(492 days)
Not Found
No
The description focuses on mechanical components and their function in a surgical procedure, with no mention of AI/ML terms, image processing, or data-driven features.
No
The device is described as an accessory set for minimally invasive procedures in nephroscopy, designed to bring instruments, telescopes, and fluids to a surgical site and widen existing openings. It facilitates a procedure to destroy kidney stones but does not directly provide a therapeutic effect itself; rather, it enables the delivery of other instruments that perform the therapy. It's a surgical tool, not a therapeutic device.
No
Explanation: The device is described as an accessory set for nephroscopy, designed to bring instruments, telescopes, and fluids to a surgical site and widen surgical openings. Its purpose is for minimally invasive procedures to destroy kidney stones, not to diagnose a condition.
No
The device description clearly outlines physical components (shaft and dilator) and their mechanical functions in a surgical procedure, indicating it is a hardware-based medical 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 the device is for "minimally invasive procedures in nephroscopy" and is designed to "bring instruments, telescopes, and fluids to the surgical site" and "widen existing surgically invasive openings." This describes a surgical instrument used in vivo (within the body) during a procedure.
- Device Description: The description details a "Mini PCNL-System" consisting of a shaft and dilator used for expanding a puncture and performing a procedure to destroy kidney stones. This is a surgical tool.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or analysis of biological materials.
Therefore, this device is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FED
Device Description
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.
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney or upper urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Reprocessing Study:
Standard Reference to Tests: EN ISO 17664 / ANSI AAMI ISO 17664: 2017, AAMI TIR30: 2011 (reapproved 2016), ANSI/AAMI ST79: 2017, ASTM E2314: 2003 (reapproved 2014), ASTM F3208: 2018, ASTM E1766: 2015, ANSI/AAMI ST67: 2011 (reapproved 2017), FDA guidance: 2015/2017.
Results: A sufficient ability of the tested master Worst Case products for an effective cleaning can be stated. All tested products showed a sufficient spore log reduction (SLR > 12) by use of standard sterilization parameters. Therefore, a sufficient ability of the tested master Worst-Case products for an effective steam sterilization can be stated.
Life Expectancy Testing:
Standard Reference to Tests: TROKAMED standard FB-26_07_010_Product Life expectancy, TROKAMED Standard Operating Procedures, FB-15_02_001_TR_Mini PCNL_01_mechanical test_15Sep2020.
Results: Material durability and functionality are verified for the given lifetime. Mechanical strength test with unaged and aged subject device.
Biocompatibility Evaluation:
Standard Reference to Tests: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10: 2010, ISO 10993-12:2012, ISO 10993-18:2020, FDA blue book memorandum (#G95-1).
Results: A cytotoxicity testing of Worst Case AUF11020 has verified that no substances of cell toxic concentration are released. The chemical characterization has shown that solvable substances or degradation products of Worst case AUF11020 do not exceed the toxicological relevant concentrations.
Mechanical Testing:
Standard Reference to Tests: none (TROKAMED Standard Operating Procedures only) for Tensile tests with tubes and Bending load of the shaft tubes.
Results for Tensile tests with tubes: Summary of bending and breaking forces of stainless steel TROKAMED instruments.
Results for Bending load of the shaft tubes: Shaft of subject device withstands maximal loading forces within minimally invasive surgery.
