(174 days)
U.S. Surgical - Auto Suture Thoracoport 11.5 mm Disposable Trocar, Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic, Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator, Snowden-Pencer - Reusable Thora-Port, Deknatel - Gabby-Frater Suture Guide
Not Found
No
The summary describes a mechanical surgical instrument (trocar) and its intended use for providing access during cardiac surgery. There is no mention of any computational or data-driven components that would suggest the use of AI or ML. The performance studies focus on mechanical and functional aspects.
No
The device is a surgical access tool, not a device intended to treat or cure a disease or condition. It facilitates a surgical procedure.
No
The device provides access for surgical instruments and accessory devices and can be used for suture organization. It is an access device used during surgery, not a device that diagnoses a condition.
No
The device description explicitly states it is a surgical trocar, which is a physical instrument used to access the thoracic cavity. It also mentions compatibility with an "Oval Light accessory device," further indicating a hardware component. The performance studies describe in vitro and in vivo evaluations, consistent with a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide access to the thoracic cavity for surgical procedures and the insertion of instruments. This is an in-vivo (within a living organism) application, not an in-vitro (outside of a living organism) diagnostic test.
- Device Description: The description focuses on the physical function of the trocar for surgical access and instrument insertion.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- Anatomical Site: The device is used within the thoracic cavity of a patient.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
Heartport Thoracic Surgical Trocars are intended to provide access to the thoracic cavity through ports 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 cardiac surgery procedures. The trocar cannula may also be used for suture organization.
Product codes
Not Found
Device Description
The 510(k) summary describes the Heartport Thoracic Surgical Trocar as a device that provides access to the thoracic cavity for endoscopic instruments, thoracoscopes, and accessory devices during cardiac surgery procedures. It can also be used for suture organization. The device is intended to be used through ports in the intercostal spaces with minimal to no rib retraction. The Heartport Thoracic Surgical Trocars combine the functions of several individual predicate devices into a single device. It may also be used with the Heartport Oval Light accessory device for illumination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Results:
Performance: The Heartport Thoracic Surgical Trocar was evaluated in vitro for performance including compatibility with endoscopic instruments and suture organization ability. In addition, the Thoracic Surgical Trocar was evaluated during in vivo studies. Performance testing demonstrated that the Heartport Surgical Thoracic Trocar was safe and effective, while meeting the anticipated clinical requirements for its intended use.
Biocompatibility: The materials used to fabricate the Heartport Thoracic Surgical Trocar and Oval Light are the same as, and in most cases identical to, the predicate devices. The materials used in the Heartport Thoracic Surgical Trocar and Oval Light have proven biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
U.S. Surgical - Auto Suture Thoracoport 11.5 mm Disposable Trocar, Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic, Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator, Snowden-Pencer - Reusable Thora-Port, Deknatel - Gabby-Frater Suture Guide
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
APPENDIX A. 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: K961463 OCT - 8 1996
Applicant Information:
Date Prepared:
April 16, 1996
Name: Address: Heartport, Inc. 200 Chesapeake Drive Redwood City, CA 94063
Contact Person: | Isabella Abati |
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Phone Number: | (415) 306-7900 |
Fax Number: | (415) 306-7905 |
Device Information:
Classification | Class II |
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Trade Name: | Heartport™ Thoracic Surgical Trocar |
Common Name: | Trocars |
Classification Name: | Trocars: Cardiovascular Devices - Trocar, 21 CFR 870.1390 |
Equivalent Devices:
The Heartport Thoracic Surgical Trocars are substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:
-
- U.S. Surgical - Auto Suture Thoracoport 11.5 mm Disposable Trocar
-
- Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic
-
- Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator
-
- Snowden-Pencer - Reusable Thora-Port
- ട. Deknatel - Gabby-Frater Suture Guide
Heartport, Inc.
CONFIDENTIAL
1
510(k) Summary of Safety and Effectiveness (continued)
Intended Use:
Heartport Thoracic Surgical Trocars are intended to provide access to the thoracic cavity through ports 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 cardiac surgery procedures. The trocar cannula may also be used for suture organization.
Comparison To Predicate Devices:
The Heartport Thoracic Surgical Trocars are equivalent in intended use and operational characteristics to the following devices: (1) U.S. Surgical - Auto Suture Thoracoport 11.5 Disposable Trocar, (2) Origin Medsystems (a Guidant Corp.) - Surgical Trocar mm Thoracic, (3) Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator, (4) Snowden-Pencer - Reusable Thora-Port and (5) Deknatel -Gabby-Frater Suture Guide.
The Heartport Thoracic Surgical Trocars combine the same functions as the individual predicate devices into a single device. Heartport Thoracic Surgical Trocars may be used with the Heartport Oval Light accessory device to provide illumination to the surgical site.
Non-Clinical Test Results:
Performance
The Heartport Thoracic Surgical Trocar was evaluated in vitro for performance including compatibility with endoscopic instruments and suture organization ability. In addition, the Thoracic Surgical Trocar was evaluated during in vivo studies. Performance testing demonstrated that the Heartport Surgical Thoracic Trocar was safe and effective, while meeting the anticipated clinical requirements for its intended use.
Biocompatibility
The materials used to fabricate the Heartport Thoracic Surgical Trocar and Oval Light are the same as, and in most cases identical to, the predicate devices. The materials used in the Heartport Thoracic Surgical Trocar and Oval Light have proven biocompatibility.
Summary:
Based on the intended use, product information, performance and biocompatibility data provided in this Notification, Heartport Thoracic Surgical Trocars have been shown to be substantially equivalent to currently marketed predicate devices.