(83 days)
The major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections. If an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure.
External CSF Drainage Management Systems
This 510(k) submission (K972994) for the Heyer-Schulte NeuroCare External CSF Drainage Management Systems does not contain a study demonstrating the device meets specific acceptance criteria in the format typically seen for AI/ML devices. Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer argues that their device is safe and effective because it is similar to devices already legally marketed.
Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable or reported in this document.
Here's a breakdown based on the provided text, heavily emphasizing the substantial equivalence argument:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Efficacy (for intended use) | Demonstrated through substantial equivalence to predicate devices: |
| - Heyer-Schulte Hermetic External CSF Drainage System (K864676A, approved 1982) | |
| - P-S Medical Becker External Drainage and Monitoring System | |
| - Codman External Drainage System II | |
| - Heyer-Schulte/Camino Ventricular Drainage System (K932769) | |
| Functionality | Substantially equivalent to predicate devices. |
| Design | Substantially equivalent to predicate devices. |
| Placement | Substantially equivalent to predicate devices. |
| Use | Substantially equivalent to predicate devices. |
| Clinical History | Years of clinical history with external drainage systems manufactured from the same materials as the predicate device (K864676A). |
| Proper Placement for Intracranial Pressure Control | Critical, controlled by height of the system; changes only by qualified personnel on physician orders. |
| Drug Compatibility | Not tested; not intended for drug administration. |
Explanation for Absence of Direct Performance Metrics:
The document explicitly states: "The determination of safety and efficacy for the Heyer-Schulte NeuroCare External CSF Drainage Management Systems is based on years of clinical history with external drainage systems manufactured from the same materials beginning with the Heyer-Schulte Hermetic External CSF Drainage System (K864676A)..." and "Heyer-Schulte NeuroCare determines substantial equivalence and safety and efficacy of the Hever-Schulte NeuroCare External CSF Drainage Management Systems based on predicate and currently marketed devices as noted in the summary above."
This indicates that a direct, new performance study with specific quantifiable acceptance criteria for this particular device was not conducted or submitted as part of this 510(k). Instead, the argument is that because the device is functionally, materially, and operationally similar to already approved devices, it can be presumed to meet similar safety and efficacy standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable (N/A) / Not reported. This information is not present because a dedicated "test set" and a study to evaluate performance against specific acceptance criteria were not part of this 510(k) submission. The reliance is on the equivalence to existing devices' performance and clinical history.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A / Not reported. The concept of "ground truth" as it pertains to a new performance study's test set is not relevant here due to the substantial equivalence pathway chosen.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A / Not reported. This relates to performance studies that are not described in the submission.
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
- No. This is a medical device for CSF drainage, not an AI/ML diagnostic tool involving human readers. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Historical clinical outcomes of predicate devices. The "ground truth," in an indirect sense, is derived from the established safety and efficacy profiles and long-term clinical use of the predicate devices. The submission leverages this existing "truth" rather than establishing a new one for this specific device.
8. The sample size for the training set
- N/A / Not reported. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- N/A / Not reported. As above, not an AI/ML algorithm.
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SECTION 2 -510(k) SUMMARY
NOV - 3 1997
510(k) Summary:
The determination of safety and efficacy for the Heyer-Schulte NeuroCare External CSF Drainage Management Systems is based on years of clinical history with external drainage systems manufactured from the same materials beginning with the Heyer-Schulte Hermetic External CSF Drainage System (K864676A), which was approved by FDA for market in 1982.
The Heyer-Schulte NeuroCare External CSF Drainage Management Systems are substantially equivalent to other legally marketed products; the P-S Medical Becker External Drainage and Monitoring System, the Codman External Drainage System II. the Hever-Schulte/Camino Ventricular Drainage System (K932769) and the Heyer-Schulte Hermetic External CSF Drainage System (K864676A) with respect to functionality, design, placement and use.
Hydrocephalic patients with cerebrospinal fluid drainage systems must be kept under close observation for signs and symptoms of changing intracranial pressure due to shunt failure. These signs and symptoms may vary from patient to patient. Increasing intracranial pressure is characterized by headache, vomiting, irritability, listlessness, drowsiness, other signs of deterioration of consciousness and nuchal rigidity. In the infant, increased scalp tension at the anterior fontanelle and congestion of scalp veins will be noted.
Proper placement of the drainage system is critical. Intracranial pressure is controlled only by the height of the system. It is essential that neither the patient nor the drainage system be raised or lowered accidentally. Height changes should only be made by qualified personnel on the orders of the physician.
These products have not been tested for drug compatibility and are not intended for drug administration.
Heyer-Schulte NeuroCare determines substantial equivalence and safety and efficacy of the Hever-Schulte NeuroCare External CSF Drainage Management Systems based on predicate and currently marketed devices as noted in the summary above.
Jai L Hays
Lori L. Hays, MT(ASCP)
Lori L. Hays, MT(ASCP) Regulatory Submissions Specialist
August 11, 1997
Date
- The "K" numbers provided above refer to the 510(k)s previously approved by the FDA
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV - 3 1997
Ms. Lori L. Hays Requlatory Submissions Specialist Heyer-Schulte Neurocare, L.P. 8401 102nd Street, Suite 200 P.O. Box 390 Pleasant Prairie, Wisconsin 53158-0390
Re: K972994 External CSF Drainage Management Systems Trade Name: Regulatory Class: II Product Code: 84JXG Dated: August 11, 1997 August 12, 1997 Received:
Dear Ms. Hays:
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 s 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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Lori L. Hays
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.
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 diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 at (301) 443-6597.
Sincerely yours,
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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SECTION 8 - DEVICE INDICATIONS FOR USE
6972994 510(k) Number (if known):
Device Name: External CSF Drainage Management Systems
Indications for Use:
The major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections.
lf an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's instructions for use.
Prescription Use Only (Per 21 CFR 801.109)
§ 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).