ORIGINS LIPOHARVESTING SYSTEM

K120328 · Sound Surgical Technologies, LLC · MUU · Sep 17, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120328
• Device Name: ORIGINS LIPOHARVESTING SYSTEM
• Applicant: Sound Surgical Technologies, LLC
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Sep 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Origins LipoHarvesting System is a reusable, closed-loop tissue collection system; consists of medical-grade canister, drain port, and lid. Used with standard liposuction aspiration pump; collects fatty tissue for aesthetic body contouring. Tissue enters canister via lid port; physician removes waste via base drain port. Harvested fat transferred to syringes for autologous re-injection. Used in clinical settings by physicians. Benefits patient by providing sterile-compatible, closed-loop collection for autologous fat grafting without additional manipulation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing verified compliance with predetermined specifications and biocompatibility standards (ISO 10993-1). Sterilization validation conducted per ISO 17665-1.

Technological Characteristics

Reusable closed-loop tissue collection system; medical-grade biocompatible materials; 100-2,000 mL volume capacity. Operates via external aspiration pump. Sterilization via user-performed autoclave. No software, electrical components, or electronic sensors.

Indications for Use

Indicated for patients undergoing aesthetic body contouring procedures requiring the aspiration, harvesting, filtering, and transfer of autologous adipose tissue.

Regulatory Classification

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 of 1/3 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.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

• Origins LipoHarvesting System (K092482)
• Shippert Medical Technologies / Tissu Trans Filtron (K101713)
• human med AG / LipoCollector II Complete Set

Submission Summary (Full Text)

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K120328

1083

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 [phone] [e-mail]

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

K092482

Sound Surgical Technologies LLC Origins LipoHarvesting System

K101713

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.

| Characteristic<br>Comparisons: | Shippert Medical<br>Technologies / Tissu Trans<br>Filtron | human med AG /<br>LipoCollector II Complete<br>Set | Origins LipoHarvesting<br>Device |
|--------------------------------|--------------------------------------------------------------|----------------------------------------------------|----------------------------------------|
| Suction source(s) | Aspiration device | Aspiration device | Aspiration device |
| Volume Range | 100 cc to 500 cc<br>100 cc to 1,000 cc<br>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<br>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<br>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.

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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 [phone] or [phone] 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

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