(186 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical properties for tissue coagulation, with no mention of AI/ML components or data processing.
No
A therapeutic device is one that treats a disease or condition. This device, an electrosurgical instrument for tissue coagulation, performs a medical procedure but is not designed to treat a disease itself; it assists in surgical intervention.
No
The device is intended to conduct electrosurgical current for coagulation of tissue, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines multiple hardware components made of materials like stainless steel and plastic, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to conduct electrosurgical current for coagulation of tissue during general surgical procedures." This describes a device used on the patient's body during surgery, not a device used to examine specimens from the body in a lab setting.
- Device Description: The description details a surgical instrument with electrodes, a handle, and connections for electrosurgical equipment. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient's tissue during a surgical procedure.
N/A
Intended Use / Indications for Use
Disposable Endoscopic Bipolar is a sterile, single use electrosurgical instrument intended to conduct electrosurgical current for coagulation of tissue during general surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
1). the mechanism of action The mechanism of action of disposable endoscopic bipolar is to hemostasis of tissue by bipolar electrocoagulation. The disposable endoscopic bipolar can carry out more precise electrocoagulation and treatment of small blood vessels and other structures. The principle of disposable endoscopic bipolar is that the electrosurgical current is released through the two electrode tips, so that the human tissue between the electrode tips of the disposable endoscopic bipolar produces the thermal effect to coagulate proteins in the blood to achieve hemostasis. Due to the mutual insulation of the two electrodes of the disposable endoscopic bipolar, only the electrode tips conduct current. During electrocoagulation, the current passes from one electrode tip to the other, and the tissue between the two electrode tips is affected by the thermal effect, while the tissue outside the electrode tips is little or not affected, which has a protective effect on the tissue.
2). mechanical structure Disposable endoscopic bipolar consists of electrode, power line, socket, handle group, inner rod, pushrod. Handle group consists of block, set screw, handle, fixed block, rivet pin, rivet cap, connecting rod, sliding block, spring, front insert, upper cover, lower cover, tail sleeve. The inner rod is set in the pushrod and handle group mechanism, and is fixed with set screws and fixed block, and the pushrod is connected to the sliding block. The back end of the push rod is shaped like a semi-circle for easy bending and use. The product is divided in straight and curved based on poshrod shape type. The electrodes are equipped with the insulating sleeve, and the outer side of the sleeve is provided with a stainless steel armor plate to prevent the push rod from rubbing the sleeve. The electrodes are fixed in the inner rod. The electrodes are connected to the socket through power line, and the socket can be connected to the high frequency surgical equipment. Disposable endoscopic bipolar materials: Stainless Steel, Plastic Material.
3). principle of operation and technological characteristics The handle group mechanism of the disposable endoscopic bipolar is a two-finger hand pinch connecting rod structure, and the rebound action is realized by the spring rebound force. Principle of operation: When kneading the handle, the two connecting rods push the sliding block and the pushrod forward, the pushrod pushes the electrode to achieve the clamping action, and then the hand is loosened, and the sliding block is pushed back by the spring, and the electrode is opened by its own elasticity, so that the closure and opening of the electrode are realized. Technological characteristics: Rated Accessory Voltage is 500Vpk. The external diameter of the pushrod is 3.2mm, working length is 175mm. Electrode tips width are 0.5-1.2mm.
4). operating procedures The disposable endoscopic bipolar specifications should be selected according to the clinical needs. Take the sterile pack, tear up and take out the disposable endoscopic bipolar, connect the product to high frequency device with special connection, the tissue attachments on the electrode tips could be removed with gauze during surgery. Disposable endoscopic bipolar has to be connected to bipolar receptacle of OBS Electrosurgical Generator (Model: OBS-350A) of Baisheng Medical Co.,Ltd. Aseptic operation and related procedures should be strictly followed, also kindly observe the patient signs during surgery. This product should be used by professional medical staff.
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
professional medical staff
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)
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, and Factory Inspection Instruction for Disposable Endoscopic Bipolar, to conduct the performances bench tests, details please refer to Performance Bench Test Report; 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 Ex-vivo experimental study on Thermal Effects of Disposable Endoscopic Bipolar; Mechanical Strength (refer to Mechanical Strength Verification and Report,included in the EMC, Wireless, & EMT Documentation attachments).
