(321 days)
The Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The Shinmed Various Model: of reusable Electro-Surgical Pencils, SW11100, SW11200, SW11202, SW11300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The cevice is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The SHINMED Various Models of Electro-Surgical Pencils used with a 510k-clearance generator are intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Not Found
The provided text is a 510(k) summary for SHINMED electrosurgical pencils. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use. However, it does not contain specific acceptance criteria, details of a performance study, or reported device performance metrics like sensitivity, specificity, or AUC, as would be expected for an AI/ML-driven medical device.
Therefore, many of the requested sections regarding acceptance criteria, study details, and performance metrics cannot be directly extracted from this document because it describes a traditional electrosurgical device, not an AI/ML system.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document is for an electrosurgical pencil, not an AI/ML device, and thus does not specify algorithmic performance metrics like sensitivity, specificity, or AUC against acceptance criteria. The "performance testing" mentioned is general validation for a medical device's function, not a specific study with AI-relevant metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This information is relevant for AI/ML device studies. The provided text doesn't describe a study with a "test set" in this context. It mentions "performance testing" to validate the device's function, but no details on sample size or data provenance in an AI/ML sense are given.
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)
- Cannot be provided. This information pertains to AI/ML model validation where ground truth is established for test data. The document describes an electrosurgical pencil, which doesn't involve such expert-driven ground truth establishment for its performance validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This is relevant for AI/ML model validation, particularly when experts interpret data to establish ground truth. This concept does not apply to the electrosurgical device described.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is specific to AI/ML systems where human readers interact with AI outputs. The document is for an electrosurgical pencil, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This applies to AI/ML algorithms. The device is a physical electrosurgical pencil.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. This is a concept related to evaluating AI/ML models against a reference standard. For an electrosurgical pencil, "ground truth" would relate to its physical and electrical performance in a lab setting, not a medical "ground truth" from patient data.
8. The sample size for the training set
- Cannot be provided. This information is pertinent to AI/ML model development. There is no concept of a "training set" for the electrosurgical pencils described.
9. How the ground truth for the training set was established
- Cannot be provided. Similar to the above, this is relevant for AI/ML model training. This document does not describe an AI/ML system.
Summary based on available information:
The provided 510(k) summary is for SHINMED various models of electrosurgical pencils (disposable models SW12200, SW12202, SW12300, and reusable models SW11100, SW11200, SW11202, SW11300).
The document states that the devices were compared to a legally marketed predicate device, the Gyrus PlasmaKinetic Superpulse System (510K No - K031085), with respect to intended use and technological characteristics.
Study Type:
The document mentions "performance testing has been done to validate the performance of the device." This implies traditional engineering and functional testing for a medical device to ensure it meets its intended specifications for cutting and coagulation, and hemostasis. However, no specific details about the methodology, sample sizes, or quantitative results of these performance tests are provided in this 510(k) summary. The focus of the 510(k) is to demonstrate substantial equivalence to a predicate device.
Conclusion:
This document details the submission for an electrosurgical pencil, a hardware medical device, and not an AI/ML-driven device. Therefore, the specific information requested, which is tailored for AI/ML performance evaluation (like acceptance criteria for AI metrics, test/training set details, expert ground truth establishment, MRMC studies, or standalone algorithm performance), is not present in the provided text. The "study" referenced is general performance validation for a hardware device against its functional requirements, rather than a clinical study evaluating diagnostic or prognostic accuracy of an algorithm.
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5. 510(K) SUMMARY
DISPOSABLE
SHINMED various models of Electro-Surgical Pencils, Models: SW12200, SW12202, SW12300
210K: KO33027
.
| Submitted by: | SHINING WORLD HEALTH CARE CO., LTD. | ||
|---|---|---|---|
| 6F, No.8, Lane 7, Wu-Chun Road, Wu-Ku Industrial | |||
| Park, Taipei, China (Taiwan) | |||
| Contact person: | Dr. Jen, Ke-Min | ||
| No.58, Fu-Chiun Street, Hsin-Chu City, Taiwan, R.O.C | |||
| Tel: 886-3-5208829 fax: 886-3-5209783 | |||
| E-mail: ceirs.jen@msa.hinet net | |||
| Date Summary Prepared: | September 20, 2003 | ||
| Name of the Device: | Device , Electrosurgical, Cutting & Coagulation &Accessories | ||
| Proprietary Name:Models: | SHINMED various models of electro-surgical pencilsSW12200, SW12202, SW12300 | ||
| Predicate Device: | Gyrus PlasmaKinetic Superpulse System(Generator & Accessories) | ||
| 510K No - K031085 |
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ge 2 of (4)
Statement of Intended Use: The Shinmed Various Models of Electro-Surgical Pencils. SW12200, SW12202, SW12300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Comparison to Predicate Devices: The Shinmed Various Model of Electro-Surgical Pencil, SW12200, SW12202, SW12300, have been carefully compared to legally marketed devices with to intended - use and - technological respect characteristics. In addition, performance testing has been done to validate the performance of the device. The comparison and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use.
