(269 days)
Not Found
No
The summary describes a standard endoscopic camera system and does not mention any AI or ML capabilities, image processing beyond basic functions, or data sets for training or testing.
No
The device is designed for observation purposes during general endoscopic procedures, not for therapeutic intervention.
No
The device description and intended use state that it is for "observation purposes in general endoscopic procedures," which implies visualization rather than the interpretation of medical conditions or diseases necessary for diagnosis. It functions as a camera system for viewing during procedures.
No
The device description explicitly states that the system consists of a camera head, a cable, and a monitor, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "general endoscopic procedures" for "observation purposes." This involves visualizing internal body structures directly, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The device is a camera system used with endoscopes to provide visual observation. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD-related terms: There is no mention of analyzing blood, urine, tissue, or any other biological samples. The focus is purely on capturing and displaying images from within the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide visual access to internal anatomy, which falls under the category of medical imaging or visualization devices, not IVDs.
N/A
Intended Use / Indications for Use
The C-cam camera head is designed for general endoscopic procedures in an operating room or a doctor's office. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and must be used with a C-MAC monitor or C-HUB for observation purposes in general endoscopic procedures.
The KSEA CMOS Camera System is a camera system designed for use in the operating room for general endoscopic procedures. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and Fiberscopes and must be used with a C-MAC™ monitor or C-HUB for observation purposes in general endoscopic procedures.
Product codes
GCJ
Device Description
The KSEA CMOS Camera System (C-CAM) consists of a camera head, a cable and a monitor. The camera head must be connected to the C-MAC monitor, 8403ZX. The KSEA CMOS Camera System is compatible for use with all standard KARL STORZ Endoscopes and Fiberscopes for endoscopic observation in general endoscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room or a doctor's office
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)
Non-Clinical Performance Data: C-CAM is tested according to the following standard: IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18
Additional bench testing for performance verification and validation purposes: Resolution, Field Flatness, White Balance
The bench testing performed verified and validated that the C-CAM has met all its design specification and is substantially equivalent to the predicate device, Tricam, for general endoscopic procedures.
Clinical Performance Data: No clinical information is required for this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tricam (K950862)
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
KARL STORZ Endoscopy America Incorporated Winkie Wong Regulatory Affairs Specialist 2151 East Grand Avenue El Segundo, California 90245
September 17, 2015
Re: K143640
Trade/Device Name: KSEA CMOS Camera System (C-cam) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 14, 2015 Received: August 18, 2015
Dear Ms. Wong:
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 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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
For
Sincerelv vours.
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143640
Device Name
KSEA CMOS Camera System (C-cam)
Indications for Use (Describe)
The C-cam camera head is designed for general endoscopic procedures in an operating room or a doctor's office. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and must be used with a C-MAC monitor or C-HUB for observation purposes in general endoscopic procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the bottom line.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy-America, Inc
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Regulatory Affairs Specialist
424-218-8379 [voice]
424-218-8519 [fax] |
| Date of Preparation: | September 10, 2015 |
| Device Identification: | Trade Name: KSEA CMOS Camera System (C-CAM)
Common Name: Endoscopic Camera System
Classification Name: Endoscopic Camera System |
| Product Code: | GCJ |
| Regulation: | CFR 876.1500 |
| Predicate Device(s): | Tricam (K950862) |
| Device Description: | The KSEA CMOS Camera System (C-CAM) consists of a
camera head, a cable and a monitor. The camera head
must be connected to the C-MAC monitor, 8403ZX. The
KSEA CMOS Camera System is compatible for use with all
standard KARL STORZ Endoscopes and Fiberscopes for
endoscopic observation in general endoscopic procedures. |
| Indications For Use: | The KSEA CMOS Camera System is a camera system
designed for use in the operating room for general
endoscopic procedures. The camera head is suitable for
attachment to all standard KARL STORZ Endoscopes and |
| | Fiberscopes and must be used with a C-MAC™ monitor or C-HUB for observation purposes in general endoscopic procedures. |
| Technological
Characteristics: | The predicate and subject devices are both camera system that are used for observation purposes in general endoscopic surgery. However, in order to provide a lower cost alternative of the subject device to the end user compare to the current high cost camera in the market, they have minor differences in the technological characteristics. These differences are: |
| | The subject device uses a CMOS sensor instead of a CCD sensor. The resolution of the device is slightly lower than the predicate (350 TVL [H]). |
| | The bench test data for the KSEA CMOS Camera System (C-CAM) demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications. |
| | Combining the minor difference in specifications with the benefit of providing a lower cost device compared to the predicate device, Tricam, C-CAM does not raise new issues of safety and effectiveness and the devices are substantially equivalent for general endoscopic application. |
| Non-Clinical
Performance Data: | C-CAM is tested according to the following standard: IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 |
| | Additional bench testing for performance verification and validation purposes: Resolution |
| | Field Flatness White Balance |
| | The bench testing performed verified and validated that the C-CAM has met all its design specification and is substantially equivalent to the predicate device, Tricam, for general endoscopic procedures. |
| Clinical Performance Data: | No clinical information is required for this submission |
| Conclusion: | The Karl Storz's CMOS Camera System (C-CAM) is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe and effective as the legally marketed devices. |
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