The SONOCA 180/185 Wound Care System is an instrument intended for selected ultrasound dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation of the site for removal of debris, exudates, fragments, and other matter.

Device Description

Ultrasonic-Assisted Wound Treatment using the Sonoca 180 / 185 applies low-frequency power ultrasound in conjunction with an irrigation solution via a moving receptacle directly to the wound tissue. An ultrasonic generator transfers electric energy to a receptacle where a high-precision piezoelectric crystal system (PZT transducer) transforms this energy into mechanic vibrations: 25,000 vibrations / second (= 25 kHz). The receptacle is continuously moved over the wound surface. This allows gentle loosening of necrotic tissue and fibrin layers and flushes them away with the irrigation solution (0.9 % NaCl or Ringer solution). The liquid is used for transmitting the ultrasound as well as for wound irrigation. Cavitation is the underlying mode of action of ultrasound: the formation and disintegration of cavities (bubbles) in liquids due to pressure fluctuations, i.e. formation and subsequent implosion of these bubbles causes turbulences and currents on the wound surface, which help to loosen necrotic tissue and fibrin layers.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Soring GmbH SONOCA 180/185 Wound Care System:

The provided document (K072904) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with specific acceptance criteria related to a new performance claim. Therefore, the information typically found in acceptance criteria tables and detailed study designs for performance (e.g., accuracy, sensitivity, specificity) is largely absent.

Instead, the "acceptance criteria" for this type of submission are primarily related to compliance with recognized standards and demonstrating that the device is substantially equivalent to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

Here's a breakdown based on your requested information:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance (Compliance Statement)
Safety and Electrical Standards	IEC 950 - Safety of Information Technology Equipment	Complies
	CISPR 22, class A - Electromagnetic Compatibility	Complies
	IEC-801-2 - Electromagnetic Compatibility	Complies
	IEC-801-3 - Electromagnetic Compatibility	Complies
	IEEE 1003.1 - General Electrical Safety for medical devices	Complies
	IEC 601-1 - Electrical Safety for medical devices using RF-power	Complies
	IEC 601-2-2 - Ultrasonic surgical devices	Complies
	DIN EN 61847	Complies
Substantial Equivalence	Similar general function, intended use, and technological characteristics to predicate devices.	Stated as "substantially equivalent to the predicate device" in areas of general function and intended use. Differences "will not affect safety or efficacy."
Risk Assessment	Device does not control any life-sustaining functions or services (implied safety characteristic)	Stated: "Similar to the predicate devices, the Sonoca 180/185 does not control any life sustaining functions or services."

Note on "Acceptance Criteria" in this context: For a 510(k) of this nature, the "acceptance criteria" are not quantitative performance metrics (like sensitivity/specificity targets) but rather adherence to consensus standards and a qualitative assessment of substantial equivalence. The document doesn't provide specific numerical targets for clinical efficacy or safety beyond compliance with general electrical and medical device safety standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This 510(k) does not describe a clinical study with a "test set" in the traditional sense of evaluating efficacy on patient data. The "performance data" section refers to compliance with safety and electrical standards, not clinical performance data on a patient cohort. Therefore, no information on sample size, data provenance, or study design (retrospective/prospective) is provided related to clinical performance. The evaluation is primarily based on engineering and design controls.

3. 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. As there is no clinical "test set" and a ground truth establishment process described, this information is not provided. The submission relies on established engineering standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication process is described.

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 wound care system, not an imaging or diagnostic AI-assisted device. Therefore, no MRMC study or AI assistance is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (ultrasonic wound cleaner), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of clinical performance evaluation. The "ground truth" for this submission would be the established requirements within the referenced safety and electromagnetic compatibility standards (e.g., electrical parameters, radiation limits, etc.).

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning algorithm requiring a "training set."

9. How the ground truth for the training set was established

Not applicable. (See answer to #8).

Summary

{0}------------------------------------------------

K072904

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

Many 8, 2008

Submitter's Information:

Predicate Device:

Mr. Jan Schueller-lwersen, Manager, Regulatory & Quality Soring GmbH Medizintechnik Justus-v.Liebig 2 25451 Quickborn Germany

Telephone: 49 4106-6100-0 Fax: 49 4106-6100-0 Email: info@soering.com

Trade Name, Common Name, Classification:

Trade Name: Common name: Classification name:

195 Sonoca™ 180/195 Wound Care System Ultrasound wound cleaner Low energy ultrasound wound cleaner, Instrument, ultrasonic Surgical

instrument, ultrasonic

surgical

K050776

Device instrument, ultrasonic wound cleaner, Classification surgical ultrasound Name 510(k) Number K062544 K012753

Device Name	SORING GMBHSONOCA 180/190	AR1000 ULTRASONICWOUND THERAPYSYSTEM	AUSS-6 ULTRASONICSURGICALASPIRATOR SYSTEM	SORING GMBHSONOCA 300
Applicant	SORING GMBHMEDIZINTECHNIK	AROBELLA MEDICAL,LLC	MISONIX, INC.	SORING GMBHMEDIZINTECHNIK
ClassificationProduct Code	LFL	NRB, FQH, LFL	LFL	LFLBTA
Decision Date	11/13/2001	01/03/2007	06/06/2005	09/23/1999
ClassificationAdvisoryCommittee	General & PlasticSurgery	General & PlasticSurgery	General & PlasticSurgery	General & PlasticSurgery

Device Description:

MAY 2 1 2008

pump, portable,

aspiration (manual or

powered)

K992026

{1}------------------------------------------------

K072904 Page 2 of 2

510(k) Summary of Safety and Effectiveness

The receptacle is continuously moved over the wound surface. This allows gentle loosening of necrotic tissue and fibrin layers and flushes them away with the irrigation solution (0.9 % NaCl or Ringer solution). The liquid is used for transmitting the ultrasound as well as for wound irrigation. Cavitation is the underlying mode of action of ultrasound: the formation and disintegration of cavities (bubbles) in liquids due to pressure fluctuations, i.e. formation and subsequent implosion of these bubbles causes turbulences and currents on the wound surface, which help to loosen necrotic tissue and fibrin layers.

Indications for Use:

Performance Data:

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 devices, the Sonoca 180/185 does not control any life sustaining functions or services.

The new device and the predicate devices are substantially equivalent in the areas of general function, and intended use. Any differences between the devices will not affect safety or efficacy.

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}------------------------------------------------

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 stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2009 JUL

Soring GmbH % Delta Quality Consulting Mr. Carl Thomas 1600 Manchester Way Corinth, Texas 76210

Re: K072904 Trade/Device Name: Sonoca 180/185 Wound Care System Regulatory Class: Unclassified Product Code: LFL Dated: May 12, 2008 Received: May 19, 2008

Dear Mr. Thomas:

This letter corrects our substantially equivalent letter of May 21, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Carl Thomas

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for D.B. D

D.e

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use

K072904 510(k) Number (if known):

Device Name:

Soring GmbH, SONOCA 180/185 Wound Care System

Indications for Use:

The SONOCA 180/185 is an instrument intended for selected ultrasound dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation of the site for removal of debris, exudates, fragments, and other matter.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Ni

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Milkman

Sign-( Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

N/A