VASOVIEW BALLOON DISSECTION SYSTEM

K964171 · Origin Medsystems, Inc. · GCJ · Feb 14, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964171
• Device Name: VASOVIEW BALLOON DISSECTION SYSTEM
• Applicant: Origin Medsystems, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VasoView™ Balloon Dissection System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used to form elongated working cavities during thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including, nerves, blood vessels and other tissues of the chest wall. The VasoView™ Balloon Dissection System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

Device Story

VasoView™ Balloon Dissection System is a single-use, sterile dissection cannula used in minimally invasive thoracoscopic surgery. Device consists of a tubular body with a distal transparent conical tapered tip, an elastomeric balloon, luer extension, and syringe. Physician inserts a 5mm rigid endoscope through the tapered tip for visualization. Device is advanced along anatomic tracts; sequential balloon inflation creates an elongated working cavity to isolate structures like nerves and blood vessels external to the parietal pleura. Facilitates surgical access and visualization for the clinician.

Clinical Evidence

Bench testing only. Biocompatibility and effectiveness established via comparison to predicate device materials and design.

Technological Characteristics

Single-use dissection cannula. Materials: Polycarbonate (cannula), Silicon Latex Rubber (balloon), Loctite™ (adhesive). Features: distal transparent conical tapered tip, elastomeric balloon, luer extension, syringe. Designed for 5mm rigid endoscope integration. Sterile, non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing thoracoscopic surgery requiring formation of elongated working cavities for exposure and dissection of structures external to the parietal pleura (nerves, blood vessels, chest wall tissues). Contraindicated when endoscopic surgery is contraindicated.

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

• ORIGIN Tapered Tip Balloon Dissection Cannula (K953377)

Submission Summary (Full Text)

{0}

FEB 14 '997

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION

VasoView™ Balloon Dissection System
K964171
Class II

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.

## 21 CFR §807.92 a(1)

Submitter: ORIGIN® Medsystems, Inc.
135 Constitution Avenue
Menlo Park, CA 94025
[phone]
contact person: Anthony Durso
date prepared: October 3, 1996

## 21 CFR §807.92 a(2)

Trade name: VasoView™ Balloon Dissection System

Common name: Dissection Cannula
Classification name: Distention Balloon

## 21 CFR §807.92 a(3)

Identification of predicate(s): Substantial equivalence for the VasoView™ Balloon Dissection System is based on its similarities to predicate device: the ORIGIN Tapered Tip Balloon Dissection Cannula. It shares the identical material, and technological characteristics as the predicate device. VasoView™ Balloon Dissection System is also similar in intended use.

## 21 CFR §807.92 a(4)

Device Description-parts and function/concept: The VasoView™ Balloon Dissection System is a single-use device which consists of a, tubular body with a distal transparent conical tapered tip, an elastomeric balloon adjacent to the tapered tip, luer extension, and syringe. It is designed to accept a 5mm diameter rigid endoscope for visualization through the tapered tip. The VasoView™ Balloon Dissection System is provided sterile. This dissection cannula is used to advance along specific anatomic tracts to isolate structures. After the cannula advancement, sequential balloon inflation forms an elongated cavity in the desired location.

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ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
VasoView™ Balloon Dissection System
Class II

Device Description-materials/physical properties: a table of the patient contact components, with their respective materials, is provided below.

| Component Name | Patient Contact | Material | Predicate |
| --- | --- | --- | --- |
| Cannula | yes | Polycarbonate | Tapered Tip Balloon Dissection Cannula k953377 |
| Balloon | yes | Silicon Latex Rubber | Tapered Tip Balloon Dissection Cannula k953377 |
| Adhesive | yes | Loctite™ | Tapered Tip Balloon Dissection Cannula k953377 |

The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.

## 21 CFR §807.92 a(5)

Intended use and relationship to predicate(s): The VasoView™ Balloon Dissection System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used to form elongated working cavities during thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including, nerves, blood vessels and other tissues of the chest wall. The predicate device (Tapered Tip Balloon Dissection Cannula) has applications in minimally invasive surgery and is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space or extremities.

The VasoView™ Balloon Dissection System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

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{2}

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
VasoView™ Balloon Dissection System
Class II

# CFR §807.92 a(6)

Technological characteristics and relationship to predicate(s):

The VasoView™ Balloon Dissection System is substantially equivalent to the Tapered Tip Balloon Dissection Cannula previously cleared product. The VasoView™ Balloon Dissection System shares the identical function, technological characteristics and materials as the predicate device.

# 21 CFR §807.92 b

This submission’s determination of substantial equivalence is based on similarities to the predicate devices in terms of intended uses, materials, and technological characteristics.

# 21 CFR §807.92 c

In accordance with the specifications of this subsection, this summary (3 pages) is its own section, and has been clearly identified as such.

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