(180 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the device and its interaction with a standard ESU. There is no mention of AI or ML.
Yes
The device is used for electrosurgical cutting and coagulation through tissues, or within tissue planes while maintaining hemostasis, which are therapeutic actions.
No
The device is described as an electrosurgical tool for cutting, coagulating, and dissecting tissues to maintain hemostasis, which are therapeutic actions, not diagnostic ones.
No
The device description clearly details physical components (beads, cutting edges, handle, connector cable) and its function as a hardware-based electrosurgical tool that connects to an ESU. There is no mention of software as the primary or sole component.
Based on the provided information, the BEED 3,8 and BEED 2,5 devices are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is for "electrosurgical cutting and coagulation through tissues, or within tissue planes while maintaining hemostasis." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a surgical instrument used for dissection and separation of tissue planes using electrical energy. This is consistent with a surgical device, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The BEED device's function is purely surgical.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (mechanical and functional tests), Sterility (conforms to a Sterility Assurance Level (SAL) of 10-6 and meets ISO 11137-2:2013 (R) 2019), EMC and Electrical Safety Testing (in accordance with IEC 60601-2-2 and IEC 60601-1-2), Thermal Safety Testing (in line with FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery"), Biocompatibility Testing (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'"), and Design & User Validation (to confirm IFU and packaging provide appropriate instructions and device meets intended use during simulated use).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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).
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 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
2
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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Image /page/3/Picture/0 description: The image features the word "Excelsior" in a stylized, cursive font. The color of the text is a vibrant blue, which contrasts with the white background. The font has elaborate swirls and loops, giving it an elegant and decorative appearance. The overall design is clean and simple, with the focus entirely on the word itself.
5. 510(k) Summary
| Applicant Name | Excelsior Resources, LLC
3011 NE 44th Street
Fort Lauderdale, FL 33308 |
|---------------------------|------------------------------------------------------------------------------------------------------|
| Contact Person | Andrea Dwyer Steiner, MS, RAC
MedLogics International, LLC
Chief Regulatory Affairs Consultant |
| Date Summary
Prepared: | March 18, 2024 |
| Device Trade Name | BEED-2,5
BEED-3,8 |
| Common Device
Name | 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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Image /page/4/Picture/0 description: The image features the word "Excelsior" in a stylized, cursive font. The text is rendered in a vibrant blue color, which stands out against the white background. The font has elaborate swirls and loops, particularly in the "E" and "r", giving it an elegant and decorative appearance. The overall design is clean and simple, with the focus entirely on the word itself.
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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Image /page/5/Picture/0 description: The image contains the word "Excelsior" in a stylized, cursive font. The text is a vibrant blue color, which contrasts with the white background. The font has elaborate swirls and loops, giving it an elegant and decorative appearance. The overall design is simple yet eye-catching, with the focus solely on the word itself.
Predicate Comparison
| Description | Utah Medical Products Inc.
Ceramic Blade Electrode (CBE)
K960255 (Predicate) | BEED (Subject Device)
510(k) TBD |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K960255 | TBD |
| Device
Image | Image: Ceramic Blade Electrodes | Image: BEED device with a dime for scale |
| Device
Description | Ceramic Blade Electrodes (CBE) device
consists of a single tip mounted on a shaft
that plugs into a standard electrosurgical
pencil which plugs into an ESG. | BEED consists of a tip mounted on a shaft
with a proximal metal post that plugs into a
ESG connector cable. A clamping handle
adjusts along the length of shaft. |
| Indications for
Use | The Utah Medical Products Inc.
Ceramic Blade Electrodes (CBE) are
intended for use in virtually every surgical
discipline where flat, paddle-type
electrosurgical blades are used for making
straight cuts through tissue.
The CBE-2XX blades are intended for use
in procedures that require precise cuts
where only light or no hemostasis is
desired. The CBE-1XX blades are
intended for use in procedures where a
greater level of hemostasis is desired.
When an electrosurgical generator blend | The BEED-3,8 and BEED-2,5 devices are used
for electrosurgical cutting and coagulation
through tissues, or within tissue planes, while
maintaining hemostasis. |
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| | 1XX blades, cauterization of the wound
will occur while the cut is being made. | | | | | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Intended Use | Cut tissue while maintaining hemostasis | | | | Same | |
| Product Code | GEI | | | | Same | |
| OTC or
Prescription | Prescription Use Only | | | | Same | |
| Energy
Source/Type | Radiofrequency Electrosurgical
Generator in monopolar mode | | | | Same | |
| Tip Description
/ Electrode
Exposure | Exposed fine wire element surrounding
the periphery of a flat, non-conductive,
blade-shaped, ceramic core. | | | | BEED 2,5 contains1 distal electrode segment
while BEED 3,8 contains 2 distal electrode
segments. The distal electrode segments are
recessed/shielded between 2 bead-like structures
and 1 proximal facing electrode segment is
recessed/shielded between 1 bead-like structure
and the ceramic shaft. | |
| Mode of
Operation | The CBE electrode is oriented so that the
distal-most end of the CBE wire
electrode cuts and/or coagulates tissue.
Using monopolar RF energy, the device
cuts through and coagulates tissues. | | | | BEED electrodes separate tissue planes during
surgery through the use of both forward and
backward strokes.
Using monopolar RF energy, the device cuts
through and coagulates tissues. | |
| Device
Activation
Mode | Finger switch button activation with
standard ESG pencil or foot switch
activation with foot-activated ESG
pencil.
Yellow button delivers CUT or Blend
energy; blue button delivers COAG
energy. | | | | Foot Switch activates ESU/ ESG to power
connector cable leading to BEED device.
Yellow button delivers CUT or Blend energy;
blue button delivers COAG energy. | |
| Tip Component
Materials | Yitria Partially-Stabilized Zirconia
Ceramic (nonconductive, blade-
shaped ceramic core)302 pr 304 Stainless Steel (electrode
wire) | | | | Yitria Partially-Stabilized Zirconia
Ceramic (nonconductive guard protectively
sequesters electrode segments)Stainless Steel 316 (electrode and its
segments) | |
| 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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| Generator
Compatibility | Any generator that accepts (A) 3-prong
accessory plugs (1 carrying RF source,
other 2 signal cut or coag modes) or (B)
single-lead foot-pedal-activated connector
cords | Any generator that accepts a universal 4mm
monopolar connector cable (foot pedal
activated) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Electrical
Safety/EMC
compliance | IEC 60601-1-2
IEC 60601-2-2 | IEC 60601 compliant |
| Maximum
Power | 150 Watts | 50 Watts |
| Sterilization
Method | 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 (