(223 days)
No
The description focuses on the physical mechanism of ultrasound and cavitation for wound debridement, with no mention of AI or ML technologies.
Yes
The device is described as a "Wound Care System" intended for "selective ultrasound dissection and fragmentation of tissue, wound debridement," and "cleansing irrigation," all of which are therapeutic applications aimed at treating wounds.
No
The document describes the device as an instrument for tissue dissection, fragmentation, wound debridement, and cleansing irrigation. These are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines hardware components such as an ultrasonic generator, a piezoelectric crystal system (PZT transducer), and a receptacle, which are integral to its function. It is not solely software.
Based on the provided information, the SONOCA 180/185 Wound Care System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a system for treating wounds by debridement and cleansing using ultrasound and irrigation. This is a direct therapeutic intervention on the patient's body.
- Device Description: The description details a system that applies ultrasound energy and irrigation solution directly to the wound surface to loosen and remove tissue and debris. This is a physical process applied externally to the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SONOCA 180/185 does not perform any such analysis of specimens.
The device is a therapeutic device used for wound treatment, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound tissue, wound surface
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)
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.
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
N/A
0
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
Device instrument, ultrasonic wound cleaner, Classification surgical ultrasound Name 510(k) Number K062544 K012753
| Device Name | SORING GMBH
SONOCA 180/190 | AR1000 ULTRASONIC
WOUND THERAPY
SYSTEM | AUSS-6 ULTRASONIC
SURGICAL
ASPIRATOR SYSTEM | SORING GMBH
SONOCA 300 |
|-----------------------------------------|-------------------------------|----------------------------------------------|---------------------------------------------------|-------------------------------|
| Applicant | SORING GMBH
MEDIZINTECHNIK | AROBELLA MEDICAL,
LLC | MISONIX, INC. | SORING GMBH
MEDIZINTECHNIK |
| Classification
Product Code | LFL | NRB, FQH, LFL | LFL | LFL
BTA |
| Decision Date | 11/13/2001 | 01/03/2007 | 06/06/2005 | 09/23/1999 |
| Classification
Advisory
Committee | General & Plastic
Surgery | General & Plastic
Surgery | General & Plastic
Surgery | General & Plastic
Surgery |
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).
MAY 2 1 2008
pump, portable,
aspiration (manual or
powered)
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:
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.
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