and Delivery Catheter (K051504) which provides stability for steering the device. The delivery catheter/probe is inserted into the working channel of a duodenoscope for entry into the duodenum for access to the indicated site.
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 SpyGlass™ Direct Visualization Probe. Electrical safety testing was performed in accordance with industry standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Boston
Scientific
K052194 pg. 1 of 2
AUG 2 4 2005
Endoscopy SECTION 11 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Contact: Allyson Barford Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: (508) 683-4356 Fax: (508) 683-5939 Date Prepared: July 8, 2005
2. Device:
Trade Name: SpyGlass™ Direct Visualization Probe Common Name: Mini-Endoscope Classification Name: Flexible Endoscope
3. Predicate Devices:
Boston Scientific. SpyGlass Direct Visualization Probe - K050403
4. Device Description:
The proposed SpyGlass Direct Visualization Probe a fiberoptic endoscope. The proposed device is used through the SpyScope Access and Delivery Catheter (K051504) which provides stability for steering the device. The delivery catheter/probe is inserted into the working channel of a duodenoscope for entry into the duodenum for access to the indicated site.
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 pancreatico-biliary system including the hepatic ducts.
6. Technological Characteristics:
The SpyGlass Direct Visualization Probe is a modification to the predicate device and has the same technological characteristics as the predicate device. The proposed device and predicate device are fiberoptic mini-scopes used in conjunction with a mother scope to access and visualize an indicated location.
1
052194 pg. 2 of 2
7. Performance Data:
A comparison of the optical performance and image quality specifications was made between the proposed and predicate SpyGlass™ Direct Visualization Probe. Electrical safety testing was performed in accordance with industry standards.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed SpyGlass Direct Visualization Probe is substantially equivalent to the predicate SpyGlass Direct Visualization Probe.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a row, with each one slightly overlapping the previous one. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles.
AUG 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Mr. Daniel W. Lehtonen Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K052194
K052194
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: August 10, 2005 Received: August 11, 2005
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(a) peace is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreatives of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, ue necs that have been receire approval of a premarket approval application (PMA). allu Cosmeter Act (1 tel) that to neview, subject to the general controls provisions of the Act. The I ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oour of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oe advisou that I Dri bream that your device complies with other requirements of the Act that I DA has made a sond regulations administered by other Federal agencies. You must of any I odelui statutes and states and the because to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It in the quality systems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty byesells (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Mr. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you'ts begin maing of substantial equivalence of your device to a legally prematice noticated. The PDF intelligention 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 If you desire specific acrisously at (240) 276-0115. Also, please note the regulation entitled, Comaon the Office of Count of County of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
eubais Bachell
Mark N. Melkerson Acting 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
K052194 P
510(k) Number:
To Be Determined
SpyGlass™ Direct Visualization Probe Device Name:
Indication for Use:
The proposed SpyGlass Direct Visualization Probe is intended to provide direct The proposed Spy Grass Direct Tisameutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
Prescription Use ど (Per 21 CFR 801.1091) (Optional Format 1-2-96) Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Janbare bus for MYM
(Division Sign-Division of General, Restorative, and Neurological Devices
OR
000007
510(k) Number K052194