(283 days)
Not Found
No
The device description and intended use focus on mechanical processes for collecting and separating adipose tissue. There is no mention of AI, ML, or any computational analysis of data.
No.
The device is a liposuction adipose tissue collection system, intended for harvesting and filtering adipose tissue, not for providing therapy.
No
The device is described as a collection system for adipose (fatty) tissue used in aesthetic body contouring and for harvesting tissue. Its functions involve aspiration, filtration, and extraction of tissue. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description details physical components like canisters, tubing, funnels, and syringes, indicating it is a hardware-based medical device for collecting and processing adipose tissue. There is no mention of software as a component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body to analyze these samples.
- Device Function: The Red Head and Jordy Connection System is a surgical device used during a procedure to collect, filter, and extract adipose tissue directly from the patient's body. It is a tool for handling tissue in vivo (within the body) and ex vivo (outside the body, but as part of a surgical procedure), not for diagnostic testing of a sample.
- Intended Use: The intended use clearly states it's for liposuction adipose collection and harvesting of autologous adipose tissue for aesthetic body contouring. This is a surgical and tissue handling function, not a diagnostic one.
- Device Description: The description details a closed-loop system for collecting and separating fat from fluids, and extracting the fat. This aligns with a surgical collection device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing the collected tissue for diagnostic purposes, detecting biomarkers, or providing information about a patient's health status based on the tissue analysis.
Therefore, the Red Head and Jordy Connection System is a surgical device for tissue collection and processing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures:
- Aspiration of adipose (fatty) tissue
- Harvesting adipose (fatty) tissue
- Filtering adipose (fatty) tissue
- Extraction of autologous adipose (fatty) tissue
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
Device Functions:
-
- Single Use closed loop system collection device (same)
-
- Canister contains ports on lids for interface between: Jordy Connection System to Canister and aspirator pump.
-
- Connection system to connect tubing to interfaces
-
- Funnel to enable fat to separate from fluids
-
- Channel for fluid evacuation.
- Toomey Syringe to extract fat from device. 6.
Device Design:
-
- Owner holds patent to predicate device and has improved performance and safety through this design.
-
- Non-Sterile, Single Use
-
- Canister able to withstand 30 in/Hg (18 in/Hg maximum vacuum used for collection of adipose (fatty tissue) for harvesting.
-
- Tissue enters canister through collection port on canister lid.
-
- Funnel perforation large enough for only adipose (fatty) tissue to be collected
-
- Waste material is removed from canister by closing valve on center of lid.
-
- Remaining adipose (fatty) tissue can be withdrawn through tissue port on bottom of center of canister for autologous adipose (fatty) tissue extraction.
Physical Properties and Materials Used:
-
- Canister, Funnel and Outer Lid made from Polycarbonate
-
- Evacuation spout and pinch clamps made from Polypropylene
-
- Tubing made from silicone
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 has demonstrated that the subject device operates as designed and functions as intended. Performance tests include Assembly Verification, Leak Testing, Canister Implosion, Tubing Collapse and Pull Off Force Testing. Biocompatibility was evaluated in accordance with ISO 10993 - Biological Evaluation of Medical Devices. Tests for cytotoxicity, intracutaneous reactivity, sensitization, and acute systemic toxicity were completed and passed. Tissue viability testing found no adverse effect on adipose tissue with use of the subject device.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
Miami Fat Supply % Ms. Ayanna Brown Bgf Consulting 325 South Mcgee Ave. Apopka. Florida 32703
Re: K161372
Trade/Device Name: The Red Head Collection Device. The Jordy Connection System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: May 9, 2016 Received: May 17, 2016
Dear Ms. Brown:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161372
Device Name
Red Head Collection Device and Jordy Connection System
Indications for Use (Describe)
The Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures:
- Aspiration of adipose (fatty) tissue
- Harvesting adipose (fatty) tissue
- Filtering adipose (fatty) tissue
- Extraction of autologous adipose (fatty) tissue
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
| Device Name: | The Red Head and Jordy Connection System |
|---|---|
| 510(k) Submission: | K161372 |
| Date of Submission: | January 25, 2017 |
| 510(k) Owner & Manufacturer: | Donnell Mark Jordan |
| Miami Fat Supply Inc. | |
| 1510 Max Hooks Rd. #F | |
| Groveland, FL 34736 | |
| Telephone: 352-557-6979 | |
| Fax: 352-388-9447 | |
| miamifatsupply@gmail.com | |
| 510(k) Submitter and Contact: | Ayanna Brown |
| BGF Consulting LLC | |
| 325 South McGee Avenue | |
| Apopka, FL 32703 | |
| Phone: 407-574-7195 | |
| Fax: 407-814-0127 | |
| ayanna@bgfconsulting.com | |
| FDA Classification Name: | 21 CFR Part 878- General and Plastic Surgery |
| Subpart E - Surgical Devices | |
| Sec. 878.5040 Suction Lipoplasty System | |
| Class II Device | |
| Product Code MUU | |
| Classification Panel: | |
| Common Name: | |
| Predicate Device: | 21 CFR Part 880- General Hospital and Personal Use |
| Subpart G - General Hospital and Personal Use | |
| Sec. 880.6960 Irrigation Syringe | |
| Class I (Sterile) Device | |
| Product Code KYZ | |
| General and Plastic Surgery | |
| Lipoplasty System | |
| K092284 Lipisystems AquaVage | |
| (Product Code MUU) | |
| 21CFR 880.6960 Irrigation Syringe Classification | |
| (Product Code KYZ) |
4
Indications for Use:
The Red Head and Jordy Connection System is indicated for use as a liposuction adipose (fatty) collection system used in the aesthetic body contouring and collection of autologous adipose tissue. The Red Head and Jordy Connection System is intended to be used in the following surgical procedures:
- Aspiration of adipose (fatty) tissue
- Harvesting adipose (fatty) tissue
- Filtering adipose (fatty) tissue
- Extraction of autologous adipose (fatty) tissue
Device Description:
Device Functions:
-
- Single Use closed loop system collection device (same)
-
- Canister contains ports on lids for interface between: Jordy Connection System to Canister and aspirator pump.
