The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 25° and 45° direction of view, 5mm diameter and 29cm working lengths.

AI/ML Overview

The provided text is a 510(k) summary for the KARL STORZ HOPKINS Telescopes. This document is a premarket notification for a medical device to demonstrate substantial equivalence to a legally marketed predicate device. As such, it focuses on comparing the new device to an existing one based on technical characteristics, rather than establishing acceptance criteria and proving performance through a clinical study for an AI/ML-driven device.

The document discusses the physical and optical characteristics of the endoscope, reprocessing methods, and non-clinical performance data (e.g., adherence to ISO standards, biocompatibility, thermal safety, reprocessing validation). It explicitly states: "There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes." This indicates that the regulatory pathway for this device does not require the kind of performance validation typically seen for AI/ML devices, which would involve acceptance criteria for metrics like sensitivity, specificity, or AUC, and detailed clinical study designs.

Therefore, the document does not contain the information required to answer the prompt questions regarding acceptance criteria for an AI/ML device. The HOPKINS Telescopes are a traditional optical medical device, not an AI/ML product.

To reiterate, the provided text does not contain any information about:

Acceptance criteria or reported device performance for AI/ML metrics.
Sample sizes for test sets or data provenance (as it's not an AI/ML study).
Number and qualifications of experts for ground truth establishment.
Adjudication methods.
MRMC comparative effectiveness studies or effect sizes.
Standalone algorithm performance studies.
Type of ground truth (as it's not a diagnostic AI/ML device).
Sample size for training sets (no AI/ML training is mentioned).
How ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

December 20, 2022

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

Re: K221004

Trade/Device Name: HOPKINS Telescopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 19, 2022 Received: November 21, 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 medical devices and radiation-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,

Jessica Carr -S

for Long Chen, PhD Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K221004

Device Name HOPKINS Telescopes

Indications for Use (Describe)

The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.

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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Image /page/3/Picture/0 description: The image shows the logo for STORZ. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

510(k) Summary K221004

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:	December 19, 2022
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: HOPKINS TelescopesClassification Name: Laparoscope, General and Plastic Surgery (21 CFR876.1500)
Regulatory Class:	II
Product Code:	GCJ
ClassificationPanel:	General and Plastic Surgery
PredicateDevice(s):	KARL STORZ HOPKINS I and II Rigid Autoclavable Telescopes (K935279)
DeviceDescription:	The HOPKINS Telescopes are rigid telescopes that utilize the rod lenstechnology. At the distal end of the telescope's shaft is the lens and the otherend of the shaft is attached to the eyepiece. Throughout the central lumen ofthe HOPKINS Telescopes, optical glass rods are used to transmit and magnifythe image received from the lens. The HOPKINS Telescopes are availablewith 0°, 25° and 45° direction of view, 5mm diameter and 29cm workinglengths.
Intended Use andIndications forUse:	The HOPKINS Telescopes are intended to provide visualization duringlaparoscopy, thoracoscopy and general surgery in adults and pediatrics.

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Image /page/4/Picture/0 description: The image contains the logo for STORZ. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

TechnologicalCharacteristics.	TechnologicalCharacteristics	HOPKINSTelescopes	KARL STORZHOPKINS I and IIRigid AutoclavableTelescopes	Comparison
		SubjectDeviceK221004	PredicateDevice K935279
	Physical Characteristics
	Endoscope Type	Rigid, rod lens	Rigid, rod lens	same
	Outer Diameter	5mm	4mm-10mm	similar
	Working Length	29cm	29cm-35cm	similar
	Optical Characteristics
	Direction of View	0°, 25°, 45°	0°, 30°	different
	Field of View	68°	65°- 70°	similar
	Depth of Field	15.1mm-200mm	11.4mm- 200mm	different
	Light source	External	External	same
	Reprocessing Methods
	Cleaning	Manual,Automatic	Manual	different
	Sterilizationmodalities	Steam (pre-vacuum),STERRAD100S,STERRADNX,STERRAD100NX,STERIS V-PRO 1, V-PRO 1 Plus	Steam (pre-vaccum), EO,ChemicalDisinfection	different
Non-ClinicalPerformance Data:	There are no performance standards or special controls developed underSection 514 of the FD&C Act for endoscopes. However, the HOPKINSTelescopes follows the FDA recognized consensus standards and is testedaccording to the following standards and FDA Guidance:ISO Endoscopic Standards• ISO 8600-1• ISO 8600-3• ISO 8600-5• ISO 8600-6

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Image /page/5/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is blue and features 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 professional, and it is likely used to represent the company's brand.

Biocompatibility Summary
Cytotoxicity (ISO 10993-5) Acute Systemic Toxicity (ISO 10993-11) Intracutaneous Irritation (ISO 10993-10) Maximization Sensitization (ISO 10993-10)
Thermal Safety
IEC 60601-2-18:2009 (3RD Edition)
Reprocessing (Cleaning and Sterilization)
AAMI TIR12: 2010 AAMI TIR30: 2011 ANSI/AAMI ST8: 2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017 ANSI/AAMI ST81:2004/(R)2010 AAMI/ISO 14937:2009 ANSI/AAMI/ISO 17655-1:2006/2013 Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling
Comparative bench testing between the subject and predicate device demonstrated that the HOPKINS Telescopes has met all its design specification and is substantially equivalent to its predicate device.
Clinical Performance Data:	Published literature was provided to support the safety and effectiveness of the HOPKINS Telescopes for use in pediatrics during laparoscopy, thoracoscopy and general surgery.
Conclusion:	The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device.

Regulation Number and Section

§ 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.