(104 days)
Not Found
No
The description focuses on electro-mechanical control and software for creating an anatomical map and interpreting sensor data, without mentioning AI or ML algorithms for image analysis, decision support, or automated control.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device provides "therapeutic access to the adult lower gastrointestinal tract" and is used for "endoscopic surgery." The "Device Description" also mentions "A standard tool channel is incorporated for therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended to "provide visualization and diagnostic / therapeutic access."
No
The device description clearly outlines significant hardware components including a colonoscope with a CCD camera, fiber optic illumination, a tool channel, valves, and fifteen active electro-mechanically controlled segments. While software is mentioned as being required to interpret, monitor, and control these segments, the device is fundamentally a hardware system with integrated software control, not a software-only medical device.
Based on the provided information, the NeoGuide Endoscopy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- NeoGuide System Function: The NeoGuide Endoscopy System is described as a device for visualization and diagnostic/therapeutic access to the lower gastrointestinal tract. It uses a camera to provide images directly from inside the body and allows for therapeutic procedures. It does not process or analyze specimens taken from the body.
The system's function is to provide direct visual information and a means for intervention within the patient's body, which falls under the category of an in vivo (within the living body) device, not an in vitro (in glass/outside the living body) diagnostic device.
N/A
Intended Use / Indications for Use
The NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
Product codes
FDF
Device Description
The NeoGuide Endoscopy System has many features in common with currently marketed colonoscopes. The colonoscope is manually inserted and withdrawn by the physicial, who manually steers and controls it using up/down and left/right steering control knobs on a handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination. A standard tool channel is incorporated for therapeutic procedures, as well as valves to control insuflation air, water irrigation, and suction.
The NeoGuide Colonoscope differs from currently marketed colonoscopes in that it incorporates fifteen active electro-mechanically controlled segments designed to allow the shape of the insertion tube to conform to the path defined by the physician as the colonoscope tip is manually steered through the colon lumen. The active segments are similar to conventional colonoscope steerable tips, as they each employ four control cables to articulate in the up/down and left/right directions. In order to determine the path selected by the physician during a procedure, the NeoGuide endoscopy system incorporates transducers that measure the angle of articulation of the steerable tip and the depth of insertion of the colonoscope into the patient. Software is required to create an anatomical map and interpret, monitor, and control the insertion tube segments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve)
Indicated Patient Age Range
adult
Intended User / Care Setting
physicial
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)
in vitro bench, in vivo animal and clinical study
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001241, K961563, K032688, K033954
Reference Device(s)
Not Found
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
1. 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
510(k) Number: K052930
Applicant Information:
| Date Prepared: | January 20, 2006 |
|---|---|
| Name: | |
| Address: | NeoGuide Systems, Inc. |
| 104 Cooper Court | |
| Los Gatos, CA 95032 | |
| Phone: 408-399-9999 | |
| Fax: 408-399-3386 | |
| Contact Person: | |
| Phone Number: | |
| Facsimile Number: | Michael A. Daniel |
| Office: 925-254-5228 / Cell 415-407-0223 | |
| (925) 254-5187 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | NeoGuide Endoscopy System |
| Common Name: | Colonoscope |
| Classification Name: | Colonoscope, 78 FDF / 21 CFR 876.1500 |
Predicate Devices:
The NeoGuide Endoscopy System is substantially equivalent in intended use and method of operation to a combination of the following predicate devices:
K001241 - Olympus Optical Co, Ltd. EVIS EXERA Colonovideoscope K961563 - Pentax Precision Instrument Corporation EC3840TL, Video Colonoscope K032688 - Sightline, Colonosight, Video Colonoscope K033954 - USGI Shape Locking Endoscopic Overtube
Device Description:
The NeoGuide Endoscopy System has many features in common with currently marketed colonoscopes. The colonoscope is manually inserted and withdrawn by the physicial, who manually steers and controls it using up/down and left/right steering control knobs on a handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination. A standard tool channel is incorporated
1
for therapeutic procedures, as well as valves to control insuflation air, water irrigation, and suction.
The NeoGuide Colonoscope differs from currently marketed colonoscopes in that it incorporates fifteen active electro-mechanically controlled segments designed to allow the shape of the insertion tube to conform to the path defined by the physician as the colonoscope tip is manually steered through the colon lumen. The active segments are similar to conventional colonoscope steerable tips, as they each employ four control cables to articulate in the up/down and left/right directions. In order to determine the path selected by the physician during a procedure, the NeoGuide endoscopy system incorporates transducers that measure the angle of articulation of the steerable tip and the depth of insertion of the colonoscope into the patient. Software is required to create an anatomical map and interpret, monitor, and control the insertion tube segments.
Intended Use:
The NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endossopy and endoscopic surgery.
Comparison to Predicate Device(s):
The NeoGuide Colonoscope is very similar to the predicates listed, including indications for use, patient contacting materials, and physician interface. It features a mechanically actuated tip using a conventional pull wire system which is used to steer the device with a handle essentially identical to the Olympus and Pentax predicates. The NeoCuide Endoscopy System is designed for use in the same manner as existing colonoscopes. However, the steerable distal tip section is replicated multiple times down the length of the insertion tube allowing mechanical control of the insertion tube shape and reproduction of the directional path established by the physician
Summary:
Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, including in vitro bench, in vivo animal and clinical study, the NeoGuide Endoscopy System has been shown to be subsanially equivalent to currently marketed predicate devices.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2006
Mr. Michael A. Daniel Regulatory and Clinical Affairs NeoGuide Systems, Inc. 104 Cooper Court LOS GATOS CA 95032
RE: K052930
Trade/Device Name: NeoGuide Navigator Endoscopy System and Accessories Regulation Number: 21 CFR § 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: December 22, 2005 Received: December 23, 2005
Dear Mr. Daniel:
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 (Premarket Approval), 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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K052930
Device Name: NeoGuide Endoscopy System and Accessories
Indications for Use:
The NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
Sign-Off
n of Reproductive, Abdominal, a Prological Devices 0(k) Number
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