(25 days)
Microsurge Detachatip Surgical Instruments, Karl Storz Thoracoscopic Scissors, Surgical Technologies International, Inc., Thoracoscopic Scissors
Not Found
No
The device description focuses on mechanical components and surgical function, with no mention of AI/ML, image processing, or data-driven performance metrics.
No.
The document describes "Microsurge Thoracoscopic Scissors" which are reusable general surgical scissors intended to cut, dissect, and manipulate tissues. This is an instrument used during a procedure, not a device that provides a therapeutic effect itself.
No
Explanation: The device is described as reusable general surgical scissors intended "to cut, dissect and manipulate tissues during general open and thoracoscopic procedures." This function is for surgical intervention, not for identifying or diagnosing a condition.
No
The device description clearly describes physical surgical instruments (scissors, shafts, tips, handles) and their physical characteristics (size, shape, cleaning port). There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, dissecting and manipulating tissues during general open and thoracoscopic procedures." This describes a surgical instrument used on a patient, not a device used to test samples from a patient outside the body.
- Device Description: The description details a surgical instrument with shafts, tips, and handles designed for use in surgical procedures. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device described is a surgical instrument used directly in a surgical setting.
N/A
Intended Use / Indications for 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.
Product codes
78KOG
Device Description
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.
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)
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 biocompatability standards and a rigorous, company-devised test simulating the levice's anticipated field use to evaluate its durability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Microsurge Detachatip Surgical Instruments, Karl Storz Thoracoscopic Scissors, Surgical Technologies International, Inc., Thoracoscopic Scissors
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
510(k) SUMMARY: MICROSURGE THORACOSCOPIC SCISSORS
- (1) Microsurge, Inc. 150 A Street Needham, MA 02194
(617)444-2300
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 |
- Predicates: Microsurge Detachatip Surgical Instruments (3) 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.
'
1
Microsurge Thoracoscopic Scissors 510(k) Submission February 8, 1996
- (ર) 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.
- Technological Characteristics: The Microsurge Thoracoscopic Scissors have the (6) 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 biocompatability standards and a rigorous, company-devised test simulating the levice's anticipated field use to evaluate its durability.