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.

Device Description

The HD Mediastinoscope is a reusable videoendoscope intended to be used in conjunction with the X-link module of the Image1 S Camera Control Unit. The HD Mediastinoscope is comprised of four main components: CMOS sensor at the distal end of the endoscope, an oval insertion portion (spatula), handle, and internal LED light source. The spatula can accommodate up to 2 x 5 mm instruments.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HD Mediastinoscope:

Due to the nature of the device (a physical surgical instrument rather than an AI/software device), the provided document does not contain information typically found in acceptance criteria and studies for AI/ML devices, such as sensitivity, specificity, or AUC.

Based on the provided text, the "acceptance criteria" appear to be related to the device's technical specifications and safety/effectiveness in comparison to predicate devices, rather than specific performance metrics like those for an AI algorithm.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied through the comparison with existing predicate and reference devices and compliance with recognized standards. The "performance" is demonstrated through non-clinical testing, particularly a cadaver test study.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (K954910)	Demonstrated through technical characteristics, intended use, indications for use.
Compliance with electrical safety and EMC standards	ANSI/AAMI ES:60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC 62471:2006
Compliance with biocompatibility standards	ISO 10993-10:2010, ISO 10993-11:2006/(R) 2010
Compliance with reprocessing validation standards	AAMI TIR 12:2010, AAMI TIR 30:2011, AAMI/ANSI/ISO 11737-1:2006/(R)2011, ASTM E1837-96:2014
Change in spatula design does not raise new questions of safety and effectiveness	Demonstrated through a cadaver test study.

Details of the Study (Non-AI/ML Device)

Since this is a traditional medical device (mediastinoscope) and not an AI/ML device, many of the requested points related to AI/ML studies (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or not specified in this 510(k) summary.

However, based on the information provided:

Sample size used for the test set and the data provenance:
- The primary non-clinical performance test mentioned is a cadaver test study.
- The sample size (number of cadavers or tests performed) is not specified in the document.
- The data provenance (country of origin, retrospective/prospective) is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "a cadaver test study was conducted to demonstrate that the change in spatula design...". It does not specify the use of "experts" to establish a "ground truth" in the way an AI/ML study would (e.g., radiologists labeling images). Instead, the study likely involved technical assessment and observation by qualified personnel (e.g., surgeons, engineers).
- Not explicitly stated in terms of "ground truth experts" for an AI/ML context.
Adjudication method for the test set:
- Not applicable / Not specified for this type of device and study.
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:
- No, an MRMC study was not conducted. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the cadaver study, the "ground truth" would likely be the direct observation and technical assessment of the device's performance in a cadaveric model (e.g., ease of introduction, visualization, ability to facilitate instrument use, assessment of tissue damage, etc.) by the study investigators. This is not a "ground truth" in the sense of a diagnostic label for an AI.
The sample size for the training set:
- Not applicable. This device does not use a training set as it is not an AI/ML product.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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".

June 23, 2022

Karl Storz Endoscopy America, Inc. Alita McElroy Senior Regulatory Affairs Specialist 2151 E. Grand Ave El Segundo, California 90245

Re: K213194

Trade/Device Name: HD Mediastinoscope Regulation Number: 21 CFR 874.4720 Regulation Name: Mediastinoscope And Accessories Regulatory Class: Class II Product Code: EWY Dated: May 31, 2022 Received: June 2, 2022

Dear Alita McElroy:

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

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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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 Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213194

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)
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X 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 written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

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:	Alita McElroySenior Regulatory Affairs SpecialistPhone: (424) 218-8376Email: Alita.McElroy@karlstorz.com
Date ofPreparation:	June 23, 2022
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):	Predicate Device: Optical Mediastinoscope (K954910)Reference Devices: HOPKINS I & II Rigid Autoclavable Telescope (K935279),C- cam (K143640), HD Mediastinoscope (K202272)
DeviceDescription:	The HD Mediastinoscope is a reusable videoendoscope intended to be used inconjunction with the X-link module of the Image1 S Camera Control Unit. The HDMediastinoscope is comprised of four main components: CMOS sensor at the distalend of the endoscope, an oval insertion portion (spatula), handle, and internal LEDlight source. The spatula can accommodate up to 2 x 5 mm instruments.
Intended Use:	The HD Mediastinoscope System is intended for visualization purposes duringsurgical procedures.
Indications for Use:	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.
TechnologicalCharacteristics.	The subject device, HD Mediastinoscope is substantially equivalent to the KARLSTORZ Optical Mediastinoscope, (510(k) Number: K954910), marketed by KARLSTORZ Endoscopy-America. The Hopkins telescope (K935279) and C-cam(K143640) were chosen as reference devices to be used with the predicate to supportoptical characteristics as they are required to be used with the predicate for a
	complete imaging system.
	The subject and predicate devices have the same intended use, indications for use, similar technological and optical characteristics. The main differences between the subject and the predicate devices include the following:The subject device is a videoendoscope equipped with an internal light source and CMOS sensor chip whereas the predicate is an optical mediastinoscope that requires connection to external components (Hopkins telescope, camera head, light source) The insertion shaft diameter, field of view and on-axis resolution are slightly different when compared to the predicate device The distal tip spatula radius of the subject device is different when compared to the predicate device
	The subject device is a modification of the reference device, HD Mediastinoscope (510(k) Number: K202272), marketed by KARL STORZ Endoscopy-America. The difference between the subject device and the reference is that the subject device has a rounded spatula edge with an increased distal tip spatula radius of 5mm +2/-1mm and wall thickness of 1.2mm 0/-0.25mm in comparison to the cleared device with a sharp spatula edge, distal tip spatula radius of 1mm and spatula wall thickness of 0.77mm.
	The cleared HD Mediastinoscope (510(k) Number: K202272) has been chosen as reference device to leverage previous testing such as optical performance tests, electrical safety, biocompatibility and reprocessing to demonstrate safety and effectiveness of the subject device when compared to the predicate device.
Non-ClinicalPerformance Data:	The subject device, HD Mediastinoscope is compliance with the following FDA recognized standards:Electrical Safety and EMC ANSI/AAMI ES:60601-1:2005+A1:2012 IEC 60601-1-2:2014 IEC 62471:2006 Biocompatibility ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010 Reprocessing Validation Summary AAMI TIR 12:2010 AAMI TIR 30:2011 AAMI/ANSI/ISO 11737-1:2006/ (R)2011 ASTM E1837-96:2014
	A cadaver test study was conducted to demonstrate that the change in spatula design of the subject device does not raise new questions of safety and effectiveness when
	compared to the predicate device and the reference device.
ClinicalPerformance Data:	Clinical testing was not required to demonstrate the substantial equivalence to thepredicate devices. Non-clinical bench testing was sufficient to establish thesubstantial equivalence of the subject device to the predicate device.
Conclusion:	The nonclinical test demonstrates that the subject device is substantially equivalent tothe predicate device.

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Image /page/4/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, sans-serif font.

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Image /page/5/Picture/0 description: The image shows the logo for STORZ. The logo is in blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font. The logo is simple and modern, and it is likely used to represent a company that specializes in endoscopy products.

Regulation Number and Section

§ 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.