(116 days)
Not Found
No
The description focuses on the electrosurgical and smoke evacuation functions of a physical pencil device, with no mention of AI or ML capabilities.
No
The "ShinEvac® Smoke Evacuation Pencil" is described as a device for general electrosurgical applications like cutting and coagulation, and for removing smoke during electrosurgery. While it performs a surgical effect, it's primarily an accessory for an electrosurgical unit and is not itself described as providing a therapeutic effect for treating a disease or condition in the way a therapeutic device would be. It facilitates a surgical procedure rather than directly administering therapy.
No
The device is an electrosurgical pencil designed for cutting and coagulation, and for removing smoke during surgery. It is a therapeutic device, not a diagnostic one, as its function is to perform surgical procedures rather than diagnose conditions.
No
The device description clearly describes a physical electrosurgical pencil with a cable, tip electrode, and connection for smoke evacuation, indicating it is a hardware device.
Based on the provided text, the ShinEvac® Smoke Evacuation Pencil is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery." This describes a surgical tool used directly on a patient's tissue during a procedure.
- Device Description: The description reinforces its function as an electrosurgical pencil that conducts current to the operative site for surgical effects. It also mentions smoke evacuation, which is a function related to the surgical environment, not diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Performing tests outside of the body (in vitro)
In summary, the ShinEvac® Smoke Evacuation Pencil is a surgical device used for electrosurgery and smoke removal during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ShinEvac® Smoke Evacuation Pencil is designed 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 and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Product codes
GEI
Device Description
The ShinEvac® Smoke Evacuation Pencil, model: SW12200-APBCSE36, SW12200-APBCSE36G, SW12200-APBCSE56, SW12200-APBCSE56G, SW12200-APBCSB36 and SW12200-APBCSB56 is designed 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. Electro surgical Pencil is one of accessories of HF Electro Surgical Unit generates frequency from 300~600KHz for coagulation and cutting function, power up to 80W and 120W respectively. It is connected with cable conducting electro energy from unit and is holding a detachable tip electrode for the electrosurgery. This device is compatible with the Ø 2.38mm tip electrode and the maximum voltage is 4.5 KV peak. This device can remove surgical smoke when connected to a smoke evacuator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Operative site
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)
- a. Performance Testing
- Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, 2020.
- Animal study and clinical investigation
The Animal study was evaluated the safety and performance of the device in three different tissues under worst case scenarios. The outputs of energy were applied with low, moderate, and high watts in liver, kidney and muscle to test of the cutting performance and also evaluated the safety from tissue temperature, tissue cooling time and the extent of tissues' thermal damage. - Clinical investigation isn't required for these devices.
- b. Safety Test:
-IEC 60601-1:2005+COPR.1:2006+COPR.2:2007+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility requirements and tests - IEC 60601-2-2:2017, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- c. Biocompatibility testing
The biocompatibility evaluation and testing of the ShinEvac® Smoke Evacuation Pencilwas conducted in accordance with the following standards and guidance, as recognized by the FDA:
-FDA Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing".
-ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
-ISO 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
-ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
-USP 42/NF37:2019 Pharmacopeia US : Pyrogen Test - d. Sterilization Validation
- ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 28, 2021
Shining World Health Care Co., Ltd. Mrs. Anita Chen Regulatory Advisor No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist New Taipei City, Taiwan 248 Taiwan (R.O.C)
Re: K213317
Trade/Device Name: ShinEvac Smoke Evacuation Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 16, 2021 Received: October 4, 2021
Dear Mrs. Chen:
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 a ware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/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.
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); 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 (OS) 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-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-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,
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) K213317
Device Name ShinEvac® Smoke Evacuation Pencil
Indications for Use (Describe)
The ShinEvac® Smoke Evacuation Pencil is designed 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 and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
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
Section 5 510(k) Summary
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92
| 1. | Manufacturer | Shining World Health Care Co., Ltd. |
|---|---|---|
| Address | No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist., New | |
| Taipei City 248, Taiwan (R.O.C.). | ||
| TEL: +886-2-22900966 | ||
| FAX: +886-2-22903966 | ||
| Establishment Registration No.: | 1000448660 | |
| Contact Person | Mrs. Anita Chen/ Regulatory Advisor of Shining | |
| World Health Care Co., Ltd. | ||
| Cell Phone: | +886-939-855-759 | |
| Phone: | +886-2-22900966 | |
| E-mail: | Anita9104303@gmail.com | |
| Date Prepared | January 21, 2022 |
| The assigned 510(k) Number: | K213317 |
|---|---|
| ----------------------------- | --------- |
| 2 | Device Name | |
|---|---|---|
| Proprietary Name: | ShinEvac® Smoke Evacuation Pencil | |
