(183 days)
Disposable Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.
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.
This is a 510(k) summary for a medical device, specifically Disposable Bipolar Forceps. It describes the device, its intended use, and its comparison to a predicate device to demonstrate substantial equivalence to the FDA.
The document does not describe an acceptance criteria table or specific study results to prove a device meets acceptance criteria in the way typically expected for a diagnostic AI/ML device.
Instead, this 510(k) pertains to a physical medical device (electrosurgical forceps) and its acceptance criteria are primarily met through non-clinical testing to demonstrate performance, safety, and substantial equivalence to a legally marketed predicate device. The "acceptance criteria" here are essentially compliance with recognized standards and demonstration of comparable performance to the predicate device.
Here's an attempt to answer your questions based on the provided text, acknowledging that the format of the "acceptance criteria" and "study that proves the device meets the acceptance criteria" will not align with a diagnostic AI/ML context:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this physical medical device are derived from compliance with recognized industry standards and demonstration of comparable performance to the predicate device. The document does not present a formal "acceptance criteria table" with numerical targets as might be seen for a diagnostic device's sensitivity/specificity. Instead, it lists the types of tests performed and implies that the results met the requirements of these standards and showed equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from Text) |
|---|---|
| Electrical Safety | Evaluated according to recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. (Implied: Passed these standards, demonstrating safe electrical operation). |
| Electromagnetic Compatibility (EMC) | Evaluated according to recognized standards (listed as "EMC"). (Implied: Passed these standards). |
| Biocompatibility | Evaluated through: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute systemic toxicity test, Pyrogenicity test. (Implied: Passed these tests, demonstrating materials are biocompatible). |
| Sterility | Demonstrated (device is sold sterile). Sterilization Method: Ethylene oxide. (Implied: Achieves and maintains sterility as required). |
| Thermal Effects (Coagulation Performance) | Ex-vivo experimental study on Thermal Effects was conducted following the "Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff." (Implied: Demonstrated effective and safe coagulation comparable to the predicate device per guidance). |
| Mechanical Strength | Tested. (Implied: Demonstrated sufficient mechanical integrity for intended use). |
| Shelf Life | Established as 3 years. (Implied: Device maintains performance and safety for this duration). |
| Packaging Integrity | Packaging: Rigid PETG Tray, Tyvek lid. (Implied: Packaging is suitable for maintaining sterility and device integrity). |
| Substantial Equivalence to Predicate | "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." ("The subject device Disposable Bipolar Forceps is similar by technological specifications and intended use to the predicate device.") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the context of diagnostic performance. For the described non-clinical tests (electrical safety, biocompatibility, mechanical strength), the "sample size" would refer to the number of device units tested according to the specific testing protocols for those standards. This information is not detailed in the summary.
- Data Provenance: The studies are described as "Ex-vivo experimental study on Thermal Effects" and other non-clinical tests. This indicates laboratory testing, not human subject data from a specific country or retrospective/prospective clinical data.
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 is not applicable as the device is a physical electrosurgical tool, not an AI/ML diagnostic system requiring expert interpretation for ground truth. The "ground truth" for performance is established by objective measurements against engineering specifications and validated test methods (e.g., measuring current leakage, tissue temperature changes, mechanical force).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of physical medical device and its non-clinical testing. Adjudication methods are typically relevant for human interpretation in diagnostic studies.
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. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described:
- Electrical Safety & EMC: Ground truth is defined by the passing criteria of the referenced IEC standards.
- Biocompatibility: Ground truth is defined by the absence of toxicity, sensitization, or reactivity as measured by specific cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity assays.
- Thermal Effects: Ground truth relates to measurable tissue changes (e.g., temperature, coagulation effect) produced by the device in ex-vivo experimental settings, evaluated against established scientific principles and potentially in comparison to the predicate device's known effects.
- Mechanical Strength: Ground truth is defined by resistance to breakage or deformation under specified forces/stresses.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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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"
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(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
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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)
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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
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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
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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
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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 ofComparison | Subject Device | Predicate Device |
|---|---|---|
| Company | Jiangsu Hope BiomedicalScience&TechnologyCo.,Ltd. | Synergetics, Inc. |
1)General Comparison
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| Device Name | Disposable Bipolar Forceps | Synergetics DisposableSpetzler-Mails StandardBipolar Forceps |
|---|---|---|
| Model | ZKN-3CWZ | Disposable Spetzler-MalisStandard 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 Forcepsare single use devices soldsterile and are intended foruse in electrosurgery forcoagulation of tissue. | The Synergetics DisposableSpetzler-Mails StandardBipolar Forceps are single usedevices sold sterile and areintended for use inelectrosurgery for coagulationof 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 SafetyTesting | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 |
| Biocompatibility | CytotoxicitySensitizationIntracutaneous ReactivityAcute systemic toxicity testPyrogenicity test | Biocompatible Silver platedAluminum base with PVDFinsulation |
| Sterility | Yes | Yes |
| SterilizationMethod | Ethylene oxide | Ethylene oxide |
| Shelf Life | 3 years | 5years |
| Packaging | Rigid PETG Tray, Tyvek lid | Rigid PETG Tray, Tyvek lid |
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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.
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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.
§ 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.