(116 days)
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 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.
The provided text describes a medical device, the ShinEvac® Smoke Evacuation Pencil, seeking FDA clearance via a 510(k) submission. This type of submission generally demonstrates substantial equivalence to a predicate device rather than providing extensive de novo clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, the study described here focuses on demonstrating that the new device performs similarly to a legally marketed predicate device, especially regarding safety and functional aspects, rather than setting and meeting specific quantitative clinical performance metrics like sensitivity, specificity, or AUC as one might see for diagnostic AI devices.
However, I can extract information related to performance testing and safety, which serve as the acceptance criteria for this type of device within the context of a 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria Definition / Purpose | Reported Device Performance (Summary) |
|---|---|---|---|
| Performance Testing | Electrosurgical cutting performance | To evaluate the safety and performance of the device in cutting various tissues under worst-case scenarios. | The animal study 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." (Implied: met expected performance for cutting and safety based on thermal damage). |
| Safety Testing | IEC 60601-1 (Basic Safety and Essential Performance General) | To ensure the device meets fundamental safety requirements for medical electrical equipment. | The device was tested in accordance with this standard. (Implied: passed, confirming basic safety). |
| IEC 60601-1-2 (Electromagnetic Compatibility) | To ensure the device does not interfere with other equipment and is not adversely affected by electromagnetic interference. | The device was tested in accordance with this standard. (Implied: passed, confirming EMI compatibility). | |
| IEC 60601-2-2 (HF Surgical Equipment & Accessories) | Specific safety and essential performance requirements for high-frequency surgical equipment and their accessories (like this device). | The device was tested in accordance with this standard. (Implied: passed, confirming specific HF surgical safety). | |
| IEC 60601-1-6 (Usability) | To ensure the device is safely and effectively usable by its intended users. | The device was tested in accordance with this standard. (Implied: passed, confirming usability). | |
| Biocompatibility Testing | ISO 10993-5 (Cytotoxicity) | To assess the potential for the device materials to cause cell damage. | The device was tested in accordance with this standard. (Implied: passed, confirming non-cytotoxic). |
| ISO 10993-10 (Irritation & Sensitization) | To assess the potential for the device materials to cause irritation or allergic reactions. | The device was tested in accordance with this standard. (Implied: passed, confirming minimal irritation/sensitization). | |
| ISO 10993-11 (Systemic Toxicity) | To assess the potential for the device materials to cause systemic toxic effects. | The device was tested in accordance with this standard. (Implied: passed, confirming no systemic toxicity). | |
| USP 42/NF37:2019 <151> (Pyrogen Test) | To test for the presence of substances that can cause fever. | The device was tested in accordance with this standard. (Implied: passed, confirming non-pyrogenic). | |
| Sterilization Validation | ISO 11135 (Ethylene Oxide Sterilization) | To confirm the efficacy and reliability of the Ethylene Oxide (EO) sterilization process used for the device. | The device was tested in accordance with this standard for "development, validation and routine control of a sterilization process." (Implied: validated, ensuring sterility). |
2. Sample size used for the test set and the data provenance
- Performance Testing (Animal Study): The animal study involved evaluating the device in "three different tissues" ("liver, kidney and muscle"). The exact number of animals or trials within each tissue type is not specified.
- Data Provenance: The animal study is prospective (conducted for the purpose of this submission). The country of origin for the animal study is not specified in the provided text.
- Other tests (Safety, Biocompatibility, Sterilization): These are typically laboratory-based tests conducted on device samples. The specific sample sizes for these tests are not provided but would be defined by the respective international standards (e.g., ISO, IEC).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is an electrosurgical pencil, not an AI/diagnostic device that typically relies on expert-established ground truth for its performance metrics (like sensitivity/specificity).
- For the animal study, the evaluation of "safety from tissue temperature, tissue cooling time and the extent of tissues' thermal damage" would likely involve veterinary pathologists or researchers with expertise in electrosurgery and tissue histopathology. However, the exact number and qualifications of these experts are not specified in the document.
- For the other tests (safety, biocompatibility, sterilization), the "ground truth" is established by adherence to the objective criteria and protocols defined in the referenced international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not a diagnostic AI device requiring expert consensus for ground truth labeling. Performance is assessed against objective engineering and biological standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools and is not applicable to an electrosurgical pencil. The submission is for a physical medical device, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical electrosurgical tool and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study, the "ground truth" for assessing cutting performance, tissue temperature, cooling time, and thermal damage is established through direct observation, measurement, and potentially pathological examination of a histologist or other experts.
- For safety, biocompatibility, and sterilization tests, the "ground truth" is defined by the objective pass/fail criteria and methodologies stipulated within the referenced IEC and ISO international standards. Compliance with these standards serves as the benchmark.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI algorithm that requires a training set.
{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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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., NewTaipei City 248, Taiwan (R.O.C.).TEL: +886-2-22900966FAX: +886-2-22903966 | |
| Establishment Registration No.: | 1000448660 | |
| Contact Person | Mrs. Anita Chen/ Regulatory Advisor of ShiningWorld 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 Ø2.38mm tip electrode and the maximum voltage is 4.5KV peak. Th is device can remove surgical smokewhen connected to a smoke evacuator. | ||
|---|---|---|
| 5. | Intended Use: | The ShinEvac® Smoke Evacuation Pencil isdesigned for general electrosurgical applications,including cutting and coagulation, and for removingsmoke generated by electrosurgery when used inconjunction with an effective smoke evacuationsystem. The pencil enables the operator to remotelyconduct and electrosurgical current from the outputconnector of an electrosurgical unit to the operativesite for the desired surgical effect. |
| 6. | Technological Characteristicsand Substantial EquivalenceComparison with Predicate: | A comparison of the device features, intended use,and other information demonstrates that theShinEvac® Smoke Evacuation Pencil is substantiallyequivalent to the predicate device as summarized inTable 1. The differences raise no new question ofsafety 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 Pencilis designed for general electrosurgicalapplications, including cutting andcoagulation, and for removing smokegenerated by electrosurgery when used inconjunction with an effective smokeevacuation system. The pencil enables theoperator to remotely conduct andelectrosurgical current from the outputconnector of an electrosurgical unit to theoperative site for the desired surgicaleffect. | The PLUMEPEN is designed for generalelectrosurgical applications, includingcutting and coagulation, and for removingsmoke generated by electrosurgery whenused in conjunction with an effectivesmoke evacuation system. The pencilenables the operator to remotely conductand electrosurgical current from theoutput connector of an electrosurgical unitto the operative site for the desiredsurgical effect. |
| Regulation name | Electrosurgical cutting andcoagulation device and accessories | Electrosurgical cutting andcoagulation 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 evacuationtube | Pencil body with removable evacuationtube |
{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 withremovableevacuation tube | Extendable suctiontube | Pencil body with removable evacuationtube |
| Specification | Disposable with65mm electrode,3M/5M cable, andholster. Cut andCoagulation button | Disposable with70mm electrode,3M/5M cable, andholster. Cut andCoagulation button | Disposable with 70mm electrode, 3Mcable, and holster. Cut and Coagulationbutton |
{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 <151> 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.
§ 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.