The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy. The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site. The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.
Device Story
Mini PCNL-System consists of reusable, rigid stainless steel/plastic shafts and dilators. Used in minimally invasive nephroscopy to facilitate access to the surgical site. Dilators widen existing openings; shafts serve as introducers for instruments, telescopes, and irrigation fluids. Operated by physicians in clinical settings. During stone removal, irrigation fluid and cleaning pressure automatically transport kidney stones out through the proximal end of the shaft. Device is non-sterile upon delivery and requires manual/automated cleaning and steam sterilization before each use. Provides mechanical access for lithotripsy procedures.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical performance testing, including reprocessing validation (cleaning/sterilization), biocompatibility (cytotoxicity, sensitization, irritation), and mechanical testing (tensile strength, bending load, and stability of connecting points).
Indicated for patients with kidney or upper urinary tract conditions requiring a nephroscopic procedure.
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.
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Image /page/0/Picture/0 description: The image contains 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. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2021
TROKAMED GmbH Stefan Weiland Regulatory Affairs Manager Kleine Breite 17 Geisingen, BW 78187 Germany
Re: K200770 Trade/Device Name: Mini PCNL-System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated: June 10, 2021 Received: June 14, 2021
Dear Stefan Weiland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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# Indications for Use
510(k) Number (if known) K200770
Device Name
Mini PCNL-System
Indications for Use (Describe)
The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy.
The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site.
The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.
Patient Target Group
Patients with kidney or upper urinary tract conditions who require a nephroscopic procedure.
| 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/1 description: The image shows the logo for TROKAMED GmbH. The logo features the company name in bold, gray letters, with a blue semi-circle design element on the left side. Below the company name, in smaller letters, is the phrase "ZUVERLÄSSIGE PRÄZISION" which translates to "RELIABLE PRECISION".
TROKAMED GmbH · Kleine Breite 17 · 78187 Geisingen U.S. Food and Drug Administration Center for Devices and Radiological Health Document Control Center (DCC) - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
July 28, 2021
# 510(k) Summary
| Submitted by: | TROKAMED GmbH<br>Kleine Breite 17<br>78187 Geisingen<br>Germany |
|---------------|-----------------------------------------------------------------|
|---------------|-----------------------------------------------------------------|
# Contact Information
| Primary contact person | Alternate contact person |
|------------------------------|------------------------------------|
| Karlheinz Tröndle | Stefan Weiland |
| CEO | Regulatory Affairs |
| Phone: +49 (0)7704/9244-0 | Phone: +49 (0)7704/9244-51 |
| Fax: +49 (0)7704/9244-44 | Fax: +49 (0)7704/9244-84 |
| E-Mail: troendle@trokamed.de | E-Mail: stefan.weiland@trokamed.de |
www.trokamed.de mail: info@trokamed.de Fon +49 (0) 7704 / 92 44-0 Fax +49 (0) 7704 / 9244-44 VAT-No. DE279596571
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Image /page/4/Picture/1 description: The image is a logo for TROKAMED GmbH. The logo features the company name in gray letters, with a blue semi-circle underlining the "TRO" portion of the name. Below the company name is the phrase "ZUVERLÄSSIGE PRÄZISION" in blue letters.
# Predicate Device
| Manufacturer | 510(k) Number | Device Name |
|-------------------------------------------------|---------------|-----------------|
| RICHARD WOLF Medical<br>Instruments Corporation | K994223 | Nephroscope Set |
# Comparison of Technological Characteristics with the Predicate Device
| Description | Subject device | Predicate Device (K994223) |
|----------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------|
| Picture of the device | Image: Subject device | Image: Predicate Device |
| Design of dilator | Cannulated, two lumens | Cannulated |
| Design of shaft | Round, without irrigation tap, meatus<br>ring, distal end straight | Round, fixed irrigation tap, distal end<br>straight |
| Material of the shaft | Stainless steel, plastic | Titanium, stainless steel, plastic |
| Material of dilator | Stainless steel | Stainless steel |
| Lumen/Inner diameter of<br>the dilator | 1 mm, 1mm; 1 mm, 1.3 mm | 4 mm; 5 mm |
| Outer diameter of the<br>dilator | 15 Fr.; 17 Fr. | 12 Fr.; 15 Fr. |
| Wall thickness | 0.5 mm | 0.25 mm |
| Working length of the<br>dilator | 370 mm | 320 mm |
| Outer diameter of the<br>sheath | 18 Fr., 20 Fr. | 18 Fr. |
| Working length of the<br>sheath | 130 mm; 160 mm | 150 mm |
| Device packaged as<br>sterile | No | No |
| Requires sterilization<br>prior to use | Yes | Yes |
| Single-Use/Reusable | Reusable | Reusable |
| Sterilization method | Steam sterilization | Moist Heat or Steam Sterilization<br>Ethylene Oxide<br>Hydrogen Peroxide |
www.trokamed.de mail: info@trokamed.de
Fon +49 (0) 7704 / 92 44-0
Fax +49 (0) 7704 / 9244-44 VAT-No. DE279596571
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Image /page/5/Picture/1 description: The image shows the logo for TROKAMED GmbH. The logo features the company name in gray, with the "TRO" portion partially encircled by a blue arc. Below the company name, the phrase "ZUVERLÄSSIGE PRÄZISION" is written in a smaller, gray font.
