K252800 · Karl Storz SE & CO. KG · OCZ · Jun 3, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K252800
Device Name
KARL STORZ Endoscopic Accessories for Urology
Applicant
Karl Storz SE & CO. KG
Product Code
OCZ · Gastroenterology, Urology
Decision Date
Jun 3, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients from birth and older. Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients 2 years of age and older. Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy in adults.
Device Story
Manual stainless steel surgical instruments for grasping, biopsy, and cutting. Proximal handle mechanically transmits motion to distal jaw (open/close). Shafts inserted through endoscope working channel; available in rigid, semi-rigid, and flexible configurations. Used by surgeons in clinical urology settings. Output is physical tissue manipulation or stone/foreign body removal. Benefits include minimally invasive access to urinary tract for diagnostic or therapeutic intervention.
Clinical Evidence
No clinical data. Substantial equivalence established via non-clinical bench testing and literature review for pediatric use claims.
Technological Characteristics
Stainless steel manual instruments; 3-9 Fr diameter; 30-100 cm length. Rigid, semi-rigid, or flexible shafts. Double/single-action jaws. Biocompatibility per ISO 10993-1, -2, -5, -10, -11, -12, -18, -23. Reprocessing per ISO 17664-1, ISO 17665-1, ISO 14937, AAMI ST79, ST77, ST98.
Indications for Use
Indicated for qualified surgeons performing endoscopic urology procedures (cystoscopy, urethroscopy, ureteroscopy, ureterorenoscopy). Patient populations include adults, children (2+ years), and infants (birth and older) depending on specific model.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
KARL STORZ Flexible Accessories for Endoscopic Urology Procedures (K950434)
Submission Summary (Full Text)
{0}
**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 3, 2026
Karl Storz Se & Co. Kg
Jennifer Downing
Senior Regulatory Affairs Specialist
Dr.-Karl-Storz-Straße 34
Tuttlingen, BW 78532
GERMANY
Re: K252800
Trade/Device Name: KARL STORZ Endoscopic Accessories for Urology
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: OCZ
Dated: May 2, 2026
Received: May 4, 2026
Dear Jennifer Downing:
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/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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (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'
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov
{1}
K252800 - Jennifer Downing
Page 2
(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 bear a unique 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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
{2}
K252800 - Jennifer Downing
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
Mark R. Kreitz -S
for Mark J. Antonino, M.S.
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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K252800
Device Name
KARL STORZ Endoscopic Accessories for Urology
Indications for Use (Describe)
The indications for use are the same for all subject devices, except for differences in which devices are indicated for use in pediatric populations.
• For 11274FE, 11274ZE, 27023FM, 27095F, 27095P, 27095Z:
Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients from birth and older.
• For 27034FK, 27034FL, 27034S:
Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients 2 years of age and older.
• For 11275FE, 11275ZE, 27023FE, 27023ZE, 27035D, 27035F, 27035L, 27035S, 27178A, 27178B, 27424F, 27424P, 27424R, 27424U, 27424Z, 27425F, 27425FG, 27425P, 27425PG, 27425R, 27425RG, 27425U, 27425Z, 27425ZG:
Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
{4}
K252800
Page 1 of 7
STORZ
KARL STORZ—ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Endoscopic Accessories for Urology
