(145 days)
No
The summary describes a physical medical device combining electrosurgery and hydrosurgery functions, with no mention of AI or ML in its operation or control.
Yes
The device is intended for monopolar cutting and coagulation, and tissue-selective hydrodissection for lifting mucosal lesions, which are therapeutic interventions.
No.
The device is described as a flexible monopolar probe that combines hydrosurgery and electrosurgery for cutting, coagulation, hydrodissection, and injection, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a "flexible monopolar probe" and a "sterile, single use device," which are physical hardware components. It also mentions being used with other hardware units (hydrosurgical unit and electrosurgical unit) and connected via cables/tubings.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures (cutting, coagulation, injection, hydrodissection) directly on tissue within the body during endoscopic interventions.
- Device Description: The description details a flexible monopolar probe that combines hydrosurgery and electrosurgery functions for direct tissue manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for therapeutic and procedural purposes.
N/A
Intended Use / Indications for Use
The HYBRIDknife flex is intended for:
· monopolar cutting and coagulation.
· needle-free injection and tissue-selective hydrodissection including lifting mucosal lesions by injection into the submucosa (soft tissue).
The HYBRIDknife flex is used in endoscopic interventions.
Product codes
GEI, FQH
Device Description
The HYBRIDknife flex is a flexible monopolar probe that combines the technologies of hydrosurgery and electrosurgery in one instrument. Each function can be activated without the need to change instruments. The HYBRIDknife flex is a sterile, single use device which is used with endoscopes with a minimal working channel diameter of 2.8mm. The hydrosurgical function is intended to deliver a pressurized fluid for tissue-selective hydrodissection and needle-free injection whereas the electrosurgical function is intended for cutting and coagulation of tissue. By means of needle-free injection a fluid cushion is formed in the submucosa, which provides a mechanical and thermal protection layer during cutting and coagulation of the target tissue. The elevation thus reduces the risk of perforation. All HYBRIDknife flex probes have a length of 2.3 meters and an outer diameter (OD) of 2.6mm. The only difference between the variants is the electrode type and length. The HYBRIDknife flex is available with a "T-type" electrode and an "I-type" electrode whereas both electrode types are available as a long (i.e. 2mm length) and short (i.e. 1.5mm) version. The protrusion of the T-type electrode gives the user the possibility to hook and move tissue. The instruments are designed for operation with the hydrosurgical unit ERBEJET 2 (K072404; K143306 & K231023) in combination with an Erbe Electrosurgical unit of the "VIO" series (e.g. VIO 3 K190823). HYBRIDknife flex is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done by using a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
submucosa (soft tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in endoscopic interventions. 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)
Non-clinical performance testing:
- Functional testing and design controls to verify both safety and performance of the subject device was performed in compliance with 21 CFR 820.30 to ensure that the subject device performs as intended and meets design specifications.
- Tissue testing was performed in compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued on March 9, 2020, to validate cutting and coagulation performance and the waterjet function compared to the predicate device.
- EMC and Electrical safety of the subject device was tested in compliance with IEC 60601-1 Edition 3.2; IEC 60601-2-2 Edition 6.0; IEC 60601-2-18: Edition 3.0 and IEC 60601-1-2 Edition 4.0
- Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to demonstrate biocompatibility with the new materials that were used.
- Sterilization validation was performed in compliance with ISO 11135 and documentation was provided according to FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" showing an SAL of 10-6. EO residual testing and limits are in compliance with ISO 10993-7.
- Packaging and shelf-life validation was performed in compliance with ISO 11607-1 and accelerated aged devices (ASTM F 1980).
Key results: The subject device does not raise new or different questions of safety and effectiveness, and the subject device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ERBE Hybrid Knife - K083608, ERBEJET® 2 System K231023
Reference Device(s)
ERBEJET 2 (K072404; K143306 & K231023), VIO 3 K190823
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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November 29, 2023
Erbe Elektromedizin GmbH Matthias Kollek Regulatory Affairs Specialist Waldhoernlestrasse 17 Tuebingen, 72072 Germany
Re: K232033
Trade/Device Name: HYBRIDknife® flex Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, FQH Dated: October 30, 2023 Received: October 31, 2023
Dear Matthias Kollek:
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.
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).
1
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: 2023.11.29 Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232033
Device Name HYBRIDknife® flex
Indications for Use (Describe)
The HYBRIDknife flex is intended for:
· monopolar cutting and coagulation.
· needle-free injection and tissue-selective hydrodissection including lifting mucosal lesions by injection into the submucosa (soft tissue).
