(228 days)
Not Found
No
The device description and performance studies explicitly state that the device does not contain software or electrical components, which are typically required for AI/ML implementation.
No.
The device is used for harvesting and transferring autologous tissue for aesthetic body contouring, which is not considered a therapeutic function. Therapeutic devices are typically used for treating or alleviating disease, injury, or other medical conditions.
No
The device description indicates it is used for aspiration, harvesting, filtering, and transferring autologous tissue, specifically for aesthetic body contouring. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states that the system consists of physical components (canister, drain port, lid) and is used with a standard liposuction aspiration pump. The performance studies also mention sterilization, biocompatibility, and bench testing of these physical components, and explicitly state that the device does not contain software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Origins LipoHarvesting System Function: The Origins LipoHarvesting System is used to collect, filter, and transfer autologous tissue (fat) for re-implantation or aesthetic body contouring. It is a surgical tool used during a procedure on the patient's body.
- Lack of Diagnostic Purpose: The device does not analyze the collected tissue to provide diagnostic information about the patient's health or condition. Its purpose is purely for the physical manipulation and transfer of the tissue.
The description clearly outlines a system for handling tissue for use in the body, not for diagnostic testing outside the body.
N/A
Intended Use / Indications for Use
The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of autologous tissue. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of adipose autologous tissue for aesthetic body contouring. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.
Product codes
MUU
Device Description
The Origins LipoHarvesting System consists of a reusable, closed loop tissue collection system comprised of a medical grade canister, a drain port and a lid intended to be used with a standard liposuction aspiration pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the collection canister via a port in the canister lid. The physician removes unwanted waste materials from the collection system via the drain port at the base. This process leaves fatty tissue that can be transferred to syringes for autologous fat re-injection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance Testing:
Sterilization
The Origins LipoHarvesting System is not provided sterile, but is sterilized by the user prior to use. The sterilization of the Origins LipoHarvesting System will be validated prior to commercial distribution in accordance with ISO 17665-1: 2006, Sterilization of health care products – Moist heat – Part 1 : Requirements for the development, validation and routine control of a sterilization process for medical devices.
Biocompatibility
The Origins LipoHarvesting System has patient contact materials and is made from medical grade biocompatible materials. Test results and analyses indicate that the Origins LipoHarvesting System materials comply in accordance with ISO 10993-1: 2009, Biological evaluation of medical devices – Part 1: Evaluation and testing.
Software Testing
The Origins LipoHarvesting System does not contain software, and therefore this section does not apply.
Electromagnetic Compatibility Testing and Electrical Safety
The Origins LipoHarvesting System does not contain electrical components, and therefore this section does not apply.
Performance Testing - Bench
The Origins LipoHarvesting System is tested for performance in accordance with its predetermined specifications as specified in Section 11, Device Description - Performance Specifications, of this submission.
Test results indicate that the Origins LipoHarvesting System complies with its predetermined specification.
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
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
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SEP 1 7 2012
510(k) Summary
Submission Date:
30 January 2012
Submitter: .
Sound Surgical Technologies LLC 357 McCaslin Boulevard, Suite 100 Louisville, CO 80027
Submitter and Official Contact: Mr. Stephen C. Smith Vice President of RA/QA Sound Surgical Technologies LLC 357 McCaslin Boulevard, Suite 100 Louisville, CO 80027 +1 (720) 240-2970 SSmith@soundsurgical.com
Manufacturing Site:
Sound Surgical Technologies LLC 357 McCaslin Boulevard, Suite 100 Louisville, CO 80027
Trade Name:
Quito, Ecuador
Common Name: Suction lipoplasty system
Classification Name: System, Suction, Lipoplasty
Sound Model
LipoHarvesting
Origins
System
Classification 21 CFR §878.5040 Regulation:
Product Code: MUU
Substantially Equivalent Devices: Predicate 510(k) Number
Predicate Manufacturer and Model
Sound Surgical Technologies LLC Origins LipoHarvesting System
Shippert Medical Technologies / Tissu Trans Filtron
human med AG / LipoCollector II Complete Set
1
Device Description:
The Origins LipoHarvesting System consists of a reusable, closed loop tissue collection system comprised of a medical grade canister, a drain port and a lid intended to be used with a standard liposuction aspiration pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the collection canister via a port in the canister lid. The physician removes unwanted waste materials from the collection system via the drain port at the base. This process leaves fatty tissue that can be transferred to syringes for autologous fat re-injection.
Intended Use:
The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of autologous tissue. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
Technology Comparison: The Origins LipoHarvesting System employs the same technological characteristics as the predicate devices.
| Characteristic
Comparisons: | Shippert Medical
Technologies / Tissu Trans
Filtron | human med AG /
LipoCollector II Complete
Set | Origins LipoHarvesting
Device |
|--------------------------------|--------------------------------------------------------------|----------------------------------------------------|----------------------------------------|
| Suction source(s) | Aspiration device | Aspiration device | Aspiration device |
| Volume Range | 100 cc to 500 cc
100 cc to 1,000 cc
100 cc to 2,000 cc | Up to 1,000 mL | 100 to 2,000 mL |
| Shipped sterile | Yes | Yes | No, sterilized by user prior
to use |
| Initial Method | Gamma radiation | Ethylene oxide (EtO) | Not applicable |
| Sterility assurance level | 10-6 | 10-6 | 10-6 |
| Disposable or reusable | Single use, disposable | Canister, lid and basket
are reusable | Reusable |
| Resterilization Method | Not applicable | Autoclave | Autoclave |
Performance Testing:
Sterilization
The Origins LipoHarvesting System is not provided sterile, but is sterilized by the user prior to use. The sterilization of the Origins LipoHarvesting System will be validated prior to commercial distribution in accordance with ISO 17665-1: 2006, Sterilization of health care products – Moist heat – Part 1 : Requirements for the development, validation and routine control of a sterilization process for medical devices.
1120328
7.83
2
V1120328
30f3.
made from medical grade biocompatible materials. Test results and analyses indicate that the Origins LipoHarvesting System materials comply in accordance with ISO 10993-1: 2009, Biological evaluation of medical devices – Part 1: Evaluation and testing. The Origins LipoHarvesting System does not contain software, and Software Testing therefore this section does not apply. The Origins LipoHarvesting System does not contain electrical Electromagnetic components, and therefore this section does not apply. Compatibility Testing and Electrical Safety The Origins LipoHarvesting System is tested for performance in Performance Testing - Bench
therefore this section does not apply.
accordance with its predetermined specifications as specified in Section 11, Device Description - Performance Specifications, of this submission.
The Origins LipoHarvesting System is not provided sterile, and
The Origins LipoHarvesting System has patient contact materials and is
Test results indicate that the Origins LipoHarvesting System complies with its predetermined specification.
Conclusion
Shelf-Life
Biocompatibility
Verification and validation activities were conducted to establish the performance and safety characteristics of the Origins LipoHarvesting System. The results of these activities demonstrate that the Origins LipoHarvesting System is considered substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters, arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
1 > 2012
Sound Surgical Technologies, LLC
% Mr. Stephen C. Smith
Vice President of Regulatory Affairs and Quality Affairs
357 McCaslin Boulevard, Suite 100
Louisville, Colorado 80027
Re: K120328
Trade/Device Name: Origins LipoHarvesting System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: August 17, 2012 Received: August 28, 2012
Dear Mr. Smith:
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Mr. Stephen C. Smith
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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark Al Melleman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
K120328
Device Name:
Indications for Use:
Origins LipoHarvesting System
The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of adipose autologous tissue for aesthetic body contouring. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
(21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number 1/120328
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