(99 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called Sonoca 300, an ultrasonic surgical instrument. However, the document does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics, sample sizes for test or training sets, ground truth establishment, or details about expert involvement.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Sonoca III) by confirming the modified device's intended use has not changed and that it complies with various electrical and medical device safety standards.
Therefore, I cannot fulfill all parts of your request with the provided input. Below, I will present the information that is available based on the given text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics for the Sonoca 300. Instead, its acceptance is based on compliance with established safety and compatibility standards, and its substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance (Compliance) |
|---|---|---|
| Errors | Standard data communications controls to detect errors | Complies |
| Safety of IT Equipment | IEC 950 - Safety of Information Technology Equipment | Complies |
| Electromagnetic Compatibility | CISPR 22, class A - Electromagnetic Compatibility | Complies |
| Electromagnetic Compatibility | IEC-801-2 - Electromagnetic Compatibility | Complies |
| Electromagnetic Compatibility | IEC-801-3 - Electromagnetic Compatibility | Complies |
| General Electrical Safety | IEEE 1003.1 - General Electrical Safety for medical devices | Complies |
| Electrical Safety (RF-power) | IEC 601-1 - Electrical Safety for medical devices using RF-power | Complies |
| Ultrasonic Surgical Devices | IEC 601-2-2 - Ultrasonic surgical devices | Complies |
| Standard | DIN EN 61847 | Complies |
| Life Sustaining Functions | Does not control any life sustaining functions or services. | Met (Similar to predicate device) |
| Functionality | Functions as an Ultrasonic Dissector | Met (Similar to predicate device) |
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a performance study with a test set of data. The evaluation is based on compliance with standards and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication for a test set.
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
Not applicable. This device is an ultrasonic surgical instrument, not an AI-assisted diagnostic tool involving human "readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This information is relevant for AI/software devices. The Sonoca 300 is a hardware surgical instrument.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's regulatory acceptance is its compliance with established safety and performance standards and its substantial equivalence to a legally marketed predicate device, rather than a clinical ground truth established for diagnostic accuracy.
8. The sample size for the training set
Not applicable. The document does not describe a study with a training set for an algorithm or model.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a study with a training set for an algorithm or model.
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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.
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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.
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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.
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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
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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
§ 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.