(175 days)
No
The description focuses on the mechanical components and intended use of a physical catheter and procedure tray, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to prevent lung collapse and drain fluid from the chest cavity, which are therapeutic interventions.
No
The device is a catheter used for drainage and to prevent pressure in the chest cavity, which are therapeutic actions, not diagnostic ones.
No
The device description clearly details a physical, indwelling catheter and associated components, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to create a passageway in the chest cavity for drainage and pressure relief. This is a surgical/interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical catheter and insertion system designed for direct insertion into the chest. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
Therefore, this device falls under the category of a surgical or interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity. The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package.
Product codes
74DQR, 80CSS
Device Description
The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter. The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest cavity
Indicated Patient Age Range
Neonatal/Pediatric
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) Summary of Safety & Efficacy: Argyle Turkel Neonatal/ Pediatric Thoracic Catheter Insertion Tray
Submitted by: Sherwood Medical Co., 1915 Olive St., St. Louis, MO 63103, (314) 621-7788 Contact : Dennis Pozzo, Regulatory Affairs Manager Date Prepared: revised July 26, 1996
The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. This device is a Class II device per 21 CFR 870.1300 or 880.6740, Procode: 74DQR or 80CSS.
The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity. The catheter will be available in 8, 10 and 12 fr sizes.
The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.
The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray is substantially equivalent to Sherwood Medical's currently marketed Argyle Turkel Safety Pneumothorax Procedure Tray (K934428) in that both share the same basic 1) components, 2) intended use and 3) the catheters are introduced in the chest via a trocar. The major differences are: 1) the proposed device will be indicated specifically for neonatal/pediatric use and 2) the addition of a 10 & 12 Fr catheter for the neonatal/pediatric tray.
The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray is substantially equivalent to Sherwood Medical's currently marketed Argyle Trocar Catheters & Trocar Catheter Kits (preamendment) in that they all: 1) have the same intended use and 2) utilize trocars to introduced the catheters into the chest. The major differences are: 1) the proposed device will be indicated specifically for neonatal/pediatric use and 2) the proposed device is a "safety" device.
AUG - 5 1996