(263 days)
No
The summary describes a 3D endoscopic system and its components, focusing on visualization and documentation. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The testing described is standard for medical devices and does not indicate the use of AI/ML algorithms for image analysis or other functions.
No
The device is described as an endoscope and camera control unit intended for visualization and documentation during diagnostic and surgical procedures, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for use during diagnostic and/or surgical procedures."
No
The device description explicitly states it is a "medical device system which consists of the camera control unit (CCU)... and 3D Tipcam®1," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for use during diagnostic and/or surgical procedures to provide endoscopic video assistance. It is used to visualize internal anatomy within the peritoneal and thoracic cavity. This is a direct visualization tool used in vivo (within the living body).
- Device Description: The description confirms it's a system for visualizing and documenting endoscopic and microscopic procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on biological specimens.
The device is clearly an endoscopic system used for direct visualization during medical procedures, which falls under the category of surgical or diagnostic instruments, not IVDs.
N/A
Intended Use / Indications for Use
3D TIPCAM®1: The Rigid Videoendoscope is intended to be used together with the camera control unit is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological anatomy.
IMAGE1 SPIES 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
HET, GCJ, FGB
Device Description
The SPIES 3D System is intended for use during diagnostic and/or surgical procedures when endoscopic video assistance is required within the peritoneal and thoracic cavity, including gynecological and urological anatomy.
The SPIES 3D System is a medical device system which consists of the camera control unit (CCU) – a combination of the previously 510k cleared device (K131953) – Image1 Connect module (TC200) and the D3-Link module, and 3D Tipcam®1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peritoneal and thoracic cavity, including gynecological and urological anatomy.
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
Non-Clinical Performance Data: Software validation was completed for a moderate level of concern per the FDA guidance document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
Reprocessing validation as completed per the FDA guidance document: "Reprocessing Medical Devices in Heath Care Settings: Validation Methods and Labeling" dated March 2, 2015.
SPIES 3D System is tested according to the following standard:
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-18
• ISO 10993-5, 2009 (Cytotoxicity)
• ISO 10993-11, 2010 (Systemic Toxicity)
• ISO 10993-10, 2010 (Sensitization and Irritation)
Additional bench testing for performance verification and validation purposes:
• Resolution
• Brightness
• White Balance
• 3D-2D Mode
• Color Performance
• Latency
• Electrosurgical Unit Susceptibility
• Minimum Illumination
• Auto Exposure Setp Response
• Zero Degree Parallax
The bench testing performed verified and validated that the SPIES 3D System has met all its design specification and is substantially equivalent to the predicate device, ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE SYSTEM, for use in all endoscopic procedures within the peritoneal and thoracic cavity, including gynecological and urological anatomy.
Clinical Performance Data: No clinical information is required for this submission
Key Metrics
Not Found
Predicate Device(s)
ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE SYSTEM (K123365)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Karl Storz Endoscopy-America, Inc. Winkie Wong Regulatory Affairs Specialist 2151 E. Grand Ave El Segundo, California 90245
Re: K150525
Trade/Device Name: SPIES 3D System Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope And Accessories Regulatory Class: Class II Product Code: HET, GCJ, FGB Dated: October 16, 2015 Received: October 19, 2015
Dear Winkie 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
1
the quality systems (OS) 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.
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150525
Device Name SPIES 3D System
Indications for Use (Describe)
3D TIPCAM®1: The Rigid Videoendoscope is intended to be used together with the camera control unit is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological anatomy.
IMAGE1 SPIES 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 logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
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
El Segundo, CA 90245 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Regulatory Affairs Specialist
424-218-8379
424-218-8519 |
| Date of Preparation: | February 25, 2015 |
| Device Identification: | Trade Name: SPIES 3D System
Common Name: Endoscopic Camera System
Classification Name: Gynecologic Laparoscope And
Accessories |
| Product Code: | HET, GCJ, FGB |
| Regulation: | 21 CFR 884.1720 |
| Predicate Device(s): | ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
SYSTEM (K123365) |
| Device Description: | The SPIES 3D System is intended for use during diagnostic
and/or surgical procedures when endoscopic video
assistance is required within the peritoneal and thoracic
cavity, including gynecological and urological anatomy.
The SPIES 3D System is a medical device system which
consists of the camera control unit (CCU) – a combination of
the previously 510k cleared device (K131953) – Image1
Connect module (TC200) and the D3-Link module, and 3D
Tipcam®1. |
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| Indications For Use: | 3D TIPCAM®1: The Rigid Videoendoscope is intended to be
used together with the camera control unit is for use during
diagnostic and/or surgical procedures when endoscopic
video assistance is required. For use in all endoscopy and
endoscopic surgery within the peritoneal and thoracic
cavity, including gynecological and urological anatomy.
IMAGE1 SPIES 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 predicate and subject devices are both camera systems
that are used for observation purposes in general
endoscopic surgery within the thoracic and peritoneal
cavity, including gynecological and urological anatomy.
There are some minor differences in the technological
characteristics. These differences are: |
| | • The subject device uses a CMOS sensor instead of a
CCD sensor.
• The subject device has a more limited specification
on field of view (82° vs. 90°) due to the deflectable tip
in the predicate device.
• The subject device includes different patient
contacting materials |
| | The bench test data for the SPIES 3D System 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. The
performance validation test report is provided in section
021_Performance Testing of this submission. |
| | The minor difference in specifications when compared to the
predicate device, ENDOEYE FLEX 3D DEFLECTABLE
Videoscope System, is that the SPIES 3D System does not
raise new issues of safety and effectiveness and the devices
are substantially equivalent for general endoscopic
application within the thoracic and peritoneal cavity. |
| Non-Clinical | Software validation was completed for a moderate level of concern per the FDA guidance document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005. |
| Performance Data: | Reprocessing validation as completed per the FDA guidance document: "Reprocessing Medical Devices in Heath Care Settings: Validation Methods and Labeling" dated March 2, 2015. |
| | SPIES 3D System is tested according to the following standard: |
| | • IEC 60601-1 |
| | • IEC 60601-1-2 |
| | • IEC 60601-2-18 |
| | • ISO 10993-5, 2009 (Cytotoxicity) |
| | • ISO 10993-11, 2010 (Systemic Toxicity) |
| | • ISO 10993-10, 2010 (Sensitization and Irritation) |
| | Additional bench testing for performance verification and validation purposes: |
| | • Resolution |
| | • Brightness |
| | • White Balance |
| | • 3D-2D Mode |
| | • Color Performance |
| | • Latency |
| | • Electrosurgical Unit Susceptibility |
| | • Minimum Illumination |
| | • Auto Exposure Setp Response |
| | |
| | • Zero Degree Parallax |
| | The bench testing performed verified and validated that the SPIES 3D System has met all its design specification and is substantially equivalent to the predicate device, ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE SYSTEM, for use in all endoscopic procedures within the peritoneal and thoracic cavity, including gynecological and urological |
| | anatomy. |
| Clinical | No clinical information is required for this submission |
| Performance Data: | |
| Conclusion: | The SPIES 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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