(106 days)
Not Found
No
The summary describes a standard RF instrument for tissue coagulation and does not mention any AI or ML components or functionalities.
Yes
The device is used for tissue and vessel coagulation (hemostasis) by means of radiofrequency current, which is a therapeutic intervention.
No
The device is an RF instrument used for tissue and vessel coagulation (hemostasis) during surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical instrument consisting of a handpiece, electrode front part, cable, and plug, made of stainless steel and insulated tubing. It is a hardware device used for tissue coagulation.
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 used for "tissue and vessel coagulation (hemostasis) by means of radiofrequency current" during surgical procedures. This is a therapeutic and surgical function, not a diagnostic one.
- Device Description: The description details a surgical instrument (electrodes) used for applying energy to tissue.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a direct surgical action on the body.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- 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 testing were conducted and the device complies with FDA recognized electrical safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18.
Mechanical strength and functionality performance testing was performed and showed that design specifications are met.
Thermal effects on tissue testing was performed to determine thermal effects 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 testing evaluated both the FlexTip Bipolar electrodes single-use and the interaction with the Sutter CURIS® RF generator and showed that design specifications are met.
Biocompatibility testing:
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". Categorized as externally communicating devices in indirect contact with tissue/bone for a limited time (
§ 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.
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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.
1
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure:
3
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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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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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 | Comparison
Analysis |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | RF Instrument BIPO | FlexTip | - |
| Prescription use | x | x | identical |
| Device Identification | | | |
| | Richard
Wolf Medical
Instruments Corp. | Sutter
GmbH
Medizintechnik | |
| Regulation
Number
and - Name | 21CFR878.4400
Electrosurgical cutting and
coagulation device and
accessories | 21CFR878.4400
Electrosurgical cutting and
coagulation device and
accessories | identical |
| Regulatory Class | II | II | identical |
| Product Code | GEI | GEI | identical |
| 510(k) number | K170377 | TBD | - |
| Description and Indication for Use | | | |
| General Device
Description | Steril, disposable single-use,
bipolar radiofrequency (RF)
instrument used for tissue
and vessel coagulation
(hemostasis) by means of
radio-frequency current. | Steril, disposable single-use,
bipolar radiofrequency (RF)
instrument used for tissue
and vessel coagulation
(hemostasis) by means of
radio-frequency current. | Identical |
| 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 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. | Identical |
| | The types of surgery intended
are:
- Endoscopic Procedures
- Orthopedic coagulation
- Neurosurgical coagulation | The types of surgery
intended are: - Endoscopic procedures
- Orthopedic procedures
- Neurosurgical coagulation | |
| | Predicate Devices | Subject Device | Comparison
Analysis |
| | Biological Characteristics | | |
| Duration of
Contact | Time related to the
procedure | Time related to the
procedure | Identical |
| Contact with
body fluids/tissue | Yes | Yes | Identical |
| Sterility | Instruments are provided
sterilized by ETO to a | Instruments are provided
sterilized by ETO to a | Identical |
| | SAL 10-6. | SAL 10-6. | |
| Meets
ISO 10993-1 | Yes | Yes | Same |
| | Technical Characteristics | | |
| Electrode Design
Handle Design | Bended tips | Bended tips | Identical
Identical
working
principle,
different design of
handle design
(grip). The
differences do not
affect safety and
effectiveness. |
| Diameter of the
Electrode Tip | 2 mm | 2 mm | Identical |
| Working length | 280 mm
350 mm | 280 mm
350 mm | Identical |
| Material
Tips, Branches | Stainless steel, two
components glue | Stainless steel, two
components glue | Same |
| Handle | polymer | polymer | Same |
| Insulation | polymer | polymer | Same |
| Product
Packaging | PTEG Blister
Tyvek pouch
Cardbox | PTEG Blister
Tyvek pouch
Cardbox | Same materials,
different size
because of the
different handle
design. |
| Combination with
radiofrequency
generator | 4 MHz | 4 MHz | Same |
| Maximum peak
voltage | 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 (