(62 days)
KNOT FOUND
Not Found
No
The summary describes standard endoscopic instruments for grasping, manipulating, cutting, and cauterizing tissue. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The predicate devices are also standard endoscopic instruments.
No
The device is described as surgical instruments (graspers, dissectors, scissors) used to manipulate and cut tissue, which are tools used during therapy but are not therapeutic devices themselves.
No
Explanation: The device description states its intended use is for grasping, manipulating, cutting, and cauterizing soft tissue, which are interventional actions, not diagnostic ones. It does not mention any function for identifying or analyzing medical conditions.
No
The device description explicitly states it is a line of hand-held, non-sterile, reusable instruments, which are physical hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "grasp, manipulate, cut, cauterize soft tissue." This describes a surgical or procedural instrument used directly on the patient's body.
- Device Description: The description mentions "hand-held, non-sterile, reusable instruments." This further supports the idea of a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are typically used to detect, measure, or identify substances or characteristics in biological samples.
Therefore, the Interceptre™ Endoscopic Instruments are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue.
Product codes
78 GCJ, 85 HET, 79 BWA, 78 KNS
Device Description
The Interceptre™ Endoscopic instruments are a line of hand-held, non-sterile, reusable instruments
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)
Karl Storz Take-Apart Endoscopic Instruments, Richard Wolf Laparoscopic Instruments, Smith and Nephew Endoscopic Instruments
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
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MAR | 8 |997
Section 7- 510k Summary of Safety and Effectiveness
| 7.1
Statement | This summary of 510k safety and effectiveness information is being submitted in
accordance with the requirements of SMDA 1990 and CFR 807.92 |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2
Submitter | Smith & Nephew, Inc., Endoscopy Division
130 Forbes Boulevard
Mansfield, Ma. 02048 |
| 7.3
Company
Contact | Susan Finneran
Clinical/ Regulatory Affairs
(508) 261-3772 |
| 7.4
Device
Name | Proprietary Name: Interceptre™ Laparoscopic Instruments
Common Name: Minimally Invasive Surgical Instruments: graspers, dissectors,
scissors,
Classification Name: Endoscopic accessories(78 GCJ)
Laparoscopic accessories (85 HET)
Electrosurgical accessories (79 BWA, 78 KNS) |
| 7.5
Predicate
Legally
Marketed
Devices | Karl Storz Take-Apart Endoscopic Instruments Richard Wolf Laparoscopic Instruments Smith and Nephew Endoscopic Instruments |
| 7.6
Device
Description | The Interceptre™ Endoscopic instruments are a line of hand-held, non-sterile,
reusable instruments |
| 7.7
Intended Use | The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and
scissors which are intended to be used to grasp, manipulate, cut, cauterize soft
tissue. |