-
- Connection system to connect tubing to interfaces
-
- Funnel to enable fat to separate from fluids
-
- Channel for fluid evacuation.
- Toomey Syringe to extract fat from device. 6.
Device Design:
-
- Owner holds patent to predicate device and has improved performance and safety through this design.
-
- Non-Sterile, Single Use
-
- Canister able to withstand 30 in/Hg (18 in/Hg maximum vacuum used for collection of adipose (fatty tissue) for harvesting.
-
- Tissue enters canister through collection port on canister lid.
-
- Funnel perforation large enough for only adipose (fatty) tissue to be collected
-
- Waste material is removed from canister by closing valve on center of lid.
-
- Remaining adipose (fatty) tissue can be withdrawn through tissue port on bottom of center of canister for autologous adipose (fatty) tissue extraction.
Physical Properties and Materials Used:
-
- Canister, Funnel and Outer Lid made from Polycarbonate
-
- Evacuation spout and pinch clamps made from Polypropylene
-
- Tubing made from silicone
Intended use of Device:
For use in aspirating subcutaneous fatty tissue including autologous fat collection.
5
Predicate and Reference device comparison table
| Device Name | The Red Head
Miami Fat Supply | Medical Device ResourceCorp.
Lipisystems Aquavage
Predicate Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The Red Head is a single use, closed loop
tissue collection device comprised of a
medical grade canister, vacuum port,
collection port, tissue port and cap
intended to be used with standard
liposuction aspiration to collect fatty
tissue for aesthetic body contouring. As
the tissue is harvested from the patient it
enters the canister through the collection
port on the canister lid. The physician
removes waste materials from the canister
by closing the valve on the center of the lid.
The fatty tissue remains that can be
withdrawn through the tissue port on the
bottom center of the canister for
autologous fat re-injection. | The Lipisystems Aquavage consists of a
plastic canister, silicone tubing, with a
vacuum port, collection port and bottom
tissue port and lid, intended to be used
with a standard liposuction pump to
collect fatty tissue for aesthetic body
contouring. As the tissue is harvested
from the patient it enters the canister via
the port in the canister lid. The physician
removes unwanted waste materials from
the collection system via the vacuum port
by closing the valve on the lid. This
process leaves fatty tissue that can be
transferred to syringes via the tissue port
for autologous fat reinjection. |
| Picture of
Product | Image: The Red Head product | Image: Lipisystems Aquavage product |
| Intended Use: | The Red Head is used in the aspiration,
harvesting, filtering and extraction of
autologous adipose tissue for aesthetic
body contouring | The Aquavage is used in the aspiration,
harvesting, filtering and extraction of
autologous adipose tissue for aesthetic
body contouring |
| Technology
Comparison | The Red Head employs the same
technological characteristics as the
predicate device. | The Lipisystems Aquavage employs the
same technological characteristics as the
predicate device. |
| Suction
Source | Aspiration Device | Aspiration Device |
| Volume | Up to 2500 mL | 2000 cc or 1200 cc |
| Range | | |
| Shipped Sterile | No, sterilized by user prior to use | Yes |
| Sterility Assurance Level | $10^{-6}$ | $10^{-6}$ |
| Disposable or Reusable | Single Use, Disposable | Single Use Disposable |
| Resterilization Method | Not Applicable | Not Applicable |
6
Substantial Equivalence Discussion:
The Subject and Predicate device are identical in terms of function and performance. Performance testing has demonstrated that the subject device operates as designed and functions as intended. Performance tests include Assembly Verification, Leak Testing, Canister Implosion, Tubing Collapse and Pull Off Force Testing. Biocompatibility was evaluated in accordance with ISO 10993 - Biological Evaluation of Medical Devices. Tests for cytotoxicity, intracutaneous reactivity, sensitization, and acute systemic toxicity were completed and passed. The subject device of this submission is indicated for collection and transfer of autologous adipose tissue. Tissue viability testing found no adverse effect on adipose tissue with use of the subject device. The minimally manipulated nature of such tissue in the subject device and the predicate device form the basis of substantial equivalence.
Conclusion for the Substantial Equivalence of the Device:
Based on the performance and comparison data contained within this submission, Miami Fat Supply deems that the Red Head and Jordy Connection System is substantially equivalent to the identified predicate device.