Victan

K230593 · Jiangsu Haize Medical Scientific Development Co., Ltd. · GEI · May 30, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230593
• Device Name: Victan
• Applicant: Jiangsu Haize Medical Scientific Development Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Victan is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.

Device Story

Victan is a sterile, single-patient-use electrosurgical accessory; functions as a conduit for high-frequency (HF) electrical current from an external generator to tissue for cutting and coagulation; provides integrated suction and irrigation capabilities via connection to a negative pressure drainage device. Device components include electrode, external tube, irrigation/suction tubes, control buttons, rotator, handle, and connectors. Operated by clinicians in surgical settings; requires HF generator with nominal frequency between 300 kHz and 3 MHz. Output is controlled by the surgeon to perform tissue manipulation and site maintenance. Benefits include combined electrosurgical and fluid management functionality in a single sterile device.

Clinical Evidence

No clinical data or animal studies were provided. Substantial equivalence is supported by bench testing, including appearance, dimension, leakage, pressure resistance, continuity, irrigation/suction flow, and tensile strength. Biocompatibility was evaluated per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity). Electrical safety and EMC testing were performed per IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2.

Technological Characteristics

Monopolar electrosurgical accessory; stainless steel electrode; pistol or trumpet-style handle; EO sterilized (3-year shelf life). Operates with HF generators (300 kHz–3 MHz). Complies with IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2. No software or algorithm components.

Indications for Use

Indicated for use as a sterile, single-patient-use electrosurgical accessory for cutting and coagulation of tissue and/or providing suction and irrigation functions at the surgical site.

Regulatory Classification

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.

Predicate Devices

• LAP-iX (K173112)

Submission Summary (Full Text)

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May 30, 2023

Jiangsu Haize Medical Scientific Development Co., Ltd. Vincy Gao RA No.99, Furongzhongsan Road, Xishan Economical Development Zone Wuxi, Jiangsu 214000 China

Re: K230593

Trade/Device Name: Victan Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: May 9, 2023 Received: May 9, 2023

Dear Vincy Gao:

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

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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 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Mark Trumbore -S. The date of the signature is 2023.05.30. The time of the signature is 10:01:30 -04'00'.

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

Enclosure

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### Indications for Use

510(k) Number (if known) K230593

Device Name Victan

Indications for Use (Describe)

Victan is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.

| 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)

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### 510(K) Summary

### Single Use Surgical Electrocoagulator

| Compiled by: | Vincy Gao |
|--------------|--------------|
| Date: | 2023.01.02 |
| Reviewed by: | Zhang Rong |
| Date: | 2023.01.16 |
| Approved by: | Qian Jianmin |
| Date: | 2023.02.15 |

### Jiangsu Haize Medical Scientific Development Co.,Ltd

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### 510(k) Summary

#### 1. Submitter Information

| Applicant/Submitter: | Jiangsu Haize Medical Scientific Development Co.,Ltd. |
|----------------------|-------------------------------------------------------|
| | No.99, Furongzhongsan Road, Xishan Economical |
| | Development Zone, Wuxi, Jiangsu, China |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Vincy Gao |
| | [e-mail] |

#### 2. Device

| Trade Name | Victan |
|---------------------|-------------------------------------------------------------|
| Common Name | Single Use Surgical Electrocoagulator |
| Classification Name | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number | 21 CFR 878.4400 |
| Device Class | Class II |
| Product Code | GEI |
| 510(K) Number | K230593 |

#### 3. Predicate Device

| Manufacturer | Product Name | 510(K) Number |
|--------------------------|--------------|---------------|
| Sejong Medical Co., Ltd. | LAP-iX | K173112 |

#### 4. Device Description

The Single Use Surgical Electrocoagulator is a sterile, single-patient-use electrosurgical accessory, and deliver electrical current from high-frequency generator to the surgical site. At the same time ,

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the product can also provides suction or irrigation by connecting to a negative pressure drainage device. The proposed product consists of Electrode, External tube, Irrigation and suction tube, External tube control button, Rotator, Irrigation switch, Suction switch, Handle, Suction connecting tube, Suction connector, Irrigation connector, Cable, Irrigation connecting tube, Outer tube.

Single Use Surgical Electrocoagulator should be operated with HF generators having a nominal frequency of the HF voltage between 300 kHz and 3 MHz. Lower frequencies may cause nerve stimulation and thus uncontrolled convulsion. In case of higher frequencies, user/patient safety cannot be guaranteed because insulation may heat up so that dielectric strength is no longer given. All equipment conforming to this specs can be used.

