(153 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning or neural networks. The image processing described is standard for video endoscopy systems.
No
The device is described as a videoendoscope and camera control unit used for visualization during surgical procedures, not for treating a condition.
No
The device is described as assisting in visualization during surgical procedures, not for making a diagnosis. While it can be used during "diagnostic and/or surgical procedures," its primary function highlighted is visualization for surgical intervention.
No
The device description explicitly states the system consists of a rigid videoendoscope (hardware) and a camera control unit (hardware), in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the visualization of ventricles and structures within the brain during neurological surgical procedures. This is a direct visualization tool used in vivo (within the living body) during a surgical procedure.
- Device Description: The device is a rigid videoendoscope system used for visualization during surgical procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on biological specimens.
The device is clearly intended for direct visualization within the body during surgery, which falls under the category of surgical or endoscopic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use in the visualization of ventricles and structures within the brain during neurological surgical procedures.
IMAGE 1S is a camera control unit (CCU) for use with camera heads of videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
The TIPCAM®1S 3D System is intended for use during diagnostic and/or surgical procedures when endoscopic video assistance is required for visualization within ventricles and structures within the brain during neurological surgical procedures. The TIPCAM®1S 3D System is a medical device system which consists of a 4mm Tipcam®1S and a previously 510k cleared camera control unit (CCU), K150525.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic video
Anatomical Site
ventricles and structures within the brain
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. However, SPIES 3D System follows the FDA recognized consensus standards and is tested according to the following standard and FDA Guidance: Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 ISO Endoscopes Standards ISO 8600-1 ISO 8600-3 ISO 8600-4 ISO 8600-5 ISO 8600-6 Biocompatibility testing (ISO 10993-1) Cytotoxicity Systemic toxicity Intracutaneous irritation Maximization sensitization Mucosal Irritation Software Verification and Validation Testing Guidance for the Content of Premarket Submissions for Software Contained in Medical Device The software is moderate level of concern Performance Testing White Balance Brightness Image Enhancement Video Output Format Zoom Image Quality Image Capture Latency Interface Control 3D-2D mode Reprocessing (Cleaning and Steam Sterilization) AAMI TIR30:2011 AAMI TIR12:2010 ANSI/AAMI/ISO 14937:2009 ANSI/AAMI ST79:2010/A4:2013 ISO TS 15883-5:2005 Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
Clinical Performance Data:
No clinical information is required for this submission
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.
VS3 Stereoscopic High Definition Vision System (K131434)
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.
SPIES 3D System (K150525)
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
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
Karl Storz Endoscopy America, Inc. Winkie Wong Senior Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
Re: K162880
Trade/Device Name: TIPCAM 1S 3D System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: February 10, 2017 Received: February 14, 2017
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 devicerelated 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.
1
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" (21 CFR 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.
Sincerely yours,
Michaelリ. Hoffmann -S
for
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162880
Device Name TIPCAM 1S 3D System
Indications for Use (Describe)
TIPCAM 1S 3D: The Rigid Videoendoscope is intended to be used together with the camera control unit for use in the visualization of ventricles and structures within the brain during neurological surgical procedures.
IMAGE 1S is a camera control unit (CCU) for use with camera heads of videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.
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 shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.
510(k) SUMMARY
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 |
| Senior Regulatory Affairs Specialist | |
| 424-218-8379 | |
| 424-218-8519 | |
| Date of Preparation: | October 12th, 2016 |
| Device Identification: | Trade Name: TIPCAM®1S 3D System |
| Common Name: Endoscopic Camera System | |
| Classification Name: Endoscopic Camera System | |
| Product Code: | GWG |
| Regulation: | 21 CFR 882.1480 |
| Predicate Device(s): | VS3 Stereoscopic High Definition Vision System (K131434) |
| Reference Device | SPIES 3D System (K150525) |
| Device Description: | The TIPCAM®1S 3D System is intended for use during diagnostic |
| and/or surgical procedures when endoscopic video assistance is | |
| required for visualization within ventricles and structures within | |
| the brain during neurological surgical procedures. The | |
| TIPCAM®1S 3D System is a medical device system which consists | |
| of a 4mm Tipcam®1S and a previously 510k cleared camera | |
| control unit (CCU), K150525. | |
| Indications For Use: | TIPCAM®1S 3D: The Rigid Videoendoscope is intended to be |
| used together with the camera control unit for use in the | |
| visualization of ventricles and structures within the brain during | |
| neurological surgical procedures. | |
| IMAGE1 S is a camera control unit (CCU) for use with camera | |
| heads or videoendoscopes for the visualization and | |
| documentation of endoscopic and microscopic procedures. | |
| Technological | |
| Characteristics: | The TIPCAM®1S 3D System includes the following components: |
| 4mm 3D TIPCAM®1S Videoendoscope, 0° or 30° Image1S CCU (Image1S Connect + D3-Link) The 4mm TIPCAM®1S 3D Videoendoscope is intended to be | |
| connected to a compatible light source via a light cable as the source | |
| of illumination to allow visualization of inside the patient's anatomy captured by the videoendoscope, processed by the CCU and finally | |
| projected to any connected medical grade monitors. | |
| Non-Clinical | |
| Performance Data: | There are no performance standards or special controls |
| developed under Section 514 of the FD&C Act for endoscopes. | |
| However, SPIES 3D System follows the FDA recognized | |
| consensus standards and is tested according to the following | |
| standard and FDA Guidance: Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 ISO Endoscopes Standards ISO 8600-1 ISO 8600-3 ISO 8600-4 ISO 8600-5 ISO 8600-6 Biocompatibility testing (ISO 10993-1) Cytotoxicity Systemic toxicity Intracutaneous irritation | |
| Maximization sensitization Mucosal Irritation Software Verification and Validation Testing Guidance for the Content of Premarket Submissions for Software Contained in Medical Device The software is moderate level of concern Performance Testing White Balance Brightness Image Enhancement Video Output Format Zoom Image Quality Image Capture Latency Interface Control 3D-2D mode Reprocessing (Cleaning and Steam Sterilization) AAMI TIR30:2011 AAMI TIR12:2010 ANSI/AAMI/ISO 14937:2009 ANSI/AAMI ST79:2010/A4:2013 ISO TS 15883-5:2005 Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. | |
| Clinical Performance Data: | No clinical information is required for this submission |
| Substantial Equivalence: | The TIPCAM®1S 3D System also has the same intended use, similar indications, principles of operation and technological characteristics as the cleared Visionsense's VS3 Stereoscopic High Definition Vision System (K131434). |
Standard Performance Parameters Performance: |
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| TIPCAM®1S 3D System | VS3 Stereoscopic High Definition Vision System | ||
|---|---|---|---|
| K131434 | |||
| Subject Device | Primary Predicate | ||
| Depth of Field | 7 – 44 mm | 7 – 30mm and 15 – 60 mm | |
| Direction of View | 0° & 30° | 0 - 70° | |
| Field of View | 80° | 70 - 95° | |
| Working Length | 175 mm | 175 – 300 mm | |
| Diameters | 4mm | 4mm & 5.5mm | |
| Light Source Compatibility | Xenon & LED | Xenon | |
| Zoom | Yes | Yes | |
| Image Enhancement | Yes | Yes | |
| Image Capture | Yes | Yes | |
| Video Recording | Yes | Yes | |
| Switch Between 2D and 3D Image | Yes | Yes | |
| Scope Diameters | 4 mm | 4mm & 5.5mm | |
| Resolution | HD | SD | |
| Conclusion: | The TIPCAM®1S 3D System 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. |