(14 days)
Not Found
No
The summary describes a standard RF surgery device with cold plasma technology. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies. The performance studies focus on electrical safety and electromagnetic compatibility, not algorithmic performance.
Yes
The device is intended to cut and or coagulate soft biological tissue during general surgical procedures, which are therapeutic actions.
No
The device is described as a surgical tool intended to cut and coagulate soft biological tissue, not to diagnose conditions.
No
The device description clearly details the use of RF energy and cold plasma technology with Helium gas for cutting and coagulating tissue, which are hardware-based functionalities. The summary also mentions compliance with standards related to electrical safety and RF power for medical devices, further indicating a hardware component.
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 or coagulate soft biological tissue with gas-enhanced coagulation during general surgical procedures." This describes a surgical tool used directly on the patient's tissue, not a device used to examine samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The description details how the device uses RF energy and cold plasma technology to interact with tissue for cutting and coagulation. This is a description of a surgical procedure, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The devices are intended to cut and or coagulate soft biological tissue with gasenhanced coagulation during general surgical procedures. Typical users of this system are trained medical professionals.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
During the use of RF surgery devices, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts. Lower RF-voltages (below 150veff) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coagulation.
Cold plasma technology using Helium gas is a very gentle method for coagulating or dissecting specific types of tissue. In contrast to conventional RF surgery, the penetration depth related to tissue damage and the electrical strain on the patient are significantly reduced (no electrical current flowing through the patient). The significantly lower peak current value (as compared to conventional spray coagulation) results in far less damage to tissue lavers immediately beneath the treatment area because constant sine-shaped currents are used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft biological tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals / general surgical procedures
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)
The Soring GmbH CPC™ devices and predicate devices both use standard data communications controls to detect errors. Both devices comply with IEC 950 -Safety of Information Technology Equipment, CISPR 22, class A -Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility, IEEE 1003.1 - General Electrical Safety for medical devices, IEC 601-1 -Electrical Safety for medical devices using RF-power, IEC 601-2-2 -Special specifications for the safety of RF-surgery units
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
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Date Prepared:
28 December 28, 2002
Submitter's Information:
Soring GmbH Medizintechnik Justus-v. Liebig 10 25451 Quickborn Germany
Trade Name, Common Name, Classification:
| Trade name: | Soring GmbH CPC™ devices |
|---|---|
| Common name: | Electrosurgical conductive gas coagulation |
| Classification name: | 878.4400 - Device, Electrosurgical, Cutting & |
| Coagulation & Accessories |
Predicate Device:
| Name: | Söring GmbH, ARCO 3000, ARCO 2000, ARCO
1000, MBC |
|-------------------|----------------------------------------------------------------------------|
| 510(k) Number | K993265 |
| Regulation Number | 878.4400 - Device, Electrosurgical, Cutting &
Coagulation & Accessories |
| Product Code | GEI |
| Decision Date | 10/22/1999 |
Device Description:
During the use of RF surgery devices, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts. Lower RF-voltages (below 150veff) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coagulation.
Cold plasma technology using Helium gas is a very gentle method for coagulating or dissecting specific types of tissue. In contrast to conventional RF surgery, the penetration depth related to tissue damage and the electrical strain on the patient are significantly reduced (no electrical current flowing through the patient). The significantly lower peak current value (as compared to conventional spray coagulation) results in far less damage to tissue lavers immediately beneath the treatment area because constant sine-shaped currents are used.
1
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Indications for Use:
The devices are intended to cut and or coagulate soft biological tissue with gasenhanced coagulation during general surgical procedures. Typical users of this system are trained medical professionals.
Performance Data:
The Soring GmbH CPC™ devices and predicate devices both use standard data communications controls to detect errors. Both devices comply with IEC 950 -Safety of Information Technology Equipment, CISPR 22, class A -Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility, IEEE 1003.1 - General Electrical Safety for medical devices, IEC 601-1 -Electrical Safety for medical devices using RF-power, IEC 601-2-2 -Special specifications for the safety of RF-surgery units
Conclusion:
Similar to the prodicate device, the Soring GmbH CPC™ devices do not control any life sustaining functions or services. The new devices and the predicate devices share the same conformance to performance standards and both function as RF surgery units. Based on the information supplied in this 510(k), we conclude that the subject devices are safe, effective, and substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them, resembling a bird in flight.
Public Health Service
JAN 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Soring GmbH Medizintechnik c/o Mr. Carl Alletto President Delta Quality Consulting 1100 Lakeview Boulevard Denton, Texas 76208
Re: K030028
Trade Name: Soring GmbH CPCTM Devices Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: January 3, 2002 Received: January 3, 2002
Dear Mr. Alletto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
3
Page 2 - Mr. Carl Alletto
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
(col 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
4
Page 1 of -1
510(k) Number:
Device Name: Soring, CPC™ devices
Indications for Use:
The devices are intended to cut and or coagulate soft biological tissue with gas-enhanced coagulation during surgical procedures.
Typical users of this system are trained medical professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﺎ (Per 21 CFR 801.109)
Over -The-Counter Use _
(Optional Format 1-2-96)
Musiam C. Provost
ision Sign-Off) Division of General, Restorative and Neurological Devices
K630028 510(k) Number -