(90 days)
For telescopes with diameter ranging from 3mm-5mm
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.
For telescopes with diameter ranging from 5.5mm- 11mm
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults.
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°, 6°, 30° and 45° direction of view, diameters ranging from 3mm to 11mm and working lengths from 18cm- 50cm.
The provided text describes the submission of a 510(k) summary for the HOPKINS Telescopes, comparing it to a predicate device. It details non-clinical performance data and references published literature for clinical performance, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of an AI/ML device.
The device described, "HOPKINS Telescopes," is a rigid endoscope that utilizes rod lens technology for visualization during surgery. There is no mention of AI or machine learning components. Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone AI performance, are not applicable to the information provided in this document.
However, based on the non-clinical performance data section, we can infer some "acceptance criteria" related to standards compliance and general performance.
Here's an attempt to answer the questions based only on the provided text, recognizing that it does not pertain to AI/ML device performance:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML device, the "acceptance criteria" are related to compliance with recognized standards and successful bench testing. The document states:
"the HOPKINS Telescopes has met all its design specification and is substantially equivalent to its predicate device."
| Criteria Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Standards (Endoscopy) | Compliance with ISO 8600-1, ISO 8600-3, ISO 8600-5, ISO 8600-6 | Met these standards. |
| Biocompatibility | Compliance with ISO 10993-5, -11, -10 (twice) | Passed Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Irritation, Maximization Sensitization tests. |
| Electrical & Thermal Safety | Compliance with IEC 60601-2-18:2009 (3RD Edition) | Met this standard. |
| Reprocessing (Cleaning & Sterilization) | Compliance with AAMI TIR12, TIR30, ST8, ST77, ST79, ST81, ISO 14937, ISO 17655-1 | Met these standards during reprocessing validation. |
| General Performance | Substantial equivalence to predicate device in bench testing | Demonstrated substantial equivalence; met all design specifications. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an AI/ML model. The evaluation involves non-clinical bench testing and comparison to a predicate device. No specific sample sizes for these tests are mentioned, nor is there information about data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical endoscope, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.
4. Adjudication method for the test set
Not applicable.
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, as this is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would be established by physical measurements, chemical analyses, and adherence to the specified performance parameters outlined in the referenced standards. For the pediatrics indication expansion, the ground truth is based on "published literature" supporting safety and effectiveness, which would implicitly rely on clinical data outcomes.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device with a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 30, 2023
KARL STORZ Endoscopy-America, Inc Alita Mcelroy Senior Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
Re: K223923
Trade/Device Name: HOPKINS Telescopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: December 29, 2022 Received: December 30, 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
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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Jianting Wang -S
For Long Chen 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) K223923
Device Name HOPKINS Telescopes
Indications for Use (Describe)
For telescopes with diameter ranging from 3mm-5mm
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.
For telescopes with diameter ranging from 5.5mm- 11mm
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
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 phrase "KARL STORZ - ENDOSKOPE" in smaller 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: | December 29, 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°, 6°, 30° and 45° direction of view, diameters ranging from 3mm to11mm and working lengths from 18cm- 50cm. |
| Intended Use andIndications forUse: | For telescopes with diameter ranging from 3mm-5mmThe HOPKINS Telescopes are intended to provide visualization duringlaparoscopy, thoracoscopy and general surgery in adults and pediatrics.For telescopes with diameter ranging from 5.5mm- 11mmThe HOPKINS Telescopes are intended to provide visualization during |
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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.
| laparoscopy, thoracoscopy and general surgery in adults. | ||||
|---|---|---|---|---|
| TechnologicalCharacteristics. | TechnologicalCharacteristics | HOPKINSTelescopes | KARL STORZHOPKINS I and IIRigid AutoclavableTelescopes | Comparison |
| SubjectDevice | PredicateDevice K935279 | |||
| Physical Characteristics | ||||
| Endoscope Type | Rigid, rodlens | Rigid, rod lens | same | |
| Outer Diameter | 3mm- 11mm | 4mm-10mm | different | |
| Working Length | 18cm- 50cm | 29cm-35cm | different | |
| Optical Characteristics | ||||
| Direction ofView | 0°, 6°, 30°, 45°Endocameleon: 10°- 90° | 0°, 30° | different | |
| Field of View | 55°- 80° | 65°- 70° | different | |
| Depth of Field | 4.8mm- 200mm8.9mm –200mm16mm – 200mm20.8mm-200mm | 11.4mm- 200mm21.6mm- 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 | Steam (pre-vacuum), EO,ChemicalDisinfection | different |
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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 features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Non-ClinicalPerformance Data: | There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. However, the HOPKINS Telescopes follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: |
|---|---|
| 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 and 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. | |
| ClinicalPerformance Data: | Published literature was provided to support the safety and effectiveness of the HOPKINS Telescopes ranging in diameters from 3mm to 5mm 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. |
§ 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.