(528 days)
No
The device description and performance studies focus on the physical components, electrosurgical function (cutting and coagulation using HFAC), and comparison to a predicate device based on thermal effects and safety standards. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes.
The device is used for cutting and coagulation of tissue and control bleeding, which are therapeutic actions.
No
The device is an electrosurgical pencil used for cutting and coagulation of tissue during surgery, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly details physical components such as an electrode tip, hand piece handle, cable, and plug, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device used for direct surgical intervention (cutting and coagulation of soft tissue) using electrical current. This is consistent with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a surgical accessory used in conjunction with an electrosurgical unit for therapeutic purposes (tissue removal and bleeding control).
N/A
Intended Use / Indications for Use
The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Disposable Electrosurgical pencils are used for the cutting and coagulation of soft tissue and have a conductive cable which is designed for use with high frequency surgical generator (Electrosurgical unit).
The connector or plug fits into electrosurgical unit. The hand-pieces are made of plastic with two buttons (cutting and coagulation buttons) in the case of the handcontrolled pencils, while the foot controlled pencils is activated by a monopolar footswitch connected to the generator. One button or switch is to control the cutting mode, CUT, of the ESU while the other controls the coagulation mode, COAG. The applied electrosurgery, monopolar, is the emittance of the high frequency alternating current, HFAC, from the diathermy via an active electrode through the patient's body tissues and then returned back to the diathermy machine via a dispersive electrode (patient return pad).
The proposed device mainly consists of electrode tip, hand piece handle, cable, and plug. For all applied device models, only one kind of dimension of electrode tip, standard hex blade electrode is available. However, two kind of cable length, 3m or 5m, and three kind of available hand-piece color, white/blue/green color, are available
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
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)
Bench Testing (non-clinical):
The proposed Disposable Electrosurgical Pencils had evaluated the Performance of Thermal effects on tissues, comparing with reference device specified in K092634. Three tissue types, liver, kidney and muscle tissue, were used for this evaluation by measuring the thermal damage zone sizes (length, width, and depth). The comparison tests conclusively prove that the proposed electrode is similar / equivalence in the performance of thermal effects on tissues as the predicate device.
The safety performances of subject device are demonstrated by the Third party, TUV Rheiland, through testing following IEC 60601-1:2005+CORR. 1(2006) + CORR.2(2007), Part 1- General requirements for basic safety and essential performance, and IEC 60601-2-2:2009, 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.
Package integrity and functional performance testing were completed on the subject device following aging and real time stability tests to support the proposed shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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July 19, 2018
Cathay Manfacturing Corp. % Ren Ren Manager No. 328, Xishe Road Maogang Town, Songjiang Area Shanghai, China 201607
Re: K170369
Trade/Device Name: Disposable Electrosurgical Pencils, CP1001 Series Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: July 3, 2018 Received: July 3, 2018
Dear Ren Ren:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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
1
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170369
Device Name
Disposable Electrosurgical Pencils (CP1001 Series)
Indications for Use (Describe)
The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.
| 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
510(k) Summary
| Submitter: | CATHAY MANUFACTURING CORP.
No. 328, Xishe Road, Maogang Town, Songjiang Area
Shanghai, CN 201607 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Ren, Ren
Phone: (86)021-57878328
Email: rubyfantasy@qq.com |
| Date Prepared: | July. 6, 2018 |
| Device Trade Name: | Disposable Electrosurgical Pencils |
| Model: | CP1001 Series |
| Device Common Name: | Disposable Electrosurgical Pencils |
| Classification Name:
accessories | Electrosurgical cutting and coagulation device and |
| Class: | II |
| Classification Name: | 21 CFR 878.4400 |
| Product Code: | GEI |
Predicate Device:
| Device | Company | Product Code | 510(k) Number |
|---|---|---|---|
| OBS Disposable | |||
| Electrosurgical Pencils | Jiangmen City Xinhui | ||
| Baisheng Medical | |||
| Equipment Co., Ltd | GEI | K092634 |
1. Indication for Use:
The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.
4
2. Product Description:
The Disposable Electrosurgical pencils are used for the cutting and coagulation of soft tissue and have a conductive cable which is designed for use with high frequency surgical generator (Electrosurgical unit).
The connector or plug fits into electrosurgical unit. The hand-pieces are made of plastic with two buttons (cutting and coagulation buttons) in the case of the handcontrolled pencils, while the foot controlled pencils is activated by a monopolar footswitch connected to the generator. One button or switch is to control the cutting mode, CUT, of the ESU while the other controls the coagulation mode, COAG. The applied electrosurgery, monopolar, is the emittance of the high frequency alternating current, HFAC, from the diathermy via an active electrode through the patient's body tissues and then returned back to the diathermy machine via a dispersive electrode (patient return pad).