510(k) Summary
### 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 KARL STORZ's knowledge.
| Submitter: | KARL STORZ SE & CO. KG (KST) Dr.-Karl-Storz-Straße 34 Tuttlingen, Baden-Wurttemberg, Germany, 78532 Establishment Registration Number: 9610617 |
| --- | --- |
| Contact: | Jennifer Downing Senior Regulatory Affairs Specialist jennifer.downing@karlstorz.com Tel.: 1-424-218-8115 |
| Date of Preparation: | May 25, 2026 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: KARL STORZ Endoscopic Accessories for Urology |
| Common Name: | Endoscopic Accessories for Urology |
| Regulatory Class: | II |
| Product Code: | OCZ |
| Classification Name: | Endoscopic Grasping/Cutting Instrument, Non-Powered |
| Device Panel: | Gastroenterology/Urology |
| Predicate Device(s): | K950434, KARL STORZ Flexible Accessories for Endoscopic Urology Procedures The predicate devices have not been subject to any recalls. |
| Device Description: | The devices are manual surgical, stainless steel instruments for grasping, biopsy taking and cutting. At the proximal end there is a handle. Operating the handles is mechanically transmitted to the jaw part causing the branches to move (open/close). The instrument shaft is inserted through the working channel of an endoscope or sheath into the operating field, and the cutting/grasping/biopsy taking is controlled by opening and closing the |
Page 1 of 7
{5}
K252800
Page 2 of 7
STORZ
KARL STORZ—ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Endoscopic Accessories for Urology
510(k) Summary
| | handles. The instrument shafts can be rigid, semi-rigid (bendable) or fully flexible. Instruments are available from 3-9 Fr in diameter and 30-100 cm in working length. The distal tip/jaw has the following variations: • Biopsy Forceps, for tissue biopsy • Scissors, for the cutting of tissue • Splitting forceps and through-cutting forceps, for breaking apart kidney, bladder, or ureter stones • Grasping Forceps, for grasping and removing stone fragments, tissue and foreign bodies such as stents |
| --- | --- |
| Indications For Use: | The indications for use are the same for all subject devices, except for differences in which devices are indicated for use in pediatric populations. • For 11274FE, 11274ZE, 27023FM, 27095F, 27095P, 27095Z: Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients from birth and older. • For 27034FK, 27034FL, 27034S: Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients 2 years of age and older. • For 11275FE, 11275ZE, 27023FE, 27023ZE, 27035D, 27035F, 27035L, 27035S, 27178A, 27178B, 27424F, 27424P, 27424R, 27424U, 27424Z, 27425F, 27425FG, 27425P, 27425PG, 27425R, 27425RG, 27425U, 27425Z, 27425ZG: Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy in adults. |
Page 2 of 7
{6}
K252800
Page 3 of 7
STORZ
KARL STORZ—ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Endoscopic Accessories for Urology
510(k) Summary
Comparison with Predicate Device Indications for Use:
The Predicate Device (K950434) Indications for Use / Intended Use are:
- KARL STORZ Flexible Accessories for Endoscopic Urology Procedures are intended for use by qualified surgeons for endoscopic surgical procedures in Urology.
Comparing phrasing between the Predicate and Subject Devices, with differences underlined:
| Predicate K950434 | Subject Device |
| --- | --- |
| Flexible Accessories for Endoscopic Urology | Endoscopic accessories for urology |
| are intended for use by qualified surgeons | are indicated for use by qualified surgeons |
| for endoscopic surgical procedures in Urology. | during endoscopic surgical urology procedures |
| | such as [examples of procedures] |
| | [patient age ranges] |
Summarizing the table above, the differences in Indications for Use are limited to:
- Removal of a descriptive word (“flexible”). Does not change the use of the device.
- Word order changes (e.g., “Accessories for Endoscopic Urology” vs “Endoscopic accessories for urology”). The meaning remains the same; does not change the use of the device.
- At the end, after “during endoscopic surgical procedures”, the subject device Indications for Use adds “such as ...” and names examples of these types of procedures. Since these are already included in the larger, more general group (endoscopic surgical urology procedures), and this group is the same for both the subject and predicate devices, there is no change to the use of the device.
