(192 days)
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No
The summary describes a mechanical surgical instrument (trocar) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a surgical tool (trocar) used to create access for other instruments during cardiothoracic surgery. It does not directly treat a disease or condition.
No
The provided text describes a medical device, the Heartport Thoracic Trocar, which is used to provide access to the thoracic cavity for surgical procedures. Its function is to facilitate the insertion of endoscopic instruments and other devices during cardiothoracic surgery. This is a surgical access tool, not a device that diagnoses medical conditions.
No
The device is described as a "Thoracic Trocar," which is a physical instrument used for surgical access. The performance studies also describe in vivo testing related to insertion and removal force, indicating a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Heartport Thoracic Trocar is a surgical instrument used to create access into the thoracic cavity during surgery. It is used on the patient's body, not for testing samples taken from the body.
- Intended Use: The intended use clearly states it's for providing access to the thoracic cavity for surgical procedures, not for diagnostic testing of specimens.
Therefore, based on the provided information, the Heartport Thoracic Trocar is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracic cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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.
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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.