(22 days)
Not Found
No
The description focuses on the mechanical design and intended use of surgical scissors, with no mention of AI or ML.
No.
The device is a surgical tool used to cut and dissect tissue, not to treat a disease or medical condition.
No
The device is described as "Laparoscopic scissors tips" and "surgical blades used to cut and dissect various abdominal tissue," indicating its function is for surgical intervention, not diagnosis. There is no mention of it being used to detect, identify, or monitor any medical condition.
No
The device description clearly states it is a physical surgical instrument (scissors tips and handles) used for cutting and dissecting tissue, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures". This describes a surgical instrument used on the body, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details surgical blades and handles used for cutting and dissecting tissue during surgery. This aligns with the function of a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting markers, or providing diagnostic information based on in vitro analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
"Selecta-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
Product codes
Not Found
Device Description
The Selecta-Tip" Laparoscopic Scissors are surgical blades used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of reusable tips.
The tip assembly is designed with a proprietary single thread and ball system, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Scissors tip configurations include:
- · Metzenbaum.
- · Mini,
- · Hook,
- · Endocut, and
- · Micro.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal tissue
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
A. Submittor Information
Microline, Inc. 181 Elliott Street Beverly, MA 01915 (508) 922-9810 Telephone:
MAR 2 8 .
March 3, 1997 Date Prepared:
B. Device Identification
Contact Person:
Common/Usual Name: Manual Detachable Surgical Instruments "Selecta-Tip" Laparoscopic Scissors Tips Proprietary Name:
Mr. Huges de Laforcade
President
C. Identification of Predicate Device(s)
The "Selecta-Tip" Laparoscopic Instruments are substantially equivalent to their predicate, "Re-New (K962119), previously cleared and currently marketed.
D. Device Description
The Selecta-Tip" Laparoscopic Scissors are surgical blades used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of reusable tips.
The tip assembly is designed with a proprietary single thread and ball system, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Scissors tip configurations include:
- · Metzenbaum.
- · Mini,
- · Hook,
- · Endocut, and
- · Micro.
E. Substantial Equivalence
The technical characteristics of the "Selecta-Tip" Laparoscopic scissors tips are almost identical to those of the Microline "Re-New". Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "Selecta-Tip" relative to its predicate.
"Selecta-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
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