(203 days)
The device is to be used in combination with a standard electrosurgical generator to cut and coagniate soft tissus by means of high frequency electrical current during an electrosurgical procedure.
The Single use electrosurgical pencil with electrode is a monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. It directs high frequency alternating current to heat target tissue thereby bringing about cutting and coagulation during surgical procedures.
The electrosurgical pencil handpiece consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode.
The electrosurgical pencil handpiece is available in 3 models, differing only in their button configuration: Push Button Electrosurgical Pencil (Model #: GDSA), Electrosurgical Rocker Pencil (Model #: GDSB), and Electrosurgical Foot Control (Model #: GDJA).
The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball, needle and dermal tip. The electrode tip is either coated or noncoated. There may or may not be a heat shrink attached. There are 47 different types of electrodes.
The model number of each subjective device "Single use electrosurgical pencil with electrode" consists of two parts: the first four letters representing model number of the pencil, and the second part representing model number of the electrode. For example, model number: GDSA-DA-C66 is for Push Button Electrosurgical Pencil with Standard Blade 2.6". There are 141 different combinations of pencil and electrode.
The diameter of the conductive post is 2.36mm. The pencil with electrode attached is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure.
The switching method of this electrosurgical pencil may be push button, rocker switch or foot switch. The cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug.
The provided text describes a 510(k) premarket notification for a "Single use electrosurgical pencil with electrode". This is a medical device application for a new version of an existing device, aiming to demonstrate substantial equivalence to a previously cleared predicate device.
The document focuses on comparing the proposed device to its predicate, rather than providing a detailed acceptance criterion table with numerical performance metrics and a specific study that proves the device meets those criteria in a typical clinical or diagnostic sense with specificity/sensitivity.
Instead, the "acceptance criteria" here are largely compliance with international standards and equivalence to the predicate device in various performance aspects. The "study" refers to performance and safety testing conducted to ensure this compliance and equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for an electrosurgical pencil, the "acceptance criteria" are primarily related to safety, functional performance, and biocompatibility, benchmarked against standards and the predicate device. The "reported device performance" is a statement of compliance with these standards and equivalence to the predicate.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (K192542) | "The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation." - Same as predicate. |
| Indications for Use | Same as predicate device (K192542) | "To cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure." - Same as predicate. |
| Energy Delivery | High frequency electrical current/energy (same as predicate) | "High frequency electrical current/energy" - Same as predicate. |
| Monopolar/Bipolar | Monopolar (same as predicate) | "Monopolar" - Same as predicate. |
| Generator Compatibility | Compatibility with standard electrosurgical generator (same as predicate) | "To be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection" - Same as predicate. |
| Design/Structure | Similar materials, structure, and electrode types to predicate; no new safety/effectiveness issues. | Handpiece: ABS/PVC; Switching: Push button, rocker switch & footcontrol. Electrode: Stainless steel, insulation (Kynar Shrink Wrap and/or ABS/HIPS overmold), various lengths, ~2.36mm diameter. Tip configurations: Blade, Needle, Ball. Coating: Teflon. - Similar to predicate. Materials and structure are "very similar and do not raise safety and effectiveness issues because those were tested according to IEC test and biocompatibility requirements." |
| Rated Accessory Voltage | Similar to predicate (4kVp, 5kVp) | "4kVp" - Similar. "The proposed electrode passes the required tests according to IEC60601-1 and IEC60601-2-2 so there are not any issues for safety and performance." |
| Sterilization | EO sterile, validated according to ISO 11135 (same as predicate) | "EO sterile" - Same. "EO sterilization is validated according to ISO 11135." |
| Shelf Life | 3 years (same as predicate) | "3 years" - Same as predicate. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 | "Comply with dielectric strength in accordance with IEC60601-1, IEC60601-1-2 & IEC60601-2-2" - Complies. |
| Biocompatibility | Compliance with ISO 10993 series for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity. | "Comply with ISO10993" - Testing for Cytotoxicity, Skin sensitization, Intracutaneous reactivity test, Acute systemic toxicity, Pyrogen Testing was conducted. - Complies. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "The product complies with the IEC 60601-1-2 standard for EMC." - Complies. |
| Performance Testing | Comparable penetrating thermal tissue effects to predicate device. | "A study was performed to compare the penetrating thermal tissue effects of the Shun Ye Medical Electrosurgical Pencil to MMEO Electrosurgical Pencil." using porcine liver, kidney, and muscle tissues. - Implicitly, results showed equivalence or acceptable performance. |
Since this is a 510(k) summary for a relatively straightforward electrosurgical device, the detailed metrics often found in AI/diagnostic device submissions are not present. The "study" mentioned for performance testing is a comparative study, implying the new device's performance was found to be similar to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and biocompatibility testing.
