(126 days)
No
The document describes a camera control unit with standard image processing features and connectivity, but there is no mention of AI or ML technologies.
No
The device is described as a camera control unit and camera head for visualization, image recording, and documentation during endoscopic and microscopic procedures. It does not exert any direct therapeutic effect on the patient.
No
This device is described as a camera control unit (CCU) for visualization, image recording, and documentation during endoscopic and microscopic procedures. It processes images for viewing and recording but does not interpret or analyze them to provide a medical diagnosis on its own.
No
The device description explicitly states it is a "medical device which consists of the Image1 S Connect (TC200US), Image1 S Connect II (TC201US) modules and the link modules," which are physical hardware components. The software is an upgrade to the control unit, not the entirety of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "visualization, image recording and documentation during general endoscopic and microscopic procedures." This describes a device used for direct observation and recording of internal or microscopic structures within the body, not for testing samples taken from the body.
- Device Description: The description focuses on the components and features related to capturing and processing images from camera heads and endoscopes. There is no mention of analyzing biological samples or performing diagnostic tests on them.
- Input Imaging Modality: The input modalities are "Endoscopic and microscopic procedures," which are in-vivo (within the living body) or ex-vivo (outside the living body, but still direct observation of tissue or structures) procedures, not in-vitro (in glass or in a test tube) diagnostic tests.
IVD devices are specifically designed to perform tests on specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Image 1 S is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures.
The Image 1 S 4U camera head is intended to the Image1 S Camera Control Unit (CCU) and compatible endoscope for visualization, image recording and documentation during general endoscopic and microscopic procedure.
Product codes
FET
Device Description
The Image1 S camera control unit is a medical device which consists of the Image1 S Connect (TC200US), Image1 S Connect II (TC201US) modules and the link modules. The link modules are Image1 S H3-Link (TC300US), Image1 S X-Link (TC301US), Image1 S D3-Link (TC302US) and Image1 S 4U-Link (TC304US).
The Image1 S Connect (TC200US) and the Image1 S Connect II (TC201US) modules can be connected to a minimum of one and a maximum of three links modules. The modularity enables customers to customize their Image1 S system to their specific current and future video needs.
The Image1 S includes, but not limited to, the following features:
• Brightness control
• Enhancement Control
• Automatic Light Source Control
• Shutter Control
• Image/Video Capture
When the Image1 S Connect II module is used with the 4U-Link and the Image1 S 4U camera head, it can output a 4K image to the monitor and also offers 7 increments of zoom ranging from 1x to 2.5x.
The software version of the Image1 S camera control is upgraded to version 4.0. Software version 4.0 introduces the KS HIVE, an Ethernet based interface that allows for communication between the Image 1 S camera control unit and certain KARL STORZ devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video Endoscopes
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Comparative testing of optical parameters and software verification and validation testing demonstrated that the subject device is as safe and as effective as the predicate device.
Cleaning and sterilization validations were conducted for the Image1 S 4U camera head. The reprocessing data submitted is in compliance with the following standards:
• ANSI/AAMI/ISO 14937:2009/(R) 2013
• AAMI TIR 12:2010
• ANSI/AAMI ST81:2004/(R) 2010
• ANSI/AAMI ST79: 2010/A4:2013
• ANSI/AAMI ST 58:2005
• ANSI/AAMI/ISO 14161:2000
Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the Image1 S has met all its design specification and is substantially equivalent to its predicate device.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 1, 2020
Karl Storz Endoscopy-America, Inc. Alita McElroy Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K201135
Trade/Device Name: Image1 S CCU (TC200US, TC201US, TC300US, TC301US, TC302US, TC304US); Image1 S 4U Camera Head (TH120) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: July 31, 2020 Received: August 3, 2020
Dear Alita McElroy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201135
Device Name Image1 S CCU (TC200US, TC201US, TC300US, TC301US, TC302US, TC304US) Image1 S 4U Camera Head (TH120)
Indications for Use (Describe)
The Image 1 S is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures.
The Image 1 S 4U camera head is intended to the Image1 S Camera Control Unit (CCU) and compatible endoscope for visualization, image recording and documentation during general endoscopic and microscopic procedure.
Type of Use (Select one or both, as applicable)
| ☑ 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 is the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
510(k) Summary
This 510(k) Summary 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.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alita McElroy
Regulatory Affairs Specialist
Phone: (424) 218-8376
Fax: (424) 218-8519 |
| Date of
Preparation: | September 1, 2020 |
| Type of 510(k)
Submission: | Traditional |
| Device Name:
(Model numbers) | Image1 S CCU (TC200US, TC201US, TC300US, TC301US,
TC302US, TC304US)
Image1 S 4U Camera Head (TH120) |
| Common Name: | Endoscopic Video Imaging System/Component |
| Regulation
Number: | 21CFR 876.1500 |
| Regulation
Name: | Endoscope and Accessories |
| Regulatory
Class: | II |
| Product Code: | FET |
| Product Code
Name | Endoscopic Video Imaging System/Component |
| Device Panel: | Gastroenterology/Urology |
| Predicate
Device(s): | Image1 S (K160044) |
| Device
Description: | The Image1 S camera control unit is a medical device which consists
of the Image1 S Connect (TC200US), Image1 S Connect II
(TC201US) modules and the link modules. The link modules are
Image1 S H3-Link (TC300US), Image1 S X-Link (TC301US), Image1
S D3-Link (TC302US) and Image1 S 4U-Link (TC304US). |
| | |
| | The Image1 S Connect (TC200US) and the Image1 S Connect II
(TC201US) modules can be connected to a minimum of one and a
maximum of three links modules. The modularity enables customers to
customize their Image1 S system to their specific current and future
video needs. |
| | The Image1 S includes, but not limited to, the following features:
• Brightness control
• Enhancement Control
• Automatic Light Source Control
• Shutter Control
• Image/Video Capture |
| | When the Image1 S Connect II module is used with the 4U-Link and
the Image1 S 4U camera head, it can output a 4K image to the monitor
and also offers 7 increments of zoom ranging from 1x to 2.5x. |
| | The software version of the Image1 S camera control is upgraded to
version 4.0. Software version 4.0 introduces the KS HIVE, an Ethernet
based interface that allows for communication between the Image 1 S
camera control unit and certain KARL STORZ devices. |
| Intended Use and
Indications for
Use: | The Image1 S is a camera control unit (CCU) for use with camera
heads or video endoscopes for visualization, image recording and
documentation during general endoscopic and microscopic procedures.
