Who is the manufacturer of HEARTPORT NEEDLE TROCAR?

Heartport, Inc. submitted the Traditional clearance for HEARTPORT NEEDLE TROCAR (K965051).

What is the FDA product code for HEARTPORT NEEDLE 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 NEEDLE TROCAR?

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

What are the predicate devices for HEARTPORT NEEDLE TROCAR?

Heartport Surgical Thoracic Trocar; Popper & Sons Biopsy Needle.

HEARTPORT NEEDLE TROCAR

K965051 · Heartport, Inc. · DRC · Mar 12, 1997 · Cardiovascular

Device Facts

Record ID	K965051
Device Name	HEARTPORT NEEDLE TROCAR
Applicant	Heartport, Inc.
Product Code	DRC · Cardiovascular
Decision Date	Mar 12, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1390
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Needle trocar; provides thoracic cavity access; facilitates insertion of suture snares/small instruments during minimally invasive cardiothoracic surgery. Used by surgeons in clinical/OR settings. Device design/performance equivalent to biopsy needles; enables instrument passage through thoracic wall.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established via design and performance comparison to predicate devices.

Technological Characteristics

Needle-based trocar design; biocompatible materials. Mechanical device for thoracic access. No software or electronic components.

Indications for Use

Indicated for patients undergoing minimally invasive cardiothoracic surgery requiring thoracic cavity access for insertion of suture snares or similar small devices.

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

Heartport Surgical Thoracic Trocar
Popper & Sons Biopsy Needle

Related Devices

K964302 — HEARTPORT THORACIC TROCAR · Heartport, Inc. · May 9, 1997
K961463 — HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 · Heartport, Inc. · Oct 8, 1996
K091350 — ESTECH HAWKEYE INTRODUCER SYSTEMS · Endoscopic Technologies, Inc. D/B/A Estech · Sep 15, 2009
K150549 — Reactor(TM) Trocar and Sleeve · Sharp Medical Prducts, LLC · Jun 1, 2015
K063859 — SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA · Surgiquest, Inc. · Mar 14, 2007

Submission Summary (Full Text)

{0} Heartport™ Needle 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: **K965051** MAR 12 1997 ## 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: Heartport™ 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. Heartport, Inc. CONFIDENTIAL Page 18 {1} Heartport™ Needle Trocars Appendices ## 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 Page 19