(181 days)
No reference devices were used in this submission.
No
The document mentions "image post processing algorithm" and "digital post processing image enhancement technology" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe training or test sets which are typical for AI/ML models. The description of the image processing is focused on local contrast enhancement and modification of RGB components, which are standard digital image processing techniques, not necessarily indicative of AI/ML.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the system "provides access for therapeutic interventions using standard endoscopy tools." Additionally, the "Device Description" reiterates that the system is "indicated for diagnostic visualization and therapeutic intervention of the digestive tract."
Yes
The "Intended Use / Indications for Use" section explicitly states that both the "Fuse Colonoscopy System" and the "Fuse 1G Gastroscopy System" are "intended for diagnostic visualization of the digestive tract." This directly indicates its diagnostic purpose.
No
The device description explicitly states that the system includes hardware components such as camera heads, endoscopes, video system, light source, and the FuseBox processor, which is responsible for hardware functions like pneumatic control in addition to image processing. While it includes software for image processing, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Fuse Colonoscopy and Gastroscopy Systems are designed for diagnostic visualization of the digestive tract using endoscopy. They involve inserting a device into the body to directly view internal structures.
- Lack of Sample Analysis: The system does not analyze samples taken from the body. It processes and enhances images captured within the body.
- Intended Use: The intended use is for "diagnostic visualization" and "therapeutic interventions," not for analyzing biological samples for diagnostic purposes.
- Device Description: The description focuses on image processing, video signals, and pneumatic control, all related to the endoscopic procedure itself, not laboratory analysis of samples.
While the system is used for diagnostic purposes (helping physicians visualize and identify potential issues), it does so through direct observation and imaging, not through in vitro testing of biological samples.
N/A
Intended Use / Indications for Use
Fuse Colonoscopy System
The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing inage enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
Fuse 1G Gastroscopy System
The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
PEA, FDF, FDS
Device Description
The Fuse Endoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the digestive tract. The system labeled for healthcare facilities/hospitals enables physicians to view a high-resolution wide field of view. The FuseBox is responsible for image processing, transferring video signals from the endoscope, pneumatic control, and outputting high definition (HD 1080p) video signal. The current FuseBox version, unlike the version used with the two predicate devices, includes image post processing algorithm as an adjunct tool to white light visualization.
The feature provides real-time enhancement and will be used as an adjunctive tool. to supplement the white light endoscopic examination. The new feature may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest when present.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve), upper digestive tract (including the esophagus, stomach and duodenum)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
healthcare facilities/hospitals
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)
The following testing has been performed to demonstrate that the design outputs of the modified version meet the design input requirements. The tests were performed within EndoChoice's laboratory or by accredited third parties.
In house Bench tests functional/software testing:
- . Image quality testing (spatial resolution, field of view, depth of field, uniformity, geometric distortion, noise properties and color performance)
- Clinical Survey on videos with the Lumos compared to white light .
All test results demonstrated that the device is safe and effective in comparison with the predicate device.
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.
No reference devices were used in this submission.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2016
EndoChoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta. GA 30009
Re: K160275
Trade/Device Name: Fuse® Endoscopy System with FuseBox® Processor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Codes: PEA, FDF, FDS Dated: June 30, 2016 Received: July 1, 2016
Dear Mr. Hoefer:
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. 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160275
Device Name
Fuse® Endoscopy System with FuseBox® Processor
Indications for Use (Describe) Fuse Colonoscopy System
The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing inage enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
Fuse 1G Gastroscopy System
The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for EndoChoice. The logo consists of a green and blue swirl on the left, followed by the word "ENDOChoice" in blue and green. The first four letters, "ENDO", are in blue, while the rest of the word, "Choice", is in green.
This traditional 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92
510K Summary - K160275
I. Applicant information:
EndoChoice Inc. 11810 Wills Road Alpharetta, GA 30009 Establishment Registration: 3007591333
| Contact Person: | Daniel Hoefer, EndoChoice Inc. USA |
|---|---|
| Phone: | 678-708-4743 |
| Fax: | 678-878-3373 |
| E-mail: | daniel.hoefer@endochoice.com |
| Date Prepared: | July 29, 2016 |
II. Device information:
| Trade Name: | Fuse® Endoscopy System with FuseBox® Processor |
|---|---|
| Common Name: | Endoscope and accessories, flexible/rigid |
| Classification: | Class II per 21 CFR 876.1500 |
| Product Code: |
| Classification Name | CFR
Section | Product
Codes |
|---------------------------------------------------------------------------|--------------------|------------------|
| Endoscope, accessories, image
post processing for color
enhancement | 21 CFR
876.1500 | PEA |
| Colonoscope And Accessories,
Flexible/Rigid | | FDF |
| Gastroscope And Accessories,
Flexible/Rigid | | FDS |
III. Predicate Device:
Fuse Gastroscopy System K152182 (EndoChoice Inc.) Fuse Colonoscopy System K141598 (EndoChoice Inc.)
No reference devices were used in this submission.
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IV. Device Description:
The Fuse Endoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the digestive tract. The system labeled for healthcare facilities/hospitals enables physicians to view a high-resolution wide field of view. The FuseBox is responsible for image processing, transferring video signals from the endoscope, pneumatic control, and outputting high definition (HD 1080p) video signal. The current FuseBox version, unlike the version used with the two predicate devices, includes image post processing algorithm as an adjunct tool to white light visualization.
