(69 days)
No
The 510(k) summary describes a standard electrosurgical electrode and does not mention any AI or ML components or functionalities.
Yes
The device is intended to cut and coagulate target soft tissue using radio frequency current in surgical procedures, which are therapeutic actions.
No
The device is described as an electrode for cutting and coagulation of tissue using radiofrequency current in surgical procedures, indicating a therapeutic rather than diagnostic function.
No
The device description clearly describes a physical electrode made of stainless steel with insulation, intended to conduct RF current. It is a hardware component used in electrosurgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "conducting radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures." This describes a surgical tool used directly on the patient's tissue during a procedure.
- Device Description: The description details a "sterile, single-use, monopolar electrode" that conducts RF current. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a patient's health. The provided information does not mention any interaction with patient specimens or diagnostic purposes.
Therefore, the Edge™ Insulated Blade Electrode is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
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.
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
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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.
1
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
2
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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3
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.
4
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 Device
Edge™ Insulated Blade
Electrode (E1455G) | Predicate Device
MegadyneTM E-Z Clean™
Electrosurgical Electrode
(0012M) [K081791] | Results
(compared to
predicate) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Regulation | 878.4400 | 878.4400 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| 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. | E-ZTM Clean electrosurgical
electrodes are 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.
Some tip configurations have a
specific geometry that minimizes
blanching and thermal damage in
skin incisions when used in
conjunction with the generator's
Advanced Cutting Effect (ACE)
mode. | Equivalent -
The subject
device is not
indicated for
use with
Advanced
Cutting Effect
(ACE) mode.
Differences do
not change the
intended use of
the 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.
5
K210338
| Characteristic | Subject Device
EdgeTM Insulated Blade
Electrode (E1455G) | Predicate Device
MegadyneTM E-Z CleanTM
Electrosurgical Electrode
(0012M) [K081791] | Results
(compared to
predicate) |
|----------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Rated Accessory
Voltage |