(183 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical properties of a simple electrosurgical tool, with no mention of AI or ML.
Yes.
The device is intended for "coagulation of tissue" and "electrocoagulation hemostasis," which are therapeutic applications within electrosurgery.
No
The device is described as electrosurgical forceps intended for coagulation of tissue and electrocoagulation hemostasis, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components (forceps pieces, holder, wire, insulation layer) made of specific materials (silver plated brass, brass, epoxy resin) and describes a mechanical action (pinching) and electrical function (high frequency current). This is a hardware device with an electrical function, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in electrosurgery for coagulation of tissue." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical instrument used to apply high-frequency current to tissue for electrocoagulation. This is a therapeutic/surgical function, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
Disposable Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Disposable Bipolar Forceps consists of forceps pieces, forceps holder, wire. The tail end of the forceps pieces are connected with the forceps holder. The forceps holder is provided with a high frequency input wire, and the wire can be connected with the high frequency surgical equipment through a plug. The outer surface of the forceps pieces are provided with an insulation layer. Disposable Bipolar Forceps materials: forceps tips material: silver plated brass; forceps pieces material: brass; forceps pieces coating: epoxy resin; packaging: PETG tray, Tyvek lid. The structure of Disposable Bipolar Forceps is double forceps pieces. Two fingers pinch the left and right forceps pieces, so that the forceps tips gently clamp the tissues, through the high frequency current to achieve electrocoagulation hemostasis. The rebound action is realized by the rebound force of the forceps pieces. Rated Accessory Voltage is 500Vpk.
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)
EMC, electrical safety, biocompatibility and sterility were evaluated according to recognized standards listed above. To demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified, we follow the Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff.; Ex-vivo experimental study on Thermal Effects, was conducted follow Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff which refer to Exvivo experimental study on Thermal Effects of Disposable Bipolar Forceps; and Mechanical Strength.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
March 6, 2024
Jiangsu Hope Biomedical Science&Technology Co., Ltd. % Kitty Zhang Regulation Affair Staff Shanghai Jiushun Enterprise Management Technology Service Co 15 floor, 25 floor,Bao An Tower,No.800 Dongfang Road Shanghai, Shanghai 200122 China
Re: K232703
Trade/Device Name: Disposable Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: January 31, 2024 Received: February 2, 2024
Dear Kitty Zhang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Mark Digitally signed by Mark Trumbore -S Trumbore -S Date: 2024.03.06 13:48:41
-05'00' Mark Trumbore, 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
2
K232703
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
Disposable Bipolar Forceps
Indications for Use (Describe)
Disposable Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coaqulation of tissue.
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."
pe of Use (Select one or both, as applicable)
Prescription Use (Part 21 CER 801 Subn
- Over-The-Counter Use (21 CFR 801 Subpart C
3
510(k) Summary
March 6, 2024
1. Submitter Information
Company Name: Jiangsu Hope Biomedical Science&Technology Co.,Ltd.
Address: No.3 Building, Hi-tech Innovation Service Center, Jiangdu District,
Yangzhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA.
Applicant Contact: Shaote Geng
Applicant Contact Telephone: +86-514-87185186
Applicant Contact Email: shaote.geng(@hoboat.com
Correspondent Name: Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.
Correspondent Address: 15 floor,25 floor,Bao An Tower,No.800,Dongfang
Road, Shanghai, China. Shanghai Shanghai 200122 China
Correspondent Contact: Mrs. Kitty Zhang
Correspondent Contact Telephone: +86-21-50931939
Correspondent Contact Email: kitty-zhang@jisosh.com
Correspondent Contact Telephone: +86-21-50931939
Subject Device Information 2.
Common Name: Electrosurgical cutting and coagulation device and accessories
Trade Name: Disposable Bipolar Forceps
Model: ZKN-3CWZ
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
4
Review Panel: General and Plastic Surgery
Product Code: GEI
Regulation Number: 21 CFR 878.4400
Regulation Class: II
3. Predicate Device Information
Sponsor: Synergetics, Inc.
