(252 days)
No
The description focuses on fiberoptic technology, mechanical components (cannulas, working channel), and standard visualization equipment (ocular, light source, camera, monitor). There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery." The "Device Description" also mentions "a working channel to allow access of various accessories for different therapeutic applications."
No
The device is primarily for visualization and enabling therapeutic procedures through a working channel for accessories. While visualization can be part of diagnosis, the description does not explicitly state its primary purpose is to diagnose diseases or conditions by providing a medical diagnosis. It focuses on viewing and facilitating interventions.
No
The device description clearly details physical components such as fiberoptic technology, a semi-rigid optic system, a working channel, cannulas, an ocular, and a light source cable. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is an endoscope used for direct visualization of body cavities, hollow organs, canals, and dental surfaces. It is used in vivo (within the living body) for diagnostic and therapeutic procedures, not for analyzing in vitro specimens.
The description clearly outlines its function as a tool for visualization and accessing anatomical sites within the body, which is characteristic of an endoscopic device, not an IVD.
N/A
Intended Use / Indications for Use
The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery, including but not limited to, salivary gland diseases.
Product codes
GCJ
Device Description
The Modular Endoscope utilizes a fiberoptic technology to allow visualization of body cavities. The 6000/10,000 pixel optic system is semi rigid and is contained within a very small diameter of less than 1mm. The endoscope contains a working channel to allow access of various accessories for different therapeutic applications.
The Modular Endoscope is used with single use, multi port (2 or 3 port), sterile cannulas with diameters ranging from 0.9-2.3 mm, which provide the surgeon good flexibility in choosing the right equipment for the clinical procedure.
The single lumen cannula is inserted into the salivary gland or other body cavities or canals and serves as a working and irrigation channel, as well as containing the fiberoptic system. The fiberoptic system is protected from surgical tools and instruments by a nitinol coating.
An ocular is connected at the proximal end and light is transmitted via a light source cable from various commercially available Xenon lamp light sources to the optic system. The image can be visualized by connecting the endoscope to a camera and a monitor screen. The light source, camera and monitor are user-supplied.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fiberoptic
Anatomical Site
Body cavities, hollow organs and canals (in ENT procedures), dental surfaces, salivary gland
Indicated Patient Age Range
Not Found
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
Non-Clinical Performance Data: The Modular Endoscope has been tested for performance as follows: Resolution and Distortion testing
Clinical Performance Data: Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope, information regarding the use of the device for dental surfaces is presented in Section 20.
Key Metrics
Not Found
Predicate Device(s)
KSEA Sialoendoscope and accessories (K012527), Midiview series of microendoscopes (K051073), SpyGlass™ Direct Visualization Probe (K050403), OraScope (K991101)
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
Image /page/0/Picture/1 description: The image shows the text "Page 1 of 3" in a handwritten style. The word "Page" is written in cursive, followed by the number 1. The word "of" is also written in cursive, and the number 3 is enclosed in a circle.
SIALOTECH MODULAR ENDOSCOPE
510(k) Number K093785
Applicant Name:
AUG 1 8 2010
| Company Name: | Sialo Technologies Ltd. |
|---|---|
| Address: | 11 Ben Gurion Blvd., Suite 220 |
| Ashkelon 78182 | |
| Israel | |
| Tel: | +972-8-6710795 |
| Fax: | +972-9-6782524 |
| E-mail: | itzik@sialotechnology.com |
Contact Person:
| Official Correspondent: | Ahava Stein/ Eyal Ozeri |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 44425 | |
| Israel | |
| Tel: | +972-9-7670002 |
| Fax: | +972-9-7668534 |
| E-mail: | ahava@asteinrac.com or eyal@asteinrac.com |
| Date Prepared: | June 2010 |
Trade Name: Modular Endoscope
Classification Name: CFR Classification section 876.1500 (Product code GCJ)
Classification: Class II medical Device
Predicate Device:
The Modular Endoscope is comparable to the following predicate devices:
- KSEA Sialoendoscope and accessories (K012527) manufactured by Karl Storz � Endoscopy.
- Midiview series of microendoscopes (K051073) manufactured by Millennium . Devices Inc.
- SpyGlass™ Direct Visualization Probe (K050403) manufactured by Boston t Scientific Corporation.
