(180 days)
The BEED 3,8 and BEED 2,5 device are used for electrosurgical cutting and coagulation through tissues, or within tissue planes while maintaining hemostasis.
The BEED device is available in two configurations as BEED-2,5 or BEED-3,8 and is a monopolar, Bead-Enhanced Electrosurgical Dissector (BEED) that dissects and separates tissue planes using both forward and backward strokes. Distal facing beads and lysing segments enable forward dissection. The proximal facing bead and lysing segment allow for rearward dissection.
BEED operates when connected to a compatible electrosurgical unit (ESU) via a universal 4mm monopolar connector cable, and a neutral electrode that shall be used with the ESU. The compatible ESU supplies current and voltage to the device and is typically controlled via a footswitch. The power supplied to the BEED device can range from 20- 50 Watts, depending on user preference.
The BEED-2.5 model consists of two bead-like structures, two RF electrified (monopolar) cutting edges protectively recessed between two non-conductive ceramic protrusions on the distal end and measures 5mm in width and may be preferred for smaller cuts. Whereas the BEED-3,8 model is larger and consists of three bead-like structures and three RF electrified (monopolar) cutting edges protectively recessed within three non-conductive ceramic protrusions on the distal end and measures 8mm in width.
Each BEED model is provided with a clamp-on, adjustable plastic handle that can lock along various lengths of the shaft.
This FDA 510(k) summary provides information on the BEED 2.5 and BEED 3.8 electrosurgical devices, but it does not contain a typical acceptance criteria table for the device's performance nor a detailed study description with performance metrics in the way a clinical trial or AI/ML device submission would. This document is a premarket notification for electrosurgical cutting and coagulation devices, which are typically evaluated through non-clinical performance data like electrical safety, thermal safety, sterility, biocompatibility, and functional testing, rather than studies involving human readers or AI algorithms.
Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to the information provided for this type of medical device submission.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document mentions that the device met "all applicable acceptance criteria" for various tests, but it does not specify the numerical or qualitative acceptance criteria themselves or the exact reported performance values. It states that the device "successfully evaluated" or "met all acceptance criteria" for the tests listed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterility | Conforms to a Sterility Assurance Level (SAL) of 10^-6. Meets ISO 11137-2:2013 (R) 2019. |
| EMC and Electrical Safety | Met all applicable acceptance criteria in accordance with IEC 60601-2-2 and IEC 60601-1-2. |
| Thermal Safety | Successfully evaluated in line with FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," issued March 9, 2020. |
| Biocompatibility | Met all acceptance criteria in accordance 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." |
| Design Verification | Confirmed that design inputs met design output requirements. |
| Design & User Validation | Confirmed that the IFU and packaging provide appropriate instructions and that the device meets its intended use during simulated use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The performance data section refers to "the BEED device" being subjected to tests, implying a sufficient number of units as per the respective standards and test protocols. These are non-clinical tests, so there isn't a "test set" of patient data.
- Data Provenance: Not applicable in the context of patient data for this device type. The performance data is from a series of non-clinical, in-vitro/bench testing as per international standards and FDA guidance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for electrosurgical device performance is established by adherence to engineering specifications, safety standards (e.g., electrical, thermal), biocompatibility norms, and functional testing protocols, not by expert consensus on clinical findings.
4. Adjudication method for the test set
- Not applicable. This concept typically applies to studies where multiple human readers interpret data, and their findings are then reconciled. For electrosurgical device testing, results are measured against predefined technical specifications and standards.
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
- No. This is an electrosurgical device, not an AI/ML diagnostic or interpretive device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML algorithm; it's a physical electrosurgical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is based on engineering specifications, compliance with recognized international standards (e.g., IEC 60601 series, ISO 11137-2, ISO 10993-1), and FDA guidance documents for electrosurgical devices. This includes physical measurements, electrical properties, material properties, sterility validation, and functional performance benchmarks.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
March 20, 2024
Excelsior % Andrea Steiner Regulatory Affairs Consultant Medlogics International LLC 12245 NW 48th Drive Coral Springs, Florida 33076
Re: K233002
Trade/Device Name: Beed 2,5, Beed 3,8 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 16, 2024 Received: February 16, 2024
Dear Andrea Steiner:
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 OS 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 medical devices and radiation-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 0ate: 2024.03.20
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)
Device Name BEED 3,8 BEED 2,5
Indications for Use (Describe)
The BEED 3,8 and BEED 2,5 device are used for electrosurgical cutting and coagulation through tissues, or within tissue planes while maintaining hemostasis.
