(192 days)
The Heartport Thoracic Trocars are intended to provide access to the thoracic cavity by inserting them into incisions in the intercostal spaces, with minimal-to-no rib retraction. The Heartport Thoracic Trocar allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiothoracic surgery procedures.
Not Found
The provided text is a 510(k) summary for a medical device (Heartport Thoracic Trocar) and does not contain the specific information requested in the prompt regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in studies for AI/ML-based medical devices.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than what would typically require the detailed study information outlined in your request.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance (Table): The document states "Performance testing demonstrated that the Heartport Thoracic Trocar is safe and effective, while meeting the anticipated clinical requirements for its intended use." It mentions evaluating "insertion force, removal force and compatibility with endoscopic instruments and vision equipment," but it does not provide specific quantitative acceptance criteria or reported numerical performance values for these aspects.
- Sample Size (Test Set) and Data Provenance: Not mentioned. The testing was "in vivo," implying animal or human cadaver studies, but details are absent.
- Number of Experts and Qualifications: Not applicable as this is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable; this is a physical medical device, not an AI assistance tool.
- Standalone Performance: The "Performance" section describes the device's function, but it's not a standalone algorithm in the sense of AI.
- Type of Ground Truth: Not applicable in the context of diagnostic accuracy. The ground truth for this device would be its physical properties and functionality (e.g., successful insertion, removal, compatibility).
- Sample Size (Training Set): Not applicable. This device does not have a training set in the AI/ML sense.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document describes a traditional medical device submission (trocar) and not an AI/ML-based device. Therefore, the detailed study design, ground truth, and acceptance criteria information requested for AI/ML product evaluation are not present.
{0}------------------------------------------------
APPENDIX B. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K964302
MAY - 9 1997
Applicant Information:
Date Prepared:
October 28, 1996
Name: Address: Heartport, Inc. 200 Chesapeake Drive Redwood City, CA 94063
| Contact Person: | Marianne C. Drennan |
|---|---|
| Phone Number: | (415) 306-7900 |
| Fax Number: | (415) 306-7905 |
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Heartport™ Thoracic Trocar |
| Classification Name: | Cardiovascular Devices - Trocar |
| 21 CFR 870.1390 |
Equivalent Devices:
The Heartport Thoracic Trocar is substantially equivalent in intended use and/or method of operation to the Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic.
Intended Use:
The Heartport Thoracic Trocars are intended to provide access to the thoracic cavity by inserting them into incisions in the intercostal spaces, with minimal-to-no rib retraction. The Heartport Thoracic Trocar allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiothoracic surgery procedures.
{1}------------------------------------------------
510(k) Summary of Safety and Effectiveness (continued)
Comparison To Predicate Devices:
The Heartport Thoracic Trocars are equivalent in intended use and operational characteristics to the Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic.
Non-Clinical Test Results:
Performance
The Heartport Thoracic Trocar was evaluated in vivo for performance including insertion force, removal force and compatibility with endoscapic instruments and vision equipment. Performance testing demonstrated that the Heartport Thoracic Trocar is safe and effective, while meeting the anticipated clinical requirements for its intended use.
Biocompatibility
The materials used to fabricate the Heartport Thoracic Trocar are similar to those used in the predicate device. The materials used in the Heartport Thoracic Trocar have proven biocompatibility.
Summary:
Based on the intended use, product information, performance and biocompatibility data provided in this Notification, Heartport Thoracic Trocars have been shown to be substantially equivalent to a currently marketed predicate 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.