HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2

K961463 · Heartport, Inc. · GCJ · Oct 8, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961463
• Device Name: HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2
• Applicant: Heartport, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Device provides thoracic cavity access via intercostal spaces; facilitates insertion of endoscopic instruments, thoracoscopes, and accessory devices; enables suture organization. Used in cardiac surgery; operated by surgeons. Device integrates functions of multiple predicate trocars and suture guides into single unit. Compatible with Heartport Oval Light for surgical site illumination. Benefits include minimal to no rib retraction during endoscopic procedures.

Clinical Evidence

Bench testing (in vitro) evaluated compatibility with endoscopic instruments and suture organization. In vivo studies conducted to confirm performance. Results demonstrated device is safe, effective, and meets clinical requirements.

Technological Characteristics

Thoracic trocar cannula and obturator system. Materials are identical to predicate devices with established biocompatibility. Designed for intercostal access. Compatible with external illumination accessory (Oval Light).

Indications for Use

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

Regulatory Classification

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.

Special Controls

*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.

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
• Deknatel - Gabby-Frater Suture Guide

Submission Summary (Full Text)

{0}

Heartport™ Thoracic Surgical Trocars
Appendices

# 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: Heartport, Inc.
Address: 200 Chesapeake Drive
Redwood City, CA 94063

Contact Person: Isabella Abati
Phone Number: [phone]
Fax Number: [phone]

## Device Information:

Classification: Class II
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:

1. U.S. Surgical - Auto Suture Thoracoport 11.5 mm Disposable Trocar
2. Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic
3. Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator
4. Snowden-Pencer - Reusable Thora-Port
5. Deknatel - Gabby-Frater Suture Guide

Heartport, Inc.
CONFIDENTIAL
Page 20

{1}

Heartport™ Thoracic Surgical Trocars
Appendices

# 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 mm Disposable Trocar, (2) Origin Medsystems (a Guidant Corp.) - Surgical Trocar 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.

Heartport, Inc.
CONFIDENTIAL
Page 21