(37 days)
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No
The device description and intended use describe a purely mechanical grasping tool with no mention of software, image processing, or AI/ML terms.
Yes
This device is intended to remove foreign bodies (calculi/stones) from a patient during a urological procedure, which is a therapeutic intervention.
No
The device is described as "foreign body grasping forceps" used in "urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects." This indicates its function is for intervention (removal/manipulation), not for identifying or characterizing a disease or condition (diagnosis).
No
The device description explicitly states the device is composed of stainless steel and describes physical characteristics like diameter and length, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal, manipulation, or grasping of objects within the body during a urological procedure. This is a direct intervention on the patient.
- Device Description: The device is a physical tool (forceps) used for mechanical action.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a patient's health status. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, this device falls under the category of a surgical instrument used for a therapeutic or interventional purpose, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
ID:303-617-7929
Image /page/0/Picture/2 description: The image contains the words COMEG ENDOSCOPY. The words are written in a sans-serif font. The word COMEG is also written in a larger font in the middle of the image, inside of a black rectangle.
MAR 1 9 1997
K 970489
p192
SUMMARY OF SAFETY AND EFFECTIVENESS FOR GRASPING FORCEPS
6807.92 (a)(1)
Contact Person:
Peter Dufly Vice President
Date of Summary Preparation; March 19, 1997
8807.92 (a)(2)
COMEG Endoscopy Grasping Forceps Trade Name:
Cominon Name: Stone dislodger
Classification Name: Ureteral stonc dislodger (21 CFR §876.4680)
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Karl Storz Grasping forceps for removal of foreign bodies
$807.92 (a)(4)
Description of Device:
The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.
8807.92 (a)(5)
Intended Use:
The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.
1
Image /page/1/Picture/3 description: The image shows the word "COMEG" in a bold, sans-serif font. The letters are white and the background is black. The letters appear to be stenciled, with some breaks in the solid white fill.
e n d o s c o p y
K970489
P2092
page 2- Summary of Safety and Effectiveness for Grasping Forceps
§807.92 (a)(6)
Comparison of Technical Characteristics; The subject and predicate devices are similar in diameter, length, material, tip configuration, and tip action.