(133 days)
Not Found
No
The description focuses on motorized control via foot or voice, without mentioning AI/ML for image analysis, decision-making, or autonomous control beyond direct surgeon input.
No.
The device's intended use is to hold and position a rigid endoscope during endoscopic surgical procedures, which is a supportive role in surgery, not a direct treatment or therapy.
No
The ViKY system is a motorized endoscope holder used during surgical procedures to hold and position a rigid endoscope. It assists the surgeon in controlling the endoscope's movement, but it does not perform any diagnostic function such as analyzing patient data or providing a medical diagnosis.
No
The device description explicitly states it is a "motorized device" and a "motorized endoscope holder," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ViKY System is a motorized device used to hold and position a rigid endoscope during endoscopic surgical procedures. This is a surgical tool used in vivo (within the body) to assist the surgeon with visualization.
- 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. The ViKY System does not perform any such tests.
- Device Description: The description reinforces that it's a motorized endoscope holder for surgical procedures, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the ViKY System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ViKY System is a motorized device whose intended use is to allow a surgeon to hold and position a rigid endoscope during endoscopic surgical procedures. Its light architecture allows the ViKY System to be maintained above the patient by a dedicated arm attached to the table. The ViKY System movements are controlled by the surgeon either by a foot controller or a voice controller.
The ViKY System is indicated for thoracic and laparoscopic minimally invasive procedures for the purpose of holding and controlling the movement of standard rigid endoscopes within surgical cavities during endoscopic surgery.
Product codes
GCJ
Device Description
ViKY is a motorized endoscope holder for thoracic, abdominal, and pelvic minimally invasive procedures. ViKY is maintained by a dedicated arm attached to the table. It is moved according to surgeon orders by means of either a foot controller or a voice controller, in caudal, cranial and lateral directions, as well as zoom in and zoom out of the field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, abdominal, and pelvic surgical cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / endoscopic surgical procedures
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
In addition, summaries of testing on animals and clinical experience with the system were provided.
Key Metrics
Not Found
Predicate Device(s)
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
510(k) Summary ViKY
DEC 1 8 2008
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
510(k) Submitter:
EndoControl 5 avenue du Grand Sablon 38700 La Tronche France Phone : +33 476637583 Fax : +33 476637592
Contact Name:
Carine Huguel carine.huguel@endocontrol-medical.com
Date Prepared:
December 12th, 2008.
Proposed Device:
| Trade Name: | ViKY |
|---|---|
| Common Name: | Endoscope Holder |
| Classification Name: | General & Plastic Surgery, 21 CFR PART 876.1500 |
| Device Class: | II |
| Product Code: | GCJ |
Predicate Device:
The ViKY System is substantially equivalent to AESOP 3000 System and accessories that were cleared by FDA under K972699 on December 17, 1997, and to GMP|Surgical Solutions Inc. Laparocision™ Scope Controller System that was cleared by FDA under K050027 on January 27, 2005.
Device Description:
ViKY is a motorized endoscope holder for thoracic, abdominal, and pelvic minimally invasive procedures. ViKY is maintained by a dedicated arm attached to the table. It is moved according to surgeon orders by means of either a foot controller or a voice controller, in caudal, cranial and lateral directions, as well as zoom in and zoom out of the field.
1
Intended Use:
The ViKY System is a motorized device whose intended use is to allow a surgeon to hold and position a rigid endoscope during endoscopic surgical procedures. Its light architecture allows the ViKY System to be maintained above the patient by a dedicated arm attached to the table. The ViKY System movements are controlled by the surgeon either by a foot controller or a voice controller.
Indications for Use:
The ViKY System is indicated for thoracic and laparoscopic minimally invasive procedures for the purpose of holding and controlling the movement of standard rigid endoscopes within surgical cavities during endoscopic surgery.
Comparison of Technological Characteristics:
The ViKY System and the predicate devices have electronic components to control the position of laparoscopes during laparoscopic surgical procedures. ViKY System has a light architecture that allows it to be attached to the table by a dedicated arm, which is similar to both LAPAROCISION (K050027), and AESOP (K972699). The main technological difference is that the ViKY System is sterilized, although the predicate devices are protected by a sterile covers. The differences in technology do not raise any significant questions or issues regarding the safety and effectiveness of the device.
Testing:
Electrical Safety is tested in accordance with the following standards:
- EN 60601-1:1990, Medical electrical equipment Part 1: General requirements for safety .
- UL 60601-1:2003, Medical Electrical Equipment -Part 1: General Requirements for Safety .
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988; Amendment 1, 1991-11, Amendment 2, 1995.
Electromagnetic Compatibility (EMC) is tested in accordance with the following standards:
- IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment Part 1-2: General . Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests.
In addition, summaries of testing on animals and clinical experience with the system were provided.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2008
EndoControl % Ms. Carine Huguel Quality Manager 5 Avenue Du Grand Sablon La Tronche 38700 France
Re: K082233 Trade/Device Name: ViKY Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 12, 2008 Received: December 15, 2008
Dear Ms. Huguel:
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 (PMA), 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
3
Page 2 - Ms. Carine Huguel
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for use
510(k) Number: K082233
Device Name: ViKY
Indications For Use:
The ViKY System is indicated for thoracic and laparoscopic minimally invasive procedures for the purpose of holding and controlling the movement of standard rigid endoscopes within surgical cavities during endoscopic surgery.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Oden forman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082233
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