(43 days)
Not Found
No
The summary describes traditional surgical instruments and does not mention any AI or ML related terms or functionalities.
No
The devices described are surgical instruments used for minimally invasive procedures (e.g., endoscopes, graspers, scissors, electrodes), which are tools to perform surgery, not to directly treat a disease or condition therapeutically.
No
The device description indicates all the instruments are for surgical use (e.g., endoscopes, graspers, scissors, knife blades), not for diagnosing conditions.
No
The device description explicitly lists various physical surgical instruments (endoscopes, graspers, scissors, etc.), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that these are "endoscopic surgical instruments" used during surgical procedures on the body (minimally invasive cardiac procedures). They are tools for manipulating tissue, cutting, grasping, etc., within the body.
- Intended Use: The intended use is for performing surgical procedures, not for analyzing samples outside the body.
The information provided describes surgical instruments, which are a different category of medical device than IVDs.
N/A
Intended Use / Indications for Use
Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG)procedures), and saphenous vein harvesting.
Product codes
Not Found
Device Description
The devices are separated into several groups: endoscopes, endoscopic needle holders, endoscopic graspers and clamps, endoscopic scissors, endoscopic knife blade handles, hooks and clip appliers, endoscopic irrigation probes, endoscopic electrodes, retractors and rib spreaders, thoraports and cannulas.
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
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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)
The endoscopes and endoscopic surgical instruments for cardiac procedures will have equivalent performance standards to our currently marketed line of general and plastic surgery endoscopes and endoscopic surgical instruments.
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.
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.
Not Found
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).
Not Found
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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 § 876.9.
0
MAR 12 1996
195400
510(k) Summary
Submitter:
Deknatel Snowden Pencer (DSP) 5175 South Royal Atlanta Drive Tucker, GA 30084 Phone: (770) 496-0952 Fax: (770) 934-8659 Contact: Julie A.K. Stephens
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Trade Name Diamond-Touch® and Micro Diamond-Touch® Instruments; Diamond-Line® Instruments; Diamond Port (Access Ports); Endo CABG (TM Approval Pending); CARDIO Port (TM Approval Pending)
Common Name - Endoscope and Accessories for Minimally Invasive Cardiovascular Surgery Classification Name - Endoscope and Accessories (per 21 CFR 876.1500) -
Equivalent Device Snowden-Pencer 510(k) # K930666 Reusable Laparoscopic/Endoscopic Surgical Instruments with Electrosurgical Connections and Accessories and Snowden-Pencer 510(k) # K930667 -- Reusable Laparoscopic Surgical Instruments for General Surgery, and Plastic and Reconstructive Surgery, Including Aesthetic Surgery
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Device Description The devices are separated into several groups: endoscopes, endoscopic needle holders, endoscopic graspers and clamps, endoscopic scissors, endoscopic knife blade handles, hooks and clip appliers, endoscopic irrigation probes, endoscopic electrodes, retractors and rib spreaders, thoraports and cannulas.
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Intended Use Various endoscopic surgical instruments for use in minimally invasive cardiac procedures including single bypass and multiple bypass (coronary artery bypass grafting (CABG)procedures), and saphenous vein harvesting.
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Summary of Technical Characteristic Equivalence The endoscopes and endoscopic surgical instruments for cardiac procedures will use equivalent materials (such as stainless steel. titanium, rigid and flexible plastics, and insulation) and use the same designs (same handles, tubes, and jaws) as our current marketed line of general and plastic surgery endoscopes and endoscopic surgical instruments.
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Summary of Performance Equivalence The endoscopes and endoscopic surgical instruments for cardiac procedures will have equivalent performance standards to our currently marketed line of general and plastic surgery endoscopes and endoscopic surgical instruments.
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