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510(k) Data Aggregation
(210 days)
The device is intended to be used for aesthetic body contouring.
The subject device is used in conjunction with the Lipomatic Handpiece. The Lipomatic Handpiece is a motorized pneumatic handle with interchangeable canulae. The Lipomatic handpiece can be used with readily available air sources at the hospital or clinic.
The EVA sp6 is an aspiration system that can be used with the Lipomatic handpiece for the purposes of aesthetic body contouring.
The EVA sp6 can be in continuous operation or can be controlled by a foot pedal. The device has two modes; infiltration and aspiration. Syringes are used for infiltration.
The EVA sp6 has wheels to allow it to move around the clinical or hospital as needed.
The list of accessories include:
- Pedal .
- . Hospital Grade Power Cord and Plug
- Replacement Fuses .
- Tubing (5 kits) .
- Twisted Pipe of 5 meter with one connector .
- Aspiration Jars (2 jars) .
The request is to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text.
Based on the provided FDA 510(k) submission summary for the "Euromi EVA sp6 Lipoplasty Suction System" (K101413), here's the information regarding acceptance criteria and supporting studies:
- A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Electrical | 110-120 V | 110-120 V (Implied by specification. No test result explicitly states the measured voltage, but passing electrical safety testing implies conformity.) |
| Power | 250 W | 250 W (Implied by specification. No test result explicitly states the measured power, but passing electrical safety testing implies conformity.) |
| Noise Level | 57 dB | 57 dB |
| Weight | 10 Kg | 10 Kg |
| Final Vacuum (mb relative) | -850 | -850 |
Note: The document lists "Specification" which functions as the acceptance criteria for these characteristics. The "Reported Device Performance" is implied to meet these specifications as the device passed non-clinical testing.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text indicates that non-clinical testing was performed on the subject device. For electrical safety, EMC, FCC Part 15, and accuracy testing, typically a sample size of one or a small number of devices is used to demonstrate compliance. The exact sample size is not specified in the document. The data provenance is also not specified, but given it's for an EU manufacturer (Euromi SA in Belgium) seeking US FDA clearance, the testing would generally follow internationally recognized standards (like IEC) and potentially be conducted by accredited labs. It is a prospective test in the sense that the device was specifically tested for these parameters.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device is a lipoplasty suction system, not an AI or diagnostic imaging device that requires expert-established ground truth for performance evaluation in the context of the provided document. The performance data relates to engineering specifications and safety standards.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As above, this is about engineering performance and safety testing, not diagnostic accuracy requiring adjudication among experts.
- 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
No. A MRMC comparative effectiveness study was not performed. This device is a medical instrument (lipoplasty suction system), not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance evaluation was for the standalone physical device. The device was subjected to standalone non-clinical testing for electrical safety, EMC, FCC Part 15, and accuracy.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data (electrical, power, noise, weight, vacuum), the "ground truth" is established by engineering specifications and measurements against recognized standards. For example, electrical safety is measured against IEC 60601-1. The vacuum level is a direct measurement.
- The sample size for the training set
Not applicable. This is not an AI/machine learning device. There is no training set mentioned or implied.
- How the ground truth for the training set was established
Not applicable. There is no training set for this device.
Ask a specific question about this device
(168 days)
The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.
The principle of operation and technology incorporated in the Dispenser DP 20 are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. As with all peristaltic pumps, the Dispenser DP 20 contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action. Sterility: Tubing set; disposable with plug-in cannula, sterile, length 4 m
The provided text is a 510(k) summary for the NOUVAG Dispenser DP 20, an infiltration pump. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria in the way you've outlined.
Therefore, the information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.
The 510(k) summary does contain the following relevant points:
- Device Description and Intended Use: The Dispenser DP 20 is an infiltration pump intended for general surgical fluid irrigation and infiltration under physician control, using a peristaltic action. It is not for intravascular infusion.
- Predicate Devices: The document identifies two predicate devices:
- Substantial Equivalence Claim: The manufacturer claims substantial equivalence based on the principle of operation and technology (peristaltic action for fluid delivery) being similar to other irrigation devices previously cleared by the FDA.
- Nonclinical Testing: A brief summary states: "The Dispenser DP 20 has been designed and tested to applicable safety standards. The Dispenser DP 20 does not raise any new issues of safety, effectiveness, or performance of the product." This indicates some form of testing was done to safety standards, but no specific criteria or results are provided.
In summary, this 510(k) document is a regulatory submission focused on comparing technological characteristics and intended use to existing devices, not on providing a detailed performance study with quantifiable acceptance criteria and results as typically found for novel AI/diagnostic devices.
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(77 days)
The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.
The principles of operation and technology incorporated in the Infiltration Pump are equivalent to peristaltic infiltration/irrigation devices, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.
The Infiltration Pump uses a multiple roller pump and a mechanical tubing clamp to squeeze and hold tubing and assist in moving fluid from an IV fluid bag to the infiltration site. As with all peristaltic pumps, the Infiltration Pump contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.
The provided 510(k) summary for the Infiltration Pump (K050324) states that the device's substantial equivalence is based on the "principles of operation and technology incorporated" being equivalent to existing peristaltic infiltration/irrigation devices.
Therefore, this submission is a traditional 510(k) submission based on substantial equivalence to predicate devices, and not a de novo submission requiring clinical performance studies and defined acceptance criteria.
As such, the document does not contain information on:
- Acceptance criteria or reported device performance for a study.
- Sample size, data provenance, or ground truth for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.) beyond conceptual equivalence.
- Sample size for a training set.
- How ground truth for a training set was established.
The document primarily focuses on establishing "substantial equivalence" to predicate devices, which means demonstrating that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. This typically involves comparing technological characteristics, indications for use, and performance claims to the listed predicates (PSI-TEC Peristaltic Infiltration Pump K040149 and Klein Surgical Infiltration Pump, Model KIP-II K031432).
To fulfill the request, a clinical study with detailed acceptance criteria and performance metrics would be required, which is beyond the scope of this 510(k) summary.
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