(273 days)
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.
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).
This document describes the FDA's 510(k) clearance for the Karl Storz HD Mediastinoscope (K202272). The device is intended to aid surgeons in viewing the mediastinum and facilitating the introduction and removal of surgical instruments during ENT endoscopic procedures.
The information provided focuses on the substantial equivalence determination based on non-clinical performance data, rather than a study proving the device meets AI-specific acceptance criteria. Therefore, most of the requested information regarding AI model performance, ground truth establishment, expert review, and clinical study details is not present in the provided text.
Here is a breakdown of what can be extracted and what is not available based on the request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format for performance. Instead, it states compliance with recognized standards and successful completion of various bench tests.
| Test Category | Acceptance Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC | Compliance with ANSI/AAMI ES:60601-1:2005+A1:2012 and IEC 60601-1-2:2014 | In compliance with the stated standards. |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5:2009/(R) 2014, ISO 10993-10:2010, ISO 10993-11:2006/(R) 2010, and FDA Guidance | Evaluation performed, tests conducted based on contact type and duration. |
| Reprocessing Validation | Compliance with AAMI TIR 12:2010, AAMI TIR 30:2011, AAMI/ANSI/ISO 11737-1:2006/(R)2011, ASTM E1837-96:2014 | Validation activities performed for cleaning and sterilization; in compliance with standards. |
| Optical Performance | Not explicitly quantified, but successful completion of tests is implied for substantial equivalence. | |
| - Color Reproduction & Contrast | (Implied successful performance for medical imaging) | Tested. |
| - Illumination Detection Uniformity | (Implied successful performance) | Tested. |
| - Instantaneous Dynamic Range (IDR) & Detection Linearity | (Implied successful performance) | Tested. |
| - Spatial Resolution & Depth of Field | (Implied successful performance) | Tested. |
| - Distortion & Field of View | (Implied successful performance) | Tested. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "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." This means there was no clinical test set in the traditional sense for assessing device performance in a human population. All testing was non-clinical bench testing. Therefore, sample size and data provenance (country, retrospective/prospective) related to a clinical test set are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set or ground truth in the context of diagnostic interpretation (e.g., for an AI model) was established. The ground truth for bench testing would be metrology standards and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set involving human readers or interpretation was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mediastinoscope (a physical viewing instrument), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the ground truth would be based on established engineering and optical metrology standards, and potentially manufacturer specifications for the device's components. For biocompatibility and reprocessing, the ground truth is compliance with the listed ISO and AAMI standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 AvenueEI Segundo, CA 90245 |
|---|---|
| Contact: | Winkie WongManager, Regulatory AffairsPhone: (424) 218-8379Email: Winkie.wong@karlstorz.com |
| Date ofPreparation: | May 3rd, 2021 |
| 510K Number | K202272 |
| Type of 510(k)Submission: | Traditional |
| DeviceIdentification: | Trade Name: HD MediastinoscopeClassification Name: Mediastinoscope and accessories (21 CFR 874.4720) |
| Regulatory Class: | II |
| Product Code: | EWY |
| ClassificationPanel: | ENT |
| PredicateDevice(s): | Optical Mediastinoscope (K954910) - PredicateHopkins I & II Rigid Autoclavable Telescope (K935279) – ReferenceC-cam (K143640) – ReferenceThe above predicate and reference devices have not been subjected to any recall |
| DeviceDescription: | The components subject of this submission are: HD Mediastinoscope (PartNumber: 10973HD), and the IMAGE1 S CCU. The CCU consists of theIMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 SX-Link (Model Number: TC301US). |
| Intended Use: | The HD Mediastinoscope System is intended for visualization purposesduring surgical procedures. |
| Indications ForUse: | The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinumand facilitate the introduction and removal of surgical instruments during ENTendoscopic 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.
| TechnologicalCharacteristics: | Comparison Table: Subject vs. Predicate Devices | ||
|---|---|---|---|
| Subject Device | Predicate DeviceK954910 | ||
| Physical Characteristics | |||
| Type ofScope | Rigid | Rigid | |
| InsertionShaftDiameter | 20 mm | 25 mm | |
| InsertionShaftLength | 18 cm | 17 cm | |
| WorkingChannel | 1 instrument channel (for up to 2x 5mminstrument) | •1 instrument channel (for up to 2x 5mminstrument)•1 telescope channel | |
| Optical Characteristics | |||
| Type ofImager | CMOS | CCD (via camera head) | |
| Direction ofView | 30° | Same as the subject device | |
| LightSource | Internal LED | External | |
| Depth ofField | 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 usedwith the predicate to support scientific methodology during the comparison of optical characteristics. | |||
| Non-ClinicalPerformanceData: | Electrical Safety and Electromagnetic Compatibility SummaryThe electrical safety and EMC data included in the submission is in compliance with thefollowing FDA recognized standards:• ANSI/AAMI ES:60601-1:2005+A1:2012• IEC 60601-1-2:2014Bench Testing SummaryThe performance data submitted in the submission is in compliance with the following FDArecognized standards:• IEC 62471:2006Optical Performance Testing:• Color Reproduction and Color Contrast• Illumination Detection Uniformity• Instantaneous Dynamic Range (IDR) & Detection Linearity• Spatial Resolution & Depth of Field• Distortion & Field of viewBiocompatibility SummaryThe biocompatibility evaluation for the patient contacting components of the HDMediastinoscope was performed according to ISO 10993-1 and FDA Guidance. Thefollowing 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 SummaryThe 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 devicecontacts intact mucosal membranes so it is a semi-critical device per SpauldingClassification. We performed validation activities for cleaning and sterilization according tothe FDA Guidance. The reprocessing data submitted is in compliance with the followingstandards:AAMI TIR 12:2010 AAMI TIR 30:2011 AAMI/ANSI/ISO 11737-1:2006/ (R)2011 ASTM E1837-96:2014 | |
|---|---|
| ClinicalPerformanceData: | Clinical testing was not required to demonstrate the substantial equivalenceto the predicate devices. Non-clinical bench testing was sufficient toestablish the substantial equivalence of the modifications. |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that thesubject device, the HD Mediastinoscope system is substantially equivalent tothe legally marketed predicate device. |
§ 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.