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
| Applicant Name | Excelsior Resources, LLC3011 NE 44th StreetFort Lauderdale, FL 33308 |
|---|---|
| Contact Person | Andrea Dwyer Steiner, MS, RACMedLogics International, LLCChief Regulatory Affairs Consultant |
| Date SummaryPrepared: | March 18, 2024 |
| Device Trade Name | BEED-2,5BEED-3,8 |
| Common DeviceName | Electrosurgical, Cutting & Coagulation & Accessories |
| Device Classification | Class II |
| Review Panel | General & Plastic Surgery |
| Product Code | GEI |
| Regulation Number | 21 CFR Section 878.4400 |
| Predicate Device | K960255 - Epitome Ceramic Blade Electrode |
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Device Description
The BEED device is available in two configurations as BEED-2,5 or BEED-3,8 and is a monopolar, Bead-Enhanced Electrosurgical Dissector (BEED) that dissects and separates tissue planes using both forward and backward strokes. Distal facing beads and lysing segments enable forward dissection. The proximal facing bead and lysing segment allow for rearward dissection.
BEED operates when connected to a compatible electrosurgical unit (ESU) via a universal 4mm monopolar connector cable, and a neutral electrode that shall be used with the ESU. The compatible ESU supplies current and voltage to the device and is typically controlled via a footswitch. The power supplied to the BEED device can range from 20- 50 Watts, depending on user preference.
The BEED-2.5 model consists of two bead-like structures, two RF electrified (monopolar) cutting edges protectively recessed between two non-conductive ceramic protrusions on the distal end and measures 5mm in width and may be preferred for smaller cuts. Whereas the BEED-3,8 model is larger and consists of three bead-like structures and three RF electrified (monopolar) cutting edges protectively recessed within three non-conductive ceramic protrusions on the distal end and measures 8mm in width.
Each BEED model is provided with a clamp-on, adjustable plastic handle that can lock along various lengths of the shaft.
Indications for Use
The BEED devices are used for electrosurgical cutting and coagulation through tissues, or within tissue planes, while maintaining hemostasis.
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Predicate Comparison
| Description | Utah Medical Products Inc.Ceramic Blade Electrode (CBE)K960255 (Predicate) | BEED (Subject Device)510(k) TBD |
|---|---|---|
| 510(k) | K960255 | TBD |
| DeviceImage | Image: Ceramic Blade Electrodes | Image: BEED device with a dime for scale |
| DeviceDescription | Ceramic Blade Electrodes (CBE) deviceconsists of a single tip mounted on a shaftthat plugs into a standard electrosurgicalpencil which plugs into an ESG. | BEED consists of a tip mounted on a shaftwith a proximal metal post that plugs into aESG connector cable. A clamping handleadjusts along the length of shaft. |
| Indications forUse | The Utah Medical Products Inc.Ceramic Blade Electrodes (CBE) areintended for use in virtually every surgicaldiscipline where flat, paddle-typeelectrosurgical blades are used for makingstraight cuts through tissue.The CBE-2XX blades are intended for usein procedures that require precise cutswhere only light or no hemostasis isdesired. The CBE-1XX blades areintended for use in procedures where agreater level of hemostasis is desired.When an electrosurgical generator blend | The BEED-3,8 and BEED-2,5 devices are usedfor electrosurgical cutting and coagulationthrough tissues, or within tissue planes, whilemaintaining hemostasis. |
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| 1XX blades, cauterization of the woundwill occur while the cut is being made. | ||||||
|---|---|---|---|---|---|---|
| Intended Use | Cut tissue while maintaining hemostasis | Same | ||||
| Product Code | GEI | Same | ||||
| OTC orPrescription | Prescription Use Only | Same | ||||
| EnergySource/Type | Radiofrequency ElectrosurgicalGenerator in monopolar mode | Same | ||||
| Tip Description/ ElectrodeExposure | Exposed fine wire element surroundingthe periphery of a flat, non-conductive,blade-shaped, ceramic core. | BEED 2,5 contains1 distal electrode segmentwhile BEED 3,8 contains 2 distal electrodesegments. The distal electrode segments arerecessed/shielded between 2 bead-like structuresand 1 proximal facing electrode segment isrecessed/shielded between 1 bead-like structureand the ceramic shaft. | ||||