- Performance Testing (Penetrating thermal tissue effects): The "test set" consisted of "Porcine Liver, Porcine Kidney, Porcine Muscle tissues." The sample size (number of tissue samples or repetitions) is not specified. The data provenance is ex-vivo (animal tissue), likely conducted in a controlled lab environment (implicitly, in China, based on the submitter's location). This type of testing is generally considered prospective in terms of data collection and analysis for the submission, even if it uses ex-vivo samples.
- Biocompatibility Testing: The specific sample sizes for tests like cytotoxicity, sensitization, systemic toxicity, and pyrogen testing are not specified. These tests typically involve in-vitro assays (cytotoxicity) and in-vivo animal models (sensitization, systemic toxicity, pyrogen). The provenance would be from lab testing, likely conducted in China or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable and not provided for this device. The "ground truth" for electrosurgical pencils involves objective physical/biological measurements (e.g., thermal effect depth, electrical parameters, biocompatibility reactions) rather than expert interpretation of images or clinical data. The standards themselves (IEC, ISO) define the "ground truth" for compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in expert assessment (e.g., in radiology studies). This submission relies on objective testing following defined international 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
Not applicable and not provided. MRMC studies are specific to AI-assisted diagnostic devices involving human readers. This device is an electrosurgical pencil, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable and not provided. This is not an AI algorithm. Its performance is assessed through physical, electrical, and biological testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance and safety is established by objective measurements and adherence to recognized international standards.
- For electrical safety and EMC, the ground truth is defined by the parameters and limits specified in IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- For biocompatibility, the ground truth is defined by the acceptable limits and biological responses outlined in ISO 10993 series standards.
- For performance (thermal tissue effects), the ground truth is the measured penetrating thermal effect compared to the predicate device's measured effects on porcine tissues. Implicitly, similar or equivalent effects are the "ground truth" for demonstrating equivalence.
8. The sample size for the training set
Not applicable and not provided. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable and not provided for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ningbo Shun Ye Medical Company, Ltd. Mr. Frank Yu Official Correspondent No.5 Industry Road, Zhangqi Industry Zone, Cixi Ningbo City , Zhejiang 315313 China
June 27, 2022
Re: K213786
Trade/Device Name: Single use electrosurgical pencil with electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 19, 2022 Received: April 28, 2022
Dear Mr. Yu:
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 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.
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
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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/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 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,
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) K213786
Device Name
single use electrosurgical pencil with electrode
Indications for Use (Describe)
The device is to be used in combination with a standard electrosurgical generator to cut and coagniate soft tissus by means of high frequency electrical current during an electrosurgical procedure.
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/0 description: The image shows a logo with the text "CiRx" in a light blue, sans-serif font. Below "CiRx" are two Chinese characters in a similar light blue color. A circled "R" trademark symbol is located in the upper right corner of the logo.
SECTION 5
510(K) SUMMARY
Page 1 of 10
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510(k) SUMMARY
(Submitted As Required per 21 CFR 807.92)
I. GENERAL INFORMATION
| Submitter Name: | Ningbo Shun Ye Medical Company, Ltd. | |
|---|---|---|
| Establishment RegistrationNumber: | 3007593903 | |
| Submitter Address: | No. 5 Industry Road, | |
| Zhangqi Industry Zone, Cixi, Ningbo City315313 Zhejiang, China | ||
| Submitter Telephone Number: | 011 - 86 - 574 - 6377 - 8018 | |
| Submitter FAX Number: | 011 - 86 - 574 - 6377 - 8028 | |
| Contact Person: | Frank YuGeneral Manager | |
| Date Prepared: | October 2021 |
II.DEVICE IDENTIFICATION
| Proprietary Name: | Single use electrosurgical pencil with non-coated and non-stickelectrode; |
|---|---|
| Common Name: | Single use electrosurgical pencil with electrode |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
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Image /page/5/Picture/0 description: The image shows a logo with the letters "CiR" in a light blue color. Below the letters, there are two Chinese characters in a similar light blue hue. A circled "R" trademark symbol is positioned in the upper right corner of the logo, slightly above and to the right of the "R" in "CiR".
III.PREDICATE DEVICE
Table 1: Predicate device information
| Predicate device | 510k number | 510k holder | Clearance date |
|---|---|---|---|
| Single UseElectrosurgical pencilwith non-coated andnon-stick electrode | K192542 | Modern MedicalEquipmentManufacturing Limited | 16-Jun-20 |
IV.DEVICE DESCRIPTION
The Single use electrosurgical pencil with electrode is a monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. It directs high frequency alternating current to heat target tissue thereby bringing about cutting and coagulation during surgical procedures.
