(108 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven learning components. The device is described as an RF generator for coagulation, which is a standard electrosurgical technique.
Yes
The device is indicated for "coagulation of soft tissue," which is a medical procedure aimed at treating or modifying biological tissue, fitting the description of a therapeutic device.
No
Explanation: The device is indicated for "coagulation of soft tissue," which is a therapeutic function, not a diagnostic one. It generates radiofrequency energy for surgical applications, not for detecting or identifying medical conditions.
No
The device description explicitly states "MSI S-500 RF Generator," which is a hardware component used for electrosurgery. The intended use also describes "coagulation of soft tissue," which is a physical action performed by 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 "coagulation of soft tissue." This is a therapeutic procedure performed directly on a patient's body, not a diagnostic test performed on a sample outside the body.
- Device Description: The device is an "RF Generator," which is a type of electrosurgical equipment used for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. This device's function is to perform a surgical action (coagulation) on tissue.
N/A
Intended Use / Indications for Use
MSI S-500 RF Generator is intended for coagulation of soft tissue. These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
MSI S-500 RF Generator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgery.
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)
Performance testing was done to validate its intended use. The comparison and performance testing results in this 510(k) notification shows MSI S-500 RF Generator is substantially equivalent to predicate device and is safe and effective in its intended use.
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
APR - 2 2004
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:
December 12, 2003
Name of the Device:
Trade / Proprietary Name: MSI S-500 RF Generator
Common / usual Name: Electrosurgical Generator and Accessories
- Classification Name: Electrosurgical cutting and coagulation device (21CFR878.4400)
Predicate Devices:
Somnus Model 225 Electro Surgical Generator (K963772)
Description:
MSI S-500 RF Generator
Statement of Intended Use:
MSI S-500 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-500 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-500 RF Generator is substantially equivalent to predicate device and is safe and effective in its intended use.
1
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized lines forming the body and wings.
APR = 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eric Kao Vice President of Quality and Regulatory Affairs Medsphere International, Inc. 48511 Warm Springs Boulevard, Suite 212 Fremont, California 94539
Re: K033888
Trade/Device Name: MSI S-500 RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 2, 2004 Received: March 4, 2004
Dear Mr. Kao:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
2
Page 2 - Mr. Eric Kao
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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
3
Section D - Statement of Indications for Use
K 033 888
.
Indications for Use
| Applicant: | MedSphere International, Inc. |
|---|---|
| 48511 Warm Springs Blvd., Suite 212, Fremont, CA 94539 | |
| 510(k) Number (if known): | |
| Device Name: | MSI S-500 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. | |
| (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 | K6 33888 |
| Prescription Use | ✓ |
| OR Over-the-Counter Use | |
| (Per 21 CFR 801.109) | |
| (Optional format 1-2-06) |
.