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

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.

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

Submission Summary (Full Text)

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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: [phone]
Fax Number: [phone]

## 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

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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
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