(42 days)
CSF Shunt components are designed to provide controlled Cerebrospinal Fluid (CSF) flow from the ventricles of the brain to the right atrium of the heart or the peritoneal cavity.
The PS Medical Neurosurgical Implants are manufactured with silicone adhesive. The devices are used as shunt components.
This document concerns a 510(k) submission for Medtronic PS Medical® Neurosurgical implants, specifically CSF Shunt components. It is a traditional 510(k) submission, intended to demonstrate substantial equivalence to previously cleared devices rather than providing a de novo study with strict acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this 510(k) submission.
Here's why and what can be inferred:
- Substantial Equivalence: The core of a 510(k) submission for devices like this is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves demonstrating similar materials, intended use, performance characteristics, and design specifications. It does not usually involve extensive new clinical trials or performance studies with predefined acceptance criteria in the way a novel device or a device requiring a PMA (Premarket Approval) would.
- Focus on Predicate Device: The submission explicitly states: "Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the CSF-Flow Control Shunt components are equivalent to the previously reviewed and cleared products. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the products based upon the predicate and currently marketed devices."
- Lack of Performance Data: The provided text does not include any performance data, clinical trial results, or study methodologies that would address the questions posed.
Summary based on available information:
| Information Category | Detail from Submission |
|---|---|
| Acceptance Criteria & Reported Device Performance | Not provided. The submission focuses on substantial equivalence to predicate devices based on materials, intended use, performance characteristics, and design specifications. There are no explicitly stated acceptance criteria or reported device performance metrics from a new study presented in this document. |
| Sample Size (Test Set) & Data Provenance | Not applicable/Not provided. This type of 510(k) submission does not typically involve a new "test set" in the context of a performance study with human-interpreted data. The comparison is against predicate devices and their established safety and efficacy profiles. |
| Number of Experts & Qualifications (Ground Truth) | Not applicable/Not provided. No new ground truth establishment study is described. Substantial equivalence relies on the established safety and efficacy of the predicate devices. |
| Adjudication Method | Not applicable/Not provided. No new ground truth establishment study is described. |
| MRMC Comparative Effectiveness Study | No. This type of device (physical shunt components) does not involve AI or image interpretation where an MRMC study would be relevant. |
| Standalone Performance Study (Algorithm Only) | No. This device is a physical medical implant, not a software algorithm. |
| Type of Ground Truth Used | Not applicable/Not provided. The "ground truth" implicitly relies on the historical clinical performance and regulatory clearances of the predicate CSF shunt devices. |
| Sample Size for Training Set | Not applicable/Not provided. No machine learning or AI model training is involved. |
| How Ground Truth for Training Set was Established | Not applicable/Not provided. No machine learning or AI model training is involved. |
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510k Summary 4.
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.
| Establishment Registration Number: | 2021898 |
|---|---|
| Address of Manufacturer: | Medtronic Neurosurgery125 Cremona DriveGoleta CA, 93117(805) 968-1546 ext. 1773Fax: (805) 968-9336 |
| Contact Person: | Jeffrey Henderson |
| Date: | August 11, 2004 |
| Trade or Proprietary Name: | Medtronic PS Medical® Neurosurgical implants |
| Common usual or Classification Name: | Central Nervous System Flow Control Shunts andAccessories ( 882.5550) |
| Predicate Device Identification: | PS Medical® Neurosurgical implants (K803257,K831678, K841442, K833822, K873247, K874468,K874498, K900676, K902783, K911410, K913412,K934545, K951258, K991502, K012052, K033850.) |
The PS Medical Neurosurgical Implants are manufactured with silicone adhesive. The Description: devices are used as shunt components.
Intended Use: CSF Shunt components are designed to provide controlled Cerebrospinal Fluid (CSF) flow from the ventricles of the brain to the right atrium of the heart or the peritoneal cavity.
Intended Use of predicate device(s): CSF Shunt components are designed to provide controlled Cerebrospinal Fluid (CSF) flow from the ventricles of the right atrium of the heart or the peritoneal cavity.
Technological comparison:_Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the CSF-Flow Control Shunt components are equivalent to the previously reviewed and cleared products. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the products based upon the predicate and currently marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle.
SEP 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey Henderson Vice President, Quality and Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117
Re: K042198
Trade/Device Name: Medtronic Neurosurgical Implants Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components. Regulatory Class: II Product Code: JXG Dated: August 11, 2004 Received: August 27, 2004
Dear Mr. Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wfo neve ro rowed your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfed in the encreases)77 the enactment date of the Medical Device Amendments, or to commerce price that have been reclassified in accordance with the provisions of the Federal Food, Drug, do noos mat have e e e e e equire approval of a premarket approval application (PMA). You 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 (PMA), it If your de roo to such additional controls. Existing major regulations affecting your device can may be babyer is been Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jeffrey Henderson
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your e FDA finding of substantial equivalence of your device to a legally premated notineted in " 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), please If you a the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K042198 510(k) Number (if known):
Device Name: Medtronic Neurosurgical implants
Indications For Use:
CSF Shunt components are designed to provide controlled Cerebrospinal Fluid (CSF) flow from the ventricles of the brain to the right atrium of the heart or the peritoneal cavity.
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
..
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __ 1__
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K042198 510(k) Number_
§ 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).