The feature provides real-time enhancement and will be used as an adjunctive tool. to supplement the white light endoscopic examination. The new feature may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest when present.
V. Indication for Use:
Fuse Colonoscopy System
The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
Fuse 1G Gastroscopy System
The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
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Comparison of Characteristics and intended use VI.
| Table | 5 | .1 |
|---|---|---|
| Category | Predicate:
Fuse Colonoscopy System
K141598 (EndoChoice Inc.) | Predicate:
Fuse Gastroscopy System
K152182 (EndoChoice Inc.) | Proposed device:
Fuse System with
FuseBox Processor |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Characteristics | | | |
| Intended use | Diagnostic visualization of the
digestive tract. The system
also provides access for
therapeutic interventions using
standard endoscopy tools. The
system consists of EndoChoice
camera heads, endoscopes,
video system, light source and
other ancillary equipment. | Diagnostic visualization of the
digestive tract. The system
also provides access for
therapeutic interventions using
standard endoscopy tools. The
system consists of
EndoChoice camera heads,
endoscopes, video system,
light source and other
ancillary equipment. | Same as predicates |
| Mode of Operation | The Processor relays the image
from the endoscope to a video
monitor | The Processor relays the
image from the endoscope to a
video monitor | Same as predicates |
| User Interface | Manual and GUI | Manual and GUI | Same as predicates |
| Field of View | 300° horizontal
330° diagonal | 210° horizontal
245° diagonal | Same as predicates
(combined) |
| Depth of Field [mm] | 3-100 | 3-100 | Same as predicates |
| FuseBox Characteristics | | | |
| Digital Output (Display) | 3 channels DVI | 3 channels DVI | Same as predicates |
| Analog Video Output
(Image Management
System) | 3 X S Video | 3 X S Video | Same as predicates |
| Imaging algorithm for
enhancement feature | None | None | *Lumos Adaptive Matrix
ImagingTM |
| Enhancement mechanism | None | None | Image processing of local
contrast enhancement of
intensity and tone
resulting in modification
of the combination of
RGB components for
each pixel.
Fuse system enhancement
mechanism allows
retaining the neutral color
of the tissue for human
observer. |
| Number of enhancement | None | None | 2 graduating enhancement |
| Category | Predicate:
Fuse Colonoscopy System
K141598 (EndoChoice Inc.) | Predicate:
Fuse Gastroscopy System
K152182 (EndoChoice Inc.) | Proposed device:
Fuse System with
FuseBox Processor |
| levels | | | modes for each intended
use:
Low gastro, high gastro
Low colono, high colono |
| Adjustable image settings
(GUI) | Red, blue, Brightness | Red, blue, Brightness,
Sharpness (default level only) | **Adjustable sharpness
levels added |
| LED Intensity control | Yes | Yes | Same as predicates |
| Zoom | Yes | Yes | Same as predicates |
| Freeze/Release | Yes | Yes | Same as predicates |
| Flash Mode | Yes | Yes | Same as predicates |
| Control signals | White balance
A/W pump control
LED control | White balance
A/W pump control
LED control | Same as predicates |
| Illumination | Integral LED illumination | Integral LED illumination | Same as predicates |
| CCD type | Color | Color | Same as predicates |
| Electrical class | Class I , Type BF | Class I , Type BF | Same as predicates |
| Umbilical cord | 90 degree orientation available | 90 degree orientation available | Same as predicates |
| Locking lever | Yes | Yes | Same as predicates |
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*The main difference is the addition of Lumos Adaptive Matrix Imaging) feature. The feature is used as an adjunct to the white light image for visualization of the digestive tract.
** Addition of manually adjustable sharpness levels in order to support user preference, the low level is similar to default sharpness level of predicate K152182
VII. Performance testing:
The following testing has been performed to demonstrate that the design outputs of the modified version meet the design input requirements. The tests were performed within EndoChoice's laboratory or by accredited third parties.
In house Bench tests functional/software testing:
- . Image quality testing (spatial resolution, field of view, depth of field, uniformity, geometric distortion, noise properties and color performance)
- Clinical Survey on videos with the Lumos compared to white light .
All test results demonstrated that the device is safe and effective in comparison with the predicate device.
Substantial Equivalence:
The data presented above demonstrate that:
The Fuse Endoscopy System with FuseBox Processor and the predicate devices, have a.
7
the same intended use.
- The Fuse Endoscopy System with FuseBox Processor and the predicate devices have b. similar indications, the Lumos Adaptive Matrix Imaging feature is an addition to the indication for use
- Fuse Endoscopy System with FuseBox Processor and the predicate devices have C. similar technological characteristics
- The Fuse Endoscopy System with FuseBox Processor and the predicate devices have d. same performance characteristics of white light. The Lumos Adaptive Matrix Imaging) provides an additional feature adjunct to white light endoscopy.
VIII. Conclusion:
Based on the results of verification, validation, and performance testing, the impact of the above differences is insignificant in terms of the device safety and effectiveness for the device's intended use. The modified device performs as well as intended in all testing performed. It is the opinion of EndoChoice Inc., that the modified version of the Fuse Endoscopy System is substantially equivalent to the predicate devices in terms of safety and effectiveness.