(140 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical function (suction/irrigation) and comparison to a predicate device without mentioning any computational or learning capabilities.
No.
The device is used to clear the surgical site for better visibility, which is a supportive function during surgery, not a direct treatment for a disease or condition. Its indication is for suction and irrigation during surgical procedures.
No
The device is described as an "AUTO SUTURE* Suction / Irrigation** device" used in surgical procedures to "gently blow blood and debris from the surgical site." Its intended use is described as aiding in "endoscopic surgery" and "open and thoracoscopic surgery (non-insufflated)." These functions are therapeutic or assistive during surgery, rather than diagnostic. A diagnostic device would typically be used to identify, detect, or monitor a disease or condition.
No
The device description explicitly refers to a "Suction / Irrigation device" and discusses its use as a "hand instrument" in surgical procedures, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for surgical procedures (open and thoracoscopic surgery) to suction and irrigate the surgical site. This is a direct interaction with the patient's body during surgery, not an in vitro test performed on samples outside the body.
- Device Description: The description focuses on its function as a surgical instrument for suction and irrigation.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural during surgery.
N/A
Intended Use / Indications for Use
The sole difference the wabject and device and the predicate device, is that the prodicate device is indicated for endosessic surgery while the subject device is only indicated for open and thoracoscopic surgery (non-insufflated).
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The AUTO SUTURE* Suction / Irrigation** device
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): 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
§ 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
SEP 2 5 1996
SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:
The AUTO SUTURE* Suction / Irrigation** device is identical in safety and effectiveness to its currently marketed predicate - U.S. Surgical Corp.'s Endoscopic Suction / Irrigation ** device - 510(k) #K903207. United States Surgical Corporation has been manufacturing hand instruments as accessories in surgical procedures for a number of years. It is now the intention of USSC to expand the utility of the AUTO SUTURE* Endoscopic Suction / Irrigation ** device to allow the surgeon to gently blow blood and debris from the surgical site. The information included in this notification demonstrates that the device is substantially equivalent to its predicate in respect to design, function, performance, labeling and sterilization. The sole difference the wabject and device and the predicate device, is that the prodicate device is indicated for endosessic surgery while the subject device is only indicated for open and thoracoscopic surgery (non-insufflated).
- . Both the subject and predicate devices are designed and to perform the exact same functions.
- . Both the subject devices and other currently marketed United States Surgical Corporation devices are manufactured in the same facilities, using similar processes and controls.
- . Both the subject devices and other currently marketed United States Surgical Corporation devices are packaged in the same facilities using similar processes and controls.
- Both the subject and predicate devices perform the exact same function in the same way.
- . Both the subject and predicate devices are manufactured from the exact same bio-approved materials