(69 days)
The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
The Edge™ Insulated Blade Electrode (E1455G) is a sterile, single-use, monopolar electrode intended to conduct radiofrequency (RF) current. It is a coated stainless-steel electrode blade with insulation. It is compatible with electrosurgical pencils that have a 0.093" insertion diameter or commonly referred to as a standard 3/32" insertion diameter, this includes the Covidien Valleylab™ Rocker Switch Pencil Family (SEP5000, SEP5015) cleared in K182772.
The provided FDA 510(k) summary for the Edge™ Insulated Blade Electrode (K210338) describes performance testing, but it fundamentally differs from the study of an AI/ML powered device. This document is for a traditional medical device, an electrosurgical electrode, not a software or AI/ML product. Therefore, the specific questions regarding AI/ML powered devices, such as sample sizes for test/training sets, ground truth establishment for AI, number of experts, adjudication methods, and MRMC studies, are not applicable to this submission.
The "acceptance criteria" and "reported device performance" in this context refer to traditional engineering and biological testing to ensure the device is safe and effective and substantially equivalent to a predicate device, not evaluation of algorithmic accuracy.
Here's an interpretation of the available information for a traditional device:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are generally derived from recognized standards and internal specifications to demonstrate safety and effectiveness and substantial equivalence to the predicate. The performance reported here relates to meeting those standards, not to a specific quantitative metric like sensitivity or specificity.
| Acceptance Criteria Category | Specific Tests/Standards Met | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity) | The subject device complies with the relevant clauses of ISO 10993-1. (Direct tissue contacting materials: stainless steel, silicone, and polymer insulation) |
| EMC & Electrical Safety | IEC 60601-1, IEC 60601-2-2 (Electrical Safety), IEC 60601-1-2 (EMC) | The subject device complies with relevant clauses of these standards. |
| Mechanical/Functional | Related design inputs and product specifications | Mechanical, electrical, and functional testing verified that the subject device performs as expected and conforms to requirements. (Details of specific tests are not provided in this summary, but would be in the full submission). |
| Ex vivo Thermal Effect | Comparison to predicate device | Monopolar ex vivo testing evaluated thermal effect across a range of power settings and modes on different tissue types. The subject device demonstrated substantial equivalence to the predicate device. |
| Rated Accessory Voltage | (Implicitly, that it does not negatively affect electrical safety or performance compared to predicate) | Subject Device: <4500Vpk; Predicate Device: <10.8kV. The document states: "Rated accessory voltage does not affect electrical safety or performance." (This implies it either meets a safe threshold or is equivalent to the predicate in terms of safety impact). |
Regarding AI/ML specific questions (2-9):
Since this is not an AI/ML powered device, the following points are not applicable and cannot be answered from the provided document:
- Sample sizes for the test set and data provenance: N/A (No AI/ML test set)
- Number of experts used to establish the ground truth for the test set and their qualifications: N/A (No AI/ML ground truth)
- Adjudication method: N/A (No AI/ML adjudication)
- Multi-reader multi-case (MRMC) comparative effectiveness study: N/A (Not an AI-assisted diagnostic/interpretive device)
- Standalone (algorithm only) performance: N/A (No algorithm in this sense)
- Type of ground truth used: N/A (No AI/ML ground truth)
- Sample size for the training set: N/A (No AI/ML training set)
- How the ground truth for the training set was established: N/A (No AI/ML training set)
This submission demonstrates substantial equivalence for a physical electrosurgical electrode primarily through comparisons of technological characteristics and standard safety and performance testing.
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April 15, 2021
Covidien LLC Miranda Miles Associate Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301
Re: K210338
Trade/Device Name: Edge Insulated Blade Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 4, 2021 Received: February 5, 2021
Dear Miranda Miles:
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 Mav 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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.
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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 and Part 809): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 53 1 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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/cdrl-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-ind-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 Long H. Chen Long H. Chen-S -s Date: 2021.04.15 16:19:33 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210338
Device Name EdgeTM Insulated Blade Electrode
Indications for Use (Describe)
The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
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)
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K210338
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510(k) Summary
Date summary prepared: April 15, 2021
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Miranda Miles Associate Regulatory Affairs Specialist Telephone: 303-530-6205 Email: miranda.r.miles(@medtronic.com
Subject Device
| Trade Name: | Edge™ Insulated Blade Electrode |
|---|---|
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| (21 CFR 878.4400, Class II, GEI) |
Predicate Device
| Trade Name: | Megadyne™ E-Z Clean™ Electrosurgical Electrode |
|---|---|
| Classification Name: | Electrosurgical cutting and coagulation device and accessories(21 CFR 878.4400, Class II, GEI) |
| 510(k) Number: | K081791 |
| Recalls: | This device has not been subject to a design-related recall |
No reference devices were used in this submission.
