DETACHATIP THORACOSCOPIC SCISSORS

K960554 · Microsurge, Inc. · GEI · Mar 5, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960554
• Device Name: DETACHATIP THORACOSCOPIC SCISSORS
• Applicant: Microsurge, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Microsurge Thoracoscopic Scissors are a line of reusable general surgical scissors intended to be used to cut, dissect and manipulate tissues during general open and thoracoscopic procedures.

Device Story

Reusable modular surgical scissors; consists of shafts (24-43 cm) and interchangeable tips (curved Metzenbaum, straight, hook); shafts available straight or with reverse 'S' curve for improved access; includes cleaning port for lumen maintenance; used in OR by surgeons; manual operation via handle finger/thumb loops; provides mechanical cutting/dissection of tissue; enhances surgical access during endoscopic procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Durability evaluated via company-devised simulation testing.

Technological Characteristics

Reusable manual surgical instrument; stainless steel construction; modular design (shafts and tips); 5 mm diameter; 24-43 cm length; straight or reverse 'S' shaft geometry; manual actuation; cleaning port for lumen access.

Indications for Use

Indicated for patients undergoing general open or thoracoscopic surgical procedures requiring tissue cutting, dissection, or manipulation.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Microsurge Detachatip Surgical Instruments
• Karl Storz Thoracoscopic Scissors
• Surgical Technologies International, Inc., Thoracoscopic Scissors

Submission Summary (Full Text)

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Microsurge Thoracoscopic Scissors
510(k) Submission
February 8, 1996
K960554

# 510(k) SUMMARY: MICROSURGE THORACOSCOPIC SCISSORS

(1) Microsurge, Inc.
150 A Street
Needham, MA 02194
[phone]

Contact Person: Richard Lariviere
Date Summary Prepared: February 8, 1996

(2) Trade or Proprietary Name: Detachatip™ Thoracoscopic Scissors

Common Name: Endoscopic Accessory, Manual Surgical Instruments

Classified Name(s): Endoscope and/or Accessories (78KOG)
21 CFR § 876.1500, Class II,
Endoscope and Accessories

(3) Predicates: Microsurge Detachatip Surgical Instruments
Karl Storz Thoracoscopic Scissors
Surgical Technologies International, Inc., Thoracoscopic Scissors

(4) Description of Device: The Microsurge Thoracoscopic Scissors are a modular line of reusable surgical scissors consisting of various size scissors shafts and tips. These integral shafts and tips are essentially identical to the scissors shafts of the Microsurge Detachatip Surgical Instruments and are intended to be used in conjunction with the handles that have been cleared for marketing as part of the Microsurge Detachatip Surgical Instruments.

The scissors tips and shafts are sized to fit through 5 mm cannula or directly through intercostal incisions. The shafts range in length from 24 to 43 cm, consistent with other endoscopic instruments such as the Detachatip line manufactured by Microsurge. The shafts are provided either straight or with a prefabricated reverse "S" shaped curve. The curve provides for increased range of motion when rotating the instrument, thus improving access to internal structures during endoscopic procedures. The shafts are also equipped with a cleaning port to enhance cleaning via direct delivery of cleaning solutions to the lumen of the instruments.

The scissors tips are provided in a variety of styles: curved (Metzenbaum), straight, and hook. Each style is suited for specific surgical requirements and tissue types.

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Microsurge Thoracoscopic Scissors
510(k) Submission
February 8, 1996

(5) Intended Use: The Microsurge Thoracoscopic Scissors are a line of reusable general surgical scissors intended to be used to cut, dissect and manipulate tissues during general open and thoracoscopic procedures.

(6) Technological Characteristics: The Microsurge Thoracoscopic Scissors have the same technological characteristics as the predicate devices. The devices are reusable devices intended to cut, dissect and manipulate tissue through manual cycling of the handle finger and thumb loops.

(7) Conclusion

The new device has the same intended uses and technology as the predicates identified in the premarket notification submission. The Microsurge Thoracoscopic Scissors are at least as safe and effective as the predicate devices based on the device being in conformance with well-established biocompatibility standards and a rigorous, company-devised test simulating the device's anticipated field use to evaluate its durability.