| Mode ofOperation | The CBE electrode is oriented so that thedistal-most end of the CBE wireelectrode cuts and/or coagulates tissue.Using monopolar RF energy, the devicecuts through and coagulates tissues. | BEED electrodes separate tissue planes duringsurgery through the use of both forward andbackward strokes.Using monopolar RF energy, the device cutsthrough and coagulates tissues. | ||||
| DeviceActivationMode | Finger switch button activation withstandard ESG pencil or foot switchactivation with foot-activated ESGpencil.Yellow button delivers CUT or Blendenergy; blue button delivers COAGenergy. | Foot Switch activates ESU/ ESG to powerconnector cable leading to BEED device.Yellow button delivers CUT or Blend energy;blue button delivers COAG energy. | ||||
| Tip ComponentMaterials | Yitria Partially-Stabilized ZirconiaCeramic (nonconductive, blade-shaped ceramic core)302 pr 304 Stainless Steel (electrodewire) | Yitria Partially-Stabilized ZirconiaCeramic (nonconductive guard protectivelysequesters electrode segments)Stainless Steel 316 (electrode and itssegments) | ||||
| Tip Dimensions | ||||||
| CBE-100 | CBE-150 | BEED 2,5 | Beed 3,8 | |||
| Blade Length | 17.8mm | 17.8mm | Tip Length (ceramic) | 17.2mm | 17.2mm | |
| Blade Width | 4.3mm | 4.3mm | Tip Width | 5.27mm | 7.9mm | |
| Blade Thickness | 0.58mm | 0.58mm | Tip Thickness | 2.65mm | 2.76mm | |
| Electrode Length | 39mm | 39mm | Electrode Length | 3mm | 5mm | |
| Total Exposed | Total Recessed |
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| GeneratorCompatibility | Any generator that accepts (A) 3-prongaccessory plugs (1 carrying RF source,other 2 signal cut or coag modes) or (B)single-lead foot-pedal-activated connectorcords | Any generator that accepts a universal 4mmmonopolar connector cable (foot pedalactivated) |
|---|---|---|
| ElectricalSafety/EMCcompliance | IEC 60601-1-2IEC 60601-2-2 | IEC 60601 compliant |
| MaximumPower | 150 Watts | 50 Watts |
| SterilizationMethod | Ethylene Oxide | Gamma |
Performance Data
The FDA guidance document, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" (2020) was considered in evaluating BEED's electrical and functional capabilities. The device was evaluated through the following non-clinical performance tests
Design Verification
The BEED device was subjected to a series of mechanical and functional tests to evaluate its safety and efficacy. The design verification evaluation confirmed that the design inputs met the design output requirements.
Sterility
The BEED device is supplied sterile and conforms to a Sterility Assurance Level (SAL) of 10 ° BEED meets the sterilization requirements of ISO 11137-2:2013 (R) 2019.
EMC and Electrical Safety Testing
The BEED device was evaluated for electrical and electromagnetic safety testing in accordance with IEC 60601-2-2 and IEC 60601-1-2 respectively and met all applicable acceptance criteria.
Thermal Safety Testing
The thermal safety of the device was successfully evaluated in line with FDA guidance. "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued March 9, 2020.
Biocompatibility Testing
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BEED is classified as an external communicating device that contacts tissue/ bone/dentin for a limited exposure (<24 hours). The device was evaluated in accordance 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" and met all acceptance criteria.
Design & User Validation
The BEED device was evaluated during a user validation to confirm that the IFU and packaging provide the user with appropriate instructions and that the device meets its intended use during simulated use.
Conclusion
The successful completion of all testing verify that the BEED devices do not raise new or different risks from that of the Utah Medical CBE predicate and therefore can be considered substantially equivalent based on the similarity of intended use, technological characteristics, materials of construction and principles of operation,
§ 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.