| Model Name | Classic, AIO | |
| Model No. | SW12200-APBCSE36 | |
| SW12200-APBCSE36G | ||
| SW12200-APBCSE56 | ||
| SW12200-APBCSE56G | ||
| SW12200-APBCSB36 | ||
| SW12200-APBCSB56 | ||
| Regulation Number: | 21 CFR 878.4400 | |
| Regulation Name: | Electrosurgical cutting and coagulation device and |
Section 5. 510(k) Summary
4
| accessories | |
|---|---|
| Regulatory Class: | Class II |
| Product Code: | GEI |
| 3 | Predicate Device Name | PLUMEPEN® Integrated Smoke Evacuation Pencil |
|---|---|---|
| 510(k) number | K103375 | |
| Trade/Device Name: | PLUMEPEN | |
| Regulation Number: | 21 CFR 878.4400 | |
| Regulation Name: | Electrosurgical cutting and coagulation device and | |
| accessories | ||
| Regulatory Class: | Class II | |
| Product Code: | GEI |
| 4 | Device Description | The ShinEvac® Smoke Evacuation Pencil, model: |
|---|---|---|
| SW12200-APBCSE36, | ||
| SW12200-APBCSE36G, | ||
| SW12200-APBCSE56, | ||
| SW12200-APBCSE56G, | ||
| SW12200-APBCSB36 and SW12200-APBCSB56 is | ||
| designed 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. | ||
| Electro surgical Pencil is one of accessories of HF | ||
| Electro Surgical Unit generates frequency from | ||
| 300~600KHz for coagulation and cutting function, | ||
| power up to 80W and 120W respectively. It is | ||
| connected with cable conducting electro energy from | ||
| unit and is holding a detachable tip electrode for the |
5
| | | electrosurgery. This device is compatible with the Ø
2.38mm tip electrode and the maximum voltage is 4.5
KV peak. Th is device can remove surgical smoke
when connected to a smoke evacuator. |
|----|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5. | Intended Use: | The ShinEvac® Smoke Evacuation Pencil is
designed 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 and electrosurgical current from the output
connector of an electrosurgical unit to the operative
site for the desired surgical effect. |
| 6. | Technological Characteristics
and Substantial Equivalence
Comparison with Predicate: | A comparison of the device features, intended use,
and other information demonstrates that the
ShinEvac® Smoke Evacuation Pencil is substantially
equivalent to the predicate device as summarized in
Table 1. The differences raise no new question of
safety and effectiveness. |
6
Table 1
| MEDTEK DEVICES, INC., | ||
|---|---|---|
| Manufacturer | Shining World Health Care Co., Ltd. | dba Buffalo Filter |
| Predicate device | ||
| Subject Device | PLUMEPEN® INTEGRATED SMOKE | |
| Device name | ShinEvac® Smoke Evacuation Pencil | EVACUATION PENCIL |
| 510(k) Number | K213317 | K103375 |
| Intended Use | The ShinEvac® Smoke Evacuation Pencil | |
| is designed 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 and | ||
| electrosurgical current from the output | ||
| connector of an electrosurgical unit to the | ||
| operative site for the desired surgical | ||
| effect. | The PLUMEPEN is designed 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 | ||
| and electrosurgical current from the | ||
| output connector of an electrosurgical unit | ||
| to the operative site for the desired | ||
| surgical effect. | ||
| Regulation name | Electrosurgical cutting and | |
| coagulation device and accessories | Electrosurgical cutting and | |
| coagulation device and accessories | ||
| Rag Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Product Code | GEI | GEI |
| Class | II | II |
| Energy Source | Electrosurgical Generator | Electrosurgical Generator |
| Sterility | Sterile by Ethylene Oxide (EO) | Sterile by Ethylene Oxide (EO) |
| Technical Design | Pencil body with removable evacuation | |
| tube | Pencil body with removable evacuation | |
| tube |
7
| Patient Contact | Invasive tissue contact | Invasive tissue contact | |
|---|---|---|---|
| Electrode | Stainless/non-stick | Stainless/non-stick | |
| Patient Population | General population | General population | |
| Prescription or OTC | Prescription | Prescription | |
| Single Use | Yes | Yes | |
| Model | Classic | AIO | NA |
| Design | Pencil body with | ||
| removable | |||
| evacuation tube | Extendable suction | ||
| tube | Pencil body with removable evacuation | ||
| tube | |||
| Specification | Disposable with | ||
| 65mm electrode, | |||
| 3M/5M cable, and | |||
| holster. Cut and | |||
| Coagulation button | Disposable with | ||
| 70mm electrode, | |||
| 3M/5M cable, and | |||
| holster. Cut and | |||
| Coagulation button | Disposable with 70mm electrode, 3M | ||
| cable, and holster. Cut and Coagulation | |||
| button |
8
7. Performance and Safety Test
-
a. Performance Testing
-
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, 2020.
-
Animal study and clinical investigation ।
The Animal study was evaluated the safety and performance of the device in three different tissues under worst case scenarios. The outputs of energy were applied with low, moderate, and high watts in liver, kidney and muscle to test of the cutting performance and also evaluated the safety from tissue temperature, tissue cooling time and the extent of tissues' thermal damage. -
Clinical investigation isn't required for these devices. -
-
b. Safety Test:
-IEC 60601-1:2005+COPR.1:2006+COPR.2:2007+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility requirements and tests
- IEC 60601-2-2:2017, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
c. Biocompatibility testing
The biocompatibility evaluation and testing of the ShinEvac® Smoke Evacuation Pencilwas conducted in accordance with the following standards and guidance, as recognized by the FDA:
-FDA Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing".
-ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro
9
cytotoxicity
-ISO 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
-ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
-USP 42/NF37:2019 Pharmacopeia US : Pyrogen Test
d. Sterilization Validation
- ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
8. Conclusion
Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the ShinEvac® Smoke Evacuation Pencil is substantially equivalent to the predicate device and raises no new questions of safety or effectiveness.