The Subdural Drainage Catheter Kit is intended for drainage of extraventricular fluid collections, such as hygromas and chronic hematomas, into an external drainage system (such as the Suction Reservoir or the EDS or IDS Systems from Elekta) or an implanted catheter communicating with an appropriate drainage site. The patient's clinical pathology dictates whether the Subdural Drainage Catheter is connected to an internal or external drainage system.

Device Description

The Subdural Drainage Catheter is intended for drainage of extraventricular fluid collections, such as hygromas and chronic hematomas, into an external drainage system, (such as the Suction Reservoir or the EDS or IDS Systems from Elekta) or an implanted catheter communicating with an appropriate drainage site (i.e., peritoneum).

The patient's clinical pathology dictates whether the Subdural Drainage Catheter is connected to an internal or external drainage system.

The catheter is manufactured from silicone elastomer (with barium sulfate) equivalent to those of other Cordis catheters and CNS fluid shunt systems and components. The distal catheter ends in a hollow, ovoid-shaped structure ("cage") with slit-like openings. For implantation, a stylet is passed through the proximal end of the catheter, and is pushed against the interior cage bottom. This elongates the cage and allows the catheter to be passed through a 5 mm diameter burr hole. When the distal tip is appropriately placed, the stylet is removed and the catheter tip returns to its cage-like appearance.

AI/ML Overview

This document, K974726, describes the clearance of a medical device, the Elekta Subdural Drainage Catheter Kit, as substantially equivalent to existing predicate devices. It does not contain information about a study that establishes acceptance criteria for device performance in the way one would typically find for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, many of the requested sections regarding acceptance criteria and performance studies, particularly those related to AI or a multi-reader multi-case (MRMC) comparative effectiveness study, cannot be extracted from this document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance (Not applicable in the typical sense for SaMD)

This document is a 510(k) clearance, which means the device was found substantially equivalent to predicate devices already on the market. The "acceptance criteria" here are primarily about demonstrating equivalence in design, materials, manufacturing, indications for use, and biocompatibility, rather than meeting specific quantitative performance metrics against a clinical ground truth like an AI/SaMD product.

The document states:

"The materials used to manufacture the Subdural Drainage Catheter have been subjected to biocompatibility testing. The tests reveal that the materials used are safe for their intended use." This is a key acceptance criterion for the materials, not the overall clinical performance for which you're likely asking.
"The indications and contraindications of the Subdural Drainage Catheter Kit are equivalent to those of the predicate devices and their accessories."
"The design, materials, manufacturing methods and specifications of the Subdural Drainage Catheter are similar to those of the predicate Cordis Ventricular Catheters and do not raise any new issues relating to safety and effectiveness for its intended use."

Thus, there isn't a table of specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) and reported device performance metrics in the context of a clinical study, as these are typically not required for a 510(k) clearance based on substantial equivalence for this type of hardware device.

Unable to Extract Information For:

The following information cannot be extracted from the provided text because the document pertains to the 510(k) clearance of a physical medical device (a catheter kit), not an AI/SaMD product or a clinical study evaluating its efficacy or performance against clinical endpoints.

A table of acceptance criteria and the reported device performance: As explained above, the "acceptance criteria" for a 510(k) for a physical device are about equivalence and safety of materials, not quantitative clinical performance metrics. There are no reported device performance metrics like sensitivity, specificity, or accuracy.
Sample size used for the test set and the data provenance: No clinical testing or test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no such ground truth establishment is described.
Adjudication method for the test set: Not applicable.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K974726

SUMMARY OF SAFETY AND EFFECTIVENESS

Trade (proprietary) Name 1.

Subdural Drainage Catheter Kit

Common/Classification Name 2.

Drainage Catheter/Central Nervous System (CNS) Fluid Shunt and Components

Applicant's Name and Address 3.

Elekta Implants S.A. Parc de Sophia Antipolis Route des Dolines 2905 F-06921 Sophia Antipolis, France

4. Classification

The kit includes devices classified as Class II (21 CFR 882.5550 and 21 CFR 882.4300).

5. Predicate Devices

・

Cordis Straight Ventricular Catheter with oval holes P.S. Medical Surgical Drain Cordis Orbis Sigma® Valve Cordis Polypropylene Burr Hole Reservoirs Cordis Ventricular Antechamber Cordis Right Angle Catheter Guide Cordis CSF Reservoir

6. Performance Standards

No applicable performance standards have been established by FDA under Section 514 of the Food, Drug and Cosmetic Act.

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Intended Use and Device Description 7.

The patient's clinical pathology dictates whether the Subdural Drainage Catheter is connected to an internal or external drainage system.

8. Biocompatibility

The materials used to manufacture the Subdural Drainage Catheter have been subjected to biocompatibility testing. The tests reveal that the materials used are safe for their intended use.

9. Summary of Substantial Equivalence':

The indications and contraindications of the Subdural Drainage Catheter Kit are equivalent to those of the predicate devices and their accessories. The design, materials, manufacturing methods and specifications of the Subdural Drainage Catheter are similar to those of the predicate Cordis Ventricular Catheters and do not raise any new issues relating to safety and effectiveness for its intended use.

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 premarket approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement 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 that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 1998

Ms. Barbara Ramseyer Elekta Implants 6011 Cellini Street Coral Gables, Florida 33146

Re : K974726 Subdural Drainage Catheter Kit, Trade Name: Subdural Catheter Regulatory Class: II Product Code: JXG Dated: December 15, 1997 December 18, 1997 Received:

Dear Ms. Ramseyer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 1. 1 market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Ramseyer

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stuphe Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Elekta Subdural Drainage Catheter Kit

大974726 510(k) Number:

Elekta Subdural Drainage Catheter Kit Device Name:

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription (Per CFR 801.109) or

Over the Counter Use (Optional Format 1-2-96)

Page 14

Stephen Rhode

of General Restorative Devices

Regulation Number and Section

§ 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).