(24 days)
Image1 SPIES (K131953)
No
The summary describes a camera control unit with image enhancement features and software updates, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic development. The performance studies focus on standard imaging metrics and software verification.
No
The device is described as a camera control unit for visualization, image recording, and documentation during endoscopic and microscopic procedures. Its function is to capture and process images, not to treat or diagnose a disease or condition.
No
This device is described as a camera control unit for visualization, image recording, and documentation during endoscopic and microscopic procedures. Its intended use focuses on providing visual information to support procedures, not on diagnosing medical conditions.
No
The device description explicitly states it is a "camera control unit" and includes an "additional camera head," indicating it is a hardware device with associated software, 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 is for "visualization, image recording and documentation during general endoscopic and microscopic procedures." This describes a device used during a medical procedure to visualize internal structures, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description reinforces its use with camera heads and video endoscopes for procedures.
- Input Imaging Modality: Endoscopic and microscopic procedures involve direct visualization of the body.
- Anatomical Site: The specified anatomical sites are within the body (peritoneal and thoracic cavity, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is clearly focused on image capture and visualization during procedures.
N/A
Intended Use / Indications for Use
The IMAGE1 SPIES 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.
Product codes
FET
Device Description
The modified Image1 SPIES (Storz Professional Image Enhancement System) camera control unit includes an additional camera head that can be connected to the X-link module and software updates for improvement of existing features and bug fixes. The SPIES Camera System is intended and designed for use during endoscopic and microscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
within the 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
Bench testing for performance verification and validation purposes were conducted. The tests included: Resolution, Brightness, White Balance, Color Performance, Latency, Temporal Noise, Residual Spatial Noise, Step Response of Automated Exposure System, and Software Verification Tests. The bench testing performed verified and validated that the Image1 SPIES System has met all its design specification and is substantially equivalent to the predicate device, Image1 SPIES, for use in all endoscopic procedures within the peritoneal and thoracic cavity, including gynecological and urological anatomy.
Key Metrics
Not Found
Predicate Device(s)
Image1 SPIES (K131953)
Reference Device(s)
Not Found
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2016
Karl Storz Endoscopy America, Inc. Winkie Wong Regulatory Affairs Specialist 2151 E. Grand Ave El Segundo, CA 90245
Re: K160044 Trade/Device Name: Image1 SPIES System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FET Dated: January 6, 2016 Received: January 8, 2016
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
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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.
for
Sincerely yours,
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. 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)
Device Name Image1 SPIES System
Indications for Use (Describe)
The IMAGE1 SPIES 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.
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 phrase "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 1, 2016 |
| Device Identification: | Trade Name: Image1 SPIES System
Common Name: Endoscopic Camera System
Classification Name: Endoscope and accessories |
| Product Code: | FET |
| Regulation: | CFR 876.1500 |
| Predicate Device: | Image1 SPIES (K131953) |
| Device Description: | The modified Image1 SPIES (Storz Professional Image
Enhancement System) camera control unit includes an
additional camera head that can be connected to the X-link
module and software updates for improvement of existing
features and bug fixes. The SPIES Camera System is
intended and designed for use during endoscopic and
microscopic procedures. |
| Indications For Use: | The IMAGE1 SPIES 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. |
| Technological
Characteristics: | The predicate and subject devices are both camera systems that
are used for the visualization and documentation of endoscopic
and microscopic procedures. 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 smaller telescope size attachment than the predicate device. |
| | The bench test data for the Image1 SPIES 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 can be provided upon request. |
| | The minor difference in specifications when compared to the
predicate device, Image1 SPIES System, does not raise new
issues of safety and effectiveness and the devices are
substantially equivalent for the visualization and
documentation of endoscopic and microscopic procedures. |
| Non-Clinical
Performance Data: | Image1 SPIES System undergone bench testing for
performance verification and validation purposes:
Resolution Brightness White Balance Color Performance Latency Temporal Noise Residual Spatial Noise Step Response of Automated Exposure System Software Verification Tests |
| | The bench testing performed verified and validated that the
Image1 SPIES System has met all its design specification
and is substantially equivalent to the predicate device,
Image1 SPIES, 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 Image1 SPIES 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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