The proposed device mainly consists of electrode tip, hand piece handle, cable, and plug. For all applied device models, only one kind of dimension of electrode tip, standard hex blade electrode is available. However, two kind of cable length, 3m or 5m, and three kind of available hand-piece color, white/blue/green color, are available
| ELEMENT OF
| COMPARISON | SUBJECT DEVICE | Predicate Device |
|---|---|---|
| K092634 | ||
| OBS Disposable Electrosurgical Pencils | ||
| Indications for Use | used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip. | used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip. |
| Classification | 878.4400 | 878.4400 |
| Product Code | GEI | GEI |
| OTC or | ||
| Prescription | For Prescription Use | For Prescription use |
| Energy source | ||
| type | RF Energy | RF Energy |
| Sterility and for | ||
| single use | Yes, Sterile and for single use | Yes, Sterile and for single use |
| Sterilization | ||
| method | EO Sterilization | EO Sterilization |
| Monopolar or | ||
| Bipolar electrode | Monopolar electrode | Monopolar electrode |
| Electrode | ||
| materials | Stainless steel | Stainless steel |
| Electrode | ||
| insulation material | ABS | ABS |
| Electrode coating | N/A | N/A |
| Electrode shape | ||
| and dimensions | standard hex blade electrode, 2.36 x 70mm | standard hex blade electrode, 2.36 x 70mm; |
| other shape and dimensions | ||
| Shaft materials | ABS | ABS |
| Handle length | 95 mm | 90 mm |
4. Summary of Technology Characteristics and Performance Testing (Comparison to the Predicate Device)
5
K170369
CATHAY MANUFACTURING CORP.
| Shaft length | 50mm | 50 mm | |
|---|---|---|---|
| Total length | 145mm | 140mm | |
| Shaft diameter | 2.36 mm | 2.36 mm | |
| Cable materials | Blue PVC cable | Blue PVC cable | |
| Cable length | 3m or 5m | 3m or 5m | |
| Foot control model | Yes, has foot control mode | Yes, has foot control mode | |
| Standards applied | IEC 60601-1; IEC 60601-2-2; | ||
| ISO 11135; ISO 11607 | IEC 60601-1; IEC 60601-2-2; | ||
| ISO 11135; ISO 11607 | |||
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 | |
| Labeling | confirm to 21 CFR Part 801 | confirm to 21 CFR Part 801 | |
| Performance | Conforms to IEC 60601-1 and | ||
| IEC 60601-2-10:2012, | |||
| Part 2 particular requirements for the basic | |||
| safety and essential performance of high | |||
| frequency surgical equipment and high | |||
| frequency surgical accessories. | |||
| Performance conforms the requirements | |||
| specified in 'Premarket Notification (510(k)) | |||
| Submissions for Electrosurgical Devices for | |||
| General Surgery' | Conforms to IEC 60601-1 and | ||
| IEC 60601-2-10:2012, | |||
| Part 2 particular requirements for the basic | |||
| safety and essential performance of high | |||
| frequency surgical equipment and high | |||
| frequency surgical accessories Performance | |||
| conforms the requirements specified in | |||
| 'Premarket Notification (510(k)) Submissions | |||
| for Electrosurgical Devices for General | |||
| Surgery' | |||
| Stability and shelf | |||
| life | 3 year | 3 year |
5. Bench Testing (non-clinical):
Compare to predicate product specified in K092634, our device and the predicate device are same in Essential Components, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equivalence evidence of proposed electrode can be demonstrated.
And also following the 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, the proposed Disposable Electrosurgical Pencils had evaluated the Performance of Thermal effects on tissues, comparing with reference device specified in K092634. Three tissue types, liver, kidney and muscle tissue, were used for this evaluation by measuring the thermal damage zone sizes (length, width, and depth).
The comparison tests conclusively prove that the proposed electrode is similar / equivalence in the performance of thermal effects on tissues as the predicate device device.
The safety performances of subject device are demonstrated by the Third party, TUV Rheiland, through testing following IEC 60601-1:2005+CORR. 1(2006) + CORR.2(2007), Part 1General requirements for basic safety and essential performance, and IEC 60601-2-2:2009, 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.
6
CATHAY MANUFACTURING CORP.
The results of bench testing & type testing provide reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use.
Package integrity and functional performance testing were completed on the subject device following aging and real time stability tests to support the proposed shelf life.
6. Conclusion:
Based on the indication for use, technology characteristics, and performance testing, the proposed product, Disposable Electrosurgical Pencils, has been shown to be appropriate for its indication for use and is considered to be substantially equivalent to the predicate device.