(89 days)
The SONOCA 180/190 is an instrument intended for selected ultrasound dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.
SONOCA 180 & 190 is a desktop unit that controls ultrasonic handpieces used in general surgery, vascular surgery, and dermatological surgery.
general bargery, vacual carget case; technologically derived from the Sonoca 300 family of units (K992026) with the same general modules (hardware and software).
During the use of this ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue and is a supplementary tool for the selective dissection of human tissue.
The provided text describes the regulatory filing for the Sonoca 180/190 ultrasonic surgical instrument, focusing on its substantial equivalence to a predicate device (Sonoca 300). However, the document does not contain the detailed performance study information typically found in an AI/Software as a Medical Device (SaMD) submission. The performance data section refers to compliance with general safety and electromagnetic compatibility standards for the device itself (hardware and software controls for error detection), not to the clinical performance of an AI algorithm in the way a diagnostic AI would be evaluated.
Therefore, many of the requested items cannot be answered from the provided text.
Here's what can be extracted and what cannot:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety of Information Technology Equipment (IEC 950) | Complies with IEC 950 |
| Electromagnetic Compatibility (CISPR 22, class A) | Complies with CISPR 22, class A |
| Electromagnetic Compatibility (IEC-801-2, IEC-801-3) | Complies with IEC-801-2, IEC-801-3 |
| General Electrical Safety for medical devices (IEEE 1003.1) | Complies with IEEE 1003.1 |
| Electrical Safety for medical devices using RF-power (IEC 601-1) | Complies with IEC 601-1 |
| Ultrasonic surgical devices (IEC 601-2-2) | Complies with IEC 601-2-2 |
| General Electrical Safety (DIN EN 61847) | Complies with DIN EN 61847 |
| Overall Performance Claim | "The subject and predicate devices both use similar software controls to detect errors." "The device and the predicate device share the same conformance to performance standards and both function as Ultrasonic Dissectors." |
Study Details (Information Not Available in the Provided Text for AI/SaMD Context)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document focuses on regulatory compliance of a hardware device with software controls, not an AI algorithm evaluated on a test set of data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. This is not an AI/diagnostic device that generates specific outputs requiring expert adjudication for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No adjudication of AI output against expert ground truth is described.
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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/Not provided. This is a surgical instrument, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. "Standalone" performance in the context of AI refers to the algorithm's diagnostic accuracy without human involvement. This document describes a surgical instrument, not an AI algorithm with such a function. The "software controls to detect errors" are part of the device's basic functionality, not an AI a standalone AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. No ground truth in the context of AI performance evaluation is mentioned. The "ground truth" for this device's performance would be its adherence to established safety and functional standards.
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The sample size for the training set:
- Not applicable/Not provided. This device is not described as having an AI component that undergoes a training phase with a dataset.
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How the ground truth for the training set was established:
- Not applicable/Not provided. As there's no mention of a training set for an AI component, this information is not relevant or provided.
Summary of Device and Performance Context:
The Sonoca 180/190 is an ultrasonic surgical instrument. Its "performance data" refers to its compliance with a list of regulatory and safety standards (e.g., IEC, CISPR, IEEE, DIN EN) and its functional equivalence to a predicate device (Sonoca 300) in terms of using "similar software controls to detect errors" and functioning as an ultrasonic dissector. This is a traditional medical device submission, not an AI/SaMD submission, which is why the requested details about AI performance studies are missing.
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510(k) Summary of Safety and Effectivenes
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
August 2, 2001
Submitter's Information:
Soring GmbH Medizintechnik Justus-v.Liebig 10 25451 Quickborn Germany
Telephone: 49 4106-6100-0 Fax: 49 4106-6100-0 Email: info@soering.com
Trade Name, Common Name, Classification:
| Trade Name: | Sonoca 190, Sonoca 180 |
|---|---|
| Common Name: | Instrument, Ultrasonic Surgical |
| Classification Name: | General & Plastic Surgery |
Predicate Device:
| Applicant: | Söring GmbH |
|---|---|
| 510(k) Number: | K992026 |
| Device: | Sonoca 300 |
Device Description:
SONOCA 180 & 190 is a desktop unit that controls ultrasonic handpieces used in general surgery, vascular surgery, and dermatological surgery.
general bargery, vacual carget case; technologically derived from the Sonoca 300 family of units (K992026) with the same general modules (hardware and software).
During the use of this ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue and is a supplementary tool for the selective dissection of human tissue.
Indications for Use:
The SONOCA 180/190 is an instrument intended for selected ultrasound dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.
Typical users of this system are trained professionals; physicians, nurses, and technicians.
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Performance Data:
The subject and predicate devices both use similar software 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 180/190 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2001
Soring GmbH Medizintechnik c/o Mr. Carl Alletto 1100 Lakeview Boulevard Denton, Texas 76208
Re: K012753
Trade/Device Name: Soring GmbH, Sonoca 180/190 Regulation Name: Ultrasonic surgical instrument Regulatory Class: Unclassified Product Code: LFL Dated: July 30, 2001 Received: August 16, 2001
Dear Mr. Alletto:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are carrer or 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 If your device is elassino (toonal 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 or any I 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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark n Millerson
elia 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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NOV 1 3 2001
Page 1 of -1
(Indications for Use Form)
510(k) Number: JA (12753
Device Name: Soring GmbH, SONOCA 180/190
Indications for Use:
The SONOCA 180/190 is an instrument intended for selected ultrasound THE BONOON Tool foo for the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.
Typical users of this system are trained professionals; physicians, nurses, and technicians.
OR
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use
(Per 21 CFR 801.109)
Mark N. Wilkinson
for Wilkinson Sim Off
eneral. F storative and Neurological Deveres
510(k) Number __ K012753
(Optional Format 1-2-96)
N/A