(329 days)
No
The device description and performance studies focus on the physical properties and electrical performance of a simple electrode, with no mention of AI/ML capabilities or data processing.
Yes
The device is used to cut and coagulate tissue, which are therapeutic actions performed on the patient during surgical procedures.
No
Explanation: The device is described as being used to "cut and coagulate selected tissue for laparoscopic procedures," indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components (electrode tip, insulated shaft, conductive post) and its function involves delivering electrical current for cutting and coagulation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut and coagulate the selected tissue for laparoscopic procedures." This describes a surgical procedure performed directly on a patient's tissue in vivo (within the living body).
- Device Description: The description details a surgical electrode that delivers high-frequency current to tissue for cutting and coagulation. This is a surgical tool, not a device used to examine specimens in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are typically used in laboratories or point-of-care settings to diagnose diseases or conditions.
Therefore, this device is a surgical instrument used for therapeutic purposes during laparoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The electrode is used to cut and coagulate the selected tissue for laparoscopic procedures.
Product codes
GEI
Device Description
Disposable Laparoscopic Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or non-coated and the conductive post is either 2.36mm or 4mm. The conductive post is inserted into the electrode entry of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in laparoscopic procedure. During the operation, the electrode tip and the insulated shaft are to be inserted through a 5mm trocar. This device is used in conjunction with a compatible electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
selected tissue
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)
Validation and Verification testing was performed on the device and packaging. Simulation Tests include comparative testing was performed on porcine kidney, liver, and muscle for both Cut and Coagulation modes at 30W, 50W, and 100W output power. It demonstrates that the performance of device operation and result of eschar buildup on the tip of electrode are no significant difference between proposed device and predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Megadyne E-Z Clean Disposable Laparoscopic Electrodes (K913281), Modern Medical Equipment Mfg. Ltd. - Laparoscopic Instrument, Electrode and Cable (K032965)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2014
Modern Medical Equipment Manufacturing Limited Mr. Thomas Chan Tsz Fung Regulatory Supervisor 35-41 Tai Lin Pai Road, Unit F 5th Floor, Gold King Ind. Building Kwai Chung, N.T. Hong Kong, China
Re: K134006
Trade/Device Name: Disposable Laparascopic Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 20, 2014
Received: October 27, 2014
Dear Mr. Chan:
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. 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
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K134006
Device Name Disposable Laparoscopic Electrode
Indications for Use (Describe)
The electrode is used to cut and coagulate the selected tissue for laparoscopic 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)
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1. 510(k) Owner
| Name: | Modern Medical Equipment Manufacturing Limited |
|---|---|
| Address: | Modern Medical Equipment Mfg., Ltd. |
| 35-41 Tai Lin Pai Rd., Unit F, | |
| 4th Fl., Gold King Ind. Bldg | |
| Kwai Chung, N.T. Hong Kong, China | |
| Telephone: | (852) 2420 9068 |
| Fax: | (852) 2481 1234 |
| Contact person: | Thomas, Chan Tsz Fung |
Date of preparation: Oct 20 2014
2. Device
| Name of Device: | Disposable Laparoscopic electrode |
|---|---|
| Trade or proprietary name: | Disposable Laparoscopic electrode |
| Common or usual name: | Disposable Laparoscopic electrode |
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | GEI |
| Class: | II |
3. Device description
Disposable Laparoscopic Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or non-coated and the conductive post is either 2.36mm or 4mm. The conductive post is inserted into the electrode entry of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in laparoscopic procedure. During the operation, the electrode tip and the insulated shaft are to be inserted through a 5mm trocar. This device is used in conjunction with a compatible electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.
4. Intended use
The electrode is used to cut and coaqulate the selected tissue for laparoscopic procedures.
5. Predicate device
Megadyne E-Z Clean Disposable Laparoscopic Electrodes (K913281)
Modern Medical Equipment Mfg. Ltd. - Laparoscopic Instrument, Electrode and Cable (K032965)
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6. Technological characteristic
The proposed disposable laparoscopic electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or coated or non-coated stainless steel. The coated electrode eliminated the needs of using tip polisher to remove the eschar. The diameter of the conductive post is available in 1.6mm or 2.36mm.The conductive electrode tip is the conductive portion of the electrode which has 11 tip styles, delivers high frequency current onto a target tissue for cutting and/or coagulation during an electro-surgery. The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material to prevent accidental conduction of the electrosurgical current from this point to the patient. The conductive post is used to plug the electrode into the nose of an electrosurgical pencil from which it receives the electrical current.
The construction of proposed electrode and the predicted device is identical although the only differences are the coating of electrode tip and the diameter of conductive post. The predicate device only is available one type of tip finishing: coated or non-coated stainless steel and its conductive post is only 2.36mm. However, these differences are not significantly to change mechanism of operation. There are no new questions raised regarding to effectiveness and safety.
7. Substantial Equivalence
The technological characteristic in both proposed device and predicate device is identical. Moreover, performance testing data show that operation result by using posed device and predicate device shall be the same.
8. Performance Testing Data
Validation and Verification testing was performed on the device and packaging.
Simulation Tests include comparative testing was performed on porcine kidney, liver, and muscle for both Cut and Coagulation modes at 30W, 50W, and 100W output power. It demonstrates that the performance of device operation and result of eschar buildup on the tip of electrode are no significant difference between proposed device and predicate device.
9. Safety and Biocompatibility testing data
Testing was performed to comply with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)
EO and ECH residue test was performed in accordance to ISO10993-7 Biological
5
evaluation of medical devices-Part 7: Ethylene oxide sterilization residualsafter ETO sterilization to demonstrate no residue on the patient contact portion of device after aeration.
The following Biocompatibility tests were performed in accordance to ISO10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- Intracutaneous Reactivity Test
- In vitro Cytotoxicity Test
- · Acute Systemic Toxicity Test
- Skin sensitization tests
- In Vitro Hemolysis Study
10. Conclusion
Based on comparing technological characteristic and performance testing data, we believe the proposed device, disposable laparoscopic electrode is substantial equivalence to predicate device.