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 shows 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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
December 5, 2023
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: K231615
Trade/Device Name: Disposable Endoscopic Bipolar Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: November 6, 2023 Received: November 6, 2023
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.
1
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" (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 QS 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 -Date: 2023.12.05 റ 13:25:49 -05'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231615
Device Name Disposable Endoscopic Bipolar
Indications for Use (Describe)
Disposable Endoscopic Bipolar is a sterile, single use electrosurgical instrument intended to conduct electrosurgical current for coagulation of tissue during general surgical procedures.
Type of Use (Select one or both, as applicable) | |
---|---|
------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
510(k) Summary
Submitter Information 1.
Company Name: Jiangsu Hope Biomedical Science&Technology Co.,Ltd.
Address: No.3 building, High-tech Innovation Service Center, Jiangdu District,
Yangzhou City, Jiangsu Province, People's Republic of China.
Contact Person(including title): Shaote Geng (Registered Engineer)
Phone Number: +86-514-87185186
Fax Number: +86-514-86445567-8808
E-mail: hoboatfda@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,200122 Shanghai,China
Correspondent Contact Telephone: +86-21-50931939
Correspondent Contact: Mrs. Kitty Zhang
Correspondent Contact Email: kitty-zhang@isosh.com
2. Subject Device Information
Common Name: Electrosurgical cutting and coagulation device and accessories
Trade Name: Disposable Endoscopic Bipolar
Model: WZX-8XZWZ、WZX-8CZWW
Classification Name: Electrosurgical Cutting and Coagulation Device and
Accessories
Review Panel: General and Plastic Surgery
5
Product Code: GEI
Regulation Number: 21 CFR 878.4400
Regulation Class: II
3. Predicate Device Information
Sponsor: Günter Bissinger Medizintechnik GmbH
Common Name: Electrosurgical Instrumentation
Trade Name: Bipolar Micro-Coagulation Forceps
510(k) number: K172368
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 Summay
1). the mechanism of action The mechanism of action of disposable endoscopic bipolar is to hemostasis of tissue by bipolar electrocoagulation. The disposable endoscopic bipolar can carry out more precise electrocoagulation and treatment of small blood vessels and other structures. The principle of disposable endoscopic bipolar is that the electrosurgical current is released through the two electrode tips, so that the human tissue between the electrode tips of the disposable endoscopic bipolar produces the thermal effect to coagulate proteins in the blood to achieve hemostasis. Due to the mutual insulation of the two electrodes of the disposable endoscopic bipolar, only the electrode tips conduct current. During electrocoagulation, the current passes from one electrode tip to the other, and the tissue between the two electrode tips is affected by the thermal effect, while the
2 / 7
6
tissue outside the electrode tips is little or not affected, which has a protective effect on the tissue.
2). mechanical structure Disposable endoscopic bipolar consists of electrode, power line, socket, handle group, inner rod, pushrod. Handle group consists of block, set screw, handle, fixed block, rivet pin, rivet cap, connecting rod, sliding block, spring, front insert, upper cover, lower cover, tail sleeve. The inner rod is set in the pushrod and handle group mechanism, and is fixed with set screws and fixed block, and the pushrod is connected to the sliding block. The back end of the push rod is shaped like a semi-circle for easy bending and use. The product is divided in straight and curved based on poshrod shape type. The electrodes are equipped with the insulating sleeve, and the outer side of the sleeve is provided with a stainless steel armor plate to prevent the push rod from rubbing the sleeve. The electrodes are fixed in the inner rod. The electrodes are connected to the socket through power line, and the socket can be connected to the high frequency surgical equipment. Disposable endoscopic bipolar materials: Stainless Steel, Plastic Material. 3). principle of operation and technological characteristics The handle group mechanism of the disposable endoscopic bipolar is a two-finger hand pinch connecting rod structure, and the rebound action is realized by the spring rebound force. Principle of operation: When kneading the handle, the two connecting rods push the sliding block and the pushrod forward, the pushrod pushes the electrode to achieve the clamping action, and then the hand is loosened, and the sliding block is pushed back by the spring, and the electrode is opened by its own elasticity, so that the closure and opening of the electrode are realized. Technological characteristics: Rated Accessory Voltage is 500Vpk. The external diameter of the pushrod is 3.2mm, working length is 175mm. Electrode tips width are 0.5-1.2mm. 4). operating procedures The disposable endoscopic bipolar specifications should be selected according to the clinical needs. Take the sterile pack, tear up and take out the disposable endoscopic bipolar, connect the product to high frequency device
3 / 7
7
with special connection, the tissue attachments on the electrode tips could be removed with gauze during surgery. Disposable endoscopic bipolar has to be connected to bipolar receptacle of OBS Electrosurgical Generator (Model: OBS-350A) of Baisheng Medical Co.,Ltd. Aseptic operation and related procedures should be strictly followed, also kindly observe the patient signs during surgery. This product should be used by professional medical staff.
