K Number
K120902
Device Name
GID 700
Date Cleared
2012-08-15

(142 days)

Product Code
Regulation Number
878.5040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The GID Group's GID 700 device is a sterile, single use 700 ml canister and accessories used to receive and filter tissue from lipoplasty procedures. When the tissue is deposited into the canister, it is filtered through a mesh filter to capture the tissue. The vacuum source is user or institution supplied. Various ports on the canister provide access to the vacuum source, receives the harvested tissue, vent the canister during the wash process, and transfer the filtered tissue.
More Information

Not Found

No
The device description and intended use focus on mechanical filtration and collection of tissue, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

No
The device is described as a sterile canister and accessories for aspirating, harvesting, filtering, and transferring adipose tissue, primarily for aesthetic body contouring and re-implantation without further manipulation. Its function is to collect and filter tissue, not to treat a disease or condition itself.

No

The device description clearly states its function is for "aspiration, harvesting, filtering, and transferring of autologous adipose tissue" and to "receive and filter tissue." There is no mention of it being used to diagnose a medical condition, disease, or to provide any diagnostic information. Its purpose is purely for tissue collection and processing during surgical procedures.

No

The device description clearly states it is a "sterile, single use 700 ml canister and accessories," which are physical hardware components.

Based on the provided information, the GID 700 device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use clearly states the device is for "aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring." This is a surgical procedure involving the manipulation of tissue within the body or for re-implantation, not for analyzing samples in vitro (outside the body) to diagnose a condition.
  • Device Description: The description focuses on the mechanical process of receiving and filtering tissue during a lipoplasty procedure. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
  • Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substances or characteristics in a sample to provide information for diagnosis, monitoring, or treatment decisions.
  • Performance Studies: The performance studies listed are related to the physical integrity and biocompatibility of the device, not its ability to perform a diagnostic test.

IVD devices are typically used to examine samples like blood, urine, tissue biopsies, etc., to provide information about a patient's health status. The GID 700's function is purely procedural, related to the handling of tissue during surgery.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MUU

Device Description

The GID Group's GID 700 device is a sterile, single use 700 ml canister and accessories used to receive and filter tissue from lipoplasty procedures. When the tissue is deposited into the canister, it is filtered through a mesh filter to capture the tissue. The vacuum source is user or institution supplied. Various ports on the canister provide access to the vacuum source, receives the harvested tissue, vent the canister during the wash process, and transfer the filtered tissue.

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)

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

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.

K092482

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

K120902

1042

510(k) Summary

ﻬﺎ

AUG 1 5 2012

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

--------------------------------------------------------------------------------------------------
Contact PersonLewis Ward
L. W. Ward and Associates, Inc.
4655 Kirkwood Court
Boulder, CO 80301
303-530-3279
lwward@qwest.net

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| Product Name | GID 700 Tissue Canister
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ClassificationSystem, 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
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.

| Technological Characteristics | The GID Group's GID 700 device is a sterile, single use
700 ml canister and accessories used to receive and filter
tissue from lipoplasty procedures. When the tissue is
deposited into the canister, it is filtered through a mesh filter
to capture the tissue. The vacuum source is user or
institution supplied.
Various ports on the canister provide access to the vacuum
source, receives the harvested tissue, vent the canister during
the wash process, and transfer the filtered tissue. |

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Test DataCanister vacuum Implosion Test - passes
Tubing connection, tensile strength - passes
Mechanical plugging testing - passes
Biocompatibility - meets ISO 10993 requirements
Pyrogen Test - non-pyrogenic

i

:

.

| Features | GID 700 | Shippert Tissu-Trans Filtron
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
General and Plastic Surgery Panel | MUU, Class 2
General and Plastic Surgery Panel |
| Regulation Number | 878.5040 Suction Lipoplasty System | 878.5040 Suction Lipoplasty System |
| Use Mode | Single use, disposable, sterile.
Unit remains assembled throughout entire process. | Single use, disposable, sterile.
Unit remains assembled throughout entire process. |
| Sterilization Method | Electron Beam Irradiation
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

  • Tubing Connection, Tensile Strength: Passes
  • Mechanical Plugging: Passes | - Implosion test: Passes
  • Tubing Connection, Tensile Strength: Passes
  • Mechanical Plugging: Passes |
    | Biocompatibility | Meets ISO 10993 External Communicating Device, Contact