- The subject device names patient age ranges, including pediatric populations. The predicate device did not specify a
Page 3 of 7
{7}
K252800
Page 4 of 7
*KARL STORZ Premarket Notification*
KARL STORZ Endoscopic Accessories for Urology
510(k) Summary
| | patient population. For the subject device, the use of the device for the specified age ranges was supported by formal review of the clinical literature. This review determined that the safe and effective use of KARL STORZ Urological Instruments in these pediatric populations (infants, children, and adolescents) is adequately substantiated by the reviewed clinical literature. **Summary:** The differences between the subject device indications, and the predicate device indications, are not critical to the intended use of the device, and the differences do not affect the safety or effectiveness of the device when used as labeled. | | |
| --- | --- | --- | --- |
| Technological Characteristics: | The comparison of technological characteristics is as follows: | | |
| | Comparison | Subject Device | Predicate K950434 |
| | **Type of Device** | Grasping Forceps Biopsy Forceps Cutting Forceps/Scissors | Same as subject device |
| | **Jaw width (Diameter)** | 3 to 9 Fr. (1.0 to 3.0 mm) | Same as subject device |
| | **Working length** | 30 - 100 cm | 28 - 100 cm |
| | **Shaft Type** | Flexible, semi-rigid, rigid | Flexible |
| | **Jaws Opening** | Double- or Single-Action Jaws | Same as subject device |
| | **Jaws characteristics** | Grasping (grasping forceps) Cutting and Grasping (biopsy forceps) Cutting (cutting forceps / scissors) | Same as subject device |
Page 4 of 7
{8}
K252800
Page 5 of 7
*KARL STORZ Premarket Notification*
KARL STORZ Endoscopic Accessories for Urology
510(k) Summary
| | As shown in the table above, the majority of the technological characteristics are the same for both the subject and predicate device, including the size range (the range is smaller for the subject device than predicate device). One characteristic, the shaft type, is technologically different than the predicate device. The predicate device was only available with a flexible shaft. The subject device has additional shaft types, semi-rigid and rigid. These differ both in design and in the required reprocessing methodology. In order to verify that these differences do not raise new questions of safety and effectiveness, testing was carried out. In order to demonstrate equivalence with the predicate device for all subject devices, the testing was performed out on all of the subject device types (flexible, semi-rigid, and rigid). - Reprocessing validation: confirmed that the subject device can be consistently sterilized. - Bench Testing: - Load force: confirmed the devices are not damaged by the forces used in their indicated procedures - System Interlocking: confirmed the devices are correctly sized and configured to fit with their compatible access systems. - Cutting Performance: confirmed that the scissors/cutting forceps make clean cuts. - Grasping Performance: confirmed that the grasping forceps can successfully grasp and remove objects. Based on the results of the bench testing and reprocessing validation, the subject device is substantially equivalent to the predicate device. In summary, the subject device is substantially equivalent to the predicate device, and the technological differences between them do not raise any different questions of safety and effectiveness. |
| --- | --- |
| Non-Clinical Performance Data: | There are no performance standards or special controls developed under Section 514 of the FD&C Act for Endoscopic Accessories for Urology. However, the subject device follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: |
Page 5 of 7
{9}
K252800
Page 6 of 7
STORZ
KARL STORZ — ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Endoscopic Accessories for Urology
510(k) Summary
Biocompatibility testing
The system complies with the following standards:
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 10993-2: Biological evaluation of medical devices – Part 2: Animal welfare requirements
- ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests skin sensitization
- ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
- ISO 10993-18: Biological evaluation of medical devices – Part 18: Chemical characterization of materials
- ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation
Reprocessing Validation
The reprocessing data submitted complies with the following standards and guidance with regards to cleaning and sterilization:
- ISO 17664-1: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
- TIR12:2020: Designing testing and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
- ST79:2017: Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ISO 14937: Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
- ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation
Page 6 of 7
{10}
**STORZ**
KARL STORZ—ENDOSKOPE
K252800
Page 7 of 7
*KARL STORZ Premarket Notification*
KARL STORZ Endoscopic Accessories for Urology
510(k) Summary
| | and routine control of a sterilization process for medical devices - FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - ANSI / AAMI ST98: Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices - ANSI/AAMI ST77: Containment devices for reusable medical device sterilization**Bench Testing:** The following mechanical performance testing was performed and submitted. There were no applicable standards or guidance specific for this testing. For descriptions of this testing, see Technological Characteristics. - System Interlocking - Cutting Performance - Grasping Performance - Load force |
| --- | --- |
| Clinical Performance Data: | Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications. |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject device, KARL STORZ Endoscopic Accessories for Urology, is substantially equivalent to the predicate device that is currently marketed for the same intended use. |
Page 7 of 7
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
