The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Description

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°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm diameter and 26cm, 30cm, 36cm working lengths.

AI/ML Overview

The provided text is a 510(k) Summary for the HOPKINS Telescopes, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI/software component.

Therefore, the provided document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/software performance.

The document states:

"Clinical studies were not required to demonstrate substantial equivalence to the predicate device." (Page 9)
"The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination." (Page 9)

This means the submission relies on bench testing and comparison of technological characteristics to a legally marketed predicate device, not on a clinical performance study with defined acceptance criteria and human readers (or AI algorithms) in the way your prompt describes.

To directly answer your questions based only on the provided text, the answer is that this information is not present for the HOPKINS Telescopes device.

If this were an AI/software device and the information was present, here's how I would answer each point:

Table of acceptance criteria and reported device performance: This would be a table detailing metrics like sensitivity, specificity, AUC, or agreement rates, with specific target thresholds (acceptance criteria) and the actual performance achieved in the study.
Sample size and data provenance: This would specify the number of cases/patients in the test set (distinct from training data), whether the data was collected retrospectively or prospectively, and from which countries or institutions.
Number of experts and qualifications: This would state how many experts (e.g., radiologists, pathologists) were involved in establishing ground truth and their relevant experience (e.g., board-certified, years of experience, subspecialty).
Adjudication method: This would describe how discordant readings or interpretations among experts were resolved (e.g., 2+1 means two initial readers, with a third if they disagree; 3+1 means three initial readers, with a fourth for adjudication if necessary).
Multi-reader multi-case (MRMC) comparative effectiveness study: If conducted, this would provide details on how the AI system impacted human reader performance, including statistical metrics like the effect size (e.g., mean increase in AUC, sensitivity, or specificity when AI assistance was used compared to no AI assistance).
Standalone performance: This would report the performance of the algorithm itself, without any human interaction, against the ground truth.
Type of ground truth: This would specify the reference standard used (e.g., expert consensus, pathology results, follow-up clinical outcomes, surgical findings).
Sample size for training set: This would state the number of unique cases/patients used to train the AI model.
Ground truth for training set: This would explain the methodology used to label or establish the ground truth for the data utilized during the training phase of the algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 14, 2023

Karl Storz Endoscopy America, Inc. Jordan Lydia Verla Senior Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

Re: K223885

Trade/Device Name: HOPKINS Telescopes Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: August 28, 2023 Received: August 29, 2023

Dear Jordan Lydia Verla:

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.

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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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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,

Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K223885

Device Name HOPKINS Telescopes

Indications for Use (Describe)

The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and 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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Image /page/3/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 text "KARL STORZ - ENDOSKOPE" in a smaller font.

7. 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 AvenueEl Segundo, CA 90245
Contact:	Jordan Lydia VerlaSenior Regulatory Affairs SpecialistTel: (424) 218-8100 ext. 8382Email: Jordan.Verla@karlstorz.com
Date ofPreparation:	September 11, 2023
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: HOPKINS TelescopesClassification Name: Hysteroscope and accessories (21 CFR 884.1690)
Regulatory Class:	II
Product Code:	HIH
ClassificationPanel:	Obstetrics/Gynecology
PredicateDevice(s):	KARL STORZ Magnifying Hysteroscopes (K935716)The predicate device has not been subject to a design-related recall.
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 theother end of the shaft is attached to the eyepiece. Throughout the centrallumen of the HOPKINS Telescopes, optical glass rods are used to transmitand magnify the image received from the lens. The HOPKINS Telescopes areavailable with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mmdiameter and 26cm, 30cm, 36cm working lengths.
Intended Use andIndications forUse:	Intended Use:The HOPKINS Telescopes in conjunction with the sheath are intended to beused to permit viewing of the cervical canal and uterine cavity for thepurpose of performing diagnostic and surgical procedures.

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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 text "KARL STORZ - ENDOSKOPE" in a smaller font.

Indications for Use:The HOPKINS Telescopes when used with sheaths are intended to be usedto permit viewing of the cervical and uterine cavity for the purpose ofperforming diagnostic and surgical procedures.The subject and predicate devices have similar indications for use, operatingprinciple, and similar technological characteristics.
HOPKINS TelescopesSubject Device	Magnifying HysteroscopesPredicate Device K935716
Indicationsfor Use	The HOPKINS Telescopes whenused with sheaths are intended tobe used to permit viewing of thecervical and uterine cavity for thepurpose of performing diagnosticand surgical procedures.	I. Diagnostic HysteroscopyA. Indications for Use Abnormal uterinebleeding Infertility and pregnancywastage Evaluation of abnormalhysterosalpingogram Intrauterine foreign body Pelvic pain B. Absolute Contraindicationsfor Use Acute Pelvic InflammatoryDisease (PID) C. Relative Contraindicationsfor Use Inability to distend uterus Cervical/vaginal infection Uterine bleeding ormenses Known pregnancy Invasive carcinoma of thecervix Recent uterineperforation Medical contraindication Intolerance to anesthesia D. Warnings Suspicion of pregnancyshould suggest a