The product was sterilized by EO. The valid period of sterilization was 3 years.

#### 5. Indications for Use

Single Use Surgical Electrocoagulator is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.

| Item | Proposed Device | Predicate Device | Equivalence |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Trade Name | Victan | LAP-iX | / |
| Manufacturer | Jiangsu Haize Medical<br>Scientific Development<br>Co.,Ltd. | Sejong Medical Co., Ltd. | / |
| Classification Name | Electrosurgical, cutting &<br>coagulation device &<br>accessories | Electrosurgical, cutting &<br>coagulation device &<br>accessories | Same |
| 510(K) Number | K230593 | K173112 | / |
| Device Class | Class II | Class II | Same |
| Product Code | GEI | GEI | Same |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Indications for Use | Single Use Surgical<br>Electrocoagulator is a<br>sterile, single-patient-use<br>electrosurgical accessory<br>intended to conduct<br>electrosurgical current<br>for cutting and<br>coagulation of tissue<br>and/or to provide suction<br>and irrigation functions | Single Use Surgical<br>Electrocoagulator is a<br>sterile, single-patient-use<br>electrosurgical accessory<br>intended to conduct<br>electrosurgical current<br>for cutting and<br>coagulation of tissue<br>and/or to provide suction<br>and irrigation functions | Same |

#### 6. Comparison of Technological Characteristics with the Predicate Device

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| | to the surgical site. | to the surgical site. | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Energy Type | Radiofrequency | Radiofrequency | Same |
| Electrode Type | Monopolar | Monopolar | Same |
| End-tip Type | Angle, Spade, Hook, Needle | L-hook,Spoon | Different<br>(After the assessment,<br>End-tip type does not<br>affect electrical safety or<br>performance.) |
| Handle Type | Pistol Type, Trumpet Type | Pistol Type, Trumpet Type | Same |
| Length | Function Tube<br>Length:190/335/435mm | Tip Length:37/48cm | Different<br>(After the assessment,<br>End-tip type does not<br>affect electrical safety or<br>performance.) |
| Materials(Electrode) | Stainless steel | Stainless steel | Same |
| Sterilization | EO | EO | Same |
| Performance Test | Appearance, Dimension,<br>Leakage, Pressure<br>Resistance, Continuity,<br>Irrigation and Suction<br>Flow, Tensile Strength,<br>Electrical safety and<br>electromagnetic<br>compatibility (EMC) | Nominal size, Leakage,<br>Continuity,<br>Dielectric Strength Test<br>of Electrode cable, HF<br>Leakage current Test of<br>Electrode<br>cable, and Tensile<br>Strength Test of<br>Electrode cable | Equivalent<br>(The actual test results<br>are the same.) |

#### 7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

#### 7.1. Biocompatibility

The device has been evaluated for its biological safety according to ISO10993-1 Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk Management Process. Following endpoints have assessed during the evaluation:

- * Cytotoxicity
- * Sensitization
- * Intracutaneous Reactivity
- * Acute Systemic Toxicity
- * Material-Mediated Pyrogenicity

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#### 7.2. Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Single Use Surgical Electrocoagulator. The subject device complies with relevant clauses of the IEC 60601-1, IEC-60601-2-2 standards for safety and the IEC 60601-1-2 for EMC.

#### 7.3. Sterilization

The subject device and the predicate device are sterilized via Ethylene Oxide; both devices are sterilized to the same sterility assurance level.

#### 7.4. Shelf-life

Accelerated Aging testing confirmed that the expiration date of subject device is 3 year from the manufacturing date.

#### 7.5. Bench Testing

Haize Medical conducted bench testing to ensure that the design of Single Use Electrocoagulator applicable the specifications and that the product is safety and effective in use.

Test included:

- Appearance
- Dimension
- Leakage ●
- Pressure Resistance
- Continuity
- Irrigation and Suction Flow
- Tensile Strength

#### 7.6. Animal Study

This premarket notification does not rely on preclinical animal testing to demonstrate substantial equivalence.

#### 7.7. Clinical Study

This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.

#### 8. Substantial Equivalence

The subject and predicate device have the same fundamental technology and indications for use. The performance, dimensions and materials of the subject device are similar to the predicate device. Although there some minor differences with each product, these differences between the subject device and the predicate device do not raise new or different questions of safety and efficacy. There is no new technology and no difference that would raise new or different questions of safety or efficacy.

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#### 9. Conclusion

The subject device are identical in intend use, indications and technology compared to the predicate device. The results of the test demonstrate that the subject devices do not raise new questions of safety and effectiveness and are substantially equivalent to the predicate devices.