TROKAMED GmbH · Kleine Breite 17 · 78187 Geisingen Subject Device Description
Trade Name: Common Name: Classification Name: Product code:
Mini PCNL-System Endoscopic Access Overtube. Gastroenterology-Urology Endoscope and accessories (21 CFR 876.1500) FED (Endoscopic Access Overtube, Gastroenterology-Urology)
The TROKAMED GmbH Mini PCNL-System consists of shaft and dilator. The diameter is specified directly on the shaft and dilator. This ensures that the instrument can be assigned easily and only suitable components are used. The instruments cannot be disassembled. The puncture is expanded with the dilator at the beginning of surgery. The procedure, during which kidney stones can be destroyed, is then performed via the shaft. The kidney stones are automatically transported out of the proximal end of the shaft as a result of the cleaning pressure and by the irrigation fluid. The nephroscope may not be fully mounted on the shaft here.
# Shafts
The nephroscopic shafts are rigid reusable instruments with inner lumen and are used as an introducer for the instrument into the surgical site. The shaft itself is introduced into the surgical site by the help of the dilator.
Example WA2PS20S:
Image /page/5/Figure/9 description: The image shows a diagram of a medical instrument. The instrument has three labeled parts: "Meatusring/Meatus ring", "Schaft/Shaft", and "Hauptteil/Main part". The "Hauptteil/Main part" is located on the left side of the image, the "Meatusring/Meatus ring" is in the middle, and the "Schaft/Shaft" is on the right side.
# Dilators
The dilators are rigid reusable instruments. They are equipped with two lumens: one lumen in the center and one on the side. The quide wire (not included in this submission) is fed through the medial lumen. An additional safety wire (not included in this submission) can be guided through the lateral lumen. Markings indicate when the conical tip of the dilator is protruding from the shaft. Both types of dilators has the same total and working length, but different diameters. Example: WA2PD20A:
Image /page/5/Figure/12 description: The image shows a diagram of a long, thin object labeled with its parts in both German and English. The left end is labeled "Spitze/Tip", the middle section is labeled "Schaft/Shaft", and the right end is labeled "Griff/Handle". Below the diagram is contact information for TROKAMED GmbH, including their address, website, phone and fax numbers, VAT number, managing director, court of registration, HRB number, and bank details.
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Image /page/6/Picture/1 description: The image is a logo for TROKAMED GmbH. The logo features the company name in gray, with the "TRO" portion of the name partially encircled by a blue arc. Below the company name is the phrase "ZUVERLÄSSIGE PRÄZISION" in a smaller, gray font.
The Mini PCNL-System is used together with a suitable nephroscope. The nephroscope is not part of the subject device and not included in this submission.
The Mini PCNL-System is delivered in non-sterile conditions and has to be processed before using it for the first time and before each use afterwards.
