Who is the manufacturer of HEARTPORT THORACIC TROCAR?

Heartport, Inc. submitted the Traditional clearance for HEARTPORT THORACIC TROCAR (K964302).

What is the FDA product code for HEARTPORT THORACIC TROCAR?

DRC. It is classified under 21 CFR 870.1390 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for HEARTPORT THORACIC TROCAR?

510(k) clearance (submission type: Traditional).

HEARTPORT THORACIC TROCAR

K964302 · Heartport, Inc. · DRC · May 9, 1997 · Cardiovascular

Device Facts

Record ID	K964302
Device Name	HEARTPORT THORACIC TROCAR
Applicant	Heartport, Inc.
Product Code	DRC · Cardiovascular
Decision Date	May 9, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1390
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Thoracic trocar; provides access to thoracic cavity via intercostal spaces; facilitates insertion of endoscopic instruments, thoracoscopes, and accessory devices; used during cardiothoracic surgery; enables minimally invasive access with minimal-to-no rib retraction; operated by surgeons in clinical/OR settings; provides stable port for instrumentation; benefits patient by reducing surgical trauma associated with traditional rib retraction.

Clinical Evidence

Bench testing and in vivo performance evaluation; assessed insertion force, removal force, and compatibility with endoscopic/vision equipment; demonstrated safety and effectiveness meeting clinical requirements.

Technological Characteristics

Thoracic trocar; biocompatible materials; designed for intercostal insertion; compatible with standard endoscopic instruments and thoracoscopes.

Indications for Use

Indicated for patients undergoing cardiothoracic surgery requiring endoscopic access to the thoracic cavity via intercostal spaces.

Regulatory Classification

Identification

A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

Special Controls

*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.

Predicate Devices

Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic

Related Devices

K965051 — HEARTPORT NEEDLE TROCAR · Heartport, Inc. · Mar 12, 1997
K961463 — HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 · Heartport, Inc. · Oct 8, 1996
K022257 — VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX · Vomed Volzer Medizintechnik GmbH & Co. · Oct 4, 2002
K970888 — IOTEC TROCAR AND FLEXIBLE CANNULA · Iotec Industries · Jan 9, 1998
K150549 — Reactor(TM) Trocar and Sleeve · Sharp Medical Prducts, LLC · Jun 1, 2015

Submission Summary (Full Text)

{0} Heartport™ Thoracic Trocars Appendices # 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: Heartport, Inc. Address: 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. Heartport, Inc. CONFIDENTIAL Page 26 {1} Heartport™ Thoracic Trocars Appendices # 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 endoscopic 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. Heartport, Inc. CONFIDENTIAL Page 27