(273 days)
No
The summary describes a standard optical mediastinoscope and associated imaging components without mentioning any AI or ML capabilities. The focus is on viewing and instrument manipulation.
No.
The device is described as an HD Mediastinoscope intended to aid the surgeon in viewing and manipulating surgical instruments, not to treat a disease or condition.
No
Explanation: The device is described as aiding in viewing and facilitating instrument introduction/removal during surgery, but it does not claim to diagnose diseases or conditions. Its function is primarily visualization and access for surgical procedures.
No
The device description explicitly lists hardware components: HD Mediastinoscope, IMAGE1 S CCU, IMAGE1 S Connect Module, and IMAGE1 S X-Link.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures." This describes a surgical tool used for visualization and instrument manipulation within the body, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a mediastinoscope and associated imaging components (CCU, Connect Module, X-Link). These are all components of a surgical visualization system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.
Product codes
EWY
Device Description
The components subject of this submission are: HD Mediastinoscope (Part Number: 10973HD), 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
mediastinum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
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.
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+A1:2012
• IEC 60601-1-2:2014
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:
• Color Reproduction and Color Contrast
• Illumination Detection Uniformity
• Instantaneous Dynamic Range (IDR) & Detection Linearity
• Spatial Resolution & Depth of Field
• Distortion & Field of view
Biocompatibility Summary
The biocompatibility evaluation for the patient contacting components of the HD Mediastinoscope 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 HD Mediastinoscope (Part Number: 10973HD) 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 AAMI TIR 30:2011 AAMI/ANSI/ISO 11737-1:2006/ (R)2011 ASTM E1837-96:2014
Key Metrics
Not Found
Predicate Device(s)
Optical Mediastinoscope (K954910)
Reference Device(s)
Hopkins I & II Rigid Autoclavable Telescope (K935279), C-cam (K143640)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4720 Mediastinoscope and accessories.
(a)
Identification. A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
May 11, 2021
Karl Storz Endoscopy America, Inc. Winkie Wong Manager, Regulatory Affairs 2151 E. Grand Ave El Segundo, California 90245
Re: K202272
Trade/Device Name: HD Mediastinoscope Regulation Number: 21 CFR 874.4720 Regulation Name: Mediastinoscope And Accessories Regulatory Class: Class II Product Code: EWY Dated: April 2, 2021 Received: April 8, 2021
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 af fecting 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 to pic. 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 Shu-Chen Peng Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202272
Device Name HD Mediastinoscope
Indications for Use (Describe)
The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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. The logo is simple and professional.
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
Manager, Regulatory Affairs
Phone: (424) 218-8379
Email: Winkie.wong@karlstorz.com |
| Date of
Preparation: | May 3rd, 2021 |
| 510K Number | K202272 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: HD Mediastinoscope
Classification Name: Mediastinoscope and accessories (21 CFR 874.4720) |
| Regulatory Class: | II |
| Product Code: | EWY |
| Classification
Panel: | ENT |
| Predicate
Device(s): | Optical Mediastinoscope (K954910) - Predicate
Hopkins I & II Rigid Autoclavable Telescope (K935279) – Reference
C-cam (K143640) – Reference
The above predicate and reference devices have not been subjected to any recall |
| Device
Description: | The components subject of this submission are: HD Mediastinoscope (Part
Number: 10973HD), 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 HD Mediastinoscope System is intended for visualization purposes
during surgical procedures. |
| Indications For
Use: | The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum
and facilitate the introduction and removal of surgical instruments during ENT
endoscopic surgical procedures. |
4
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.
| Technological
| Characteristics: | Comparison Table: Subject vs. Predicate Devices | ||
|---|---|---|---|
| Subject Device | Predicate Device | ||
| K954910 | |||
| Physical Characteristics | |||
| Type of | |||
| Scope | Rigid | Rigid | |
| Insertion | |||
| Shaft | |||
| Diameter | 20 mm | 25 mm | |
| Insertion | |||
| Shaft | |||
| Length | 18 cm | 17 cm | |
| Working | |||
| Channel | 1 instrument channel (for up to 2x 5mm | ||
| instrument) | •1 instrument channel (for up to 2x 5mm | ||
| instrument) | |||
| •1 telescope channel | |||
| Optical Characteristics | |||
| Type of | |||
| Imager | CMOS | CCD (via camera head) | |
| Direction of | |||
| View | 30° | Same as the subject device | |
| Light | |||
| Source | Internal LED | External | |
| Depth of | |||
| Field | 18 - 50 mm | Same as subject device | |
| Reprocessing Methods | |||
| Cleaning | Manual | Same as the subject device | |
| Sterilization | Yes | Yes | |
| The Hopkins telescope (K935279) and C-cam (K143640) were chosen as reference devices to be used | |||
| with the predicate to support scientific methodology during the comparison of optical characteristics. | |||
| 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+A1:2012 | |||
| • IEC 60601-1-2:2014 |
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:
• Color Reproduction and Color Contrast
• Illumination Detection Uniformity
• Instantaneous Dynamic Range (IDR) & Detection Linearity
• Spatial Resolution & Depth of Field
• Distortion & Field of view
Biocompatibility Summary
The biocompatibility evaluation for the patient contacting components of the HD
Mediastinoscope 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 | | |
5
Image /page/5/Picture/0 description: The image shows the logo for STORZ, a company that specializes in endoscopes. 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 smaller letters.
| | Reprocessing Validation Summary
The HD Mediastinoscope (Part Number: 10973HD) 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 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 HD Mediastinoscope system is substantially equivalent to
the legally marketed predicate device. |