The following table identifies all models included in this submission:
| Article Number | Description | Key<br>components | Material | Product Dimensions |
|----------------|-------------------------------------------------------------|-------------------------------------|----------------------------|-----------------------------------------------------------------------------------------|
| WA2PS18S | Shaft, 18 Fr. | Main part,<br>Meatus ring,<br>Shaft | 1.4301<br>PPSU<br>1.4301 | Total length: 165 mm<br>Working length: 130 mm<br>Outer Ø: 18 Fr<br>Inner Ø: 15 Fr |
| WA2PS18L | Shaft, 18 Fr. | Main part,<br>Meatus Ring,<br>Shaft | 1.4301<br>PPSU<br>1.4301 | Total length: 195 mm<br>Working length: 160 mm<br>Outer Ø: 18 Fr<br>Inner Ø: 15 Fr |
| WA2PS20S | Shaft, 20 Fr. | Main part,<br>Meatus Ring,<br>Shaft | 1.4301<br>PPSU<br>1.4301 | Total length: 165 mm<br>Working length: 130 mm<br>Outer Ø: 20 Fr<br>Inner Ø: 17 Fr |
| WA2PS20L | Shaft, 20 Fr. | Main part,<br>Meatus Ring,<br>Shaft | 1.4301<br>PPSU<br>1.4301 | Total length: 195 mm<br>Working length: 160 mm<br>Outer Ø: 20 Fr<br>Inner Ø: 17 Fr |
| WA2PD18A | Dilator, 15 Fr.,<br>(to be used with<br>WA2PS18S, WA2PS18L) | Handle,<br>Shaft<br>Tip | 1.4301<br>1.4301<br>1.4301 | Total length: 390 mm<br>Working length: 370 mm<br>Outer Ø: 15 Fr<br>Inner Ø: 3 Fr, 3 Fr |
| WA2PD20A | Dilator, 17 Fr.,<br>(to be used with<br>WA2PS20S, WA2PS20L) | Handle,<br>Shaft<br>Tip | 1.4301<br>1.4301<br>1.4301 | Total length: 390 mm<br>Working length: 370 mm<br>Outer Ø: 17 Fr<br>Inner Ø: 3 Fr, 4 Fr |
Table 1: Information about subject device
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Image /page/7/Picture/1 description: The image is a logo for TROKAMED GmbH. The logo features the company name in a bold, sans-serif font, with the "TRO" portion in gray and partially encircled by a blue arc. The "KAMED" portion is also in gray, with "GmbH" stacked vertically to the right and a registered trademark symbol. Below the company name, in a smaller font, is the phrase "ZUVERLÄSSIGE PRÄZISION" in blue, which translates to "RELIABLE PRECISION".
### Indications for Use
The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy. The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site.
The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.
Patient Target Group:
Patients with kidney or upper urinary tract conditions who require a nephroscopic procedure.
### Comparison of Indications for Use with Predicate Device
Indications for Use Predicate Device:
The nephroscope, with its accessories, is used, with suction for the disintegration and removal/extraction of kidney and bladder stones are removed, under endoscopic control, through percutaneous or transurethral passages, in conjunction with intercorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.
We state that the Indications for Use are the same for the subject and the predicate device because both are used in the percutaneous treatment of renal calculi and are to be controlled by endoscopes during surgery.
**TROKAMED** GmbH
Kleine Breite 17
78187 Geisingen
Germany
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Image /page/8/Picture/1 description: The image is a logo for TROKAMED GmbH. The logo features the company name in gray letters, with the "TRO" portion of the name partially encircled by a blue arc. Below the company name is the phrase "ZUVERLÄSSIGE PRÄZISION" in smaller, gray letters.
# Non-Clinical Performance Testing
(only the non-clinical studies used for the determination of the substantial equivalence (SE) of the subject device to the predicate device)
| Tests | Standard Reference to Tests | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reprocessing | EN ISO 17664 / ANSI AAMI ISO 17664: 2017, | Summarizing the results |
| | Processing of health care products – | of improved protein test |
| Reprocessing Study | Information to be provided by the medical | and indirect microbial |
| 194101-45, | device manufacturer for the processing of | test, a sufficient ability of |
| 02 AUG 2019 | medical devices. | the tested master Worst |
| | AAMI TIR30: 2011 (reapproved 2016), A | Case products for an |
| (Worst Case principle) | compendium of processes, materials, test | effective cleaning can be |
| | methods, and acceptance criteria for cleaning | stated. |
| | reusable medical devices. | |
| | ANSI/AAMI ST79: 2017, Comprehensive | All tested products |
| | guide to steam sterilization and sterility | showed a sufficient |
| | assurance in health care facilities. | spore log reduction (SLR |
