(84 days)
K/DEN number not found in text.
Not Found
No
The summary describes a simple mechanical device (needle trocar) and explicitly states it is identical to a predicate device (biopsy needle) with no mention of AI/ML or related concepts.
No
The device is described as a surgical access tool for minimally invasive cardiothoracic procedures, allowing for the insertion of other small devices, but it does not inherently treat or cure any condition itself.
No.
The device description and intended use indicate it is an access tool for surgical procedures, not for identifying or diagnosing a condition. Its function is to allow other small devices to be inserted, similar to a biopsy needle which is used for sample collection, not diagnosis itself.
No
The device description clearly states it is a "Needle Trocar," which is a physical surgical instrument, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access to the thoracic cavity" and allow insertion of "suture snares and similar small devices" during surgery. This is a surgical access tool, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: It's described as a "Needle Trocar" and compared to a "Biopsy Needle," which are surgical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to diagnose diseases or conditions. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
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.
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 Needle Trocar is identical to the Popper & Sons Biopsy Needle in design and performance characteristics. As this predicate device has been successfully marketed for many years with well established performance, no further testing is warranted.
Key Metrics
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Predicate Device(s)
Not Found
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.
1956 The assigned 510(k) number is: _ MAR
Applicant Information:
| Date Prepared: | December 17, 1996 |
|---|---|
| Name: | Heartport, Inc. |
| Address: | 200 Chesapeake Drive |
| Redwood City, CA 94063 | |
| Contact Person: | Marianne C. Drennan |
| Phone Number: | (415) 482-4405 |
| Fax Number: | (415) 482-4346 |
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | HeartportTM Needle Trocar |
| Classification Name: | Cardiovascular Devices - Trocar |
| 21 CFR 870.1390 |
Equivalent Devices:
The Heartport Needle Trocar is substantially equivalent in intended use and/or method of operation to the Heartport Surgical Thoracic Trocar and the Popper & Sons Biopsy Needle.
Intended Use:
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.
Comparison To Predicate Devices:
The Heartport Needle Trocars are equivalent in intended use to the Heartport Surgical Thoracic Trocars. They are equivalent in operational characteristics to the Popper & Sons Biopsy Needles.
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ប់
510(k) Summary of Safety and Effectiveness, continued
Non-Clinical Test Results:
Performance
The Heartport Needle Trocar is identical to the Popper & Sons Biopsy Needle in design and performance characteristics. As this predicate device has been successfully marketed for many years with well established performance, no further testing is warranted.
Biocompatibility
The materials used in the Heartport Needle Trocar have proven biocompatibility.
Summary:
Based on the intended use, product, performance and biocompatibility information provided in this Notification, Heartport Needle Trocars have been shown to be substantially equivalent to a combination of currently marketed predicate devices.
Heartport, Inc.
CONFIDENTIAL