Device Description
The Edge™ Insulated Blade Electrode (E1455G) is a sterile, single-use, monopolar electrode intended to conduct radiofrequency (RF) current. It is a coated stainless-steel electrode blade with insulation. It is compatible with electrosurgical pencils that have a 0.093" insertion diameter or commonly referred to as a standard 3/32" insertion diameter, this includes the Covidien Valleylab™ Rocker Switch Pencil Family (SEP5000, SEP5015) cleared in K182772.
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Indications for Use
The Edge™ Insulated Blade Electrode is intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
Comparison of Technological Characteristics with the Predicate Device
The Edge™ Insulated Blade Electrode (E1455G) device is compared to the predicate device Megadyne™ E-Z Clean™ Electrosurgical Electrode (0012M), as cleared under K081791 in Table 5-1.
| Characteristic | Subject DeviceEdge™ Insulated BladeElectrode (E1455G) | Predicate DeviceMegadyneTM E-Z Clean™Electrosurgical Electrode(0012M) [K081791] | Results(compared topredicate) |
|---|---|---|---|
| ClassificationRegulation | 878.4400 | 878.4400 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| Indications for Use | The Edge™ Insulated BladeElectrode is intended to conductradio frequency (RF) current forcutting and coagulation from theRF electrosurgical generator totarget soft tissue in a broad rangeof surgical procedures requiringthe use of electrosurgery forcutting and cauterization. | E-ZTM Clean electrosurgicalelectrodes are intended to conductradio frequency (RF) current forcutting and coagulation from theRF electrosurgical generator totarget soft tissue in a broad rangeof surgical procedures requiringthe use of electrosurgery forcutting and cauterization.Some tip configurations have aspecific geometry that minimizesblanching and thermal damage inskin incisions when used inconjunction with the generator'sAdvanced Cutting Effect (ACE)mode. | Equivalent -The subjectdevice is notindicated foruse withAdvancedCutting Effect(ACE) mode.Differences donot change theintended use ofthe device. |
| Contraindications | None | None | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Electrode Material | Stainless steel | Stainless steel | Equivalent |
| Coating | Yes | Yes | Equivalent |
| Insulation | Yes | Yes | Same |
| Length | 2.5" | 2.5" | Same |
| Compatibility | 0.093" shaft insertion diameter | 0.093" shaft insertion diameter | Same |
| Sterilization | Ethylene oxide (EO) | Ethylene oxide (EO) | Same |
| Energy Type | Monopolar radiofrequency | Monopolar radiofrequency | Same |
Table 5-1. Technological and performance characteristics comparison of subject device to predicate device.
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K210338
| Characteristic | Subject DeviceEdgeTM Insulated BladeElectrode (E1455G) | Predicate DeviceMegadyneTM E-Z CleanTMElectrosurgical Electrode(0012M) [K081791] | Results(compared topredicate) |
|---|---|---|---|
| Rated AccessoryVoltage | <4500Vpk | <10.8kV | Ratedaccessoryvoltage doesnot affectelectricalsafety orperformance. |
Performance Testing
Biocompatibility
The biocompatibility evaluation for the Edge™ Insulated Blade Electrode was conducted in accordance with ISO 10993-1. The testing included the following:
- . Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- Material-Mediated Pyrogenicity .
The direct tissue contacting materials include stainless steel, silicone and polymer insulation. The subject device complies with the relevant clauses of ISO 10993-1.
Electromagnetic Compatibility (EMC) and Electrical Safety
Electromagnetic compatibility (EMC) and electrical safety were evaluated on the Edge™ Insulated Blade Electrode. The subject device complies with relevant clauses of the IEC 60601-1 and IEC 60601-2-2 standards for electrical safety and IEC 60601-1-2 standard for EMC.
Mechanical/Functional Bench Testing
Mechanical, electrical, and functional testing were carried out to verify that the subject device performs as expected and conform to requirements defined in related design inputs and product specifications.
Ex vivo Thermal Effect
Monopolar ex vivo testing evaluated thermal effect resulting from monopolar energy application across a range of power setting and modes on different tissue types. The subject device demonstrated substantial equivalence to the predicate device.
Conclusion
The comparison of device characteristics and the review of the performance data support the conclusion that the Edge™ Insulated Blade Electrode is substantially equivalent to the predicate
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K210338
device. The Edge™ Insulated Blade Electrode (E1455G) was found to be as safe and effective as the predicate device Megadyne™ E-Z Clean Electrosurgical Electrode (0012M).
§ 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.