(9 days)
Tissu Trans Filtron Syringe Fill is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
Tissu Trans Filtron Syringe Fill is used in the aspiration, harvesting, filtering and transferring of autologous tissue.
Tissue Trans Filtron is intended for use in the following surgical specialties when the 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
- Laparoscopic Surgery
Shippert Medical's Tissu Trans Filtron Syringe Fill is an optional accessory to Shippert Medical's Tissu Trans Filtron, K092482. Shippert Medical's Tissu Trans Filtron Syringe Fill is a sterile, single use, disposable device used in the aspiration, harvest, filtering and transferring of autologous tissue. Used by physicians in the harvesting of body tissues, this device is a single use, disposable sterile canister with six enclosed 60cc syringes used for collecting the harvested tissue after harvesting/aspiration.. The harvested tissue is stored in the Syringe Fill syringes and is intended for immediate reinjection of the harvested tissue back into the donor patient.
Here's a breakdown of the acceptance criteria and the study details for the Tissu Trans Filtron Syringe Fill, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Design Specifications) | Reported Device Performance |
|---|---|
| All design specifications met | Satisfied all design specifications |
| Safe | Proved to be safe |
| Effective | Proved to be effective |
| Substantially equivalent to predicate device | Substantiated by mechanical and clinical testing |
| Performed as desired | Performed as desired |
Study Details
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Sample Size Used for Test Set and Data Provenance:
- Sample Size: Not explicitly stated, though referred to as "clinical testing."
- Data Provenance: Prospective (clinical testing was "conducted by Ronald D. Shippert, M.D. to validate and verify that the proposed device met all design specifications"). No country of origin is specified beyond it being a U.S. 510(k) submission, implying U.S. based.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: One, Ronald D. Shippert, M.D.
- Qualifications: "Ronald D. Shippert, M.D." (presumably a medical doctor, likely a surgeon given the device's application). No specific years of experience are listed.
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Adjudication Method for the Test Set:
- Method: Not applicable. The "clinical testing" was conducted by a single physician without mention of additional adjudicators.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. The summary describes a single-operator clinical evaluation without a comparative effectiveness study involving multiple readers (human readers with/without AI assistance).
- Effect Size: Not applicable.
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Standalone (Algorithm Only) Performance Study:
- Was it done?: Not applicable. This device is a physical medical instrument (suction lipoplasty system accessory) and does not involve an algorithm or AI.
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Type of Ground Truth Used:
- Type: Clinical assessment/expert judgment. The ground truth was established by Ronald D. Shippert, M.D.'s clinical evaluation, where he determined if the device performed as desired, was safe and effective, and met design specifications.
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Sample Size for the Training Set:
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "clinical testing" referenced serves as the performance evaluation for the device itself.
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How the Ground Truth for the Training Set Was Established:
- Method: Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.