Common Name: Electrosurgical Instrumentation
Trade Name: Synergetics Disposable Spetzler-Mails Standard Bipolar Forceps
510(k) number: K121426
Classification Name: Electrosurgical Cutting and Coagulation Device and
Accessories
Review Panel: General and Plastic Surgery
Product Code: GEI
Regulation Number: 21 CFR 878.4400
Regulation Class: II
4. Device Description Summary
- The mechanism of action
The mechanism of action of Disposable Bipolar Forceps are to hemostasis of tissue by bipolar electrocoagulation. The Disposable Bipolar Forceps can carry out electrocoagulation of tissues. The tissue is grasped between the forceps tips, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue.
- Mechanical structure
Disposable Bipolar Forceps consists of forceps pieces, forceps holder, wire. The tail end of the forceps pieces are connected with the forceps holder. The forceps holder is
5
provided with a high frequency input wire, and the wire can be connected with the high frequency surgical equipment through a plug. The outer surface of the forceps pieces are provided with an insulation layer.
Disposable Bipolar Forceps materials: forceps tips material: silver plated brass; forceps pieces material: brass; forceps pieces coating: epoxy resin; packaging: PETG tray, Tyvek lid.
- Principle of operation and technological characteristics
The structure of Disposable Bipolar Forceps is double forceps pieces. Two fingers pinch the left and right forceps pieces, so that the forceps tips gently clamp the tissues, through the high frequency current to achieve electrocoagulation hemostasis. The rebound action is realized by the rebound force of the forceps pieces.
- Operating procedures
Disposable Bipolar forceps are connected with the bipolar output of an electrosurgical generator. Disposable Bipolar forceps must only be used with bipolar coagulation current. The bipolar forceps must be operated with the following parameters: Rated Accessory Voltage is 500Vpk.
5. Indications for Use
Disposable Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.
6. Substantial Equivalence Discussion
| Elements of
| Comparison | Subject Device | Predicate Device |
|---|---|---|
| Company | Jiangsu Hope Biomedical | |
| Science&Technology | ||
| Co.,Ltd. | Synergetics, Inc. |
1)General Comparison
6
| Device Name | Disposable Bipolar Forceps | Synergetics Disposable
Spetzler-Mails Standard
Bipolar Forceps |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | ZKN-3CWZ | Disposable Spetzler-Malis
Standard Bipolar Forceps |
| Prescription/OTC | Prescription | Prescription |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Code | GEI | GEI |
| Class | II | II |
| Indication for Use | Disposable Bipolar Forceps
are single use devices sold
sterile and are intended for
use in electrosurgery for
coagulation of tissue. | The Synergetics Disposable
Spetzler-Mails Standard
Bipolar Forceps are single use
devices sold sterile and are
intended for use in
electrosurgery for coagulation
of tissue. |
| Single Use | Yes | Yes |
| Device design | Bayonet Style | Bayonet Style |
| Length | 205mm | 180mm, 200mm, 230mm |
| Tip Size | 1.2mm | 0.5 mm, 1.0 mm, 1.5 mm |
| Color | Yellow | Yellow |
| Tips material | Silver plated | Silver plated |
| Electrical Safety
Testing | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 |
| Biocompatibility | Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute systemic toxicity test
Pyrogenicity test | Biocompatible Silver plated
Aluminum base with PVDF
insulation |
| Sterility | Yes | Yes |
| Sterilization
Method | Ethylene oxide | Ethylene oxide |
| Shelf Life | 3 years | 5years |
| Packaging | Rigid PETG Tray, Tyvek lid | Rigid PETG Tray, Tyvek lid |
7
2) Indication for Use Comparison
Indication for use of the subject device: Disposable Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.
Indication for use of the Equivalence: The Synergetics Disposable Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.
The indication for use of subject device and the Equivalence is same.
- Technological Comparison
Based on available 510(k) information provided herein, Disposable Bipolar Forceps is similar to the predicate devices in terms of material, technology, design and performance specifications.
7. Non-Clinical Tests Summary
EMC, electrical safety, biocompatibility and sterility were evaluated according to recognized standards listed above.
To demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified, we follow the Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff.; Ex-vivo experimental study on Thermal Effects, was conducted follow Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff which refer to Exvivo experimental study on Thermal Effects of Disposable Bipolar Forceps; and Mechanical Strength.
8
Conclusion:
The subject device Disposable Bipolar Forceps is similar by technological
specifications and intended use to the predicate device. Performance testing results
shows that differences do not affect the safety and effectiveness of the subject device.
Thus, the subject device is substantially equivalent to the predicate device for
requested indications for use.