(402 days)
No
The device description focuses on mechanical components and materials, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics associated with AI/ML algorithms.
Yes
The device is described as facilitating cyst puncture and allowing insertion of a ventricular catheter for cyst drainage, which is a therapeutic intervention.
No
Explanation: The device is intended to facilitate puncturing cysts and inserting a ventricular catheter for drainage, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter, stylets, and materials (silicone elastomer, barium sulfate), indicating it is a hardware medical device kit.
Based on the provided information, the Cordis Cyst Puncture Catheter Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate a surgical procedure (puncturing and draining intracranial cysts) within the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The device is a catheter and stylet system designed for direct insertion into the body. This is characteristic of a medical device used for intervention, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be performed in vitro.
Therefore, the Cordis Cyst Puncture Catheter Kit is a medical device used for a surgical procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Cordis Cyst Puncture Catheter Kit is intended to facilitate puncturing thick-walled or mobile intracranial cysts, allowing insertion of a ventricular catheter for cyst drainage.
Product codes
Not Found
Device Description
The Cordis Cyst Puncture Catheter kit consists of a ventricular catheter with enlarged holes whose distal tip has been modification allows the sharpended stylet to be inserted through and locked into the distal tip. This facilitates cyst puncture. The kit also includes sharp- and blunt-ended stylets to facilitate catheter placement. The catheter is manufactured from silicone elastomer made radiopaque with barium sulfate (see Section 5 for Biocompatibility Assessment and Appendix III for Radiopacity Validation Data).
Standard stereotactic techniques are used to localize the cyst entry point. The bluntended stylet, included in the kit, inserted into the catheter to approach the cyst wall. After contacting the cyst wall, the blunt-ended stylet is exchanged for the sharp-ended stylet. The sharp-ended stylet is pushed through the small hole in the distal catheter tip until the flange is seated against the molded shelf of the catheter. The stylet/catheter assembly is then advanced until the sharp-ended stylet punctures the cyst wall. The ventricular catheter can then be advanced into the lumen of the cyst. The stylet is then withdrawn, leaving the catheter in place to drain the cyst.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial
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)
Elekta Blacklund Needle (Preamendments), Cordis Ventricular Catheter Stylet (Preamendments), Cordis Ventricular Catheter Introducer (Orbis-Sigma Valve (K913636)), Cordis Ventricular Catheter with Enlarged Holes (K914995)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
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K955265 00-00004
SECTION 2 - SUMMARY AND CERTIFICATION
DEC 2 0 1996
Summary of Safety and Effectiveness Cordis Cyst Puncture Catheter Kit
(Pursuant to Section 513(I) of the Federal Food, Drug, and Cosmetic Act)
I. General Information:
Cordis Sharp-ended Stylet
Classification Name: Common/Usual Name: Trade/Proprietary Name:
Cordis Blunt-ended Stylet
Classification Name: Common/Usual Name: Trade/Proprietary Name:
Cordis Cyst Puncture Catheter
Classification Name: Common/Unusual Name: Trade/Proprietary Name:
Applicant's Name and Address:
Microsurgical instrument Puncture Cannula Cordis Sharp-ended Stylet
Shunt implantation instrument Stylet Cordis Blunt-ended Stylet
Ventricular Catheter Catheter Cordis Cyst Puncture Catheter
Cordis Corporation 14201 NW 60th Avenue Miami, FL 33014
- II. Name of predicate device(s):
| Component | Predicate Device |
|---|---|
| Sharp-ended stylet: | Elekta Blacklund Needle (Preamendments). |
| Blunt-ended stylet: | Cordis Ventricular Catheter Stylet (Preamendments). |
| Cordis Ventricular Catheter Introducer (Orbis-Sigma | |
| Valve (K913636)). | |
| Cyst Puncture Catheter: | Cordis Ventricular Catheter with Enlarged Holes |
| (K914995). |
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III. Classification:
When used alone as a cyst puncture needle, the Cordis Cyst Puncture Stylet is a Microsurgical Instrument (Class I - 21 CFR 882.4525). Neurosurgical shunt system instruments are Class I (21 CFR 882.4545). Ventricular Catheters are Class II (21 CFR 882.4100).
IV. Performance Standards:
No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description:
The Cordis Cyst Puncture Catheter Kit is intended to facilitate puncturing thick-walled or mobile intracranial cysts, allowing insertion of a ventricular catheter for cyst drainage.
VI. Summary of Substantial Equivalence1:
Indications for use: The Cordis Cyst Puncture Catheter Kit is used to puncture and drain thick-walled or mobile intracranial cysts.
System Description: The Cordis Cyst Puncture Catheter kit consists of a ventricular catheter with enlarged holes whose distal tip has been modification allows the sharpended stylet to be inserted through and locked into the distal tip. This facilitates cyst puncture. The kit also includes sharp- and blunt-ended stylets to facilitate catheter placement. The catheter is manufactured from silicone elastomer made radiopaque with barium sulfate (see Section 5 for Biocompatibility Assessment and Appendix III for Radiopacity Validation Data).
Standard stereotactic techniques are used to localize the cyst entry point. The bluntended stylet, included in the kit, inserted into the catheter to approach the cyst wall. After contacting the cyst wall, the blunt-ended stylet is exchanged for the sharp-ended stylet. The sharp-ended stylet is pushed through the small hole in the distal catheter tip until the flange is seated against the molded shelf of the catheter. The stylet/catheter assembly is then advanced until the sharp-ended stylet punctures the cyst wall. The ventricular catheter can
1 Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patient litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact the product can lawfully be marketed without pre-market approval or classification. This determination is not intended to haves any bearing whatever on resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seq. (1977).
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then be advanced into the lumen of the cyst. The stylet is then withdrawn, leaving the catheter in place to drain the cyst.
The indications for the Cordis Sharp- and Blunt-ended Stylets and Cyst Puncture Catheter are similar to those for the predicate devices.
Design, Materials, Manufacturing Methods and Specifications:
The design, materials, manufacturing methods and specifications of the components of the Cordis Cyst Puncture Catheter Kit are similar to those of the predicate devices and do not raise any new issues relating to safety and effectiveness for their intended use. Thus, Cordis considers the Cordis Cyst Puncture Catheter Kit to be equivalent to predicate devices.