The HYBRIDknife flex is used in endoscopic interventions.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------- |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
| Applicant | Erbe Elektromedizin GmbH |
|---|---|
| Waldhoernlestrasse 17 | |
| 72072 Tuebingen | |
| Germany | |
| Tel: 0049-7071-755-0 | |
| Fax: 0049-7071-755-179 | |
| Contact Person | Dr. Matthias Kollek |
| Regulatory Affairs Specialist | |
| E-Mail: Matthias.Kollek@erbe-med.com | |
| Date Prepared | November 29, 2023 |
| Device Information | |
| Trade/Proprietary Name: | HYBRIDknife® flex |
| Common Name: | Monopolar probe with hydro function |
| Classification Name | Electrosurgical cutting and coagulation device |
| and accessories & Jet Lavage | |
| Regulation Number: | 21 CFR 878.4400 & 21 CFR Part 880.5475 |
| Class: | II |
| Product Code: | GEI & FQH |
| Legally Marketed Predicate Devices | Primary: ERBE Hybrid Knife - K083608 |
| Secondary: ERBEJET® 2 System K231023 |
4
Device Description
The HYBRIDknife flex is a flexible monopolar probe that combines the technologies of hydrosurgery and electrosurgery in one instrument.
Each function can be activated without the need to change instruments. The HYBRIDknife flex is a sterile, single use device which is used with endoscopes with a minimal working channel diameter of 2.8mm. The hydrosurgical function is intended to deliver a pressurized fluid for tissue-selective hydrodissection and needle-free injection whereas the electrosurgical function is intended for cutting and coagulation of tissue. By means of needle-free injection a fluid cushion is formed in the submucosa, which provides a mechanical and thermal protection layer during cutting and coagulation of the target tissue. The elevation thus reduces the risk of perforation. All HYBRIDknife flex probes have a length of 2.3 meters and an outer diameter (OD) of 2.6mm. The only difference between the variants is the electrode type and length. The HYBRIDknife flex is available with a "T-type" electrode and an "I-type" electrode whereas both electrode types are available as a long (i.e. 2mm length) and short (i.e. 1.5mm) version. The protrusion of the T-type electrode gives the user the possibility to hook and move tissue. The instruments are designed for operation with the hydrosurgical unit ERBEJET 2 (K072404; K143306 & K231023) in combination with an Erbe Electrosurgical unit of the "VIO" series (e.g. VIO 3 K190823). HYBRIDknife flex is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the
Indications for Use
The HYBRIDknife flex is intended for:
instrument is done by using a footswitch.
- · monopolar cutting and coagulation.
- · needle-free injection and tissue-selective hydrodissection including lifting mucosal lesions by injection into the submucosa (soft tissue).
The HYBRIDknife flex is used in endoscopic interventions.
5
Comparison to predicate devices
| Predicate Devices | Subject Device | ||
|---|---|---|---|
| Primary Predicate | |||
| Device | Secondary Predicate | ||
| Device | HYBRIDknife flex | ||
| Characteristics | ERBE Hybrid Knife | ||
| (K083608) | Erbejet 2 System | ||
| (K231023) | |||
| Manufacturer | Erbe Elektromedizin | ||
| GmbH (Germany) | Erbe Elektromedizin | ||
| GmbH (Germany) | Erbe Elektromedizin | ||
| GmbH (Germany) | |||
| Regulation | |||
| number | 878.4400 & 880.5475 | 880.5475 | 878.4400 & 880.5475 |
| Regulatory class | II | II | II |
| Product code | GEI; FQH | FQH | GEI; FQH |
| Indications for | |||
| use | The ERBE Hybrid Knife | ||
| is intended to be used in | |||
| combination with the | |||
| Water Jet | |||
| System/ERBEJET 2 and | |||
| an ERBE ESU VIO | |||
| Model to cut and dissect | |||
| soft tissue in | |||
| neurosurgery and soft | |||
| tissue such as the liver, | |||
| kidney, etc. within the | |||
| abdomen, including Total | |||
| Mesorectal Excision | |||
| (TME) via the Water Jet | |||
| System as well as to | |||
| provide monopolar | |||
| cutting and coagulation | |||
| of the target tissue by the | |||
| ESU in open and as well | |||
| as endoscopic surgery. | The Erbe hydrosurgical | ||
| unit ERBEJET 2 with | |||
| instruments and | |||
| accessories is intended | |||
| to pressurize a medium | |||
| to perform needle-free | |||
| injection and tissue- | |||
| selective | |||
| hydrodissection of soft | |||
| tissue. The Erbe | |||
| hydrosurgical unit | |||
| ERBEJET 2 with | |||
| instruments and | |||
| accessories is used in | |||
| endoscopic and surgical | |||
| procedures. |
20150-220: The
ERBEJET probe is
intended for dissection
(tissue-selective
hydrodissection)
including separation of
soft tissue in
endoscopic
interventions. The
ERBEJET probe can be
used for needle-free
injection including lifting
of mucosal lesions by
injection into the
submucosa. | The HYBRIDknife flex is
intended for:
• monopolar cutting and
coagulation.
