(244 days)
Not Found
No
The device description explicitly states it is a "manually operated surgical instrument" and functions by "manually tightening or loosening a knob." There is no mention of any computational or learning capabilities.
No
The device is described as a manually operated surgical instrument intended to hold scopes during diagnostic, therapeutic, and surgical procedures. Its function is to assist in these procedures by holding equipment, not to directly treat a medical condition or ailment.
No
The device is a surgical instrument intended to hold scopes during procedures, not to diagnose conditions itself. Its "Intended Use" explicitly states it's for "diagnostic and therapeutic procedures" but this refers to the context of its use (holding scopes during such procedures), not that the device performs diagnostics itself.
No
The device description explicitly states it is a manually operated surgical instrument made from Stainless Steel, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "manually operated surgical device intended to hold endoscopes... and accessories during general and neurologic diagnostic and therapeutic procedures." This describes a surgical instrument used during a procedure on a patient, not a device used to examine specimens outside the body for diagnostic purposes.
- Device Description: The description reinforces this by detailing how the device holds scopes during "diagnostic, therapeutic, and surgical procedures." It's a mechanical holder, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a surgical tool used to facilitate procedures, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
OCV, GCJ
Device Description
The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
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
Not Found
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)
The following non-clinical testing were performed on the subject device:
- Holding Performance testing
- Direction of view/Image stability testing
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
October 22, 2024
KARL STORZ Endoscopy America, Inc Mario Trujillo Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
Re: K240506
Trade/Device Name: KARL STORZ Holders Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCV, GCJ Dated: September 23, 2024 Received: September 23, 2024
Dear Mario Trujillo:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Digitally signed by Long H. Long H. Chen -Chen -S S Date: 2024.10.22 13:32:12 -04'00'
Long Chen, Ph.D. 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
3
Indications for Use
510(k) Number (if known) K240506
Device Name
KARL STORZ Holders
Indications for Use (Describe)
The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.
| 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/4/Picture/0 description: The image is a 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. The logo is simple and professional.
510(k) Summary
This 510(i) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
| Submitter: | KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mario Trujillo
Regulatory Affairs Specialist
Tel.: (424) 218-8481
Email : Mario.Trujillo@karlstorz.com | | |
| Date of
Preparation: | October 21, 2024 | | |
| Device
Identification: | Trade Name: KARL STORZ Holders
Common Name: Endoscope Holder
Classification Name: Endoscope Holder (21 CFR Part 876.1500); | | |
| Regulatory
Class: | 2 | | |
| Product Code: | Primary: OCV
Secondary: GCJ | | |
| Predicate
Devices: | Walterlorenz Surgical Assist Arm Scope Holder (K190576) | | |
| Device
Description: | The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes,
arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic
procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a
knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding
systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general
surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning. | | |
| Indications For
Use: | The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc)
and accessories during general and neurologic diagnostic and therapeutic procedures. | | |
| Substantial
equivalence | The similarities of the subject device to the predicate devices are as follows: | | |
| | | Subject Device – K240506
KARL STORZ Holders | Predicate Device - K190576
WalterLorenz Surgical Assist Arm Scope
Holder |
| | Indications for Use | The KARL STORZ Holders are manually
operated surgical devices intended to hold
endoscopes (such as arthroscopes, etc)
and accessories during general and
neurologic diagnostic and therapeutic
procedures. | The WalterLorenz Surgical Assist Arm Scope
Holder is a manually operated surgical device
intended to hold scopes (such as endoscopes,
arthroscopes, etc) and accessories during
general diagnostic and therapeutic procedures.
The device is also intended to hold
endoscopes during diagnostic and therapeutic
neurologic procedures. |
| | Material of construction | Stainless Steel | Stainless Steel |
| | Devices to be held | Endoscopes and other surgical instruments | Endoscopes and other surgical instruments |
| | Mode of operation | Manual | Same as subject device |
| | Range of scope diameters | Up to 23mm | Up to 10mm |
| | Scratch Protection pads | Yes | No |
| | Maximum loading weight | 3kg | Information not available |
| | Cleaning | Manual cleaning | Manual cleaning |
| | Sterilization/ Reprocessing
Methods | Steam Sterilization | Steam Sterilization |
| Non-Clinical
Performance
Data: | The following non-clinical testing were performed on the subject device:
- Holding Performance testing
- Direction of view/Image stability testing | | |