(57 days)
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopically performed or supported surgery intended are:
-
- Endoscopic procedures
-
- Orthopedic coagulation
-
- Neurosurgical coagulation
The products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.
- Neurosurgical coagulation
The TipControl RF (Radio Frequency) Instruments, bipo are disposable single-use, sterile packaged electrosurgical devices, used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopic performed or supported surgeries. The types of surgery intended are: Endoscopic procedures, orthopedic coagulation, and neurosurgical coagulation. These products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.
The TipControl RF Instrument, bipo consists of a handle, a sheath tube, the TipControl RF electrode and a connection cable with an US 2-PIN device connector. The just mentioned components comprise a complete unit for disposable use and cannot be dismantled. They are currently available in a working length of 280 mm or 350 mm.
The TipControl RF Instruments, bipo are designed to be used in conjunction with the electrosurgical bipolar radiofrequency generators Surgitron and Surgi-Max Plus up to 4 MHz and endoscopic accessories. The RF generator provides power and delivers electrical current to the distal tips of the RF instruments.
This document is a 510(k) premarket notification for the "TipControl RF Instrument bipo Ø 2.5mm WL 280mm" and "TipControl RF Instrument bipo Ø 2.5mm WL 350mm". The device is an electrosurgical cutting and coagulation device and accessories. The filing seeks to establish substantial equivalence to a predicate device, the "Trigger Flex™ Bipolar Electrode (K003126)".
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135 (EO sterilization development, validation, routine control) | Complies with ISO 11135 |
| ISO 10993-7 (EO sterilization residuals) | Complies with ISO 10993-7 | |
| Bench Testing | General evaluation and testing within a risk management process (based on FDA guidance) | Performs successfully in bench testing |
| Electrosurgical devices for general surgery (FDA guidance) | Performs successfully in bench testing | |
| Bipolar electrosurgical vessel sealers for general surgery (FDA guidance) | Performs successfully in bench testing | |
| Biocompatibility | ISO 10993-5 (Cytotoxicity Study - XTT Assay) | Non-cytotoxic |
| ISO 10993-4, -12 (Hemolysis Study - Extract Only) | Non-hemolytic | |
| ISO 10993-10, -12 (Intracutaneous Reactivity Study in Rabbit) | Non-irritating | |
| ISO 10993-10, -12 and OECD Guideline 429 (Skin Sensitization Study in Mice) | Non-sensitizing | |
| ISO 10993-11, -12 (Systemic Toxicity Study in Mice) | Non-toxic | |
| Electrical Safety & Electromagnetic Compatibility | IEC 60601-1 (General requirements for basic safety and essential performance) | Fully complies with IEC 60601-1 |
| IEC 60601-2-2 (Particular requirements for high frequency surgical equipment and accessories) | Fully complies with IEC 60601-2-2 | |
| IEC 60601-2-18 (Particular requirements for endoscopic equipment) | Fully complies with IEC 60601-2-18 | |
| Software Verification & Validation | Not Applicable | Products do not contain software |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of an AI/algorithm-based device, as this is a traditional medical device (electrosurgical instrument). The tests performed are laboratory-based and conducted on samples of the device itself.
- Sample Size: Not explicitly stated for specific tests (e.g., how many devices were tested for biocompatibility or bench testing). These are generally conducted with a sufficient number of samples to ensure statistical validity for the relevant standard.
- Data Provenance: The device manufacturer (Richard Wolf GmbH) is located in Germany. It can be inferred that the testing and data originate from within the company's quality assurance and R&D processes, likely conducted in Germany or by certified contract laboratories. The document does not specify if data is retrospective or prospective, but as it pertains to device design verification and validation, it would be prospective for the evaluated device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes a physical electrosurgical device, not an AI/diagnostic algorithm that requires ground truth established by experts. The "ground truth" for this type of device is established through compliance with recognized standards and successful performance in defined laboratory tests (e.g., measuring electrical parameters, biological responses).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device does not involve expert adjudication as it is not a diagnostic device requiring interpretation of data by multiple experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device does not incorporate AI, therefore no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not have an algorithm component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" as it applies to AI/image analysis is not directly relevant here. For this electrosurgical device, the "ground truth" is defined by:
- Compliance with recognized international standards: e.g., ISO 11135, ISO 10993 series, IEC 60601 series.
