(24 days)
Not Found
No
The device description and intended use clearly describe a manual surgical instrument with no mention of software, data processing, or AI/ML terms.
No.
The device is described as a "manual surgical instrument" and its primary functions include cutting, measuring, and testing reflexes. While these functions are performed in a medical context, they are diagnostic or procedural tools rather than directly therapeutic interventions that treat or prevent disease. The device aids in assessment and procedures, but does not deliver therapy itself.
Yes
The device description indicates that the ruler, angle, and reflex hammer components are used to measure specific medical conditions (lacerations, wounds, fractures, rash size, tendon reflexes), which are diagnostic activities.
No
The device description clearly outlines physical components (trauma shears, ruler, angle, reflex hammer) and their manual functions, indicating it is a hardware medical device. There is no mention of software as a component or its function.
Based on the provided information, the SmartShears® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- The description of the SmartShears® clearly states its intended use is for manual surgical procedures like cutting bandages, splints, and clothes, as well as measuring and testing reflexes. These are all actions performed directly on or in relation to the patient's body, not on specimens taken from the body.
The functions described (cutting, measuring, reflex testing) are typical of surgical instruments and diagnostic tools used in a clinical setting, but they do not involve the in vitro examination of biological samples.
N/A
Intended Use / Indications for Use
SmartShears® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.
Product codes
FZT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Conphar, Inc. (K821116)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
510(k) SUMMARY
| 510(k) NUMBER: | K112400 |
|---|---|
| SUBMISSION TYPE: | Traditional |
| SUBMITTED BY: | Medix, Inc. |
| 230 A1A North | |
| Ponte Vedra, FL 32082 | |
| Tel: 904-382-8026 | |
| Fax: 866-871-3721 | |
| CONTACT PERSON: | Dan Quiggle |
| President & CEO | |
| DATE OF PREPARATION: | June 1, 2011 |
| NAME OF DEVICE: | SmartShears® |
| CLASSIFACTION NAME: | Surgical Devices; General and plastic surgery |
| (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.
2
If you have any questions regarding this letter, please contact Dwight Yen (301) 796-6401 or the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 796-7100, 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