SMARTSHEARS

K112400 · Nuscience Consulting and Management Group, LLC · FZT · Sep 12, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112400
• Device Name: SMARTSHEARS
• Applicant: Nuscience Consulting and Management Group, LLC
• Product Code: FZT · General, Plastic Surgery
• Decision Date: Sep 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Intended Use

SmartShears® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.

Device Story

SmartShears® is a 4-in-1 manual surgical instrument designed for trauma settings. It integrates trauma shears for cutting bandages, splints, and clothing; a ruler for measuring lacerations, wound size, fracture location, and rash size; an angle gauge for assessing bone fracture angulation; and a reflex hammer for testing tendon reflexes and percussing the abdomen and chest. The device is operated by healthcare providers. It functions as a multi-purpose tool to assist in rapid assessment and intervention during trauma care.

Clinical Evidence

No clinical data. The device is a manual surgical instrument exempt from premarket notification requirements.

Technological Characteristics

Manual surgical instrument; medical-grade stainless steel construction; 5 1/2" length; 4-in-1 configuration (shears, ruler, angle gauge, reflex hammer).

Indications for Use

Indicated for use in trauma situations for the removal of bandages, splints, and clothing.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Conphar, Inc. Lister Bandage Scissors (K821116)

Submission Summary (Full Text)

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## 510(k) SUMMARY

| 510(k) NUMBER: | K112400 |
|----------------------|-------------------------------------------------------------------------------------------------|
| SUBMISSION TYPE: | Traditional |
| SUBMITTED BY: | Medix, Inc.<br>230 A1A North<br>Ponte Vedra, FL 32082<br>Tel: [phone]<br>Fax: [phone] |
| CONTACT PERSON: | Dan Quiggle<br>President & CEO |
| DATE OF PREPARATION: | June 1, 2011 |
| NAME OF DEVICE: | SmartShears® |
| CLASSIFACTION NAME: | Surgical Devices; General and plastic surgery<br>(Regulation Number 21 CFR 878.4800[FZT]) |
| TRADE NAME: | Lister Bandage Scissors |
| PREDICATE DEVICE(S): | Conphar, Inc. (K821116) |

INDICATIONS FOR USE: SmartShears® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.

DEVICE DESRIPTION: SmartShears® is a 4-in-1 device used for the removal of bandages, splints, and clothes. The device consists of four configurations which include: the trauma shears, ruler, angle and reflex hammer.

Shears: Critical to the development of the SmartShears® for the cutting of bandages, splints or clothes

Ruler: The ruler is used for measuring the length of lacerations and the size of entrance/exit wounds, location of a fracture, and rash size.

Angle: The angle can be used to measure for angulation of bone fractures.

Reflex Hammer: The reflex hammer can be used during a reflex procedure when the cutting blades are closed for testing tendon reflexes and percussing both the abdominal and chest.

PREDICATE DEVICE: The SmartShears® are essentially the same as the previously marketed predicate device in both function and indication of use. The SmartShears® and the listed predicate device Conphar, Inc. Lister Bandage Scissors (K821116) are similar in size with overall length and scissor blades (5 1/2"). The device utilizes the same material made up of medical grade stainless steel materials.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

NuScience Consulting and Management Group, LLC % Ms. Nikole Goldsmith PO Box 8507 Fleming Island, Florida 32006

SEP 1 2 2011

Re: K112400

Trade Name: SmartShears® Classification Regulation Name and Number: Manual surgical instruments for general use - 21 CFR 878.4800

Regulatory Class: Class I Exempt Product Code: FZT Dated: June 1, 2011 Received: August 19, 2011

Dear: Ms. Goldsmith:

We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.

The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 878.4800. We suggest that you review this regulation since it may grant other exemptions from certain general controls of the Act. Your device classification regulation name, regulatory class, and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code.

In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 878.9 to determine whether or not your new device (s) meets the limitations of exemption from Section 510(k) of the Act.

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If you have any questions regarding this letter, please contact Dwight Yen [phone] or the Division of Small Manufacturers, International and Consumer Assistance at its toll free number [phone] or [phone], or at its Internet address "http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ucm142656.htm".

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K112400

Device Name: SmartShears®

Indications For Use: SmartShear® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ryden firmxm

(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K112400