- Successful performance in bench tests: Meeting predefined specifications for electrical performance, mechanical integrity, and functional capabilities as outlined in relevant FDA guidances.
- Biocompatibility testing results: Demonstrating non-cytotoxicity, non-hemolysis, non-irritation, non-sensitization, and non-toxicity based on established biological evaluation protocols.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5. 2017
Richard Wolf Medical Instruments Corporation Mr. Michael Loiterman US Head of Regulatory - QA/QC 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K170377
Trade/Device Name: TipControl RF Instrument bipo Ø 2.5mm WL 280mm. TipControl RF Instrument bipo Ø 2.5mm WL 350mm Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 3, 2017 Received: February 7, 2017
Dear Mr. Loiterman:
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. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170377
Device Name
TipControl RF Instrument bipo Ø 2.5mm W1 280mm, TipControl RF Instrument bipo Ø 2.5mm W1 350mm
Indications for Use (Describe)
The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopically performed or supported surgery intended are:
-
- Endoscopic procedures
-
- Orthopedic coagulation
-
- Neurosurgical coagulation
The products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.
| 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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5. 510(k) Summary
| Submitter: | Date of Preparation: | February 3, 2017Revised 04-04-2017 | |
|---|---|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: | 14 184 79 |
| Division name (if applicable): | N.A. | Phone number (include area code): | ( 847 ) 913 1113 |
| Street address: | 353 Corporate Woods Parkway | FAX number (include area code): | ( 847 ) 913 0924 |
| City: | Vernon Hills | State/Province: | Illinois |
| Country: | USA | ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Michael G. Loiterman | ||
| Contact title: | US Head of Regulatory – QA/QC | ||
| Parent Company: | |||
| Company / Institution name: | Richard Wolf GmbH | FDA establishment registration number: | 96 111 02 |
| Street address: | Pforzheimer Str. 32 | ||
| City: | Knittlingen | State/Province: | Baden-Württemberg |
| Country: | Germany | ZIP / Postal Code: | 75438 |
| Product Information: | |||
| Trade names: | RF INSTRUMENT BIPO Ø 2.5MM WL280MMRF INSTRUMENT BIPO Ø 2.5MM WL350MM | Model numbers: | 4993691149936921 |
| Common name: | TipControl RF Instrument, bipo | Classification name: | GEI, 878.4400 Electrosurgical cutting andcoagulation device and accessories. |
| Information on devices to which substantial equivalence is claimed: | |||
| 510(k) No.: | K003126 | Trade or proprietary or model name: | Trigger Flex™ Bipolar Electrode |
| Manufacturer: | ELLMAN INTL., INC. |
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5.1 Description
The TipControl RF (Radio Frequency) Instruments, bipo are disposable single-use, sterile packaged electrosurgical devices, used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopic performed or supported surgeries. The types of surgery intended are: Endoscopic procedures, orthopedic coagulation, and neurosurgical coagulation. These products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.
The TipControl RF Instrument, bipo consists of a handle, a sheath tube, the TipControl RF electrode and a connection cable with an US 2-PIN device connector. The just mentioned components comprise a complete unit for disposable use and cannot be dismantled. They are currently available in a working length of 280 mm or 350 mm.
The TipControl RF Instruments, bipo are designed to be used in conjunction with the electrosurgical bipolar radiofrequency generators Surgitron and Surgi-Max Plus up to 4 MHz and endoscopic accessories. The RF generator provides power and delivers electrical current to the distal tips of the RF instruments.
The TipControl RF Instruments, bipo are manufactured in accordance with standards for quality management (ISO 13485, ISO 9001), for electrical medical devices (IEC 60601), for sterilization (ISO 11135), and for biological safety (ISO 10993).
5.2 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 coagulation
-
- Neurosurgical coagulation
The products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.
