(106 days)
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radiofrequency current.
The products are intended for use in endoscopically performed or supported surgeries.
The types of surgery intended are:
- Endoscopic procedures
- Orthopedic procedures
- Neurosurgical coagulation
FlexTip Bipolar electrodes single-use consist of a handpiece with electrode front part, cable and plug. The Bipolar electrodes are available in two different working lengths. The FlexTip electrodes are encoded for RF generators Arthrex Inc. (AR-S9800 Synergy) and Sutter Medizintechnik GmbH (K171869 CURIS® RF Generator). The electrodes are provided sterile and are single-use instruments. Electrode shaft and tips are made of stainless steel and are insulated with PEBAX tubing.
The provided text describes the 510(k) premarket notification for the "FlexTip Bipolar electrodes single-use" device. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than detailing clinical studies with specific acceptance criteria in the context of AI/ML device performance.
Therefore, many of the requested details about acceptance criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, or multi-reader studies are not applicable to this submission, as it is for a physical medical device (electrosurgical electrodes) and not an AI/ML-based diagnostic or therapeutic software.
The document primarily covers bench testing, biocompatibility testing, and sterilization validation.
Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of quantitative acceptance criteria with numerical performance targets in the way one might for an AI/ML device (e.g., AUC > X, sensitivity > Y%). Instead, the acceptance criteria are implicitly that the device passes various engineering and biological tests, performing equivalently to the predicate device.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety & Electromagnetic Compatibility | Compliance with FDA recognized standards (IEC 60601-1, -1-2, -2-2, -2-18). | Pass |
| Mechanical Strength & Functionality | Design specifications are met under mechanical stress tests. | Pass |
| Thermal Effects on Tissue | Equivalent coagulation performance to predicate device across different power levels, application times, and tissue types (visual and digital morphometric measurement via histology). | Equivalent coagulation performance to predicate device |
| Systems Performance / Bench-top Validation | Design specifications are met; proper interaction with compatible RF generator. | Pass |
| Biocompatibility | Compliance with ISO 10993-1. | Requirements met |
| Sterilization Validation | Compliance with ISO 11135, ISO 11737-1, ISO 11137-2, ISO 14937, ISO 10993-7. SAL 10^-6, EO/ECH residuals below limits. | Compliance demonstrated; SAL 10^-6; EO/ECH limits met |
| Shelf Life Testing | Maintain functionality and sterility for specified duration per ISO 11607-1. | 1 year shelf life |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in numerical terms for each test.
- For "Thermal effects on tissue": "Three different types of tissue were used, and tests were performed in triplicate." This describes 3 samples per tissue type, tested 3 times.
- For other bench tests, the sample size is not specified but is implicitly part of the standard testing for device validation.
- Data Provenance: The testing was conducted in line with internal R&D processes and FDA guidance. The location of the testing is not specified, but the applicant (Sutter Medizintechnik GmbH) is based in Germany. These are non-clinical bench tests, not patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This is a physical device, and the "ground truth" is established by engineering and standard medical device performance testing, not by expert interpretation of patient data or images. "Visual comparison" for thermal effects implies a human assessment, but not by a panel of "experts" in the sense of clinical readers.
4. Adjudication Method for the Test Set
Not Applicable. No human-in-the-loop clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. MRMC studies are typically for evaluating diagnostic performance of imaging devices or AI algorithms. This submission is for an electrosurgical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Not Applicable. This is not an algorithm or AI device. The phrase "standalone" might refer to the device's intrinsic performance, which is assessed through the various bench tests described (electrical safety, mechanical strength, thermal effects, systems performance).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance validation is established through:
- Engineering specifications and test standards: Compliance with IEC and ISO standards for electrical safety, biocompatibility, sterilization, and packaging.
- Physical measurements and visual assessment: For mechanical strength and thermal effects on tissue (including digital morphometric measurement using histology).
- Comparison to predicate device: Demonstration of equivalent performance and characteristics to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. No training set exists.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 25, 2024
Sutter Medizintechnik GmbH % Arne Briest Managing Director VISAMED GmbH Kastellstr. 8 Karlsruhe, 76227 Germany
Re: K233425
Trade/Device Name: FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: January 12, 2024 Received: January 12, 2024
Dear Arne Briest:
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: 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.
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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" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.01.25 13:48:57 -05'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
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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) K233425
Device Name FlexTip Bipolar electrodes single-use
Indications for Use (Describe)
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radiofrequency current.
