(402 days)
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.
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.
This is a 510(k) premarket notification for a medical device (Cordis Cyst Puncture Catheter Kit) submitted in 1996. The provided text is a summary of safety and effectiveness, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.
In the context of 510(k) submissions from this era, a "study that proves the device meets the acceptance criteria" as you've described for AI/software devices is not typically conducted or summarized in this manner. Instead, the focus is on showing similarity in design, materials, manufacturing, and intended use to legally marketed predicate devices, and that these similarities do not raise new questions of safety or effectiveness.
Therefore, many of the specific questions you asked are not directly applicable or answerable from the provided text for this type of medical device submission. However, I can extract information related to what is present and explain why other information is absent.
Here's a breakdown of what can be inferred or stated based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not specify formal, quantitative "acceptance criteria" for performance in the way a modern AI/software device would. The core "acceptance" is that the device is substantially equivalent to predicate devices. This means that its design, materials, manufacturing methods, and intended use are similar enough not to raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: The device can facilitate puncturing thick-walled or mobile intracranial cysts, allowing insertion of a ventricular catheter for cyst drainage. | The kit "is used to puncture and drain thick-walled or mobile intracranial cysts." The modified distal tip of the ventricular catheter with a sharp-ended stylet inserted facilitates cyst puncture, and the catheter can then be advanced for drainage. |
| Material/Design Compatibility: Materials and design are similar to predicate devices and do not raise new safety/effectiveness issues. | "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." Silicone elastomer made radiopaque with barium sulfate is used, which is common. |
| Biocompatibility: The materials used are biocompatible. | "Section 5 for Biocompatibility Assessment" is referenced (though not provided in the excerpt), suggesting a separate assessment was made. This is a standard requirement for implantable devices. |
| Radiopacity: The catheter is radiopaque. | Made radiopaque with barium sulfate. "Appendix III for Radiopacity Validation Data" is referenced (though not provided in the excerpt), indicating validation was performed. |
Unanswerable or Not Applicable Questions (Based on the Provided Text)
The following questions cannot be answered from the provided text because they pertain to clinical or performance studies typically conducted for devices requiring more extensive proof of safety and effectiveness (e.g., PMA devices, or modern AI/software devices) or for which specific data is not detailed in a Summary of Safety and Effectiveness for a 510(k).
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of controlled clinical trials or AI evaluation is described. The submission relies on substantial equivalence to predicate devices, which generally means no new clinical data demonstrating performance in a "test set" is required for the 510(k) pathway.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set: Not applicable. No test set adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (catheter kit), not an AI/software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable in the conventional sense of clinical trials. The "ground truth" for a 510(k) is that the predicate devices are safe and effective, and the new device is sufficiently similar.
8. The sample size for the training set: Not applicable. This is a hardware medical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable. This is a hardware medical device.
In summary: The provided document is a 510(k) summary focusing on demonstrating substantial equivalence to predicate devices. It relies on comparisons of design, materials, and intended use, rather than presenting clinical study data with defined acceptance criteria and performance metrics typical of more rigorous clinical trials for novel devices or AI/software. The "proof" of meeting "acceptance criteria" (which are implicit substantial equivalence) is the argument that the device is "similar to predicate devices and does not raise any new issues relating to safety and effectiveness for their intended use."
{0}------------------------------------------------
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-SigmaValve (K913636)). |
| Cyst Puncture Catheter: | Cordis Ventricular Catheter with Enlarged Holes(K914995). |
{1}------------------------------------------------
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).
{2}------------------------------------------------
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.
§ 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).