(161 days)
Not Found
No
The description focuses on electromechanical control and manual steering by the physician, with no mention of AI or ML for image analysis, control, or other functions. The "graphical representation of the system interpretation of the tip movements commanded by the physician" appears to be a direct translation of physician input, not an AI/ML-driven interpretation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "therapeutic access" for "endoscopic surgery". Additionally, the "Device Description" mentions a "standard tool channel 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 to the adult lower gastrointestinal tract".
No
The device description clearly details hardware components such as a colonoscope with a CCD camera, fiber optic illumination, a tool channel, valves, and electromechanically controlled segments. It is a physical medical device with integrated software for control and display.
Based on the provided information, the NeoGuide Endoscopy System 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. They are used to provide information for diagnosis, monitoring, or screening.
- NeoGuide System Function: The NeoGuide Endoscopy System is a device used for direct visualization and access to the lower gastrointestinal tract within the patient's body. It uses a camera to provide images and a channel for therapeutic procedures. It does not analyze samples taken from the body.
The system's purpose is to facilitate endoscopic procedures, which are performed in vivo (within a living organism), not in vitro (in a test tube or laboratory setting).
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The NeoGuide colonoscope is manually inserted and withdrawn by the physician, who steers and controls it using the electromechanical controls located at the handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination and includes a standard tool channel for therapeutic procedures. Valves control insuflation air, water irrigation, and suction. The NeoGuide Colonoscope incorporates fifteen active electro-mechanically controlled segments, not including the tip. During a procedure, the segments shape conforms to the path defined by the physician as the tip is manually steered but electromechanically controlled through the colon lumen. Each of the active segments uses four control cables to articulate in the up/down and left/right directions. This mechanism of action is the same as the mechanism used in conventional colonoscope steerable tips. The NeoGuide Endoscopy System displays a graphical representation of the system interpretation of the tip movements commanded by the physician and the depth of insertion of the colonoscope into the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CCD camera
Anatomical Site
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
physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052930, 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
AUG 1 4 2007
1. SPECIAL 510(k) DEVICE MODIFICATIONS SUMMARY
510(k) Number: TBD
Applicant Information:
| Date Prepared: | December 12, 2006 |
|---|---|
| ---------------- | ------------------- |
NeoGuide Systems, Inc. Name: 104 Cooper Court Address: Los Gatos, CA 95032 Phone: 408-399-9999 Fax: 408-399-3386
| Contact Person: | Jorge L. Porras |
|---|---|
| Phone Number: | Office: (408) 399-9999 ext 205 |
| Facsimile Number: | (408) 399-3386 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | NeoGuide Endoscopy System |
| Common Name: | Colonoscopy System |
| Classification Name: | Colonoscope, 78 FDF / 21 CFR 876.1500 |
Predicate Devices:
The indication for use, operating principle, basic technology, physician interface and same contacting materials of the NeoGuide Endoscopy System, are equivalent to the Navigator Endoscopy System previously cleared under 510(K) K052930. Additional predicate devices are listed below:
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 colonoscope is manually inserted and withdrawn by the physician, who steers and controls it using the electromechanical controls located at the handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination and includes a standard tool channel for therapeutic procedures. Valves control insuflation air, water irrigation, and suction.
1
K. Rice
J. Rice
The NeoGuide Colonoscope incorporates fifteen active electro-mechanically controlled segments, not including the tip. During a procedure, the segments shape conforms to the path defined by the physician as the tip is manually steered but electromechanically controlled through the colon lumen. Each of the active segments uses four control cables to articulate in the up/down and left/right directions. This mechanism of action is the same as the mechanism used in conventional colonoscope steerable tips. The NeoGuide Endoscopy System displays a graphical representation of the system interpretation of the tip movements commanded by the physician and the depth of insertion of the colonoscope into the patient.
Intended Use:
The NeoGuide Navigator 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.
Comparison to Predicate Device(s):
The NeoGuide Colonoscope is similar to the predicate listed, K052930, including indications for use, the same operating principle, the same basic technology and several of the same contacting materials, and physician interface. The NeoGuide Endoscopy System is designed for use in the same manner as existing colonoscopes. However, the electromechanical actuation of the segments is replicated at the tip. The colonoscope features a physician controlled electromechanically actuated tip using the same conventional pull wire system used to steer the Navigator Endoscopy System. As with the predicate device, the NeoGuide Colonoscopy System allows 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 the NeoGuide Endoscopy System is substantially equivalent to predicate devices and does not pose any new safety or effectiveness issues.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of an eagle with three lines extending from its head. The seal is black and white and appears to be a logo or emblem.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 4 2007
NeoGuide Systems, Inc. c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road NEWTON CT 06470
Re: K070622
Trade/Device Name: NeoGuide Endoscopy System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: July 23, 2007 Received: July 26, 2007
Dear Mr. Borsai:
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.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which commemorates the 100th anniversary of the Food and Drug Administration. The logo features the letters "FDA" in a bold, stylized font, with the words "Centennial" written below. The years "1906-2006" are displayed at the top of the logo. The logo is surrounded by a circular border with text.
3
Page 2 -
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 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
NancyCbrogdon
Nancy C. B rogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K070622
NeoGuide Endoscopy System and Accessories Device Name:
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 X
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)
JWhss
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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