(88 days)
Not Found
No
The summary describes a standard electrosurgical accessory with suction and irrigation capabilities. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes.
The device is used for cutting and coagulation of tissue, which are therapeutic functions.
No
The device is described as an electrosurgical accessory intended for cutting, coagulation, suction, and irrigation of tissue, which are therapeutic and assistive functions during surgery, not diagnostic ones.
No
The device description explicitly lists multiple physical components (Electrode, External tube, Handle, Cable, etc.) and describes functions involving physical interaction with tissue (cutting, coagulation, suction, irrigation), indicating it is a hardware device with electrosurgical and fluid management capabilities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details components like electrodes, tubes, switches, and connectors, all consistent with a surgical electrosurgical accessory.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. The device's function is entirely focused on interacting with tissue in vivo (within the body) during surgery.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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 , 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.
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)
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
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.
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.
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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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
4
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: 086-0510-82833301 | |
| Fax: 086-0510-82833301 | |
| Contact Person: | Vincy Gao |
| chenll@haizemed.net |
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 ,
5
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 | ||
| Scientific Development | |||
| Co.,Ltd. | Sejong Medical Co., Ltd. | / | |
| Classification Name | Electrosurgical, cutting & | ||
| coagulation device & | |||
| accessories | Electrosurgical, cutting & | ||
| coagulation device & | |||
| 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 | ||
| 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 | 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 | Same |
6. Comparison of Technological Characteristics with the Predicate Device
6
| 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 |
| (After the assessment, | |||
| End-tip type does not | |||
| affect electrical safety or | |||
| performance.) | |||
| Handle Type | Pistol Type, Trumpet Type | Pistol Type, Trumpet Type | Same |
| Length | Function Tube | ||
| Length:190/335/435mm | Tip Length:37/48cm | Different | |
| (After the assessment, | |||
| End-tip type does not | |||
| affect electrical safety or | |||
| performance.) | |||
| Materials(Electrode) | Stainless steel | Stainless steel | Same |
| Sterilization | EO | EO | Same |
| Performance Test | Appearance, Dimension, | ||
| Leakage, Pressure | |||
| Resistance, Continuity, | |||
| Irrigation and Suction | |||
| Flow, Tensile Strength, | |||
| Electrical safety and | |||
| electromagnetic | |||
| compatibility (EMC) | Nominal size, Leakage, | ||
| Continuity, | |||
| Dielectric Strength Test | |||
| of Electrode cable, HF | |||
| Leakage current Test of | |||
| Electrode | |||
| cable, and Tensile | |||
| Strength Test of | |||
| Electrode cable | Equivalent | ||
| (The actual test results | |||
| 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
7
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.
8
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.