(153 days)
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.
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.
The provided document details the 510(k) summary for the TIPCAM®1S 3D System. The information focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than a clinical study evaluating diagnostic performance against acceptance criteria. Therefore, I cannot fully answer all aspects of your request as it pertains to a clinical study with acceptance criteria often seen in AI/ML medical device submissions.
However, I can extract information related to performance testing and equivalence to the predicate device.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists technical specifications and performance parameters that were compared to the predicate device to demonstrate substantial equivalence. The reported device performance is presented as its specifications, not as a result of a study against a specific numerical acceptance criterion.
| Performance Parameter | TIPCAM®1S 3D System (Subject Device) | VS3 Stereoscopic High Definition Vision System (Primary Predicate) | "Acceptance Criteria" (Implied Equivalence) | Reported Performance (Subject Device) |
|---|---|---|---|---|
| Depth of Field | 7 – 44 mm | 7 – 30mm and 15 – 60 mm | Comparable to predicate | 7 – 44 mm |
| Direction of View | 0° & 30° | 0 - 70° | Comparable to predicate | 0° & 30° |
| Field of View | 80° | 70 - 95° | Comparable to predicate | 80° |
| Working Length | 175 mm | 175 – 300 mm | Comparable to predicate | 175 mm |
| Diameters | 4mm | 4mm & 5.5mm | Comparable to predicate | 4mm |
| Light Source Compatibility | Xenon & LED | Xenon | Comparable to predicate | Xenon & LED |
| Zoom | Yes | Yes | Functional | Yes |
| Image Enhancement | Yes | Yes | Functional | Yes |
| Image Capture | Yes | Yes | Functional | Yes |
| Video Recording | Yes | Yes | Functional | Yes |
| Switch Between 2D and 3D Image | Yes | Yes | Functional | Yes |
| Scope Diameters | 4 mm | 4mm & 5.5mm | Comparable to predicate | 4 mm |
| Resolution | HD | SD | Equivalent or better than predicate | HD |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "No clinical information is required for this submission." Therefore, there is no clinical test set, sample size, or data provenance from a clinical study to report. The "Performance Testing" mentioned under Non-Clinical Performance Data likely refers to bench testing and engineering verification, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study with a test set requiring expert ground truth establishment was conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set requiring adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for an endoscopic camera system, not an AI/ML diagnostic algorithm. Therefore, an MRMC study and effects on human reader performance with AI assistance are not relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study requiring ground truth was conducted. For the non-clinical performance testing, the ground truth would be against established engineering standards and technical specifications.
8. The sample size for the training set
Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
Summary of Device and Evidence:
The TIPCAM®1S 3D System sought 510(k) clearance by demonstrating substantial equivalence to existing predicate devices (VS3 Stereoscopic High Definition Vision System K131434 and SPIES 3D System K150525).
The evidence for substantial equivalence was primarily based on:
- Non-Clinical Performance Data: This included tests for electrical safety and EMC (e.g., IEC 60601 series), ISO endoscopes standards (e.g., ISO 8600 series), biocompatibility testing (ISO 10993-1), software verification and validation, performance testing (White Balance, Brightness, Image Enhancement, Video Output Format, Zoom, Image Quality, Image Capture Latency, Interface Control, 3D-2D mode), and reprocessing (cleaning and steam sterilization).
- Comparison of Technical Characteristics: A direct comparison of key specifications between the subject device and the predicate device, showing similar or superior characteristics (e.g., Resolution: HD for subject device vs. SD for predicate).
The submission explicitly states, "No clinical information is required for this submission," indicating that the FDA determined that non-clinical testing and comparison to a predicate device were sufficient to establish safety and effectiveness for this device, which is a hardware-based imaging system, not a diagnostic AI/ML software. Therefore, the "acceptance criteria" and "study" are framed within the context of regulatory substantial equivalence, not a clinical performance trial.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three figures in profile forming the staff and a cloth-like element wrapping around them.
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.
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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 diagnosticand/or surgical procedures when endoscopic video assistance isrequired for visualization within ventricles and structures withinthe brain during neurological surgical procedures. TheTIPCAM®1S 3D System is a medical device system which consistsof a 4mm Tipcam®1S and a previously 510k cleared cameracontrol unit (CCU), K150525. |
| Indications For Use: | TIPCAM®1S 3D: The Rigid Videoendoscope is intended to beused together with the camera control unit for use in the |
| visualization of ventricles and structures within the brain duringneurological surgical procedures. | |
| IMAGE1 S is a camera control unit (CCU) for use with cameraheads or videoendoscopes for the visualization anddocumentation of endoscopic and microscopic procedures. | |
| TechnologicalCharacteristics: | 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 beconnected to a compatible light source via a light cable as the sourceof illumination to allow visualization of inside the patient's anatomy captured by the videoendoscope, processed by the CCU and finallyprojected to any connected medical grade monitors. |
| Non-ClinicalPerformance Data: | There are no performance standards or special controlsdeveloped under Section 514 of the FD&C Act for endoscopes.However, SPIES 3D System follows the FDA recognizedconsensus standards and is tested according to the followingstandard 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 itspredicate devices. The non-clinical testing demonstrates that thedevice is as safe and effective as the legally marketed devices. |
§ 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).