(294 days)
The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure
The Single Use Micro Electrodes are the monopolar active device which consist of a conductive electrode tip, an insulated shaft and a conductive post.
The conductive electrode tip configuration includes micro needles, scalpel blade, ball, broadbent, wire, triangle loop, diamond loop and round loop.
The conductive electrode tip is the conductive portion of the electrode which delivers high frequency current onto a soft tissue for cutting and coagulation during an electro-surgery
The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material included Polyolefin and /or PTFE Shrink Wrap, overmold, in order to prevent accidental conduction of the electrosurgical current from this point to the patient.
The conductive post is used to pluq the electrode into the nozzle of an electrosurgical pencil from which it receives the electrical current. The diameter of the conductive post is available in 2.36mm and 1.6mm.
This device is used in conjunction with electrosurgical pencil, a compatible monopolar electrosurgical generator and patient grounding pad during electrosurgical procedure.
Based on the provided text, the device in question is a "Single Use Micro Electrode" used for electrosurgical cutting and coagulation. However, the document is a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices.
This document describes a device that is compared to predicate devices based on technological characteristics and performance testing data to establish substantial equivalence. It does NOT describe a study evaluating the performance of an AI/ML powered device, nor does it lay out explicit "acceptance criteria" in the sense of performance metrics typically used for AI/ML models (e.g., sensitivity, specificity, AUC).
Therefore, I cannot extract the information required by your prompt, as the prompt's questions are geared towards the evaluation of an AI-powered diagnostic or similar system, which is not what this document pertains to.
The document discusses:
- Performance Testing Data: "Operation Tests include comparative testing was performed on porcine tissue: kidney, liver, and muscle for both Cut mode and Coagulation mode. It demonstrates that the thermal effect and tissue stickiness on the tip of electrode are no significant difference between proposed device and predicate device."
- Safety and Biocompatibility testing data: Compliance with electrical safety standards (IEC60601-1, IEC60601-2-2) and biological tests (Intracutaneous Reactivity, In vitro Cytotoxicity, Skin sensitization) showing "No biological effect resulted."
These are typical tests for electrosurgical devices to prove safety and efficacy, not AI/ML model performance.
To directly answer your request based on the absence of the information in the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document discusses comparative testing results, noting "no significant difference" in thermal effect and tissue stickiness compared to predicate devices, and that safety tests showed "no biological effect." There are no quantitative acceptance criteria (like sensitivity/specificity targets) for an AI/ML model.
- Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for the "operation tests." It mentions "porcine tissue: kidney, liver, and muscle" but not the number of samples or animals.
- Data Provenance: Porcine tissue (animal study). No country of origin is specified for the tissue or the tests themselves, only that the company is located in Hong Kong, China.
- Retrospective or Prospective: The "operation tests" would be prospective as they were performed specifically for this submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML study requiring expert ground truth for imaging or diagnostic interpretation. The evaluation seems to be based on physical properties (thermal effect, tissue stickiness) and biological reactions.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Not an AI/ML study.
- 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-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance claims appears to be based on direct measurable effects (thermal effect, tissue stickiness) and standard biological safety assays.
- The sample size for the training set: Not applicable. There is no AI/ML model involved, hence no training set.
- How the ground truth for the training set was established: Not applicable. No training set.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, one behind the other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
Modern Medical Equipment Manufacturing Limited Mr. Samson Woo Quality Assurance Manager 35-41 Tai Lin Pai Rd., Unit F, 5th Fl. Gold King Ind. Bldg. Kwai Chung, N.T. Hong Kong, China
Re: K163442
Trade/Device Name: Single Use Micro Electrode (Brass with gold plated shaft and Stainless Steel shaft) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 14, 2017 Received: August 3, 2017
Dear Mr. Woo:
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 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
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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 (OS) 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, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
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) K163442
Device Name Single Use Micro Electrode
Indications for Use (Describe)
The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure
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,5th Fl., Gold King Ind. BldgKwai Chung, N.T. Hong Kong, China |
| Telephone: | 86 (768) 8897 8999 |
| Fax: | 86 (768) 8897 8666 |
| Contact person: | Samson Woo |
| Date of preparation: | 26 July, 2017 |
| 2. Device | |
| Name of Device: | Single Use Micro Electrode |
| Trade or proprietary name: | Single Use Micro Electrode |
| Common or usual name: | Single Use Micro Electrode |
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | GEI |
| Class: | II |
3. Device description
The Single Use Micro Electrodes are the monopolar active device which consist of a conductive electrode tip, an insulated shaft and a conductive post.
The conductive electrode tip configuration includes micro needles, scalpel blade, ball, broadbent, wire, triangle loop, diamond loop and round loop.
The conductive electrode tip is the conductive portion of the electrode which delivers high frequency current onto a soft tissue for cutting and coagulation during an electro-surgery
The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material included Polyolefin and /or PTFE Shrink Wrap, overmold, in order to prevent accidental conduction of the electrosurgical current from this point to the patient.
The conductive post is used to pluq the electrode into the nozzle of an electrosurgical pencil from which it receives the electrical current. The diameter of the conductive post is available in 2.36mm and 1.6mm.
This device is used in conjunction with electrosurgical pencil, a compatible monopolar electrosurgical generator and patient grounding pad during electrosurgical procedure.
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4. Intended use
The electrode is used to cut and / or coaqulate soft tissues by means of high frequency electrical current during an electrosurgical procedure
5. Predicate device
Ellman's Ace-Tip Electrodes with 510(k) number K071343. and Unimed's Needle Electrodes with 510(k) number K944265
6. Technological characteristic
The proposed Single Use Micro Electrode has equivalent construction and performance as the predicate devices. Different electrode tip configuration accommodate various procedural conditions. There are no new questions raised regarding to effectiveness and safety.
7. Substantial Equivalence
The technological characteristic in both proposed devices and predicate devices are identical. Moreover, performance testing data verified that operation result by using proposed device and predicate device shall be the same.
8. Performance Testing Data
Validation and Verification testing was performed on the device and its packaging.
Operation Tests include comparative testing was performed on porcine tissue: kidney, liver, and muscle for both Cut mode and Coagulation mode. It demonstrates that the thermal effect and tissue stickiness on the tip of electrode are no significant difference between proposed device and predicate device.
9. Safety and Biocompatibility testing data
Electrical Safety complies with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)
The proposed device is a external device that contact tissue/bone/dentin for a limited contact duration (less than 24 hours). No biological effect resulted in below three tests
- · Intracutaneous Reactivity
- In vitro Cytotoxicity .
- · Skin sensitization
10. Conclusion
Based on comparing technological characteristic and performance testing data, we believe that the proposed device, Single Use Micro Electrodes are substantial equivalence to predicate devices (K091672 and K944265).
§ 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.