| Elements of
Comparison | Subject
Device | Predicate
Device | Result |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Company | Jiangsu Hope
Biomedical
Science&Techno
logy Co.,Ltd | Günter Bissinger
Medizintechnik
GmbH | / |
| Device Name | Disposable
Endoscopic
Bipolar | Bipolar
Micro-Coagulation
Forceps (K172368) | / |
| Model | WZX-8XZWZ,
WZX-8CZWW | POWERGRIP 3.0,
MITHRAS | / |
| Prescription/OTC | Prescription | Prescription | Same |
| Regulation Number | 21 CFR
878.4400 | 21 CFR 878.4400 | Same |
| Code | GEI | GEI | Same |
| Class | II | II | Same |
| Indication for Use | Disposable
Endoscopic
Bipolar is a
sterile, single
use
electrosurgical
instrument
intended to
conduct
electrosurgical
current for
coagulation of
tissue during
general surgical
procedures | The Bipolar
Micro-Coagulation
Forceps are
intended to remove
tissue and control
bleeding. | Similar
Note1 |
| Single Use | Yes | No | Different
Note 2. |
| Device design | Disposable
endoscopic
bipolars are
electrosurgical
tools available
with different
handles and
different tip
designs. | Bipolar
Micro-Coagulation
Forceps are
electrosurgical
tools available with
different handles
and different tip
designs. | same |
| Length | WZX-8CZWW,
WZX-8XZWZ:
$320\pm50mm$ ; | 30cm | Similar
Note 3 |
| Tip Size | $1.2\pm0.3mm$ | 0.35 – 2.8 mm | Similar
Note 4 |
| Color | Black | Black | Same |
| Tips material | Medical
Stainless Steel | Stainless Steel | Same |
| Maximum peak
Voltage(Vp) | $500\pm10%$ | 300 | Different
Note 5 |
| 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 | Same |
| Biocompatibility | Cytotoxicity
Sensitization
Intracutaneous
Reactivity
Acute systemic
toxicity test
Pyrogenicity test | Cytotoxicity
Sensitization
Irritation or
Intracutaneous
Reactivity | Different
Note 6 |
| Sterility | Yes | Non-sterile,
reusable | Different
Note 7 |
| Sterilization
Method | Ethylene oxide | NA | Different
Note 7 |
| Shelf Life | 3 years | NA | Different
Note 8 |
5. General Comparison
8
9
|--|--|--|--|
Based on available 510(k) information provided herein, Disposable Endoscopic Bipolar is considered substantially equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications. The performed tests show that the subjected device is in compliance with the applicable recognized standards. Performed comparison testing with the predicate device shows substantial equivalence to the FDA-cleared predicate device Sponsor: Jiangsu Hope Biomedical Science&Technology Co.,Ltd Subject Device: Disposable Endoscopic Bipolar Bissinger Medizintechnik GmbH Bipolar Micro-Coagulation Forceps (K172368). There are no differences between the devices which would raise new issues of safety or effectiveness. The Bipolar Micro-Coagulation Forceps is substantially equivalent to predicate device Bissinger Medizintechnik GmbH Bipolar Micro-Coagulation Forceps (K172368).
6. Non-Clinical and/or Clinical Tests Summary & Conclusions
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, and Factory Inspection Instruction for Disposable Endoscopic Bipolar, to conduct the performances bench tests, details please refer to Performance Bench Test Report; 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 Ex-vivo experimental study on Thermal Effects of Disposable Endoscopic Bipolar; Mechanical Strength (refer to Mechanical Strength Verification and Report,included in the EMC, Wireless, & EMT Documentation attachments).
Conclusion:
10
The subject device Disposable Endoscopic Bipolar has all features of the predicate device based on its intended use, The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.