5.3 Substantial Equivalence
The following information summarizes the technological characteristics' comparison of the submitted TipControl RF Instruments, bipo versus the predicate device Trigger-Flex™ Bipolar Electrode (K003126).
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5.3.1 Similarities
The submitted instruments and the predicate devices share equivalent indications for use. They have an equivalent basic operational design and use equivalent materials. Both are used in conjunction with bipolar electrosurgical radiofrequency generators, sharing equivalent technical specifications. Both the instruments and the predicate are single-use and sterile provided. And both comply with the relevant safety standards of IEC 60601.
5.3.2 Main Differences
Working Lengths
The shortest working length of the submitted instrument is 280mm vs. 240mm of the predicate instruments. The longest working length of the submitted instruments is 350mm vs. 320mm for the predicate instruments.
Diameter of the Electrode Tip
The diameter of the electrode tip (2.5mm) is 0.5mm thinner than in the predicate instrument (3.0mm).
Sterilization Method
The submitted instruments are sterilized via ethylene oxide (EO) sterilization, predicate instruments former via gamma radiation and actual with EO.
Product Packaging
While predicate instruments are packaged into sealed Tyvek pouches, the herein submitted instruments additionally utilize a PETG blister.
5.4 Performance Data
5.4.1 Sterilization
The TipControl RF Instruments, bipo comply with the applicable requirements of the FDArecognized standards listed below:
- Recognition Number 14-452: ISO 11135 Second edition 2014, sterilization of health-care . products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
- Recognition Number 14-408: ISO 10993-7 Second edition 2008-10-15, biological ● evaluation of medical devices - part 7: ethylene oxide sterilization residuals [including: technical corrigendum 1 (2009)]. (Sterility)
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5.4.2 Bench Testing
The TipControl RF Instruments, bipo perform successfully in bench testing, conducted in alignment with the following FDA guidances:
- "Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" issued June 16, 2016
- "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016
- "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers ● for General Surgery" issued August 15, 2016
Biocompatibility Testing 5.4.3
Biocompatibility Test Results:
| Test | Conclusion |
|---|---|
| ISO 10993-5: Cytotoxicity Study (XTT Assay) | non-cytotoxic |
| ISO 10993-4, -12: Hemolysis Study (Extract Only) | non-hemolytic |
| ISO 10993-10, -12: Intracutaneous Reactivity Study in Rabbit | non-irritating |
| ISO 10993-10, -12 and OECD Guideline 429 and Commission Regulation EC No. 440/2008, B.42: Skin Sensitization Study in Mice (LLNA) | non-sensitizing |
| ISO 10993-11, -12: Systemic Toxicity Study in Mice | non-toxic |
5.4.4 Electrical Safety and Electromagnetic Compatibility
The TipControl RF Instruments, bipo fully comply with the applicable requirements of the FDArecognized standards listed below:
- Recognition No. 19-4, IEC 60601-1:2005/(R)2012 and A1:2012., c1:2009/(r)2012 and ● a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod). (ES/EMC)
- Recognition No. 6-336, IEC 60601-2-2 Edition 5.0 2009-02, medical electrical equipment ● - part 2-2: particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories [including: technical corrigendum 1 (2014)]. (General Plastic Surgery/General Hospital)
- Recognition No. 9-91, IEC 60601-2-18: Edition 3.0 2009-08, medical electrical . equipment - part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment. (ObGyn/Gastroenterology/Urology)
5.4.5 Software Verification and Validation Testing
The products do not contain software.
5.4.6 Animal Studies and Clinical Studies
Neither animal studies nor clinical studies were conducted in order to demonstrate substantial equivalence.
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5.5 Conclusions
The submitted TipControl RF Instruments, bipo and the Trigger-Flex™ Bipolar Electrode (K003126) share equivalent indications for use.
The technological differences do not raise new types of questions with regard to safety and efficacy. Validation testing has shown that the TipControl RF Instruments, bipo perform in accordance with their technological specifications and operate as intended. Devices are as safe and effective as predicate devices.
Thus, substantial equivalency to the aforementioned 510(k)-cleared predicate devices has been demonstrated.
§ 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.