- OraScope (K991101) manufactured by FiberDent Corp. �
1
K093785
Device Description: `
Page 2 of 3
The Modular Endoscope utilizes a fiberoptic technology to allow visualization of body cavities. The 6000/10,000 pixel optic system is semi rigid and is contained within a very small diameter of less than 1mm. The endoscope contains a working channel to allow access of various accessories for different therapeutic applications.
The Modular Endoscope is used with single use, multi port (2 or 3 port), sterile cannulas with diameters ranging from 0.9-2.3 mm, which provide the surgeon good flexibility in choosing the right equipment for the clinical procedure.
The single lumen cannula is inserted into the salivary gland or other body cavities or canals and serves as a working and irrigation channel, as well as containing the fiberoptic system. The fiberoptic system is protected from surgical tools and instruments by a nitinol coating.
An ocular is connected at the proximal end and light is transmitted via a light source cable from various commercially available Xenon lamp light sources to the optic system. The image can be visualized by connecting the endoscope to a camera and a monitor screen. The light source, camera and monitor are user-supplied.
Intended Use/Indication for Use:
The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery, including but not limited to, salivary gland diseases.
· Performance Standards:
The Modular Endoscope has been tested and complies with the following voluntary recognized standards:
- · Electrical & Mechanical Safety testing according to IEC 60601-1 & IEC 60601-2-18
- Electromagnetic Compatibility testing according to IEC 60601-1-2 .
- Optic system testing according to ISO 8600 Parts 1, 3, 4, and 5 e
- AAMI TIR30:2003 "A compendium of processes, materials, test methods, and � acceptance criteria for cleaning reusable medical devices
- ISO 11135-1:2007 "Sterilization of health care products- Ethylene oxide-Part 1: . � Requirements for development, validation and routine control of a sterilization process for medical devices"
- ISO 10993-7:2008 "Biological evaluation of medical devices-Part 7: Ethylene oxide � sterilization residuals".
2
ISO 14937:2000 "Sterilization of health care products - General requirements characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
KO 93785
- AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for 0 reprocessing in health care facilities: A guide for medical device manufacturers.
- . ANSI/AAMI/ISO 17665-1:2006 Sterilization of health care products - Moist heat -Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ANSI/AAMI ST79:2006 Comprehensive guide to steam sterilization and sterility . assurance in health care facilities.
- AAMI/ANSI ST77:2006 Containment devices for reusable medical device 0 sterilization.
Non-Clinical Performance Data:
The Modular Endoscope has been tested for performance as follows:
- � Resolution and Distortion testing
Clinical Performance Data:
Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope, information regarding the use of the device for dental surfaces is presented in Section 20.
Substantial Equivalence:
The Modular Endoscope is similar in its intended use, indications for use, operation, performance and technological characteristics to currently marketed endoscopes intended for diagnosis and treatment of salivary gland diseases and root canal treatment, such as the Karl Storz KSEA Sialoendoscope (K012527), the OraScope manufactured by FiberDent Corporation (K991011), the Midiview series of microendoscopes (K051073) manufactured by Millennium Devices Inc., and the SpyGlass™ Direct Visualization Probe manufactured by Boston Scientific Corporation (K050403). The minor differences in the Modular Endoscope compared to the predicate devices do not raise new issues of safety or effectiveness. .
Conclusions:
Based on the performance testing and comparison to predicate devices, the Modular Endoscope is substantially equivalent to the predicate devices listed above.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sialo Technology, Ltd. % A. Stein Regulatory Affairs Consulting Ltd. Ms. Ahava Stein 20 Hata'as Street, Suite 102 Kfar Saba 44425, Israel
AUG 1 8 2010
Re: K093785
Trade/Device Name: Modular Endoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 11, 2010 Received: August 11, 2010
Dear Ms. Stein:
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
4
Page 2 - Ms. Ahava Stein
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 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/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 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 vours.
tol
Mark N. Mel Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
093785
INDICATIONS FOR USE
510(k) Number (if known): K093785
Device Name:
Modular Endoscope
Intended Use Statement:
The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery, including but not limited to, salivary gland diseases.
Prescription Use 2 (Per 21 C.F.R. 801 Subpart D)
OR
Over-The-Counter Use (Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil RP Dyler formxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093785