(14 days)
Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
MSI S-500L RF Generator
This 510(k) submission (K041980) for the MSI S-500L RF Generator provides limited information regarding specific acceptance criteria and study details. The document focuses on demonstrating substantial equivalence to a predicate device through general performance testing rather than providing detailed quantitative acceptance criteria and a standalone clinical study report.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "Performance testing was done to validate its intended use." However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for the MSI S-500L RF Generator. The evaluation primarily relies on comparison to a predicate device.
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/algorithm-based device for which this information would typically be relevant. This is an electrosurgical generator, and "performance testing" usually refers to bench testing, electrical safety, electromagnetic compatibility, and functional verification, not clinical data sets in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/algorithm-based device and no clinical "ground truth" establishment by experts is described in the provided text.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is not an AI-assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for an electrosurgical generator's performance would likely be based on established engineering standards, electrical performance specifications, and safety benchmarks, not clinical ground truth in the context of imaging or diagnostics.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information:
- Acceptance Criteria & Performance: Not explicitly detailed in quantitative terms. The submission states that "Performance testing was done to validate its intended use" and that "The comparison and performance testing results in this 510(k) notification shows MSI S-500L RF Generator is substantially equivalent to predicate device and is safe and effective in its intended use." This implies that the device's performance met the general expectations for such a device, in line with its predicate.
- Study Type: No large-scale clinical study with a "test set" in the typical sense of AI/diagnostic device evaluation is described. The focus is on demonstrating substantial equivalence to a predicate device (MSI S-500 RF Generator K033888) through engineering and functional performance testing.
- Device Type: Electrosurgical Generator, not an AI/ML-based device. Therefore, many of the requested criteria (test set, ground truth, experts, MRMC studies, training set) typically apply to AI algorithms or diagnostic devices and are not relevant or addressed in this document.
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K041980
Section E - 510(k) Summary
Submitted by:
MedSphere International, Inc.
48511 Warm Springs Blvd., Suite 212, Fremont, CA 94539
Fax: 510-656-8816 Tel: 510-656-8232
Contact Person:
Eric Kao, Vice President of Quality and Regulatory Affairs
Date Summary Prepared:
July 22, 2004
Name of the Device:
Trade / Proprietary Name: MSI S-500L RF Generator
Common / usual Name: Electrosurgical Generator and Accessories
Classification Name: Electrosurgical cutting and coagulation device (21CFR878.4400)
Predicate Devices:
MSI S-500 RF Generator (K033888)
Description:
MSI S-500L RF Generator
Statement of Intended Use:
MSI S-500L RF Generator is intended for coagulation of soft tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
MSI S-500L RF Generator has been compared to previously 510(k) cleared device with respect to intended use and technological characteristics. Performance testing was done to validate its intended use. The comparison and performance testing results in this 510(k) notification shows MSI S-500L RF Generator is substantially equivalent to predicate device and is safe and effective in its intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
Mr. Eric Kao Vice President of Quality and Regulatory Affairs MedSphere International, Inc. 48511 Warm Springs Boulevard, Suite 212 Fremont, California 94539
Re: K041980
Trade/Device Name: MSI S-500L RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 22, 2004 Received: July 23, 2004
Dear Mr. Kao:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard change the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been rechasined in assee approval of a premarket approval application (PMA). allu Cosmetic 71ct (71ct) that do not see subject to the general controls provisions of the Act. The 1 ou may, dicierore, market are act recessful and requirements for annual registration, listing of general controls provisions practice, 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 is clusion (sovated with be major regulations affecting your device can Inay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dr F 5 rocames a vour device complies with other requirements of the Act that I DA has made a determentlations administered by other Federal agencies. You must of any ireactal statutes and regulations and limited to: registration and listing (21 Comply with an the Act 810 cart 801); good manufacturing practice requirements as set CFR in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic fordt in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Eric Kao
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you'ls ough finding of substantial equivalence of your device to a legally premaired notincation. The PDF Imaling or castion 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 If you desire specific arrious. Jose (301) 594-4659. Also, please note the regulation entitled, Comact the Office of Commarket 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 your response 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
fa Cclia 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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Section D - Statement of Indications for Use
Indications for Use
| Applicant: | MedSphere International, Inc.48511 Warm Springs Blvd., Suite 212Fremont, CA 94539 |
|---|---|
| 510(k) Number (if known): | K041980 |
| Device Name: | MSI S-500L RF Generator |
| Indications For Use: | Indicated for coagulation of soft tissue |
| These devices are intended for use by qualified medical personnel trained in the use of electrosurgery. | |
| Prescription Use | X OR Over-the-Counter Use |
| (Per 21 CFR 801.109) | |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED) | |
| (Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Miriam C. Provost (Division Sign-Off) Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K041980 |
| (Optional format 1-2-06) |
§ 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.