| | ASTM E2314: 2003 (reapproved 2014), | > 12) by use of standard |
| | Standard test method for determination of | sterilization parameters. |
| | effectiveness of cleaning processes for | Therefore, a sufficient |
| | reusable medical instruments using a | ability of the tested |
| | microbiologic method (simulated use test). | master Worst-Case |
| | ASTM F3208: 2018, Standard Guide for | products for an effective |
| | selecting test soils for validation of cleaning | steam sterilization can |
| | methods for reusable medical devices. | be stated. |
| | ASTM E1766: 2015, Standard test method for | |
| | determination of effectiveness of sterilization | |
| | processes for reusable medical devices. | |
| | ANSI/AAMI ST67: 2011 (reapproved 2017), | |
| | Sterilization of health care products – | |
| | Requirements and guidance for selecting a | |
| | sterility assurance level (SAL) for products | |
| | labelled „sterile“. | |
| | FDA guidance: 2015/2017, Reprocessing | |
| | Medical Devices in Health Care Settings – | |
| | Validation Methods and Labelling. | |
| Life Expectancy<br>Testing: | TROKAMED standard FB-26_07_010_Product<br>Life expectancy<br>TROKAMED Standard Operating Procedures | Material durability and<br>functionality are verified<br>for the given lifetime.<br>(Worst-Case principle)<br>Mechanical strength test<br>with unaged and aged<br>subject device. |
| FB-<br>15_02_001_TR_Mini<br>PCNL_01_mechanical<br>test_15Sep2020<br>(Subject device<br>tested) | | |
| Tests | Standard Reference to Tests | Results |
| Biocompatibility Evaluation:<br>- Evaluation of basic biological<br>assessment<br>- 091924-20 "Cytotoxicity, L929-<br>Proliferation"<br>- 091925-20 "chemical analysis<br>(characterizations of organic<br>release products)"<br>(Worst Case principle) | ISO 10993-1:2018 Biological<br>evaluation of medical devices<br>Part 1: Evaluation and testing<br>within a risk management<br>process<br>ISO 10993-5:2009 Biological<br>evaluation of medical<br>devices - Part 5: Tests for in<br>vitro cytotoxicity<br>ISO 10993-10: 2010 Biological<br>evaluation of medical<br>devices - Part 10: Tests for<br>irritation and skin sensitization<br>ISO 10993-12:2012 Biological<br>evaluation of medical devices<br>Part 12: Sample preparation and<br>reference materials<br>ISO 10993-18:2020 Biological<br>evaluation of medical devices<br>Part 18: Chemical<br>characterization of medical<br>device materials within a risk<br>management process<br>FDA blue book memorandum<br>(#G95-1) | A cytotoxicity testing of<br>Worst Case AUF11020 has<br>verified that no substances<br>of cell toxic concentration<br>are released.<br><br>The chemical<br>characterization has shown<br>that solvable substances or<br>degradation products of<br>Worst case AUF11020 do<br>not exceed the toxicological<br>relevant concentrations. |
| Mechanical Testing:<br>- 2006-02-06 UB Tensile tests<br>with tubes_english<br>(Worst Case principle) | none<br>(TROKAMED Standard<br>Operating Procedures only) | Summary of bending and<br>breaking forces of stainless<br>steel TROKAMED<br>instruments. |
| - 2014-09-23 Bending load of the<br>shaft tubes English_10Jun2021<br>(Worst Case principle) | none<br>(TROKAMED Standard<br>Operating Procedures only) | Shaft of subject device<br>withstands maximal loading<br>forces within minimally<br>invasive surgery. |
| - FB-15_02_001_TR_Mini<br>PCNL_01_mechanical<br>test_15Sep2020<br>(Subject device tested) | none<br>(TROKAMED Standard<br>Operating Procedures only) | Stability and strength of<br>connecting points of the<br>subject device, unaged and<br>aged. |
TROKAMED GmbH Kleine Breite 17 78187 Geisingen Germany
www.trokamed.d mail: info@trokam Fon +49 (0) 7704 / 92 44-0 Fax + 49 (0) 7704 / 9244-44
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Image /page/9/Picture/1 description: The image shows the logo for TROKAMED GmbH. The logo features the company name in gray letters, with a blue semi-circle design element on the left side. Below the company name, the words "ZUVERLASSIGE PRAZISION" are written in blue.
ww.trokamed.de
mail: info@trokamed.de
Fon +49 (0) 7704 / 92 44-0
Fax +49 (0) 7704 / 92 44-0
Fax +49 (0) 7704 / 9244-44 VAT-No. DE279596571
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Image /page/10/Picture/1 description: The image shows the logo for TROKAMED GmbH. The logo features the company name in bold, gray letters, with a blue semi-circle design element on the left side. Below the company name, the words "ZUVERLÄSSIGE PRÄZISION" are written in a smaller font.