	performance of diagnostic
	hysteroscopy.
E.	Precautions
	• Vaginal ultrasonography
	prior to hysteroscopy may
	identify clinical conditions
	that will alter patient
	management.
F.	Operative Hysteroscopy
	A.Indications for Use
	• Directed biopsy
	• Removal of submucuous
	fibroids and large polyps
	• Submucosous
	myomectomy
	• Transection of
	intrauterine adhesions
	• Transection of
	intrauterine septa
	• Endometrial ablation
	B. Absolute
	Contraindications for Use
	• Acute PID
	C. Relative Contraindications
	for Use
	• Inability to distend uterus
	• Cervical/vaginal infection
	• Uterine bleeding or
	menses
	• Known pregnancy
	• Invasive carcinoma of the
	cervix
	• Recent uterine
	perforation
	• Medical contraindication
	• Intolerance to anesthesia
	D.Relative Contraindications
	to Endometrial Ablation
	• Hysteroscopic
	endometrial ablation,
	whether by laser or
	electrosurgery, should not
	be undertaken before

	adequate training,preceptorship and clinicalexperience. Additionally,tissue sampling is requiredprior to destruction of theendometrium. Thefollowing are clinicalconditions that cansignificantly complicatehysteroscopic endometrialablation:• Adenomatousendometrialhyperplasia• Severe adenomyosis• Pelvic pain (subtlePID)• Uterine anomaliesE. Relative Contraindicationsto HysteroscopicMyomectomy• Hysteroscopicmyomectomy,whether by laser orelectrosurgery,should not beundertaken beforeadequate training,preceptorship andclinical experience.The following areclinical conditionsthat can significantlycomplicatehysteroscopicmyomectomy:Severe anemiaInability tocircumnavigatethe myomaF. Warnings

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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

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Image /page/6/Picture/0 description: The image contains the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters at the top of the logo. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE". The logo is simple and professional.

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Image /page/7/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 smaller letters.

ProductCode(s)	HIH	HIH
TargetPopulation	Adults	Adults
Anatomicalsite	Cervical canal, uterine cavity	Cervical canal, uterine cavity
Where used	Hospital	Hospital
EndoscopeType	Rigid, rod lens	Rigid, rod lens
Distal TipDiameter	Scope: 2mm, 2.9mm, 4mmSheaths: 2.3mm-8mm	Scope: 2.7mm, 2.9mm, 4mm
WorkingLength	Scope: 26cm, 30cm, 36cm	Scope: 18cm, 30cm
Direction ofView	0°, 12°, 30°	30°
Field of View	79°, 59°, 88°, 82°, 86°, 62°(laboratorymeasurement)	82°, 60°, 68°, 68°, 51°, 81°
Depth of Field	0mm-362mm	5mm-302mm
Light Source	External	External

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Image /page/8/Picture/0 description: The image shows the logo for STORZ, a company that specializes in endoscopes. The word "STORZ" is written in large, bold, blue letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE", also written in blue. The logo is simple and professional, and it effectively communicates the company's name and focus.

	Patient-ContactingMaterial
		Scopes: Surgical Stainless SteelSheaths: Surgical Stainless SteelBridges: Surgical Stainless Steel	Chromium Plated Monel 400
	Cleaning	Manual, Automatic	Manual
	Sterilization	Scopes:Steam (pre-vacuum),STERRAD 100NX, STERRADNX, STERRAD 100S, STERISV-PRO	EO Sterilization
		Trophyscope:Steam (pre-vacuum),STERRAD 100NX, STERIS V-PRO
		Bridges:Steam (pre-vacuum)
		Sheaths:Steam (pre-vacuum)
Non-ClinicalPerformanceData:	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:
	FDA Guidance
	● Hysteroscopes and Gynecology Laparoscopes - Submission Guidancefor a 510(k)
	ISO Endoscopic Standards
	● ISO 8600-1
	● ISO 8600-3
	● ISO 8600-5
	● ISO 8600-6
	Biocompatibility Summary
	● Cytotoxicity (ISO 10993-5)
	● Acute Systemic Toxicity (ISO 10993-11)
	● Intracutaneous Irritation (ISO 10993-10)
	● Maximization Sensitization (ISO 10993-10)
	Electrical Safety and EMC

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K223885

Image /page/9/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller, less bold letters.

	IEC 60601-2-18 (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
ClinicalPerformanceData:	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 studies were not required to demonstrate substantial equivalence to the predicate device.
Conclusion:	The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination.

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.