BURKE CONGENITAL THORACOSCOPY INSTRUMENTS

K962771 · Pilling Weck, Inc. · DWS · Nov 19, 1996 · Cardiovascular

Device Facts

• Record ID: K962771
• Device Name: BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
• Applicant: Pilling Weck, Inc.
• Product Code: DWS · Cardiovascular
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

Burke Congenital Thoracoscopy Instruments are intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury.

Device Story

Reusable stainless steel surgical instruments for pediatric Video-Assisted Thoracoscopic Surgery (VATS); includes cannulas, lung retractors, clip appliers, grasping forceps, scissors, hooks, and clamps. Modified geometric configuration and reduced dimensions compared to adult thoracoscopy instruments to accommodate confined pediatric anatomic spaces and minimize mechanical injury to immature tissues. Operated by surgeons in clinical/OR settings to facilitate visualization and tissue manipulation during minimally invasive procedures. Output is physical surgical access and manipulation; aids in PDA interruption. Benefits include reduced tissue trauma and improved access in size-constrained pediatric environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel construction; reusable; non-sterile; compatible with autoclave or ethylene oxide gas sterilization. Form factor: reduced-dimension surgical instruments (cannula, retractor, clip applier, forceps, scissors, hooks, clamps) for pediatric VATS.

Indications for Use

Indicated for pediatric patients undergoing thoracoscopic procedures, specifically Patent Ductus Arteriosus (PDA) interruption. Contraindicated for patients with ductal diameter >1 cm, calcification, transcatheter devices in ductal lumen, or dense pleural adhesions.

Regulatory Classification

Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

Reference Devices

• K962771

Submission Summary (Full Text)

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REFERENCE 9
K962771

# SUMMARY OF SAFETY & EFFICACY

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
NOV 19 1996

## SPECIFIC INDICATION OF USE:
PATENT DUCTUS ARTERIOSUS INTERRUPTION

### DEVICE DESCRIPTION:
These instruments are equivalent to Thoracoscopy instruments for adult sizes but have a reduced dimension with a modified geometric configuration to meet reduced size requirements. These are modifications therefore of equivalent surgical instruments that can be used in general pediatric surgery but also have been designed specifically for pediatric thoracoscopic surgery. Instruments that are needed for the surgical procedures are cannula, lung retractor, clip appliers, grasping forceps with ratchets, scissors, hooks, and clamps. These instruments have specific overtures and dimensions suited for this surgical procedure.

### INTENDED USES:
Burke Congenital Thoracoscopy Instruments are intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury.

### INDICATIONS:
Pediatric Thoracoscopic Procedures
Patent Ductus Arteriosus Interruption (PDA)

### CONTRA INDICATIONS:
For PDA patients with a ductal diameter over 1 cm calcification, presence of a transcatheter device within the ductal lumen, patients with dense pleural adhesions.

### STERILIZATION:
These stainless steel instruments are reusable. They are provided non-sterile and may be autoclaved or ethylene oxide gas sterilized.