(14 days)
The devices are intended to cut and or coagulate soft biological tissue with gas-enhanced coagulation during general surgical procedures.
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.
The provided text is a 510(k) summary for the Soring GmbH CPC™ devices, an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the device itself against specific metrics.
Here's an analysis based on the information provided, highlighting what is present and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific, quantified acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) are provided in this document for the Soring GmbH CPC™ devices. The "Performance Data" section merely states that the devices use "standard data communications controls to detect errors" and comply with various electrical safety and electromagnetic compatibility standards. These are general compliance statements, not specific performance metrics against an intended clinical task.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None specified for clinical performance | None specified for clinical performance |
| Standard data communications controls to detect errors | Device uses standard data communications controls to detect errors |
| IEC 950 - Safety of Information Technology Equipment | Device complies with IEC 950 |
| CISPR 22, class A - Electromagnetic Compatibility | Device complies with CISPR 22, class A |
| IEC-801-2 - Electromagnetic Compatibility | Device complies with IEC-801-2 |
| IEC-801-3 - Electromagnetic Compatibility | Device complies with IEC-801-3 |
| IEEE 1003.1 - General Electrical Safety for medical devices | Device complies with IEEE 1003.1 |
| IEC 601-1 - Electrical Safety for medical devices using RF-power | Device complies with IEC 601-1 |
| IEC 601-2-2 - Special specifications for the safety of RF-surgery units | Device complies with IEC 601-2-2 |
2. Sample size used for the test set and the data provenance:
This information is not provided. The document does not describe a clinical or performance test set for evaluating the device's efficacy or safety against clinical outcomes. The performance data mentioned refers to compliance with electrical and safety standards, not a study involving human or animal subjects for clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Since there is no described performance test set requiring ground truth, there's no mention of experts or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. There is no described performance test set that would require an adjudication method.
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:
This information is not applicable/not provided. The Soring GmbH CPC™ device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. This device is a surgical instrument and requires human operation. It is not an algorithm, so a "standalone" algorithmic performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. As there's no described performance study for efficacy or clinical outcomes, there's no mention of ground truth types.
8. The sample size for the training set:
This information is not applicable/not provided. The device is an electrosurgical unit, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided. As above, no training set is relevant to this type of device.
Summary of the Study and Why it Meets Acceptance Criteria (as per the document):
The "study" described in the 510(k) summary is not a clinical performance study in the way one might typically expect for a diagnostic or AI device. Instead, the "study" is a demonstration of substantial equivalence to a predicate device based on:
- Identical Indications for Use: Both the Soring GmbH CPC™ devices and the predicate devices (Söring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, MBC) are "intended to cut and or coagulate soft biological tissue with gas-enhanced coagulation during general surgical procedures."
- Similar Technology: While the Soring GmbH CPC™ devices introduce "Cold plasma technology using Helium gas," the document emphasizes its function as an "Electrosurgical conductive gas coagulation" device, which aligns with the predicate's classification (Electrosurgical, Cutting & Coagulation & Accessories). The key difference highlighted is the gentler method and reduced side effects (lower penetration depth, reduced electrical strain on patient, less damage to underlying tissue) due to constant sine-shaped currents.
- Compliance with Recognized Standards: The devices comply with a list of international and industry standards for electrical safety and electromagnetic compatibility (IEC 950, CISPR 22, IEC-801-2, IEC-801-3, IEEE 1003.1, IEC 601-1, IEC 601-2-2). These standards serve as the de facto "acceptance criteria" for the safety and foundational performance aspects of such medical devices.
- No Control of Life-Sustaining Functions: Both the new and predicate devices "do not control any life sustaining functions or services," which simplifies the regulatory assessment by reducing the perceived risk level.
Conclusion stated in the document: "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."
The acceptance criteria for this 510(k) submission are implicitly met by demonstrating that the device:
- Has the same intended use as a legally marketed predicate device.
- Has similar technological characteristics.
- Complies with relevant electrical and safety standards.
- Does not raise new questions of safety or effectiveness.
The "study" that proves the device meets these (implied) acceptance criteria is the comparison to the predicate device and the declaration of compliance with the listed safety standards. The FDA's letter concurs with this determination of substantial equivalence, allowing the device to be marketed.
{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, ARCO1000, 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 -
§ 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.