(70 days)
Not Found
No
The summary describes a mechanical surgical instrument with interchangeable tips and a proprietary thread design. There is no mention of any software, algorithms, data processing, or AI/ML terms.
No.
The device is a surgical instrument used to cut and dissect tissue, not to treat a disease or medical condition.
No
Explanation: The device is described as surgical instruments used to cut and dissect tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a surgical instrument (Laparoscopic Scissors) with physical components (handles, tips, shaft). It is a hardware device used in surgical procedures.
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 "endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula." This describes a surgical instrument used within the body during a procedure.
- Device Description: The description details surgical scissors used to "cut and dissect various abdominal tissue." This is a description of a surgical tool for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue samples in a laboratory setting.
Therefore, the "Quick Switch" and "Re-New" Laparoscopic Scissors are surgical instruments, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
Product codes
Not Found
Device Description
The Re-New" Laparoscopic Scissors are surgical instruments 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 surgical tips available, which include : disposable tips, and reusable tips. The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. 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
Various 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
"Quick Switch" (K932648
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
10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
A. Submittor Information
Microline, Inc. 181 Elliott Street Beverly, MA 01915
(508) 922-9810 Telephone:
Contact Person: Mr. Huges de Laforcade President
Date Prepared: Mav 24, 1996
B. Device Identification
Common/Usual Name: Manual Detachable Surgical Instruments Proprietary Name: "Re-New" Laparoscopic Instruments
C. Identification of Predicate Device(s)
The "Re-New" Laparoscopic Instruments are substantially equivalent to their predicate, "Quick Switch" (K932648, previously cleared and currently marketed.
D. Device Description
The Re-New" Laparoscopic Scissors are surgical instruments 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 surgical tips available, which include :
- · disposable tips, and
- . reusable tips.
The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include:
- · Metzenbaum,
- · Mini,
- · Hook,
- · Endocut, and,
- · Micro.
1
E. Substantial Equivalence
The technical characteristics of the "Re-New" Laparoscopic Instruments are almost identical to those of the Microline "Quick Switch". Refer to Table A for a comparison with their predicate. Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "Re-New" relative to its predicate.
The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .
2
Image /page/2/Picture/0 description: The image shows a black and white graphic of a crescent shape. The crescent is thickest at the top and thins out towards the bottom. The shape is solid black, and the background is white.
ຂາຕອກມາງຂໍ້ມູນຂີ ອາໄດ້ຮັກວິຜົນ ໄຣນາຄຣM :ອໄດຣT ຖຸບຣາເຣຊຕາວວ A eldsT
| əldəsdə y
ലിന്തടയുടെ വിട്ടുണ്ട്. അതിനു പ്രാമ
(นเว) นุเธนอา | 1
ટદ
ટદ | 24,424,24
24'42 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|---------------------------------|
| Handle/Shaft: | | |
| SSBIO
x-Number | 11
A88888888 | il təsvirəsində kənd. Bu mənist |
| ləbələr Rəsmin fəsiləsinin cinsinə aid bitki növü. İstinadlar Rəssamlar Rəsmin Filmin fəsiləsinin cinsinə aid bitki növü. İstinadlar Respublikasının fəsiləsinə | "Otuick-Switch" | "well-ex-coller" |
| :າອານ ໄວ ຣາມ ນັກ ສະ ທ | Microline, Inc. | MICGOlline, Inc. |
: इवाग
puinteel 2 107 host puidsul Fi
səlburğu əldəsnəy
(பயர்) முறையங்கு
| sdil | sqi l | Disposable Assembly |
|---|---|---|
| Standard | prepuess | Electrocautery |
| stossipe | ടാറട്ടിവാ | selftC |
| 4.74 - 4.9 | ટે.દે | alasında bir sayının başırır. Bu başları bir bir bir bir bir bir bir bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da bir da |
| - 0.0 | ટે.દે | aldesodsia |
| Tip Length Range (cm) |
sə y
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:slesiuil2
ടലപ്പാലാവപ ിലാശ്രമദ്ര (ാർമാടവേദമി 10 ക്കുട്ടുവാന്) വിശാടവയ്യച
(ว่างของรอาหตุก) to avisuloui) วidossobu วิ
sə)
sə)
9