(185 days)
No
The summary describes a standard videoendoscope system with image processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on 3D visualization and standard image processing.
No
The device is described as being for "visualization" during both diagnostic and therapeutic procedures, but its function is limited to providing visual assistance. It does not directly perform any therapeutic action.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is for "visualization of the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures." Visualization for diagnostic purposes directly indicates it is a diagnostic device.
No
The device description explicitly states it is a "medical device system which consists of a 4mm Tipcam®1S and a previously 510k cleared camera control unit (CCU)". It also mentions a "4mm TIPCAM®1S 3D Videoendoscope" and connection to a "compatible light source via a light cable". These are all hardware components, indicating it is not a software-only 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 "visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures." This describes a device used in vivo (within the living body) for visualization, not for testing samples in vitro (outside the living body).
- Device Description: The description reinforces the in vivo use by mentioning visualization of "inside the patient's anatomy."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition. The device is a tool for direct visualization.
Therefore, the TIPCAM 1S 3D system is an endoscopic visualization system, not an In Vitro Diagnostic device.
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 to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic 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.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The TIPCAM®1S 3D System is intended for use during diagnostic and/or surgical procedures when endoscopic video assistance is required within nasal cavity and nasal pharynx. 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic video
Anatomical Site
nasal cavity and nasal pharynx
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:
- 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.
VSII Visionsense Stereoscopic Vision System (K082667)
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), KARL STORZ Rigid Telescopes (K945788)
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Karl Storz Endoscopy America, Inc. Ms. Winkie Wong Senior Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K162410
Trade/Device Name: TIPCAM 1S 3D System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: January 27, 2017 Received: January 31, 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.
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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.
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.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162410
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 to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic 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.
| 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 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: | January 24, 2017 |
| Device Identification: | Trade Name: TIPCAM®1S 3D System
Common Name: Endoscopic Camera System
Classification Name: Endoscopic Camera System |
| Product Code: | EOB |
| Regulation: | 21 CFR 874.4760 |
| Predicate Device(s): | VSII Visionsense Stereoscopic Vision System (K082667)
The above predicate has not been subject to any recall |
| Reference Device | SPIES 3D System (K150525)
KARL STORZ Rigid Telescopes (K945788)
The above reference device has not been subject to any recall |
| Device Description: | The TIPCAM®1S 3D System is intended for use during diagnostic
and/or surgical procedures when endoscopic video assistance is
required within nasal cavity and nasal pharynx. 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 to visualize
the nasal cavity and nasal pharynx during diagnostic and
therapeutic 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
and the Image1S CCU for image processing. The live image will be
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
|
| | 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 has the same intended use and indication or use, similar principles of operation and technological characteristics as the cleared Visionsense's VSII Visionsense Stereoscopic Vision System (K082667).
Below is a list of similarities between the TIPCAM®1S 3D System and its predicate devices: All systems use a 4mm diameter rigid endoscope with a length of 175mm and direction of view of 0° or 30° |
| All systems include a CCU for image processing. All systems include the same basic functional feature, such as zoom, image enhancement, image capture, video recording and switch between 2D and 3D images. The following technological differences exist between the subject and predicate devices: The subject device system includes a 4mm rigid videoendoscope while the predicate device system includes a 4mm and 5.5mm rigid endoscope to be attached to a camera head. Different resolution (HD vs. SD) LED light source compatibility | |
| 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. |
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