(102 days)
Not Found
No
The document describes image capture and processing but does not mention AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The focus is on hardware control and basic image processing for display and storage.
No
The device is described as an "Imaging System" intended for "confocal laser imaging of the internal microstructure of tissues" and for "image capture and processing". Its purpose is to assist in "medical examination procedures" by providing visual information, rather than directly treating or preventing a disease or condition.
Yes
The device is intended to allow confocal laser imaging of the internal microstructure of tissues during endoscopic medical examination procedures, and it processes this information for display, enabling the capture and storage of still images of the tissue. This process of creating images of internal structures for medical evaluation is a diagnostic function.
No
The device description explicitly states that the system consists of three main units: a Control Unit (computer-based), an Optical Unit (hardware for laser illumination and detection), and an Isolation Transformer. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that the Confocal Endoscopic Imaging System (CEIS) is used for "confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes, during endoscopic medical examination procedures." This means it is used in vivo (within the living body) to directly visualize tissue, not to analyze samples taken from the body.
- The intended use is for direct visualization during endoscopic procedures. The system is an accessory to endoscopes and is used by an endoscopist to observe tissue structure in real-time. This is a diagnostic imaging procedure, not an in vitro test.
The device is a medical imaging system used for diagnostic purposes in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Confocal Endoscopic Imaging System (CEIS) is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes (equipped with a confocal laser imaging module), during endoscopic medical examination procedures. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, KOG
Device Description
The Optiscan Confocal Endoscopic Imaging System (CEIS) is a software controlled device which is intended for use as a required accessory with a legally marketed and compatible video endoscope system that is equipped with confocal imaging module.
The Confocal Endomicroscopy Imaging System (CEIS) consists of three main units.
- The Control Unit (CEIS-CU) together with its monitor, keyboard, and footswitch, is a computer based unit which performs the instrument control, and image capture and processing functions of the CEIS.
- The Optical Unit (CEIS-OU) a specialised endomicroscope interface unit which performs the laser illumination and fluorescence detection functions of the CEIS.
- The Isolation Transformer.
A video endoscope equipped with a confocal imaging module is connected to the CEIS-OU. Under control by the endoscopist, the CEIS-OU transmits visible laser light into the connected endoscope. The endoscope transmits this light to and then subsequently receives return light signals from the subject tissue. The returned light is detected by the CEIS-OU and converted into an electrical signal. The detected signal is sent to the System Computer (CEIS-CU) which processes the confocal image information for display on the system monitor, and allows still images of the tissue to be captured and stored.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal laser imaging
Anatomical Site
internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes
Indicated Patient Age Range
adult and pediatric patient populations
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)
The submission for substantial equivalence was not based on an assessment of clinical performance data.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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093624 (1) of (2)
510(k) Summary of Safety and Effectiveness Optiscan Confocal Endoscopic Imaging System
Submitter Information:
Optiscan Pty Ltd 15-17 Normanby Rd, Notting Hill. Victoria. 3168 Australia Tel: (+61 3) 9538 3333 Fax: (+61 3) 9562 7742
PPK
3/5/10
MAR - 5 2010
Date Summary Prepared: 27 January 2010
Name of Device:
| Trade Name: | Optiscan CEIS |
|---|---|
| Classification Name | Endoscope and Accessories (21CFR876.1500) |
| Product Code | GCJ, KOG |
Predicated Device(s) Information:
| Model, Description | Manufacturer | of very be the first and the many of the program program and any the more and more of more of many of the commens of the commended to the
PMN # |
|------------------------------|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pentax Confocal Laser System | Pentax | K042740 |
Device Description:
The Optiscan Confocal Endoscopic Imaging System (CEIS) is a software controlled device which is intended for use as a required accessory with a legally marketed and compatible video endoscope system that is equipped with confocal imaging module.
The Confocal Endomicroscopy Imaging System (CEIS) consists of three main units.
- The Control Unit (CEIS-CU) together with its monitor, keyboard, and footswitch, 1. is a computer based unit which performs the instrument control, and image capture and processing functions of the CEIS.
- The Optical Unit (CEIS-OU) a specialised endomicroscope interface unit which 2. performs the laser illumination and fluorescence detection functions of the CEIS.
-
- The Isolation Transformer.
A video endoscope equipped with a confocal imaging module is connected to the CEIS-OU. Under control by the endoscopist, the CEIS-OU transmits visible laser light into the connected endoscope. The endoscope transmits this light to and then subsequently receives return light signals from the subject tissue. The returned light is detected by the CEIS-OU and converted into an electrical signal. The detected signal is sent to the System Computer (CEIS-CU) which processes the confocal image information for display on the system monitor, and allows still images of the tissue to be captured and stored.
1
093624 page ② of ③
Intended Use:
The Confocal Endoscopic Imaging System (CEIS) is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes (equipped with a confocal laser imaging module), during endoscopic medical examination procedures. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Comparison to Predicated Device(s):
The submission for substantial equivalence included Optiscan Confocal Endoscopic Imaging System (CEIS) literature including intended use and specifications. Comparison tables were provided to illustrate the comparisons to the predicated devices for intended use, technical specifications and materials. The submission for substantial equivalence was not based on an assessment of clinical performance data.
Conclusion:
Because the Optiscan Confocal Endoscopic Imaging System (CEIS) possesses the same or similar intended use, indications, and technological characteristics as the identified predicate device, with no additional questions of safety or effectiveness, the company submits that the device can be found to be substantially equivalent.
Prepared By:
Peter Parker
Peter Pavlicek Quality and Regulatory Affairs Manager
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 5 2010
TUV Rheinland of North America, Inc. % OptiScan Pty. Ltd. Mr. Peter Pavlicek 15-17 Normanby Road Notting Hill, Victoria 3168 Australia
Re: K093624
Trade/Device Name: Optiscan CEIS Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 19, 2010 Received: February 24, 2010
Dear Ms. Pavlicek:
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. Ilsting 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Peter Pavlicek
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance 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 yours
pe Rant des or
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
093624
Indications for Use
510(k) Number (if known):
Device Name: Optiscan CEIS
Indications for Use:
The Confocal Endoscopic Imaging System (CEIS) is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by legally marketed video endoscopes (equipped with a confocal laser imaging module), during endoscopic medical examination procedures. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NilAP. Al. for mkn
Division of Surgical. Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K093624