The Image1 S 4U camera head is intended to be attached to the
Image1 S Camera Control Unit (CCU) and compatible endoscope for
visualization, image recording and documentation during general
endoscopic and microscopic procedure. |
| Technological
Characteristics: | The Image1 S camera control unit consists of the Image1 S Connect
(TC200US), Image1 S H3-Link (TC300US), Image1 S X-Link
(TC301US) cleared in K131953 and the Image1 S D3-Link
(TC302US) cleared in K150525 |
| | The modified Image1 S now includes following additional
components:
• Image1 S Connect II (TC201US)
• Image1 S 4U-Link (TC304US)
• Image1 S 4U Camera Head (TH120) |
| | The following comparison table summarizes the technological
characteristics between the subject and predicate devices: |
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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Technological Characteristics | Image1 S | Image1 S | ||
|---|---|---|---|---|
| Subject Device | Predicate Device | |||
| K160044 | ||||
| Camera | ||||
| Head | Imager Type | CMOS | CMOS | |
| Sensor | ||||
| Resolution | 3840 x 2160p | 1920 x 1080p | ||
| Camera | ||||
| Control | ||||
| Unit | Zoom | 1x, 1.2x, 1.5x, | ||
| 1.75x, 2x, 2.25x, | ||||
| 2.5x | 1x, 1.2x, 1.5x, | |||
| 1.75x, 2x | ||||
| Adaptive Zoom | Yes | No | ||
| Digital Outputs | 12G/3G-SDI | |||
| DisplayPort | ||||
| DVI-D | 3G-SDI | |||
| DVI-D | ||||
| Software | ||||
| version | 4.0 | 2.4 | ||
| Communication | ||||
| Interface | KS HIVE | SCB | ||
| Non-Clinical | ||||
| Performance | ||||
| Data: | Comparative testing of optical parameters and software verification | |||
| and validation testing demonstrated that the subject device is as safe | ||||
| and as effective as the predicate device. | ||||
| There are no performance standards or special controls developed | ||||
| under Section 514 of the FD&C Act for endoscopes. | ||||
| However, the Image1 S follows the FDA recognized consensus | ||||
| standards and is tested according to the following standards and FDA | ||||
| Guidance: | ||||
| ● Electrical Safety and EMC | ||||
| o IEC 60601-1:2012 (3rd Edition)- Medical Electrical | ||||
| Equipment - Part 1: General Requirements for basic safety | ||||
| and essential performance | ||||
| o IEC 60601-1-2:2014 (4th Edition)- Medical Electrical | ||||
| Equipment - Part 1- 2: General Requirements for Basic | ||||
| Safety and Essential Performance - Collateral Standard: |
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Image /page/6/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
| | Electromagnetic Compatibility - Requirements and Tests
o IEC 60601-2-18:2009 (3rd Edition) – Medical Electrical
Equipment Part 2-18:Particular requirements for the basic
safety and essential performance of endoscopic equipment |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Software Verification and Validation Testing
o Guidance for the Content of Premarket Submissions for
Software Contained in Medical Device
o Level of concern: Moderate |
| | Cleaning and sterilization validations were conducted for the Image1 S
4U camera head. The reprocessing data submitted is in compliance
with the following standards:
• ANSI/AAMI/ISO 14937:2009/(R) 2013
• AAMI TIR 12:2010
• ANSI/AAMI ST81:2004/(R) 2010
• ANSI/AAMI ST79: 2010/A4:2013
• ANSI/AAMI ST 58:2005
• ANSI/AAMI/ISO 14161:2000 |
| | Additional bench testing was performed to ensure the device met its
design specifications. The bench testing performed verified and
validated that the Image1 S has met all its design specification and is |
| | substantially equivalent to its predicate device. |
| Clinical
Performance
Data: | Clinical testing was not required to demonstrate the substantial
equivalence to the predicate devices. Non-clinical bench testing was
sufficient to establish the substantial equivalence of the modifications. |
| Substantial
Equivalence: | The conclusions drawn from the cleaning and sterilization, software,
electrical safety and EMC as well as bench top performance tests
demonstrated that the subject device is as safe and as effective as the
predicate device. |
| | As such, we concluded that the substantial equivalence of the subject
and the predicate device has been met, and the differences between the
subject and predicate do not raise new questions of safety and
effectiveness. |