(145 days)
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.
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.
The provided text is a 510(k) summary for a medical device called HYBRIDknife® flex. This document is a regulatory submission to the FDA, demonstrating that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document is NOT a study report for an AI/ML medical device. It describes a physical electrosurgical cutting and coagulation device. Therefore, the questions about AI/ML specific acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document. The term "device" in the context of this document refers to the physical surgical instrument, not an AI model.
The document discusses non-clinical performance testing of the device, which aims to verify its safety and performance based on engineering principles and established standards for electrosurgical equipment. This is distinct from the type of performance study conducted for AI/ML devices, which involves evaluating the performance of an algorithm against a ground truth.
Here's how to address the request based on the provided text, while clarifying the limitations:
Acceptance Criteria and Device Performance (Based on the document for a physical medical device)
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit "acceptance criteria" in the way one might for an AI/ML model's performance metrics (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance is based on demonstrating that the new device does not raise new questions of safety or effectiveness and performs comparably to the predicate devices for its intended use.
The "performance" is verified through various non-clinical tests to ensure the device meets design specifications and relevant industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
As this is not an AI/ML device, a table of acceptance criteria for algorithm performance metrics (like sensitivity, specificity, AUC) is not provided in the document. Instead, the document discusses conformity to standards and comparability to predicate devices. The "performance" here refers to the device's functional integrity and safety.
| Aspect of "Performance" | Acceptance Criteria (Implied from testing) | Reported Device Performance (Summary from text) |
|---|---|---|
| Material Safety | Biocompatibility in compliance with ISO 10993. | "The different materials have no impact on safety as shown by biocompatibility testing in compliance with ISO 10993." |
| Sterility | Sterile, single-use; SAL of 10-6; EO residual limits compliant with ISO 10993-7. | "Sterilization validation was performed in compliance with ISO 11135 and documentation was provided according to FDA Guidance... showing an SAL of 10-6. EO residual testing and limits are in compliance with ISO 10993-7." |
| Packaging & Shelf-life | Compliance with ISO 11607-1; successful accelerated aging. | "Packaging and shelf-life validation was performed in compliance with ISO 11607-1 and accelerated aged devices (ASTM F 1980)." |
| Electrosurgical Function | Cutting and coagulation performance comparable to predicate. | "Tissue testing was performed... to validate cutting and coagulation performance... compared to the predicate device." "High Frequency (HF) Current with a maximum Electrical Capacity 4500 Vp (higher than predicate's 2500 Vp)." |
| Waterjet Function | Equivalent fluid cushion creation as predicate. | "As shown by respective tissue testing, the subject device HYBRIDknife flex creates equivalent fluid cushions as the primary predicate device." "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)." |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2. | "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." |
| Overall Performance & Design | Performs as intended, meets design specifications, does not raise new safety/effectiveness questions. | "Functional testing and design controls... demonstrate that the differences do not raise any new issues of safety or effectiveness... 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." |
2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI/ML test set. The testing referenced are non-clinical (e.g., tissue testing, electrical testing, biocompatibility testing, sterilization validation) of a physical device. There isn't a "test set" of patient data in the AI/ML sense. Data provenance would refer to the characteristics of the materials or test conditions used in the lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This pertains to AI/ML model validation using expert labels, which is not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to AI/ML model validation using expert labels, which is not described here.
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 pertains to AI/ML model validation. The device is a physical surgical instrument, not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to AI/ML model validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI/ML context. For this physical device, "ground truth" would be established by physical measurements, chemical analyses, biological assays (e.g., for biocompatibility), and direct observation of electrosurgical and hydrodissection effects on tissue models, as per standard engineering and medical device testing protocols. The "truth" is adherence to specifications and standards.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model and does not have a "training set" in that sense.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model and does not have a "training set" in that sense.
Summary of the Study Proving Device Meets "Acceptance Criteria" (Non-Clinical Performance Testing)
The "study" in this context refers to a series of non-clinical performance tests designed to demonstrate the safety and effectiveness of the HYBRIDknife® flex and its substantial equivalence to predicate devices. These tests were performed rather than a clinical trial or AI/ML validation study.
The primary goal was to show that despite some technological differences (e.g., higher dielectric strength, slightly different dimensions, fixed electrode states vs. adjustable), the device performs its intended functions comparably to existing, legally marketed devices and adheres to relevant safety and performance standards.
The non-clinical performance testing included:
- Functional Testing and Design Controls: To verify overall safety and performance, ensuring the device performs as intended and meets design specifications (in compliance with 21 CFR 820.30).
- Tissue Testing: To validate the cutting and coagulation performance and the waterjet function. This was done by comparing the HYBRIDknife® flex to the predicate device, specifically looking at the creation of equivalent fluid cushions. This would involve in-vitro or ex-vivo tissue models.
