(141 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms associated with AI/ML processing. The device description focuses on standard video endoscopy components.
No
The device is indicated for visualization during diagnostic procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the system is used "during diagnostic procedures," explicitly indicating a diagnostic purpose.
No
The device description explicitly lists hardware components: a Flexible HD Video-Rhino-Laryngoscope and an IMAGE1 S CCU (consisting of a Connect Module and X-Link). This indicates it is a hardware system with potentially integrated software, not a software-only device.
Based on the provided information, the KARL STORZ CMOS HD Video Rhino-Laryngoscope System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide visualization of the nasal lumens and airway anatomy... during diagnostic procedures." This describes a device used for direct visualization of internal body structures, which is characteristic of an endoscope or similar medical imaging device used in vivo (within the living body).
- Device Description: The device is described as a "Flexible HD Video-Rhino-Laryngoscope" and associated control units. This further supports its use for internal visualization.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to diagnose diseases or conditions. The description of this device does not involve the analysis of any biological specimens.
Therefore, the KARL STORZ CMOS HD Video Rhino-Laryngoscope System is a medical device used for in vivo visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KARL STORZ CMOS HD Video Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The components subject of this submission are: the Flexible HD Video-Rhino-Laryngoscope (Part Number: 11101 HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal lumens and airway anatomy (including nasopharyngeal and trachea)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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: Electrical Safety and Electromagnetic Compatibility Summary, Bench Testing Summary, Optical Performance Testing (Image Illumination Uniformity, Latency, Dynamic Range and Linearity, Signal to Noise Ratio & Sensitivity, Color Performance and Color Contrast Enhancement, System Resolution, Field of View, Distortion), Biocompatibility Summary, Reprocessing Validation Summary. Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
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.
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.
Not Found
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 11, 2020
KARL STORZ Endoscopy - America, Inc. Winkie Wong Manager Regulatory Affairs 2151 E. Grand Avenue El Segundo, California 90245
Re: K200740
Trade/Device Name: Flexible HD Video Rhino-Laryngoscope System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: July 3, 2020 Received: July 8, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for
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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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200740
Device Name
Flexible HD Video Rhino-Laryngoscope System
Indications for Use (Describe)
The KARL STORZ CMOS HD Video Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic 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 on the top line. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
K200740 - 510(k) Summary
This 510(k) Summary 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.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Regulatory Affairs Manager
Phone: (424) 218-8379 |
| Date of
Preparation: | August 8th, 2020 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: Flexible HD Video Rhino-Laryngoscope System
Classification Name: Nasopharyngoscope (flexible or rigid) and
accessories (21 CFR Part 874.4760) |
| Regulatory
Class: | II |
| Product Code: | EOB |
| Guidance
Document: | Not Applicable for EOB product codes |
| Recognized
Consensus
Standards: | 9-114: IEC 60601-2-18: Edition 3.0 2009-08
Medical electrical equipment - Part 2-18: Particular requirements for
the basic safety and essential performance of endoscopic equipment |
| Predicate
Device(s): | Primary Predicate Device: KARL STORZ Endoscopy-America's
CMOS Video Rhino Laryngoscope (K182186)
Secondary Predicate Device: KARL STORZ Endoscopy-America's
Flexible CMOS-Video- Rhino-Laryngoscope (K103467) |
| Device
Description: | The components subject of this submission are: the Flexible HD
Video-Rhino-Laryngoscope (Part Number: 11101 HD), and the
IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect
Module (Model Number: TC200US) and IMAGE1 S X-Link (Model
Number: TC301US). |
| Intended Use: | The KARL STORZ Flexible HD Video Rhino-Laryngoscope System |
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Image /page/4/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. The logo is simple and professional.
| Comparison Table: Subject vs. Primary and Secondary Predicate Devices | ||||
|---|---|---|---|---|
| Subject Device | Primary Predicate Device, K182186 | Secondary Predicate Device, K103467 | ||
| Physical Characteristics | ||||
| Type of Scope | Flexible | Same as the subject device | Same as the subject device | |
| Insertion Shaft Diameter | 3.7 mm | 2.9 mm | Same as the subject device | |
| Insertion Shaft Length | 300 mm | Same as the subject device | Same as the subject device | |
| Deflection | 140° Up, 140° Down | Same as the subject device | Same as the subject device | |
| Optical Characteristics | ||||
| Type of Imager | CMOS | Same as the subject device | Same as the subject device | |
| Direction of View | 0° | Same as the subject device | Same as the subject device | |
| Light Source | Internal LED | Same as the subject device | Same as the subject device | |
| Field of View | 100° | Same as the subject device | 85° | |
| On-axis Resolution (minimal) | 40 lp/mm@3 mm | |||
| 2.5 lp /mm@50 mm | 16 Lp/mm at 5 mm | |||
| 1.8 Lp/mm at 50 mm | 8.0 Lp/mm at 8 mm | |||
| 1.4 Lp/mm at 50 mm | ||||
| Reprocessing Methods | ||||
| Cleaning | Manual | Same as the subject device | Same as the subject device | |
| Sterilization | Yes | Yes | Yes | |
| HLD | Yes | Yes | Yes | |
| Non-Clinical | ||||
| Performance | ||||
| Data: | Electrical Safety and Electromagnetic Compatibility Summary | |||
| The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards: | ||||
| • ANSI/AAMI ES:60601-1:2005/(R) 2012 and A1:2012 | ||||
| • IEC 60601-1-2:2014 | ||||
| • IEC 60601-2-18: 2009 |
Bench Testing Summary
The performance data submitted in the submission is in compliance with the following FDA recognized standards:
• IEC 62471:2006
Optical Performance Testing:
• Image Illumination Uniformity
• Latency | | | |
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Image /page/5/Picture/0 description: The image contains 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 size.
| Dynamic Range and Linearity Signal to Noise Ratio & Sensitivity Color Performance and Color Contrast Enhancement System Resolution Field of View Distortion | |
|---|---|
| Biocompatibility Summary | |
| The biocompatibility evaluation for the patient contacting components of the neuroscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact type and duration: ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010 | |
| Reprocessing Validation Summary | |
| The Flexible HD Cysto-Urethroscope (Part Number: 11272V(H)) is provided non- sterile and is reusable. The users are required to reprocess it for initial and after each use. The subject device contacts intact mucosal membranes so it is a semi-critical device per Spaulding Classification. We performed validation activities for cleaning and sterilization according to the FDA Guidance. The reprocessing data submitted is in compliance with the following standards: AAMI TIR 12:2010 ISO 15883-5:2005 AAMI TIR 30:2011 AAMI/ANSI/ISO 11737-1:2006/ (R)2011 ASTM E1837-96:2014 | |
| Clinical | |
| Performance | |
| Data: | Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications. |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible HD Video-Rhino-Laryngoscope System is substantially equivalent to the legally marketed predicate devices. |