The electrosurgical pencil handpiece consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode.
The electrosurgical pencil handpiece is available in 3 models, differing only in their button configuration: Push Button Electrosurgical Pencil (Model #: GDSA), Electrosurgical Rocker Pencil (Model #: GDSB), and Electrosurgical Foot Control (Model #: GDJA).
The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball, needle and dermal tip. The electrode tip is either coated or noncoated. There may or may not be a heat shrink attached. There are 47 different types of electrodes.
The model number of each subjective device "Single use electrosurgical pencil with electrode" consists of two parts: the first four letters representing model number of the pencil, and the second part representing model number of the electrode. For example, model number: GDSA-DA-C66 is for Push Button Electrosurgical Pencil with Standard Blade 2.6". There are 141 different combinations of pencil and electrode.
The diameter of the conductive post is 2.36mm. The pencil with electrode attached is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure.
The switching method of this electrosurgical pencil may be push button, rocker switch or foot switch. The cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug.
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Image /page/6/Picture/1 description: The image shows a logo with the text "CiR" in a light blue color. Below the text "CiR" are two Chinese characters in a darker color. A circled "R" symbol is located in the upper right corner of the logo.
The single use electrosurgical pencil with electrode has the same intended use and energy type as the predicate device. There are no technological differences, no changes to the principle of operation or the method of application.
V.INTENDED USE/INDICATIONS
The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation.
This is identical to the intended use/indications of the predicate device.
| Compared items | Proposed device(K213786)Single use electrosurgical penciland non-coated and non-stickelectrode | Predicate device(K192542)Single use electrosurgical penciland non-coated and non-stickelectrode | Comments |
|---|---|---|---|
| Intended use | The monopolarelectrosurgical pencil withelectrode is used to deliverhigh frequency current totarget tissue for cutting andcoagulation | The monopolarelectrosurgical pencil withelectrode is used to deliverhigh frequency current totarget tissue for cutting andcoagulation | same |
| Indication for use | To cut and coagulate softtissue by means of highfrequency electrical currentduring an electrosurgicalprocedure. | To cut and coagulate softtissue by means of highfrequency electrical currentduring an electrosurgicalprocedure. | same |
| Regulationnumber | 21 CFR878.4400 | 21 CFR 878.4400 | same |
| Product code | GEI | GEI | same |
| OTC orprescription | For prescriptionuse | For prescription use | same |
| Energy delivery | High frequency electricalcurrent/energy | High frequency electricalcurrent/energy | same |
| Monopolar orbipolar | Monopolar | Monopolar | same |
| GeneratorCompatibility | To be used with a standardelectrosurgical generatorwith footswitch control and astandardreturn electrodeconnection | To be used with a standardelectrosurgical generatorwithfootswitch control and astandard return electrodeconnection | same |
| Design | Monopolar electrosurgicalpencil for cutting andcoagulation and with differentelectrode tips as blade,needle, and ball | Monopolar electrosurgicalpencil for cutting andcoagulation and withdifferent electrode tips asblade, needle, and ball | same targetpurpose |
| User Interface | Footswitch/Hand | Footswitch/Hand | same |
| StructurePencil- Housing- Cable- Switching | ABSPVCPush button, rocker switch &footcontrol | ABSPVCPush button, rocker switch&foot control | The material usedand structure amongthe proposed andpredicate devices arevery similar and donot raise safety andeffectiveness issuesbecause those weretested according toIEC test andbiocompatibilityrequirements |
| Electrode- Material | Stainless steel | Stainless steel | Same |
| - Length | 66mm, 70mm, 101mm,152mm(blade)65mm (angled blade) | 69 mm, 102mm, 152mm (blade& needle) | Similar, length ofelectrode does notraise any safety andperformance issues |
| 72mm, 101mm, 152mm (needle)60mm, 66mm (angled needle)60mm (dermal tip)49mm, 50mm, 51mm,132mm,133mm,134mm(ball) | 69-71mm, 105-107mm,135-137mm (ball) | ||
| Diameter | ~2.36mm | ~2.36mm | Same |
| Insulationmaterial | Kynar Shrink Wrap and/orABS/HIPS overmold | Polyolefin Shrink Wrapand/or PTFE Shrink Wrap,Or ABS/HIPS overmold | Similar. The proposedelectrode passes therequired tests accordingto IEC60601-1 andIEC60601-2-2 so thereare not any issues forsafety. |
| Electrode TipConfiguration | Blade, Needle, Ball | Blade, Needle, Ball | Same |
| Electrodecoating | Teflon coat | Teflon coat | Same |
| Ratedaccessoryvoltage | 4kVp | 4kVp, 5kVp | Similar. The proposedelectrode passes therequired tests accordingto IEC60601-1 andIEC60601-2-2 so thereare not any issues forsafety and performance. |
| Sterilization | EO sterile | EO sterile | Same. EO sterilizationis validated accordingto ISO 11135. |
| Shelf life | 3 years | 3 years | Same |
| Electrical safety | Comply with dielectric strength inaccordance with IEC60601-1,IEC60601-1-2 & IEC60601-2-2 | Comply with dielectric strengthin accordance with IEC60601-1,IEC60601-1-2 & IEC60601-2-2 | Same |
| Biocompatibility | Comply with ISO10993 | Comply with ISO10993 | Same |
VI. PROPOSED/PREDICATE DEVICE COMPARISON
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Image /page/7/Picture/0 description: The image shows a logo with the letters "CiR" in a stylized font, with the "R" slightly smaller and raised, accompanied by the Chinese characters "弈业" below. The letters and characters are in a light blue color. A registered trademark symbol (®) is positioned to the upper right of the "R".