• needle-free injection
and tissue-selective
hydrodissection
including lifting mucosal
lesions by injection into
the submucosa (soft
tissue).
The HYBRIDknife flex is
used in endoscopic
interventions. |
| Prescription or
OTC | Prescription | Prescription | Prescription |
| Materials | Plastics, Teflon, and
Stainless Steel | Plastics, Stainless
Steel, Silicone,
Synthetic Jewel | Stainless Steel,
Tungsten, Ceramics,
Plastics |
| Probe
Dimensions | Outer Diameter (O.D.)
2mm x Length 2.2m | O.D. 1.3mm x Length
2.2m | O.D. 2,6mm x Length
2.3m |
| Nozzle
Dimensions | 120μm | 120μm | 120μm |
| Characteristics | Predicate Devices | | Subject Device |
| | Primary Predicate Device
ERBE Hybrid Knife (K083608) | Secondary Predicate Device
Erbejet 2 System (K231023) | HYBRIDknife flex |
| Electrode type and dimensions | I-type and T-type electrode
T-Type
Length: 5.5mm
Diameter: 0.7mm
T-plate diameter: 1.6mm
T-plate thickness: 0.3mm
I-Type
Length: 5.0mm
Diameter: 0.7mm | N/A | I-type and T-type electrode
T-Type short
Length: 1.5mm
Diameter: 0.5mm
T-plate diameter: 1.2mm
T-plate thickness: 0.3mm
T-Type long
Length: 2.0mm
Diameter: 0.5mm
T-plate diameter: 1.2mm
T-plate thickness: 0.3mm
I-Type short
Length: 1.5mm
Diameter: 0.5mm
I-Type long
Length: 2.0mm
Diameter: 0.5mm |
| Physical characteristics | Probe with Retractable electrode (adjustable) | N/A | Probe with Retractable Electrode
(Only two states are possible: electrode retracted and extended).
Modified handle design (Electrode slider with latching function and thumb loop) |
| Energy delivery | High Frequency (HF)
Current with a maximum Electrical Capacity of 2500 Vp.
Pressurized Sterile Normal Saline from Effect 1 to 80 which corresponds from 14.5 to 1,160.3 psi | N/A | High Frequency (HF)
Current with a maximum Electrical Capacity 4500 Vp.
Pressurized Sterile Normal Saline with or without dye additives from Effect 1 to 60 which corresponds to a max. impact force between 0.04 – 0.063 N (14.5 to 870.2 psi). |
| Condition Provided/ Use Condition | Sterile, single-use | Sterile, single-use | Sterile, single-use |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
6
7
Comparison of Technological Characteristics with the Predicate Device
The subject device has a higher dielectric strength compared to the primary predicate device. In addition, the subject device is slightly thicker, longer, more flexible and the electrode is shorter and thinner compared to the primary predicate device to allow finer cuts. While the electrode is adjustable with the primary predicate device the subject device only allows two electrode states (retracted and extended). The subject device has different materials compared to the primary predicate device.
Regarding the waterjet function, the subject device has the same operating principle and nozzle diameter compared to both predicate devices (i.e. Erbe Hybrid Knife and ERBEJET 2 with ERBEJET probe). As shown by respective tissue testing, the subject device HYBRIDknife flex creates equivalent fluid cushions as the primary predicate device.
The different materials have no impact on safety as shown by biocompatibility testing in compliance with ISO 10993.
Non-clinical performance testing
Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate devices.
Functional testing and design controls to verify both safety and performance of the subject device was performed in compliance with 21 CFR 820.30 to ensure that the subject device performs as intended and meets design specifications.
Tissue testing was performed in compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurqical Devices for General Surgery", issued on March 9, 2020, to validate cutting and coagulation performance and the waterjet function compared to the predicate device.
EMC and Electrical safety of the subject device was tested in compliance with IEC 60601-1 Edition 3.2; IEC 60601-2-2 Edition 6.0; IEC 60601-2-18: Edition 3.0 and IEC 60601-1-2 Edition 4.0
Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to demonstrate biocompatibility
8
Erbe Elektromedizin GmbH K232033 - Traditional 510(k) for HYBRIDknife® flex
with the new materials that were used.
Sterilization validation was performed in compliance with ISO 11135 and documentation was provided according to FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" showing an SAL of 10-6. EO residual testing and limits are in compliance with ISO 10993-7.
Packaging and shelf-life validation was performed in compliance with ISO 11607-1 and accelerated aged devices (ASTM F 1980).
Conclusion
The subject device has the same intended use, the same fundamental design, substantially equivalent performance characteristics, and the same energy source as the predicate devices. The subject device was tested as described above and the minor differences in technological characteristics were assessed with regards to safety and effectiveness. Taken together, the subject device does not raise new or different questions of safety and effectiveness, and the subject device is substantially equivalent to the predicate devices.