(305 days)
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No
The document describes a standard electrosurgical device and its accessories, focusing on mechanical and electrical functions. There is no mention of AI, ML, or any related computational techniques.
Yes
The device is described as an electrosurgical cutting and coagulation device intended for "general electrosurgical applications, including cutting and coagulation," which are therapeutic procedures. It also removes smoke generated during electrosurgery, further supporting its role in a surgical, and thus therapeutic, context.
No
The device is intended for general electrosurgical applications, including cutting and coagulation, and for removing smoke, which are therapeutic and facilitative functions, not diagnostic.
No
The device description clearly outlines a physical, single-use, monopolar RF device with a blade, shaft, finger grip, and suction lumen. It is designed to be used with a generator and can be operated with a hand switch or footswitch, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general electrosurgical applications, including cutting and coagulation," and for "removing smoke generated by electrosurgery." This describes a device used on the patient during a surgical procedure, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details a "single-use, monopolar RF device" with a blade and telescoping shaft, designed for use with a generator and operated with a hand switch or footswitch. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform surgical actions (cutting and coagulation) and manage the surgical environment (smoke evacuation).
N/A
Intended Use / Indications for Use
The Duoblade is intended for general electrosurgical applications, including cutting and (Models: DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH) for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Electrosurgical Cutting and Coagulation Device and Accessories (Model: Duoblade) is a single-use, monopolar RF device. It is designed to be used with the qualified Generator as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The Duoblade consists of a single blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.
The models of of Duoblade are identified according to with/without a suction function (removing smoke).
- Suction function (Removing smoke): DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH
- No Suction function (No removing smoke): DB1SP, DB1SP-H, DB1SP-T, DB1SP-TH
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Test - Thermal effects on tissue: The purpose of this study was to compare penetrating thermal tissue damage/spread associated with the subject device and predicate device using the fresh extirpated porcine muscle, liver and kidney model. In results of histopathological examination, evidence of wound healing and thermal burn in incision site was evaluated. Although there were no significant differences between the positive control device and test device administered sites on every group, in liver under some conditions and kidney under most conditions, the midline depth and width of the test device application sites showed low tendency compared to positive control device application sites. Therefore, positive control and test article administered group assumed to have no difference in wound coagulation necrosis of incision sites. In conclusion, the test device was considered to have the equivalent penetrative thermal tissue damage/spread characteristics compared to the positive control device.
No clinical studies were considered for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the agency name in a sans-serif font.
CnC Technologies % Wooseok Jeong Regulatory Affairs Consultant KMC, Inc. Room no. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul. 08390 Korea, South
February 3, 2023
Re: K220996
Trade/Device Name: Duoblade Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 25, 2022 Received: April 4, 2022
Dear Wooseok Jeong:
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 (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/cfdocs/cfpmn/pmn.cfm 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.
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
1
device reporting (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 531-542 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/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,
Colin K. Chen -S
for
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220996
Device Name Duoblade
Indications for Use (Describe)
The Duoblade is intended for general electrosurgical applications, including cutting and (Models: DBISEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH) for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
| 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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Image /page/3/Picture/1 description: The image shows a logo with the text "CnC" in a bold, red font. The letters are positioned between two curved, red lines that resemble parentheses. Below the logo, the words "Challenge & Creative" are written in a smaller, red font. The logo appears to be for a company or organization that emphasizes challenge and creativity.
510(k) Summary
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: February 1, 2023
1. Applicant / Submission Sponsor
CnC Technologies Address: E1101, GWANG MYEONG TECHNOPARK, 60, HAAN-RO, GWANGMYEONG-SI, GYEONGGI-DO, 14322, REPUBLIC OF KOREA Tel: +82-2-2083-2200 Fax: +82-2-2083-2203
2. Submission Correspondent
WooSeok Jeong (Consultant, KMC, Inc.) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, Republic of Korea Tel: +82-10-7194-5723 Email: ws.jeong@kmcerti.com
3. Device Identification
Trade/Proprietary Name: Duoblade Common Name: Electrosurgical Cutting and Coagulation Device and Accessories Classification Regulation: 21CFR 878.4400 Product Code: GEI Device Class: 2
4. Predicate Devices
| Predicate Device 1 | ||
|---|---|---|
| Manufacturer | Covidien | |
| Device Name | Valleylab™ Smoke Evacuation Rocker Switch Pencil and | |
| Accessories and Valleylab™ Telescoping Smoke Evacuation | ||
| Rocker Switch Pencil | ||
| 510(k) number | K182772 |
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5. Description
The Electrosurgical Cutting and Coagulation Device and Accessories (Model: Duoblade) is a single-use, monopolar RF device. It is designed to be used with the qualified Generator as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The Duoblade consists of a single blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.
The models of of Duoblade are identified according to with/without a suction function (removing smoke).
- Suction function (Removing smoke): DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH
- No Suction function (No removing smoke): DB1SP, DB1SP-H, DB1SP-T, DB1SP-TH
6. Indications for use
The Duoblade is intended for general electrosurgical applications, including cutting and coagulation, and (Models: DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH) for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
7. Substantial Equivalence
The Electrosurgical Cutting and Coagulation Device and Accessories (Model: Duoblade) is substantially equivalent to the predicate device, Valleylab™ Smoke Evacuation Rocker Switch Pencil and Accessories and Valleylab™ Telescoping Smoke Evacuation Rocker Switch Pencil (K182772, Covidien). The following comparison table is presented to demonstrate substantial equivalence.
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| Subject Device | Predicate Device 1 (PD1) | Comparison | |
|---|---|---|---|
| Manufacturer | CnC Technologies, Inc. | Covidien | |
| Device Name | Duoblade | ValleylabTM Smoke Evacuation Rocker Switch Pencil | |
| and Accessories and ValleylabTM Telescoping Smoke | |||
| Evacuation Rocker Switch Pencil | |||
| 510(k) number | K220996 | K182772 | |
| Product Code | GEI | GEI | Same |
| Regulatory Class | 2 | 2 | Same |
| Indications for Use | The Duoblade is intended for general electrosurgical | ||
| applications, including cutting and coagulation, and | |||
| (Models: DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP- | |||
| TH) for removing smoke generated by electrosurgery | |||
| when used in conjunction with an effective smoke | |||
| evacuation system. | The smoke evacuation rocker switch pencil and | ||
| telescoping smoke evacuation rocker switch pencil are | |||
| intended for general electrosurgical applications, | |||
| including cutting and coagulation, and for removing | |||
| smoke generated by electrosurgery when used in | |||
| conjunction with an effective smoke evacuation | |||
| system. The pencil enables the operator to remotely | |||
| conduct an electrosurgical current from the output | |||
| connector of an electrosurgical unit to the operative | |||
| site for the desired surgical effect. | Same | ||
| Mechanism of | |||
| Action / Principle of | |||
| operation | RF Monopolar Energy | RF Monopolar Energy | Same |
| Maximum rated | |||
| accessory voltage | 4,500 Vpk | 5,550 Vpk | Rated |
| accessory | |||
| voltage | |||
| does | |||
| not | |||
| affect electrical safety | |||
| or performance. | |||
| Sterilization | EtO | Gamma | Different |
| Biocompatibility | External communicating device |