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Image /page/8/Picture/0 description: The image shows the logo for CiR, with the letters "CiR" in a light blue color. Below the letters, there are two Chinese characters in a darker color. The "R" in "CiR" has a circled "R" symbol next to it, indicating that it is a registered trademark.
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Image /page/9/Picture/0 description: The image shows the logo for CiR, which is a company or organization. The logo consists of the letters "CiR" in a light blue color, with the "R" having a curved extension. Below the letters, there are two Chinese characters in a similar light blue color. To the right of the "R", there is a circled "R" symbol, indicating that the logo is a registered trademark.
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Image /page/10/Picture/1 description: The image shows a logo with the text "CiRx" in a stylized font, with the "R" having a registered trademark symbol next to it. Below the text "CiRx" are two Chinese characters stacked vertically. The logo has a light blue color scheme.
VII. SAFETY/PERFORMANCE TESTING
The following performance data are provided in support of substantial equivalence determination.
Performance testing
Performance testing was conducted for the proposed device in accordance with requirements of FDA's Guidance: Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (issued on March 9, 2020).
A study was performed to compare the penetrating thermal tissue effects of the Shun Ye Medical Electrosurgical Pencil to MMEO Electrosurgical Pencil. Test specimens used are listed as follows:
- Porcine Liver ●
- Porcine Kidney
- Porcine Muscle tissues
Biocompatibility testing
The biocompatibility evaluation for the single use electrosurgical pencil with electrode was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Skin sensitization
- Intracutaneous reactivity test
- Acute systemic toxicity
- Pyrogen Testing
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Image /page/11/Picture/0 description: The image shows a logo with the text "CiR" in a light blue color, with the "R" having a small check mark-like symbol in the lower right corner. Above the "R" is a small circled "R" symbol, indicating a registered trademark. Below the "CiR" text are two Chinese characters in a darker color, possibly representing the company's name or a related term.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the single use electrosurgical pencil with electrode. The product complies with the IEC 60601-1 and IEC60601-2-2 standards for safety, IEC 60601-1-2 standard for EMC.
The single use electrosurgical pencil with electrode was designed in accordance with the following standards:
| International Standard | Description |
|---|---|
| IEC 60601-1, Edition 3.1 | Medical Electrical Equipment - Part 1: General Requirements for Safety |
| IEC 60601-1-2 Edition 4.0 2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-2 Edition 6.0 2017-03 | Particular requirements for the safety of high frequency surgical equipment |
| ISO 11135-1: 2007 | Sterilization of Healthcare Products – Ethylene Oxide – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. |
| ISO 10993-7:2008 | Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Residuals |
| ISO 10993-12: 2012 | Biological evaluation of medical devices – Part12: Sample preparation and reference materials |
| ISO 10993-2:2006 | Biological evaluation of medical devices Part 2: Animal welfare requirements |
| ISO 10993-11: 2017 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-1:2018 | Biological Evaluation of Medical Devices Part 1: Evaluation and Testing with a Risk Management Process |
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Image /page/12/Picture/1 description: The image shows a logo with the text "CiRx" in a stylized font, with the "Ci" in a lighter blue color and the "Rx" in a darker blue. Above the "Rx" is a circled "R" symbol, indicating a registered trademark. Below the "CiRx" text is the Chinese characters "舜业".
CONCLUSION VIII.
There is no difference between the Single use electrosurgical pencil with electrode and the predicate device in terms of intended use, principle of operation, and the technology used for device performance. There is no new technology and no difference that would raise new or different questions of safety or efficacy. Therefore, we conclude that the devices are substantially equivalent.
§ 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.