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5. 510(K) SUMMARY
Page 3 of 4
SHINMED various models of reusable Electro-Surgical Percils, Models: SW11100, SW11200, SW11202, SW11300
510K: K033027
| Submitted by: | SHINING WORLD HEALTH CARE CO., LTD. |
|---|---|
| 6F, No. 8, Lane 7, Wu-Chun Road, Wu-Ku Industrial Park, | |
| Taipei, China (Taiwan) | |
| Contact person: | Dr. Jen, Ke-Min |
| No.58, Fu-Chiun Street, Hsin-Chu City, Taiwan, ROC | |
| Tel: 886-3-5208829 Fax: 886-3-5209783 | |
| E-mail ceirs.jen@msa.hinet.net | |
| Date Summary Prepared: | September 26, 2003 |
| Name of the Device: | Device, Electrosurgical, Cutting & Coagulation & Accessories |
| Proprietary Name: | SHINMED various models of reusable electro-surgical pencils |
| Models: | SW11100, SW11200, SW1202, SW11300 |
| Predicate Device: | Gyrus PlasmaKinetic Superpulse System (Generator & Accessories) |
| 510K No - K031085 |
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lage 4 °6 5
Statement of Intended Use: The Shinried Various Model: of reusable Electro-Surgical Pencils, SW11100, SW11200, SW11202, SW11300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The cevice is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
- Devices: The Shinmed Various Model of of reusable Comparison to Predicate Electro-Surgical Penci!, SW1100, SW11200, SW11202, SW11300 have been carefully compared to legally marketed devices with respect to intended use and technological churacteristics. In addition, performance testing has been done to validate the performance of the device. The comparisor. and validation results presented in this 510k notification to the FDA show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use.
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Image /page/4/Picture/1 description: The image is a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three stylized lines that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2004
Dr. Ke-Min Jen Shining World Health Care Co., LTD. No. 58. Fu-Chiun Street Hsin-Chu City, Taiwan, ROC
Re: K033027
KUJ3027
Trade/Device Name: SHINMED Various Disposable Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300, SW11100, SW11200, SW11202, SW11300 Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 14, 2004 Received: July 22, 2004
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaren be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to regary comment date of the Medical Device Amendments, or to commerce prior to may 20, 1978, the eccordance with the provisions of the Federal Food, Drug, de nees mat have been rollire approval of a premarket approval application (PMA). and Cosmetic (110. (110.) market the device, subject to the general controls provisions of the Act. The r ou may, mercerere, manies of the Act include requirements for annual registration, listing of general voltarely provisive, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to basil as a sublimations, Title 21, Parts 800 to 898. In addition, FDA may be found in the over 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 that I DT has made a actornmanations administered by other Federal agencies. You must or any I oderal statutes and states and the mot limited to: registration and listing (21 Comply with an the Her 811 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, labeling (21 CFR Part 820); and if applicable, the electronic forth in the quiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Dr. Jen, Ke-Min
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to oegin maine of substantial equivalence of your device to a legally premarket nothleation: "The PDF intelling of casion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice for your act 100 %. Also, please note the regulation entitled, a Colliation of Compullios as (est notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 2
4. INDICATIONS FOR USE STATEMENT
Shining World Health Care Co , I td Applicant 510(k) Number : _ TOBEASSIGNED KO33027 DISPOSABLE Device Name SHINMED Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300
Indications for Use :
- The Shinned Various Models of Electro-Surgical Fencils, SW12200, SW12202, ● SW12300 used with a 510k-clearance generator are intended for use for ablation, removal, resection and coagniation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
- The device is intended for use by qualified medical personnel trained in the use ● of electrosurgical equipment
Prescription Use Per 21 CFR 801.109
೧೯
Over-The-Counter (Optional Format 1-2 ५६)
(PLEASE DO NOT WRITE BELOW THIS - INE CONTINUE QA ANQUITY B PAGE IF MEEDED, Concurrence of CDRH Office of Nevice Evaluation (ODE)
Miriam C. Provost
Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number ko 33022
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Page 2 of 2
4. INDICATIONS FOR USE STATEMENT
| Applicant : | SHINING World Health Care Co., Ltd. |
|---|---|
| 510(k) Number : | K 033027 |
| Device Name : | SHINMED electrosurgical pencils, reusable models: (SW11100, SW11200, SW11202, SW11300 ); disposable models: (SW12200, SW12202, SW12300) |
Indications for Use :
- The SHINMED Various Models of Electro-Surgical Pencils used with a ● The DITANEE generator are intended for use for ablation, removal, Trok-citcal and coagulation of soft tissue and where associated hemostasis is resocion and the endoscopic and laparoscopic surgical procedures.
- The device is intended for use by qualified medical personnel trained in the ● use of electrosurgical equipment.
| Prescription Use | √ | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Miriam C. Provost
Division Sign-Off of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number K 633027
§ 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.