(126 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional fiberscope technology.
No.
The device is used for viewing and assessing/biopsying soft tissue within the human body, which makes it a diagnostic tool rather than a therapeutic one. It does not provide treatment.
No
The device is used for viewing and assessing/biopsy soft tissue, which is an interventional procedure rather than a diagnostic one based on the provided information.
No
The device description explicitly states it consists of a "semi-rigid fiberscope with a separate irrigating outer sheath or introducer," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing an interior cavity of the human body through either a natural opening or an incision." This describes a device used for direct visualization within the body, which is a characteristic of an endoscope, not an IVD.
- Device Description: The description mentions a "semi-rigid fiberscope with a separate irrigating outer sheath or introducer to view and assess/biopsy soft tissue." This further confirms it's an endoscopic device used for direct observation and potentially tissue sampling in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, tissue samples, etc., which is the defining characteristic of an IVD.
Therefore, this device is an endoscope used for internal visualization and assessment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.
Product codes (comma separated list FDA assigned to the subject device)
ODF
Device Description
Like the predicate devices, the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source consist of a semi-rigid fiberscope with a separate irrigating outer sheath or introducer to view and assess/biopsy soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interior cavity of the human body
Indicated Patient Age Range
Not Found
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)
All necessary testing was or will be performed on the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness.
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.
0
C- Link Micro Imaging, Inc. 510K Notification Microendoscope Model S-0001 Single Light Source and Microendoscope Model D-0001 Dual Light Source
510(k) SUMMARY
K092739
Pg 1 of 2
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
A. Name, Address, Phone and Fax number of the Applicant
C-Link Micro Imaging, Inc. 1862 S. La Cienega Blvd. Los Angeles, CA 90035, Phone: 310-838-5613 Cell: 310-728-5174 Fax: 310.838 5615
JAN 1 2 2010
B. Contact Person
Mary P. Gallup Regulatory Affairs Consultant Hantel Technologies, Inc. Telephone: (510) 441-4017
C. Date Prepared
July 30, 2009
D. Device Name
Trade Name: C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source
Classification Name: Endoscope and Introducer Instruments
Device Description
Like the predicate devices, the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source consist of a semi-rigid fiberscope with a separate irrigating outer sheath or introducer to view and assess/biopsy soft tissue.
r. Intended Use
The C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.
1
Substantial Equivalence
The C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source are substantially equivalent to the Acueity ViaDuct Microendoscope and Accessories, cleared by the FDA under K011189. The design of the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source are similar to the predicate device insofar as intended use, principles of operation, anatomical site for viewing and sampling, safety characteristics and physical characteristics.
G. Device Testing Results and Conclusion
All necessary testing was or will be performed on the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
C-Link Micro Imaging, Inc. % Ms. Mary P. Gallup RegulatoryAffairs Hantel Technologies, Inc. 721 Sandoval Way HAYWARD CA 94544
JAN 1 2 2010
Re: K092739
Trade/Device Name: Microendoscope Model S-0001 Single Light Source and Model D-0001 Dual Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories . Regulatory Class: II Product Code: ODF Dated: August 31, 2009 Received: September 23, 2009
Dear Ms. Gallup:
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 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 -
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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
C- Link Micro Imaging, Inc.
510K Notification
Microendoscope Model S-0001 Single Light Source and Microendoscope Model D-0001 Dual Light Source
Indications for Use K092239
510(k) Number (if known):
X092739
Device Name: Microendoscope Model S-0001 Single Light Source and Model D-0001 Dual Light Source
Indications For Use:
This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.
Prescription Use AND/OR Over-The-Counter Use Yes No
(Part 21 CFR 801 Subpart D) (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) Page 1 of
Herbert Semmel
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Appendix B