Results for FB-15_02_001_TR_Mini PCNL_01_mechanical test_15Sep2020: Stability and strength of connecting points of the subject device, unaged and aged.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
1
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
2
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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3
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
Kleine Breite 17
78187 Geisingen
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
4
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 | ||
| 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 | |
| ring, distal end straight | Round, fixed irrigation tap, distal end | |
| straight | ||
| Material of the shaft | Stainless steel, plastic | Titanium, stainless steel, plastic |
| Material of dilator | Stainless steel | Stainless steel |
| Lumen/Inner diameter of | ||
| the dilator | 1 mm, 1mm; 1 mm, 1.3 mm | 4 mm; 5 mm |
| Outer diameter of the | ||
| dilator | 15 Fr.; 17 Fr. | 12 Fr.; 15 Fr. |
| Wall thickness | 0.5 mm | 0.25 mm |
| Working length of the | ||
| dilator | 370 mm | 320 mm |
| Outer diameter of the | ||
| sheath | 18 Fr., 20 Fr. | 18 Fr. |
| Working length of the | ||
| sheath | 130 mm; 160 mm | 150 mm |
| Device packaged as | ||
| sterile | No | No |
| Requires sterilization | ||
| prior to use | Yes | Yes |
| Single-Use/Reusable | Reusable | Reusable |
| Sterilization method | Steam sterilization | Moist Heat or Steam Sterilization |
| Ethylene Oxide | ||
| 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
5
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
components | Material | Product Dimensions |
|----------------|-------------------------------------------------------------|-------------------------------------|----------------------------|-----------------------------------------------------------------------------------------|
| WA2PS18S | Shaft, 18 Fr. | Main part,
Meatus ring,
Shaft | 1.4301
PPSU
1.4301 | Total length: 165 mm
Working length: 130 mm
Outer Ø: 18 Fr
Inner Ø: 15 Fr |
| WA2PS18L | Shaft, 18 Fr. | Main part,
Meatus Ring,
Shaft | 1.4301
PPSU
1.4301 | Total length: 195 mm
Working length: 160 mm
Outer Ø: 18 Fr
Inner Ø: 15 Fr |
| WA2PS20S | Shaft, 20 Fr. | Main part,
Meatus Ring,
Shaft | 1.4301
PPSU
1.4301 | Total length: 165 mm
Working length: 130 mm
Outer Ø: 20 Fr
Inner Ø: 17 Fr |
| WA2PS20L | Shaft, 20 Fr. | Main part,
Meatus Ring,
Shaft | 1.4301
PPSU
1.4301 | Total length: 195 mm
Working length: 160 mm
Outer Ø: 20 Fr
Inner Ø: 17 Fr |
| WA2PD18A | Dilator, 15 Fr.,
(to be used with
WA2PS18S, WA2PS18L) | Handle,
Shaft
Tip | 1.4301
1.4301
1.4301 | Total length: 390 mm
Working length: 370 mm
Outer Ø: 15 Fr
Inner Ø: 3 Fr, 3 Fr |
| WA2PD20A | Dilator, 17 Fr.,
(to be used with
WA2PS20S, WA2PS20L) | Handle,
Shaft
Tip | 1.4301
1.4301
1.4301 | Total length: 390 mm
Working length: 370 mm
Outer Ø: 17 Fr
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
8
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 | ||
| Testing: | TROKAMED standard FB-26_07_010_Product | |
| Life expectancy | ||
| TROKAMED Standard Operating Procedures | Material durability and | |
| functionality are verified | ||
| for the given lifetime. | ||
| (Worst-Case principle) | ||
| Mechanical strength test | ||
| with unaged and aged | ||
| subject device. | ||
| FB- | ||
| 15_02_001_TR_Mini | ||
| PCNL_01_mechanical | ||
| test_15Sep2020 | ||
| (Subject device | ||
| tested) | ||
| Tests | Standard Reference to Tests | Results |
| Biocompatibility Evaluation: |
- Evaluation of basic biological
assessment - 091924-20 "Cytotoxicity, L929-
Proliferation" - 091925-20 "chemical analysis
(characterizations of organic
release products)"
(Worst Case principle) | ISO 10993-1:2018 Biological
evaluation of medical devices
Part 1: Evaluation and testing
within a risk management
process
ISO 10993-5:2009 Biological
evaluation of medical
devices - Part 5: Tests for in
vitro cytotoxicity
ISO 10993-10: 2010 Biological
evaluation of medical
devices - Part 10: Tests for
irritation and skin sensitization
ISO 10993-12:2012 Biological
evaluation of medical devices
Part 12: Sample preparation and
reference materials
ISO 10993-18:2020 Biological
evaluation of medical devices
Part 18: Chemical
characterization of medical
device materials within a risk
management process
FDA blue book memorandum
(#G95-1) | A cytotoxicity testing of
Worst Case AUF11020 has
verified that no substances
of cell toxic concentration
are released.
The chemical
characterization has shown
that solvable substances or
degradation products of
Worst case AUF11020 do
not exceed the toxicological
relevant concentrations. |
| Mechanical Testing:
- 2006-02-06 UB Tensile tests
with tubes_english
(Worst Case principle) | none
(TROKAMED Standard
Operating Procedures only) | Summary of bending and
breaking forces of stainless
steel TROKAMED
instruments. |
| - 2014-09-23 Bending load of the
shaft tubes English_10Jun2021
(Worst Case principle) | none
(TROKAMED Standard
Operating Procedures only) | Shaft of subject device
withstands maximal loading
forces within minimally
invasive surgery. |
| - FB-15_02_001_TR_Mini
PCNL_01_mechanical
test_15Sep2020
(Subject device tested) | none
(TROKAMED Standard
Operating Procedures only) | Stability and strength of
connecting points of the
subject device, unaged and
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
9
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
11
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