(143 days)
The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
The Lipogems System is a pre-assembled device consisting of:
- An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and 2 stainless steel sieve filters;
- An input washing line connected to the 'blue' end-cap the processing unit;
- An access port for the loading of material to be processed with a Luer-lock connection and self-occluding valve (blue end-cap);
- A drain line connected to the 'gray' end-cap of the processing unit;
- An access port for the discharge of processed material with a Luer-lock connection and self-occluding valve (gray end-cap);
- A bag for collecting waste material.
The Lipogems System Processing Unit is supplied sterile, for single use only, and manufactured in two size variants with the same functional characteristics:
- LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve;
- LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;
This document is a 510(k) premarket notification for the Lipogems System. It focuses on demonstrating substantial equivalence to a previously cleared device (K142682, also the Lipogems System) and a reference device (Ranfac FATS Procedure Pack, K150156). The document explicitly states that "The subject device is identical in every way to the predicate device previously cleared," and later, "The Subject and Predicate device are identical in every material and functional way, as there has been no change to the device materials, design, manufacturing, sterilization, packaging or any other feature since its prior clearance under K142682."
Therefore, the submission does not present new acceptance criteria or a new study to prove the device meets new criteria. Instead, it relies on the previous clearance and asserts that the current device is the same. The only change mentioned is a "revised language of the IFU and other labelling."
Given this, I cannot provide a table of acceptance criteria and reported device performance from this document, nor details about a new study, sample sizes, experts, adjudication methods, or MRMC studies. This information would have been part of the original K142682 submission.
However, I can extract information relevant to the current submission's claims of equivalence:
- Device Name: Lipogems System
- 510(k) Number: K161636
- Predicate Device: K142682 The Lipogems System, Lipogems International, S.p.A.
- Reference Device: K150156 Ranfac FATS Procedure Pack, Ranfac Corporation
The submission emphasizes that the current Lipogems System is identical to the predicate device K142682. The comparison table with the reference device, Ranfac FATS Procedure Pack, highlights similarities across various aspects.
Below are the details that can be extracted or inferred from this specific document, primarily regarding the assertion of equivalence rather than new performance data:
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Table of Acceptance Criteria and Reported Device Performance: This document does not provide a new table of acceptance criteria or performance data for the K161636 submission because it claims the device is identical to a previously cleared predicate. Performance was presumably established during the K142682 submission process. The table provided in the document focuses on comparing the subject device (K161636 Lipogems System) to its predicate (K142682 Lipogems System) and a reference device (Ranfac FATS Procedure Pack) to establish substantial equivalence based on device characteristics and indications for use, rather than new performance metrics.
Implicit Acceptance Criterion (for Equivalence): The device (K161636) should be identical in material, functional aspects, design, manufacturing, sterilization, and packaging to the predicate device (K142682) and have similar technological characteristics and indications for use to the predicate and reference devices.
Characteristic Predicate Device (K142682) Subject Device (K161636) Reference Device (K150156) Similarity Device Name The Lipogems System The Lipogems System Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack Identical to predicate, different from reference Device Manufacturer Lipogems International SpA Lipogems International SpA Ranfac Corporation Identical to predicate, different from reference 510(k) Reference K142682 K161636 K150156 N/A (unique to each submission) FDA Product Code MUU MUU MUU Identical FDA Classification Name System, Suction, Lipoplasty System, Suction, Lipoplasty System, Suction, Lipoplasty Identical FDA Regulation Number 878.5040 878.5040 878.5040 Identical System concept Closed loop Closed loop Closed Loop Identical Device Size Variations Two: LGD 60, LGD 240 Two: LGD 60, LGD 240 None Identical to predicate, different from reference Fill Volumes Up to 30 or 120 ml of fat Up to 30 or 120 ml of fat 5ml to 25ml of fat Identical to predicate, different from reference Construction Preassembled Preassembled Preassembled Identical Sterility Supplied sterile for single use Supplied sterile for single use Supplied sterile for single use Identical Sterilization method Ethylene oxide Gas Ethylene oxide Gas Ethylene oxide Gas Identical Sterility Assurance Level (SAL) SAL = 10-6 SAL = 10-6 SAL = 10-6 Identical to predicate Biocompatibility Biocompatible Biocompatible Biocompatible Identical Indications for Use / Intended Use Similar (for processing and transfer of autologous adipose tissue in various surgical specialties) Similar (expanded list of surgical specialties, but core function is processing and transferring autologous adipose tissue) Similar (for harvesting, concentrating, and transferring autologous adipose tissue in various surgical specialties) Similar (The subject device's Indications for Use language is slightly different/expanded compared to its own predicate, but still asserts overall similarity, especially compared to the Ranfac reference device for the core function of processing and transferring autologous adipose tissue.) -
Sample size used for the test set and the data provenance: Not applicable to this filing. This submission relies on substantial equivalence to a previously cleared device (K142632) that is stated to be "identical in every way." Any performance testing data would have been part of the original K142632 filing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a new study requiring expert ground truth establishment for performance testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a new study or test set requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The Lipogems System is a physical medical device for processing adipose tissue, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The Lipogems System is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this filing. As this is a substantial equivalence claim for an identical device, new performance data and corresponding ground truth are not presented.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
§ 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.