EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM

K964919 · Emerald Medical, Inc. · HRX · Jan 28, 1997 · Orthopedic

Device Facts

• Record ID: K964919
• Device Name: EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
• Applicant: Emerald Medical, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jan 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectomy surgical procedures.

Device Story

Surgical instrument kit for minimally invasive percutaneous lumbar discectomy; used by surgeons in clinical/OR settings; facilitates disc removal; components include introduction tools and evacuation instruments; manual operation; provides mechanical assistance for tissue removal; benefits include reduced invasiveness compared to traditional open discectomy.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manual surgical instruments; materials consistent with predicate arthroscopic discectomy systems; form factor designed for percutaneous access; non-powered; non-sterile (intended for sterilization).

Indications for Use

Indicated for patients undergoing minimally invasive percutaneous lumbar discectomy surgical procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Acufex Microsurgical Interceptre Arthroscopic Discectomy System (K941709)
• Smith & Nephew Arthroscopic MicroDiscectomy System (AMD)

Reference Devices

• Surgical Dynamics instrument introduction systems
• Sofamor Danek instrument introduction systems

Submission Summary (Full Text)

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EMERALD MEDICAL, INC.
Mill Lane Rd.
Brimfield, MA 01010
JAN 28 1997
Premarket Notification
EMERALD MEDICAL, INC.
Nucleus Pulposis Evacuator System
Confidential
k964919

# 510 (k) Summary
## EMERALD MEDICAL, INC.
## Nucleus Pulposis Evacuator System

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k), Premarket Notification, was in accordance with 21 CFR 807.87.

The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectomy surgical procedures.

The conclusion that the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is substantially equivalent to legally marketed predicate systems was reached through consideration of the requirements of substantial equivalence determinations. These requirements are set forth in the document, published on June 30, 1986 by the Center for Devices and Radiological Health (CDRH), entitled "Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program."

The new disc removal tools contain substantially equivalent technology and materials as the predicate disc removal tools utilized in the Acufex Microsurgical Interceptre Arthroscopic Discectomy System, 510 (k) K941709, and the Smith & Nephew Arthroscopic MicroDiscectomy System, AMD™. The proposed introduction kit contains the same components as the current instrument introduction systems developed by Acufex Microsurgical, Surgical Dynamics, Sofamor Danek, and Smith & Nephew Spine.

Based on the reasons provided, the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is substantially equivalent to legally marketed predicate minimally invasive percutaneous lumbar discectomy surgical instruments.

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