The products are intended for use in endoscopically performed or supported surgeries.
The types of surgery intended are:
- · Endoscopic procedures
- · Orthopedic procedures
- Neurosurgical coagulation
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/4/Picture/0 description: The image features the logo of Sutter Health, a not-for-profit integrated health system. The logo consists of a teal square with two white vertical lines at the top, resembling pillars or a stylized '11'. Below the square, the word 'Sutter' is written in a bold, sans-serif font, also in white. The overall design is clean and modern, conveying a sense of stability and trustworthiness.
K233425
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92 upon which substantial equivalence is based.
l SUBMISSION SPONSOR and APPLICATION CORRESPONDANT A. SUBMISSION SPONSOR
Sutter Medizintechnik GmbH
Alfred-Walz-Str. 22 79312 Emmendingen - Germany www.sutter-med.com
Tel +49 (0) 7641 962 56 0
Contact Person :
Simone Peschl VP Business Development & Market Access simone.peschl@sutter-med.de
B. APPLICATION CORRESPONDANT
VISAMED GmbH Kastellstr. 8 D-76227 Karlsruhe-Germany www.visamed.com Tel +49 (0)721-476 4847
Contact Person : Arne Briest CEO arne.briest@visamed.com
II. Dated prepared: January 23, 2024
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Image /page/5/Picture/0 description: The image features the logo of Sutter Health. The logo consists of a teal square with two white vertical lines at the top, resembling pillars. Below the pillars, the word "Sutter" is written in white, using a simple, sans-serif font.
DEVICE IDENTIFICATION =
| Name of Device: | FlexTip bipolar electrodes single-use |
|---|---|
| Common Name: | FlexTip bipolar electrodes single-use |
| Classification Name: | Electrosurgical, Cutting & Coagulation &Accessories (21 CFR § 878.4400) |
| Classification Panel: | General & Plastic Surgery |
| Regulatory Class: | II |
| Product Code: | GEI |
| 510k #: | TBD |
IV PREDICATE DEVICE
K170377 – TipControl RF Instrument, bipo
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Image /page/6/Picture/0 description: The image features the logo of Sutter Health, a not-for-profit healthcare system. The logo consists of a teal square with two white vertical lines at the top, resembling a stylized 'H'. Below the lines, the word 'Sutter' is written in a bold, sans-serif font, also in white. The overall design is clean and modern, conveying a sense of trust and professionalism.
DEVICE DESCRIPTION >
FlexTip Bipolar electrodes sinqle-use consist of a handpiece with electrode front part, cable and plug. The Bipolar electrodes are available in two different working lengths. The FlexTip electrodes are encoded for RF generators Arthrex Inc. (AR-S9800 Synergy) and Sutter Medizintechnik GmbH (K171869 CURIS® RF Generator). The electrodes are provided sterile and are single-use instruments. Electrode shaft and tips are made of stainless steel and are insulated with PEBAX tubing.
| Model list (REF) | Working length (mm) | Tips (mm) |
|---|---|---|
| AR-S9805-0035 | 350 | 2 |
| AR-S9805-0028 | 280 | 2 |
INDICATIONS FOR USE >
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radiofrequency current.
The products are intended for use in endoscopically performed or supported surgeries.
The types of surgery intended are:
- . Endoscopic procedures
- Orthopedic procedures
- Neurosurgical coagulation
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Image /page/7/Picture/0 description: The image features the logo of Sutter Health, a not-for-profit integrated health system. The logo consists of a teal square with two white vertical lines at the top, resembling a stylized 'H'. Below the lines, the word 'Sutter' is written in a bold, sans-serif font, also in white. The overall design is clean and modern, conveying a sense of trust and professionalism associated with healthcare services.
VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The TipControl RF Instrument, bipo is the predicate device for the FlexTip Bipolar electrodes single-use.
| Predicate Devices | Subject Device | ComparisonAnalysis | |
|---|---|---|---|
| Device | RF Instrument BIPO | FlexTip | - |
| Prescription use | x | x | identical |
| Device Identification | |||
| RichardWolf MedicalInstruments Corp. | SutterGmbHMedizintechnik | ||
| RegulationNumberand - Name | 21CFR878.4400Electrosurgical cutting andcoagulation device andaccessories | 21CFR878.4400Electrosurgical cutting andcoagulation device andaccessories | identical |
| Regulatory Class | II | II | identical |
| Product Code | GEI | GEI | identical |
| 510(k) number | K170377 | TBD | - |
| Description and Indication for Use | |||
| General DeviceDescription | Steril, disposable single-use,bipolar radiofrequency (RF)instrument used for tissueand vessel coagulation(hemostasis) by means ofradio-frequency current. | Steril, disposable single-use,bipolar radiofrequency (RF)instrument used for tissueand vessel coagulation(hemostasis) by means ofradio-frequency current. | Identical |
| Indicationsforuse | The RF instruments are usedfor tissue and vesselcoagulation (hemostasis) bymeans of radiofrequencycurrent.The products are intended foruse in endoscopicallyperformed or supportedsurgeries. | The RF instruments areused for tissue and vesselcoagulation (hemostasis) bymeans of radiofrequencycurrent.The products are intended foruse in endoscopicallyperformed or supportedsurgeries. | Identical |
| The types of surgery intendedare:- Endoscopic Procedures- Orthopedic coagulation- Neurosurgical coagulation | The types of surgeryintended are:- Endoscopic procedures- Orthopedic procedures- Neurosurgical coagulation | ||
| Predicate Devices | Subject Device | ComparisonAnalysis | |
| Biological Characteristics | |||
| Duration ofContact | Time related to theprocedure | Time related to theprocedure | Identical |
| Contact withbody fluids/tissue | Yes | Yes | Identical |
| Sterility | Instruments are providedsterilized by ETO to a | Instruments are providedsterilized by ETO to a | Identical |
| SAL 10-6. | SAL 10-6. | ||
| MeetsISO 10993-1 | Yes | Yes | Same |
| Technical Characteristics | |||
| Electrode DesignHandle Design | Bended tips | Bended tips | IdenticalIdenticalworkingprinciple,different design ofhandle design(grip). Thedifferences do notaffect safety andeffectiveness. |
| Diameter of theElectrode Tip | 2 mm | 2 mm | Identical |
| Working length | 280 mm350 mm | 280 mm350 mm | Identical |
| MaterialTips, Branches | Stainless steel, twocomponents glue | Stainless steel, twocomponents glue | Same |
| Handle | polymer | polymer | Same |
| Insulation | polymer | polymer | Same |
| ProductPackaging | PTEG BlisterTyvek pouchCardbox | PTEG BlisterTyvek pouchCardbox | Same materials,different sizebecause of thedifferent handledesign. |
| Combination withradiofrequencygenerator | 4 MHz | 4 MHz | Same |
| Maximum peakvoltage | 400 Vp | 400 Vp | Same |
| Compliance to FDA recognized electrical safety standards | |||
| Meets | |||
| IEC 60601-1 | Yes | Yes | Same |
| IEC 60601-2-2 | Yes | Yes | Same |
| IEC 60601-1-2 | Yes | Yes | Same |
| IEC 60601-2-18 | Yes | Yes | Same |
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Image /page/8/Picture/0 description: The image features the logo of Sutter Health, a not-for-profit integrated health system. The logo consists of a teal square with two white vertical lines at the top, resembling a stylized 'H' or a building's facade. Below the teal square, the word 'Sutter' is written in a bold, white sans-serif font, creating a clean and modern design.
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Image /page/9/Picture/0 description: The image features the logo of Sutter Health, a not-for-profit integrated health system. The logo consists of a teal square with two white vertical lines at the top, resembling pillars or an abstract representation of a building. Below the geometric shape, the word "Sutter" is written in a bold, sans-serif font, also in white. The overall design is clean and modern, conveying a sense of stability and trustworthiness.
Both the TipControl RF Instrument, bipo and the FlexTip Bipolar electrodes single-use are designed to be used with compatible electrosurgical bipolar radiofrequency generators.
VIII NON-CLINICAL PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Bench Testing
Performance testing has been executed in line with the internal R&D process and in compliance with the proposals and recommendations of the FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, issued on March 9, 2020.
Tests were carried out with respect to following subject areas:
| Performance Data Bench Tests | |
|---|---|
| Test | Conclusion |
| Electrical Safety and Electromagnetic Compatibility | Pass |
| Mechanical strength and functionality performance testing | Pass |
| Thermal effects on tissue | Pass |
| Systems Performance / Bench-top Validation | Pass |
Electrical safety and electromagnetic compatibility
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the FlexTip Bipolar electrodes single-use.
