(126 days)
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No
The device description focuses on the physical characteristics and intended use of surgical instruments, with no mention of AI or ML capabilities.
No
The device described consists of surgical instruments (cannula, lung retractor, clip appliers, grasping forceps, scissors, hooks, and clamps) used during Video-Assisted Thoracoscopic Surgery (VATS) for pediatric procedures like Patent Ductus Arteriosus (PDA) interruption. These are tools used by surgeons to perform a medical procedure, rather than devices that directly provide a therapeutic effect on the body.
No
The device description indicates these are surgical instruments for Patent Ductus Arteriosus (PDA) interruption and general pediatric surgery, such as cannulas, lung retractors, clip appliers, grasping forceps, scissors, hooks, and clamps. These are tools used for performing procedures, not for diagnosis.
No
The device description explicitly lists physical surgical instruments (cannula, lung retractor, clip appliers, etc.) which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- This device is described as surgical instruments (cannula, lung retractor, clip appliers, grasping forceps, scissors, hooks, and clamps) intended for use within the body during a surgical procedure (Video-Assisted Thoracoscopic Surgery - VATS) to interrupt a Patent Ductus Arteriosus (PDA).
The description clearly indicates a surgical tool used for intervention and manipulation within the body, not for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
Burke Congenital Thoracoscopy Instruments are intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury. INDICATIONS: Pediatric Thoracoscopic Procedures Patent Ductus Arteriosus Interruption (PDA) CONTRA INDICATIONS: For PDA patients with a ductal diameter over 1 cm calcification, presence of a transcatheter device within the ductal lumen, patients with dense pleural adhesions.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
These instruments are equivalent to Thoracoscopy instruments for adult sizes but have a reduced dimension with a modified geometric configuration to meet reduced size requirements. These are modifications therefore of equivalent surgical instruments that can be used in general pediatric surgery but also have been designed specifically for pediatric thoracoscopic surgery. Instruments that are needed for the surgical procedures are cannula, lung retractor, clip appliers, grasping forceps with ratchets, scissors, hooks, and clamps. These instruments have specific overtures and dimensions suited for this surgical procedure.
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.
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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§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
REFERENCE 9
SUMMARY OF SAFETY & EFFICACY
BURKE CONGENITAL THORACOSCOPY INSTRUMENTS NOV 1 9 1996
SPECIFIC INDICATION OF USE: PATENT DUCTUS ARTERIOSUS INTERRUPTION
These instruments are equivalent to Thoracoscopy DEVICE DESCRIPTION: instruments for adult sizes but have a reduced dimension with a modified geometric configuration to meet reduced size requirements. These are modifications therefore of equivalent surgical instruments that can be used in general pediatric surgery but also have been designed specifically for pediatric thoracoscopic surgery. Instruments that are needed for the surgical procedures are cannula, lung retractor, clip appliers, grasping forceps with ratchets, scissors, hooks, and clamps. These instruments have specific overtures and dimensions suited for this surgical procedure. Burke Congenital Thoracoscopy Instruments are INTENDED USES: intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury. INDICATIONS: Pediatric Thoracoscopic Procedures Patent Ductus Arteriosus Interruption (PDA) CONTRA INDICATIONS: For PDA patients with a ductal diameter over 1 cm calcification, presence of a transcatheter device within the ductal lumen, patients with dense pleural adhesions. STERILIZATION: These stainless steel instruments are reusable. They are provided non-sterile and may be autoclaved or ethylene oxide gas sterilized.