(99 days)
Not Found
No
The document describes a surgical ultrasonic dissector and its functionalities (cutting, irrigating, suctioning). There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation. The performance studies focus on electrical safety and electromagnetic compatibility, not algorithmic performance.
No
The device is used for surgical procedures such as dissection, fragmenting, emulsifying, and aspiration of human tissue, which are procedures performed to treat or manage disease or injury, but it is not intended to treat, diagnose or prevent a disease, injury or condition.
No
The SONOCA 300 is described as an instrument for surgical procedures like dissection, fragmenting, emulsifying, and aspiration of human tissue, and it is explicitly stated that it is "not an alternative to conventional surgery but a supplementary tool for the selective dissection of human tissue." These functions are therapeutic, not diagnostic.
No
The device description clearly indicates it is a physical instrument with a vibrating probe tip, aspiration/irrigation function, and is used for surgical dissection, fragmenting, emulsifying, and aspiration of human tissue. This is a hardware device, not software only.
Based on the provided information, the SONOCA 300 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the SONOCA 300 is an instrument for "selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery." This describes a surgical tool used on the patient during a procedure.
- Device Description: The description reinforces this by explaining how the device works by transmitting power to tissue and collecting fragments. It explicitly states it's a "supplementary tool for the selective dissection of human tissue."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The SONOCA 300 does not perform this function. It is used directly on the patient's tissue during surgery.
Therefore, the SONOCA 300 is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.
Product codes (comma separated list FDA assigned to the subject device)
LFL, BTA
Device Description
SONOCA 300 is an upgraded version of the SONOCA III having K9942095.
During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.
The SONOCA 300 is not an alternative to conventional surgery but a supplementary tool for the selective dissection of human tissue.
Where as the scalpel and other methods of cutting are basically limited to cutting tissue. The SONOCA 300 can be used to cut, irrigate, and suction at the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human tissue (where multi-medical discipline surgery is performed).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Similar to the predicate device, the Sonoca 300 does not control any life sustaining functions or services. The device and the predicate device share the same conformance to performance standards and both function as Ultrasonic Dissectors. Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.
The subject device complies 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 - Ultrasonic surgical devices, DIN EN 61847.
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
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
992026
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Date Prepared:
17 July 1999
Submitter's Information:
Soring GmbH Medizintechnik Justus-v.Liebig 10 25451 Quickborn Germany
Telephone: 49 4106-5055 Fax: 49 4106-5271 Email: info@soering.com
Trade Name, Common Name, Classification:
| Trade Name: | Sonoca 300 |
|---|---|
| Common Name: | Instrument, Ultrasonic Surgical |
| Classification Name: | General & Plastic Surgery |
Predicate Device:
| Applicant: | Söring GmbH |
|---|---|
| 510(k) Number: | K942095 |
| Device: | Sonoca III |
Device Description:
SONOCA 300 is an upgraded version of the SONOCA III having K9942095.
During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.
The SONOCA 300 is not an alternative to conventional surgery but a supplementary tool for the selective dissection of human tissue.
Where as the scalpel and other methods of cutting are basically limited to cutting tissue. The SONOCA 300 can be used to cut, irrigate, and suction at the surgical site.
Indications for Use:
The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.
1
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
The intended use of the modified device, as described in its labeling, has not changed as a result of the modifications to the predicate device.
Performance Data:
The subiect and predicate devices both use standard data communications controls to detect errors. The subject device complies 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 - Ultrasonic surgical devices, DIN EN 61847
Conclusion:
Similar to the predicate device, the Sonoca 300 does not control any life sustaining functions or services. The device and the predicate device share the same conformance to performance standards and both function as Ultrasonic Dissectors. Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.
2
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" 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
SEP 2 3 1999
Soring GmbH Medizintechnik c/o Mr. Carl Alletto 3200 Dogwood Court Cincinnati, Ohio 45140
K992026 Re: Trade Name: Sonoca 300 Regulatory Class: II Product Code: LFL and BTA Dated: August 16, 1999 Received: August 16, 1999
Dear Mr. Alletto:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Carl Alletto
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K992026
Device Name: Soering, SONOCA 300
Indications for Use:
The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use / OR Over-The-Counter Use _
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K992026
510(k) Number