BK231013 · Musculoskeletal Transplant Foundation (MTF Biologics) Edison, NJ · QKL · May 16, 2024 · General, Plastic Surgery
Device Facts
Record ID
BK231013
Device Name
LipoGrafter® Kit
Applicant
Musculoskeletal Transplant Foundation (MTF Biologics) Edison, NJ
Product Code
QKL · General, Plastic Surgery
Decision Date
May 16, 2024
Decision
SESE
Regulation
21 CFR 878.5040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The LipoGrafter® Kit is indicated to facilitate Autologous Fat Transfer (AFT). AFT is the harvesting, sedimenting and transfer of autologous fat tissue back into the same patient following a medical procedure. The device is intended for use when the transfer of harvested adipose tissue is desired for aesthetic body contouring. The device is intended for use in the following surgical specialties: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery. Only legally marketed accessory items, such as syringes and cannulas, should be used with the system. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
Device Story
LipoGrafter Kit is a sterile, single-use, closed-loop system for harvesting, sedimenting, and transferring autologous fat. Components include KVAC syringe, AT-Valve, and collection bags with silicone tubing. Unlike predicate systems requiring external vacuum/aspirator, LipoGrafter utilizes integrated constant force springs within the syringe to generate suction. Device operates via gravity-based decantation for fat separation. Used by surgeons in clinical settings; compatible with standard luer-lock syringes and cannulas (ISO 80369-7). Output is processed adipose tissue ready for re-implantation without further manipulation. Benefits include simplified, self-contained suction mechanism for autologous fat grafting procedures.
Clinical Evidence
No clinical data. Bench testing included adipocyte cell viability, usability evaluation, plunger force testing, vacuum pressure assessment, biocompatibility, material-mediated pyrogenicity, bacterial endotoxin testing, sterilization validation, and packaging validation.
Technological Characteristics
Closed-loop kit; sterile, single-use. Materials: biocompatible. Suction: integrated constant force springs. Separation: gravity-based decantation. Connectivity: standard luer lock (ISO 80369-7). No external energy source required. No software/algorithm.
Indications for Use
Indicated for autologous fat transfer (AFT) in patients requiring aesthetic body contouring across various surgical specialties including orthopedic, neuro, GI, urological, general, gynecological, thoracic, laparoscopic, and plastic/reconstructive surgery. Contraindicated for fat manipulation beyond harvesting, sedimenting, and transfer.
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.
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## 510(k) Summary
| **Device Trade Name:** | LipoGrafter® Kit |
| --- | --- |
| **Manufacturer:** | Musculoskeletal Transplant Foundation (MTF Biologics) 125 May Street Edison, NJ 08837 USA |
| **Contact:** | Katrina Caroll Director of Regulatory Affairs Phone: 732-661- 3154 |
| **Date Prepared:** | May 9, 2024 |
| **Classifications:** | 21 CFR 878.5040; Suction lipoplasty system |
| **Class:** | II |
| **Product Codes:** | QKL |
| **Primary Predicate:** | K172714 LipiVage® by Genesis Biosystems, Inc. |
### Indications For Use:
The LipoGrafter® Kit is indicated to facilitate Autologous Fat Transfer (AFT). AFT is the harvesting, sedimenting and transfer of autologous fat tissue back into the same patient following a medical procedure. The device is intended for use when the transfer of harvested adipose tissue is desired for aesthetic body contouring. The device is intended for use in the following surgical specialties: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery. Only legally marketed accessory items, such as syringes and cannulas, should be used with the system. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
### Device Description:
The LipoGrafter Kit is a sterile, non-pyrogenic, single use disposable device that is used in harvesting, sedimenting, and transferring autologous fat to the desired anatomy. The components of the LipoGrafter Kit include: KVAC® Syringe, AT-Valve®, 4 Collection bags with silicone tubing and luer connectors. These devices utilize standard luer lock connections per ISO 80369-7 and are used in combination with FDA-cleared syringes and cannulas.
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# **Comparison of Technological Characteristics:**
| | Subject Device LipoGrafter Kit by MTF Biologics | Predicate Device BK 220714 (K172714) LipiVage® by Genesis Biosystems, Inc. | Comparison |
| --- | --- | --- | --- |
| **Administrative Information** | | | |
| Common Name | Lipoplasty System | Lipoplasty System | Same |
| Regulation Number | 21 CFR 878.5040 | 21 CFR 878.5040 | Same |
| Device Class | Class II | Class II | Same |
| Product Code | QKL; Lipoaspirate Washing System for Aesthetic Body Contouring | MUU; Lipoplasty System, Suction | Same (with current product code) |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery | Same |
| **Intended Use** | | | |
| Indications for Use | The LipoGrafter® Kit is indicated to facilitate Autologous Fat Transfer (AFT). AFT is the harvesting, sedimenting and transfer of autologous fat tissue back into the same patient following a medical procedure. The device is intended for use when the transfer of harvested adipose tissue is desired for aesthetic body contouring. The device is intended for use in the following surgical specialties: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery. Only legally marketed accessory items, such as syringes and cannulas, should be used with the system. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. | LipiVage® 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 re-implanted, the harvested fat is only to be used without any additional manipulation. LipiVage® 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. | Similar The only difference is in the predicate uses a legally marketed vacuum or aspirator apparatus as a source of suction. The subject system design includes a source of suction in the syringe. |
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| Technological Characteristics | | | |
| --- | --- | --- | --- |
| System | Closed loop, kit with syringe | Closed loop, kit with syringe | Same |
| Use and Sterility | Single-use, sterile | Single-use, sterile | Same |
| Biocompatibility | Biocompatible | Biocompatible | Same |
| Method of Separation | Collection (decantation) bag and gravity | Plunger with in-line filter in the syringe | Different |
| Source of Energy / Suction | Syringe with embedded constant force springs | Vacuum or aspirator apparatus at the user facility | Different |
| --- | --- | --- | --- |
| Centrifuge Required | No | No | Same |
| Compatible with legally marketed aspiration / injection cannulas and syringes | Yes | Yes | Same |
### Performance Testing Summary:
Non-clinical testing included:
- Adipocyte cell viability testing
- Usability evaluation
- Plunger force test
- Vacuum pressure assessment
- Biocompatibility evaluation
- Material-mediate pyrogenicity testing
- Bacterial endotoxin testing
- Sterilization validation
- Packaging validation
### Substantial Equivalence:
The subject device and the predicate device have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are both provided sterile for single-patient use. The differences between the subject and predicate devices include the method of fat separation (decantation vs. in line filter) and the source of suction (syringe with constant force springs vs. legally marketed source of suction at the user facility). The data supplied in this submission demonstrates the ability of the subject design to perform the intended use.
### Conclusion:
Based on the comparison of intended use and technological characteristics, MTF Biologics has demonstrated the subject LipoGrafter Kit is substantially equivalent to the predicate device.
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