- EMC and Electrical Safety Testing: To ensure compliance with international standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2). This verifies that the device operates safely electrically and doesn't interfere with other medical equipment.
- Biocompatibility Testing: To ensure the new materials used in the device are safe for contact with the body (in compliance with ISO 10993-1).
- Sterilization Validation: To confirm the device can be consistently sterilized to a specific sterility assurance level (SAL of 10-6) and that ethylene oxide residuals are within safe limits (in compliance with ISO 11135 and ISO 10993-7).
- Packaging and Shelf-life Validation: To ensure the device remains sterile and functional over its intended shelf-life, including accelerated aging tests (in compliance with ISO 11607-1 and ASTM F 1980).
Data Provenance and "Test Set" Details (for a physical device):
The data would originate from laboratory and bench testing conditions. This is typically controlled and prospective, conducted specifically to gather data for regulatory submission. There isn't a "country of origin of the data" in the sense of patient data, but rather the location where the testing labs are.
In conclusion, the provided document is a regulatory submission for a physical medical device, not an AI/ML model. Therefore, many of the specific questions about AI/ML acceptance criteria and study design are not applicable. The "acceptance criteria" for this device are demonstrated through adherence to design specifications, relevant industry standards, and demonstrated substantial equivalence to predicate devices via rigorous non-clinical testing.
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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).
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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
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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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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 |
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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.
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Comparison to predicate devices
| Predicate Devices | Subject Device | ||
|---|---|---|---|
| Primary PredicateDevice | Secondary PredicateDevice | HYBRIDknife flex | |
| Characteristics | ERBE Hybrid Knife(K083608) | Erbejet 2 System(K231023) | |
| Manufacturer | Erbe ElektromedizinGmbH (Germany) | Erbe ElektromedizinGmbH (Germany) | Erbe ElektromedizinGmbH (Germany) |
| Regulationnumber | 878.4400 & 880.5475 | 880.5475 | 878.4400 & 880.5475 |
| Regulatory class | II | II | II |
| Product code | GEI; FQH | FQH | GEI; FQH |
| Indications foruse | The ERBE Hybrid Knifeis intended to be used incombination with theWater JetSystem/ERBEJET 2 andan ERBE ESU VIOModel to cut and dissectsoft tissue inneurosurgery and softtissue such as the liver,kidney, etc. within theabdomen, including TotalMesorectal Excision(TME) via the Water JetSystem as well as toprovide monopolarcutting and coagulationof the target tissue by theESU in open and as wellas endoscopic surgery. | The Erbe hydrosurgicalunit ERBEJET 2 withinstruments andaccessories is intendedto pressurize a mediumto perform needle-freeinjection and tissue-selectivehydrodissection of softtissue. The Erbehydrosurgical unitERBEJET 2 withinstruments andaccessories is used inendoscopic and surgicalprocedures.20150-220: TheERBEJET probe isintended for dissection(tissue-selectivehydrodissection)including separation ofsoft tissue inendoscopicinterventions. TheERBEJET probe can beused for needle-freeinjection including liftingof mucosal lesions byinjection into thesubmucosa. | The HYBRIDknife flex isintended for:• monopolar cutting andcoagulation.• needle-free injectionand tissue-selectivehydrodissectionincluding lifting mucosallesions by injection intothe submucosa (softtissue).The HYBRIDknife flex isused in endoscopicinterventions. |
| Prescription orOTC | Prescription | Prescription | Prescription |
| Materials | Plastics, Teflon, andStainless Steel | Plastics, StainlessSteel, Silicone,Synthetic Jewel | Stainless Steel,Tungsten, Ceramics,Plastics |
| ProbeDimensions | Outer Diameter (O.D.)2mm x Length 2.2m | O.D. 1.3mm x Length2.2m | O.D. 2,6mm x Length2.3m |
| NozzleDimensions | 120μm | 120μm | 120μm |
| Characteristics | Predicate Devices | Subject Device | |
| Primary Predicate DeviceERBE Hybrid Knife (K083608) | Secondary Predicate DeviceErbejet 2 System (K231023) | HYBRIDknife flex | |
| Electrode type and dimensions | I-type and T-type electrodeT-TypeLength: 5.5mmDiameter: 0.7mmT-plate diameter: 1.6mmT-plate thickness: 0.3mmI-TypeLength: 5.0mmDiameter: 0.7mm | N/A | I-type and T-type electrodeT-Type shortLength: 1.5mmDiameter: 0.5mmT-plate diameter: 1.2mmT-plate thickness: 0.3mmT-Type longLength: 2.0mmDiameter: 0.5mmT-plate diameter: 1.2mmT-plate thickness: 0.3mmI-Type shortLength: 1.5mmDiameter: 0.5mmI-Type longLength: 2.0mmDiameter: 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 |
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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
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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.
§ 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.