(259 days)
Not Found
No
The device description focuses on traditional optical technology (rod lenses) and does not mention any AI/ML components or image processing capabilities.
No
The device is intended for visualization during surgery, not for providing therapy. It helps the surgeon see, but doesn't treat the condition itself.
No.
The device provides visualization but does not make a diagnosis or assist in making a diagnosis; it is an instrument used during surgery for viewing.
No
The device description clearly states it is a rigid telescope utilizing rod lens technology, which are physical hardware components.
Based on the provided information, the HOPKINS Telescopes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide visualization during laparoscopy and general surgery in adults and pediatrics." This describes a device used directly on or in the patient for surgical procedures, not for testing samples outside the body.
- Device Description: The description details a rigid telescope with optical components for transmitting and magnifying images. This aligns with a surgical visualization tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HOPKINS Telescopes do not fit this definition.
N/A
Intended Use / Indications for Use
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.
The HOPKINS Telescopes are intended to provide visualization during laparoscopy, thoracoscopy and general surgery in adults and pediatrics.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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°, 25° and 45° direction of view, 5mm diameter and 29cm working lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and pediatrics.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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 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
2
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 Avenue
EI Segundo, CA 90245 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alita McElroy
Senior Regulatory Affairs Specialist
Phone: (424) 218-8376
Email: Alita.McElroy@karlstorz.com |
| Date of
Preparation: | December 19, 2022 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: HOPKINS Telescopes
Classification Name: Laparoscope, General and Plastic Surgery (21 CFR
876.1500) |
| Regulatory Class: | II |
| Product Code: | GCJ |
| Classification
Panel: | General and Plastic Surgery |
| Predicate
Device(s): | KARL STORZ HOPKINS I and II Rigid Autoclavable Telescopes (K935279) |
| 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°, 25° and 45° direction of view, 5mm diameter and 29cm working
lengths. |
| Intended Use and
Indications for
Use: | The HOPKINS Telescopes are intended to provide visualization during
laparoscopy, thoracoscopy and general surgery in adults and pediatrics. |
4
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.
| Technological
Characteristics. | Technological
Characteristics | HOPKINS
Telescopes | KARL STORZ
HOPKINS I and II
Rigid Autoclavable
Telescopes | Comparison |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------|
| | | Subject
Device
K221004 | Predicate
Device 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 |
| | Sterilization
modalities | Steam (pre-vacuum),
STERRAD
100S,
STERRAD
NX,
STERRAD
100NX,
STERIS V-
PRO 1, V-
PRO 1 Plus | Steam (pre-vaccum), EO,
Chemical
Disinfection | different |
| Non-Clinical
Performance 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 | | | |
5
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. |