#### Reprocessing
The TROKAMED Mini PCNL-System is covered by the reprocessing validation (Worst Case principle) of study 194101-45 (02 AUG 2019, accredited laboratory Medical Device Services) including manual and automated cleaning before steam sterilization. Both, the subject and the predicate device are reusable, non-sterile instruments that have to be reprocessed by manual and automated cleaning before steam sterilization after receipt by the end user (before the first and after each subsequent use).
#### Life Expectancy Testing:
General product lifetime is according to 1.4301/ 304 instruments listed in document "FB-26 07 010 Product Life expectancy", nephroscopic instruments: these instruments are exposed to very low mechanical stress during minimally invasive surgery. Material durability, labeling and functionality are verified for the given lifetime. To test mechanical resistance, unaged and aged subject devices have been used and no difference between them was recognizable.
#### Biocompatibilitv
The biocompatibility of the device components has been stated in TROKAMED's biological assessment (Worst Case principle, Biocompatibility 2021-06-08, cytotoxicity, sensitization and irritation tests performed by accredited laboratories eurofins Medical Device Testing and Medical Device Services). The biological assessment is based on a Worst Case principle with a sample instrument (AUF11020) covering the subject device in all aspects of biocompatibility. The tests confirm that the materials used are biocompatible, separately as well as combined in the final subject device and including possible manufacturing contamination and residues. No potentially dangerous interactions or consequences have been identified if there is short termed contact to tissue, biological cells and body fluids of the human body.
#### Mechanical Testing:
Mechanical Test Report "2006-02-06 UB Tensile tests with tubes english" (Worst Case principle) lists details of tensile tests with TROKAMED shafts according to length and wall thickness, covering the dimensions of the subject device.
Mechanical Test Report "2014-09-23 Bending load of the shaft tubes English 10Jun2021" (Worst Case principle) shows that mechanical safety of the TROKAMED tube shaft instruments made of 1.4301/ 304 (welded and cold redrawn several times) based on strength of the tube material is given. The tested tube shaft instruments show that the TROKAMED shafts and dilators withstand the forces during application in minimally invasive surgery.
Mechanical Test Report "FB-15 02 001 TR Mini PCNL 01 mechanical test 15Sep2020" (subject device tested) is to show that the stability and strength of the connecting points of the subject device are solid enough for the forces applied during regular application according to the intended use. A cumulative simulation of processing had been performed. When used as intended, mainly axial forces occur. If at all, only very small lever forces occur in practice, which neither influence nor endanger the strength of the welded joints, nor the stability and dimensional stability of the instrument itself.
A comparison of technological characteristics between subject and predicate device shaft show that with comparable length and diameter, the wall thickness is 0.5 mm on the subject device compared to 0.25 mm on the predicate device. As a result, the mechanical stability of the subject device is at least the same as of the predicate device. The dilators are equivalent as well: the subject device has a larger working length (370 mm to 320 mm) but the larger outer diameter (4.9 mm to 4.0 mm) equalizes the mechanical stability.
Kleine Breite 17 78187 Geisingen Germany
Fon +49 (0) 7704 / 92 / Fax +49 (0) 7704 / 9244-44 /AT-No. DE279596571
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Image /page/11/Picture/1 description: The image shows the logo for TROKAMED GmbH. The logo features the company name in gray letters, with a blue semi-circle around the "TRO" portion. Below the company name is the phrase "ZUVERLÄSSIGE PRÄZISION" in smaller, gray letters.
# Conclusion
The Mini PCNL-System has the same intended use and the same major design and technical characteristics as the predicate device.
The results of the non-clinical performance tests demonstrate that the subject device is as safe and effective as the predicate device.
Overall, the subject device is equivalent to the predicate device.
TROKAMED GmbH Kleine Breite 17 78187 Geisingen Germany
www.trokamed.de mail: info@trokamed.de Fon +49 (0) 7704 / 92 44-0 Fax +49 (0) 7704 / 9244-44 VAT-No. DE279596571
Geschäftsführer: Karlheinz Tröndle Amtsgericht Stuttgart HRB 736615
Commerzbank Villingen-Schwenningen BLZ: 694 400 07 Konto: 245 932 900 Swift: (BIC) COBADEFFXXX IBAN DE50 6944 0007 0245 9329 00
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Learn the FDA Browser
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.
