(106 days)
Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired.
Tissu-Trans™ is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.
Tissue-Trans™ is a sterile, single use, disposable syringe device used in the harvesting, filtering and transferring of autologous fat. Used by acinso asounding procedures,Tissue Trans™ simplifies and reduces the steps prysiolane in the collection and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection.
Tissu-Trans™ is a piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small10cc syringe is placed inside a larger 60cc barrel type tube, which is attached to a medical grade tubing and aspiration machine. As the autologous fat is collected into the 10cc syringe, the waste products are strained through the holes in the 10cc syringe into the large 60cc barrel tube and suctioned into a waste container. The small syringe is removed from the large 60cc tube, a sleeve is attached to the small 10cc syringe around the barrel and the autologous fat is re-injected into the patient at desired locations.
The provided document is a 510(k) summary for a medical device called Tissu-Trans™ by Shippert Medical Technologies. It focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for the device itself is not available in this type of submission.
Here's an attempt to answer the questions based on the provided text, while also noting what information is not available in this type of regulatory document.
Explanation of the Submission Type:
A 510(k) premarket notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process often relies on comparisons of technological characteristics, intended use, and materials to show that the new device is as safe and effective as the predicate. It does not typically require extensive clinical trials or performance studies with detailed acceptance criteria and ground truth validation for the new device as would be seen for novel technologies or higher-risk devices.
Acceptance Criteria and Study Details for Shippert Medical Technologies Tissu-Trans™
Given the nature of a 510(k) premarket notification, the "acceptance criteria" for the device itself in terms of specific performance metrics (like accuracy, sensitivity, specificity, or error rates) are not explicitly stated or demonstrated through a formal performance study with a test set, ground truth, or expert adjudication as one might see for an AI/CAD system. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. This means that if the new device has similar technological characteristics, intended use, and materials to a legally marketed predicate, it is deemed acceptably safe and effective.
The study that "proves" the device meets these criteria is primarily the comparison to predicate devices described in the 510(k) submission.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance / Justification |
|---|---|
| Intended Use Equivalence: The device's intended use is substantially similar to predicate devices. | Tissu-Trans™ Intended Use: "harvesting, filtering and transferring of autologous fat." |
| Predicate Equivalence: This is deemed equivalent to the intended use of the predicate devices based on the product code KYZ description: "An irrigating syringe is a device intended for medical purposes that consists of a bulb or piston syringe with integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound." | |
| Technological Characteristics Equivalence: The device has similar technological characteristics to predicate devices. | Tissu-Trans™ Characteristics: "piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small 10cc syringe is placed inside a larger 60cc barrel type tube..." |
| Predicate Equivalence: "The device design and materials used, are similar to those of the Predicate Device Johnson & Johnson Syringe K884749 and LipiVage, k# unknown, and also to most of the piston syringes in the Product Code KYZ." The mechanism for separating fat from waste products is described as an improvement due to "less traumatized" fat cells and "reduced risk of infection" due to remaining in a sterile field. | |
| Materials Equivalence: Materials used are safe and similar to predicate devices. | Tissu-Trans™ Materials: Implied to be medical-grade and similar to "most of the piston syringes in the Product Code KYZ." (Specific material details are not provided in this summary but would be in the full submission). |
| Safety and Effectiveness: The device is as safe and effective as the predicate devices. | Conclusion: "The Tissu-Trans™ device described in this submission is substantially equivalent to the predicate devices, and is safe and effective." This is a declarative statement based on the comparison rather than a result of a direct performance study. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: For a 510(k) submission based on substantial equivalence to an existing device, there isn't typically a "test set" in the sense of a dataset used to validate performance metrics like accuracy or error rates for the new device. The "test" is the comparison to the predicate device's design, materials, and intended use. No specific data provenance (country, retrospective/prospective) is relevant to this type of comparison.
3. 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 / Not Provided: As there is no "test set" with performance metrics requiring ground truth in this 510(k) summary, no experts were involved in establishing ground truth for a performance study of the Tissu-Trans™ device. The FDA reviews the provided information to determine substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / None: No adjudication method was used for a test set, as no such performance study is described in this 510(k) summary.
5. 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: This is not an AI/CAD device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is not an AI/CAD device. Therefore, no standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / None: No ground truth was established for a performance study of the Tissu-Trans™ device itself. The "ground truth" for a 510(k) is effectively the established safety and effectiveness of the predicate device(s).
8. The sample size for the training set
- Not Applicable / None: This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established
- Not Applicable / None: As there is no training set for this device, no ground truth was established for it.
§ 880.6960 Irrigating syringe.
(a)
Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.