The device complies with FDA recognized electrical safety standards:
- IEC 60601-1
- IEC 60601-1-2 ●
- IEC 60601-2-2 ●
- IEC 60601-2-18
Electrical and electromagnetic tests were performed to demonstrate that design specifications and performance requirements are met.
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Image /page/10/Picture/0 description: The image features the logo of Sutter Health, a not-for-profit healthcare system. The logo consists of a teal square with the word "Sutter" in white at the bottom left. Above the word "Sutter" are two white vertical lines that are slightly angled towards each other, creating a stylized and modern design. The overall impression is clean, professional, and indicative of a healthcare organization.
Mechanical strength and functionality performance testing
Mechanical strength and functionality performance testing was performed to demonstrate that design specifications are met. Mechanical stress tests showed that the design specifications are met.
Thermal effects on tissue
Thermal effects on tissue testing were performed to determine thermal effects caused by the FlexTip Bipolar electrodes single-use at different power levels and application times in comparison to the predicate device. Three different types of tissue were used, and tests were performed in triplicate. Visual comparison as well as digital morphometric measurement using histology showed equivalent coagulation performance of subject device and predicate device.
Systems Performance / Bench-top Validation
The system performance / bench-top Validation testing was performed to demonstrate that design specifications are met. The testing evaluated both the FlexTip Bipolar electrodes single-use and the interaction with the Sutter CURIS® RF generator.
Systems Performance / Bench-top Validation tests showed that the design specifications are met.
Biocompatibility testing
The biocompatibility evaluation for FlexTip Bipolar electrodes single-use has been conducted in accordance with FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" and ISO 10993-1 – "Biological evaluation of medical devices – Evaluation and testing within a risk management system". These FlexTip Bipolar electrodes singleuse are categorized as externally communicating devices in indirect contact with tissue/bone for a limited time (<24h) per ISO 10993-1. The evaluation reveals that biocompatibility requirements are met by the FlexTip Bipolar electrodes single-use.
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Image /page/11/Picture/0 description: The image features a teal square with the word "Sutter" in white at the bottom. Above the word, there are two white vertical lines that are close together. The lines appear to be a stylized representation of a building or structure, and the overall design is clean and modern.
Biocompatibility testing was performed on the FlexTip Bipolar electrodes single-use in accordance with:
• ISO 10993-1 - Biological evaluation of medical devices- Evaluation and testing within a risk management system.
Sterilization Validation
In addition, the sterilization validation on the FlexTip Bipolar electrodes singleuse has been performed in accordance with:
- · ISO 11135 Sterilization of health care products Ethylene Oxide -Requirements for the development, validation and routine control of a sterilization process for medical device;
- ISO 11737-1 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ISO 11137-2 Sterilization of health care products Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- · ISO 14937 Sterilization of health care products General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; and
- ISO 10993-7 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.
Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 4 mg and ECH < 9 mq after 9 days of aeration (gas release) that remain on the FlexTip Bipolar electrodes single-use will not be exceeded. The sterility assurance level (SAL) was 10°. Package and product integrity of the tube sets were tested in accordance with ISO11607-1 - Packaging for terminally sterilized medical devices and ASTM-F- 1980 - Standard for accelerated aging of sterile medical device packages.
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Image /page/12/Picture/0 description: The image features the logo of Sutter Health, a not-for-profit healthcare system. The logo consists of a teal square with two white vertical lines at the top, resembling pillars or a stylized 'H'. Below the square, the word 'Sutter' is written in a bold, sans-serif font, also in white. The overall design is clean and modern, conveying a sense of stability and trustworthiness.
Shelf Life Testing
Shelf-life testing has been conducted in accordance ISO 11607-1. The aging studies established that the FlexTip Bipolar electrodes single-use and packaging remain functional and maintain sterility for up to 1 year.
Animal studies
Data from animal studies were not required to support the safety and effectiveness of the FlexTip Bipolar electrodes single-use.
Clinical Studies
Clinical data were not required to support the safety and effectiveness of the FlexTip Bipolar electrodes single-use. All validation was performed based on non-clinical performance tests.
IX CONCLUSIONS
Based on the similar intended use, the same basic technological characteristics and performance testing, the FlexTip Bipolar electrodes single-use is substantially equivalent to the predicate device TipControl RF Instrument, bipo (K170377). The minor differences raise no new issues of safety and effectiveness, as the design differences have no effect on the performance, function or intended use.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.