(84 days)
The Heartport Needle Trocars are intended to provide access to the thoracic cavity. The Heartport Needle Trocar allows suture snares and similar small devices to be inserted and used during minimally invasive cardiothoracic surgery procedures.
The Heartport Needle Trocar is identical to the Popper & Sons Biopsy Needle in design and performance characteristics.
This document is a 510(k) summary for a medical device called the "Heartport Needle Trocar." It focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with acceptance criteria, ground truth, and expert reviews in the way a diagnostic AI device summary would.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in the provided text because it describes a different type of regulatory submission (a physical medical device, not a diagnostic AI or imaging analysis device).
Here's a breakdown based on the information provided and an explanation of why other sections are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (N/A) - No specific performance metrics or acceptance criteria for the Heartport Needle Trocar are defined in this document as it relies on substantial equivalence. | The Heartport Needle Trocar is "identical to the Popper & Sons Biopsy Needle in design and performance characteristics." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No "test set" in the context of a diagnostic algorithm or performance study was used. The submission relies on the established performance of a predicate physical device.
- Data Provenance: Not applicable.
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. There was no test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is not a diagnostic AI device subject to such studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's performance is its similarity to a predicate device with "well established performance" already on the market.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
Summary Explanation:
The document describes a 510(k) submission for a needle trocar, a physical surgical instrument. The regulatory pathway chosen is substantial equivalence. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device (the "predicate device") and does not raise new questions of safety or effectiveness.
Instead of conducting new clinical trials or performance studies with acceptance criteria, the submission argues that the Heartport Needle Trocar:
- Has an identical intended use to the Heartport Surgical Thoracic Trocar.
- Is identical in design and performance characteristics to the Popper & Sons Biopsy Needle, a device with "well established performance" successfully marketed for many years.
- Uses materials with "proven biocompatibility."
Therefore, the "proof" the device meets acceptance criteria is its demonstrated substantial equivalence to predicate devices whose safety and effectiveness have already been established. The type of detailed study information requested in your prompt (e.g., sample sizes, ground truth, expert review for AI/diagnostic devices) is not relevant or included in this specific type of 510(k) submission for a physical, substantially equivalent device.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.