(228 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Origins LipoHarvesting System:
Acceptance Criteria and Device Performance for Origins LipoHarvesting System (K120328)
Based on the provided 510(k) summary, the device is a suction lipoplasty system used for harvesting and transferring autologous adipose tissue. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance testing related to materials and basic functionality, rather than clinical efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance | Comments / Study Details |
|---|---|---|
| Material Biocompatibility | Complies with ISO 10993-1: 2009 | Test results and analyses indicated compliance. |
| Performance - Bench Testing | Complies with predetermined specifications | Tested for performance in accordance with Section 11, Device Description - Performance Specifications. No specific quantitative criteria or results are provided in the summary. |
| Sterilization (by user) | To be validated prior to commercial distribution in accordance with ISO 17665-1: 2006 (Moist heat) | The device is not provided sterile. The user is responsible for sterilization. The validation of this user-performed sterilization process is a pre-market commitment. |
| Absence of Software | No software components | No software testing was applicable. |
| Absence of Electrical Components | No electrical components | No electromagnetic compatibility or electrical safety testing was applicable. |
| Substantial Equivalence | Considered substantially equivalent to predicate devices | Demonstrated through comparison of technological characteristics and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not mention any studies involving a "test set" in the context of human or animal data. The performance testing described is limited to bench testing for material biocompatibility and general performance against pre-determined specifications. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature for a test set of data is not applicable/provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no mention of a "test set" involving human or animal data needing a ground truth established by experts, this information is not applicable/provided in the summary. The studies described are primarily engineering and material conformance tests.
4. Adjudication Method for the Test Set
Not applicable, as there is no human or animal test set described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No MRMC comparative effectiveness study was described or performed. The submission is for a physical device for tissue collection, not an imaging or diagnostic AI-powered device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
Not applicable. The device does not contain an algorithm or software. It is a mechanical system.
7. The Type of Ground Truth Used
For the biocompatibility testing, the "ground truth" would be the standards themselves (ISO 10993-1: 2009). The material properties were tested against the requirements of this standard.
For the bench performance testing, the "ground truth" would be the predetermined specifications for the device's function.
8. The Sample Size for the Training Set
No training set is applicable or mentioned. The device is a physical system, not an AI or machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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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
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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.
| CharacteristicComparisons: | Shippert MedicalTechnologies / Tissu TransFiltron | human med AG /LipoCollector II CompleteSet | Origins LipoHarvestingDevice |
|---|---|---|---|
| Suction source(s) | Aspiration device | Aspiration device | Aspiration device |
| Volume Range | 100 cc to 500 cc100 cc to 1,000 cc100 cc to 2,000 cc | Up to 1,000 mL | 100 to 2,000 mL |
| Shipped sterile | Yes | Yes | No, sterilized by user priorto 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 basketare 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
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V1120328
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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.
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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
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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
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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
Page 1 of 1
§ 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.