GID 700

K120902 · The Gid Group, Inc. · MUU · Aug 15, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120902
• Device Name: GID 700
• Applicant: The Gid Group, Inc.
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Aug 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2

Intended Use

The GID 700 is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation. The GID 700 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

Device Story

GID 700 is a sterile, single-use 700 ml canister system for aspiration, harvesting, filtering, and transferring autologous adipose tissue. Device connects to a user-supplied external vacuum source; tissue is deposited into the canister and passed through an internal 200-micron mesh filter to capture adipose tissue. Features include manual stir mechanism and ports for suction, venting, input, and extraction. Used in clinical/surgical settings by physicians across multiple specialties. System remains assembled throughout the procedure; filtered tissue is collected for reimplantation without additional manipulation. Benefits include closed-system filtration, reducing potential for contamination during fat transfer procedures.

Clinical Evidence

Bench testing only. Testing included canister vacuum implosion, tubing connection tensile strength, mechanical plugging, and biocompatibility (ISO 10993). Device confirmed non-pyrogenic.

Technological Characteristics

Sterile, single-use 700 ml polymer canister; 200-micron mesh filter; manual stir mechanism; ports for suction, vent, input, and extraction. Operates via external vacuum source. Sterilized via Electron Beam Irradiation (ISO 11137). Biocompatibility meets ISO 10993 for external communicating devices with contact < 24 hours.

Indications for Use

Indicated for patients undergoing soft tissue aspiration or autologous adipose tissue harvesting for aesthetic body contouring across various surgical specialties including plastic, reconstructive, neuro, GI, urological, general, orthopedic, gynecological, thoracic, and laparoscopic surgery.

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

• Shippert Tissu-Trans Filtron 1000 (K092482)

Submission Summary (Full Text)

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K120902

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## 510(k) Summary

ﻬﺎ

# AUG 1 5 2012

| Submitted by | The GID Group Inc.<br>578 W. Sagebrush Ct.<br>Louisville, CO 80027<br>303-952-4901 |
|--------------|------------------------------------------------------------------------------------|
|--------------|------------------------------------------------------------------------------------|

| Contact Person | Lewis Ward |
|----------------|---------------------------------|
| | L. W. Ward and Associates, Inc. |
| | 4655 Kirkwood Court |
| | Boulder, CO 80301 |
| | 303-530-3279 |
| | [e-mail] |

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| Product Name | GID 700 Tissue Canister<br>But hand and see a first and to the comment of a ministration and to | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------- |
|--------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| | | | |

| Classification | System, Suction, Lipoplasty |
|----------------|-------------------------------|
| | Product Code: MUU |
| | Regulation Number: 878.5040 |
| | Device Class 2 |
| | General Plastic Surgery Panel |

| | Indication for Use Statement | |
|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | The GID 700 is used for aspiration, harvesting, filtering, and<br>transferring of autologous adipose tissue for aesthetic body<br>contouring. The system should be used with a legally<br>marketed vacuum or aspirator apparatus as a source of<br>suction. If harvested fat is to be reimplanted, the harvested<br>fat is only to be used without any additional manipulation. | |
| | The GID 700 is intended for use in the following surgical<br>specialties when aspiration of soft tissue is desired: plastic<br>and reconstructive surgery, neurosurgery, gastrointestinal<br>and affiliated organ surgery, urological surgery, general<br>surgery, orthopedic surgery, gynecological surgery, thoracic<br>surgery, and laparoscopic surgery. | |

| Technological Characteristics | The GID Group's GID 700 device is a sterile, single use<br>700 ml canister and accessories used to receive and filter<br>tissue from lipoplasty procedures. When the tissue is<br>deposited into the canister, it is filtered through a mesh filter<br>to capture the tissue. The vacuum source is user or<br>institution supplied.<br>Various ports on the canister provide access to the vacuum<br>source, receives the harvested tissue, vent the canister during<br>the wash process, and transfer the filtered tissue. |
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V120902
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| Test Data | Canister vacuum Implosion Test - passes |
|-----------|-------------------------------------------------|
| | Tubing connection, tensile strength - passes |
| | Mechanical plugging testing - passes |
| | Biocompatibility - meets ISO 10993 requirements |
| | Pyrogen Test - non-pyrogenic |

i

:

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| Features | GID 700 | Shippert Tissu-Trans Filtron<br>1000 |
|-----------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Indication for Use | Used in the aspiration, harvesting, filtering, and transferring of autologous tissue. | Used in the aspiration, harvesting, filtering, and transferring of autologous tissue. |
| Manufacturer | The GID Group, USA | Shippert Medical Technologies Corp. |
| Product Code | MUU, Class 2<br>General and Plastic Surgery Panel | MUU, Class 2<br>General and Plastic Surgery Panel |
| Regulation Number | 878.5040 Suction Lipoplasty System | 878.5040 Suction Lipoplasty System |
| Use Mode | Single use, disposable, sterile.<br>Unit remains assembled throughout entire process. | Single use, disposable, sterile.<br>Unit remains assembled throughout entire process. |
| Sterilization Method | Electron Beam Irradiation<br>ISO 11137 | Radiation |
| Canister Construction | Polymer materials, closed system filtration, and disposable tubing sets. Manual stir mechanism. | Polymer materials, closed system filtration, and disposable tubing sets |
| Source of Energy | User supplied vacuum | User supplied vacuum |
| Filtering | 200 micro mesh filter to retain tissue | 400 micron mesh filter to retain tissue |
| Accessory | None. Institutions provide collection trap. | None. Institutions provide collection trap. |
| Mechanical Testing | - Implosion test: Passes<br>- Tubing Connection, Tensile Strength: Passes<br>- Mechanical Plugging: Passes | - Implosion test: Passes<br>- Tubing Connection, Tensile Strength: Passes<br>- Mechanical Plugging: Passes |
| Biocompatibility | Meets ISO 10993 External Communicating Device, Contact < 24 hours | Meets ISO 10993 External Communicating Device, Contact < 24 hours |
| Canister Size | 700 ml | 1000 ml |
| Canister Ports | Suction, vent, input, extraction | Suction, vent, input, extraction |

| Substantial Equivalence | The GID 700 is substantially equivalent to the Shippert Tissu- |
|-------------------------|----------------------------------------------------------------|
| | Trans-Filtron 1000 canister (K092482) manufactured by |
| | Shippert Medical based on design, materials, and testing. |

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## 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 symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 15 2012

The CID Group, Incorporated % L.W. Ward and Associates, Incorporated Mr. Lewis Ward Consultant 4655 Kirkwood Court Boulder, Colorado 80301

Re: K120902

Trade/Device Name: GID 700 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: July 18, 2012 Received: July 19, 2012

### Dear Mr Ward:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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## Page 2 - Mr. Lewis Ward

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely vours.

yours,

of Peter
Melkerson

{

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Device Name: GID 700

Indications for Use:

The GID 700 is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be reimplanted. the harvested fat is only to be used without any additional manipulation.

The GID 700 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Da.l. Kramer for MM
(Division Sign-Off)

Division of Surgical. Onhopedie. and Restorative Devices

510(k) Number K120902