(245 days)
Not Found
None
No
The summary describes a physical implantable device for CSF management and does not mention any software, image processing, or AI/ML terms.
Yes
The intended use explicitly states "therapeutic drug access to the cord/or diversion of cerebrospinal fluid," indicating therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "diagnostic studies."
No
The device description clearly states "Accura Elite Gravity Compensating Reservoir," which is a physical, implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes implantation into the brain for diagnostic studies, therapeutic drug access, or CSF diversion. This involves direct interaction with the patient's body and physiological fluids in vivo.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. They are used outside the body (in vitro).
This device is clearly an implantable medical device used within the body, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
This device is intended for implantation over either right or left frontal horn, in conjunction with a shunt system for use as a means of diagnostic studies, therapeutic drug access to the CSF, and/or diversion of cerebrospinal fluid.
Product codes
JXG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
frontal horn, ventricles
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)
Not Found
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2003
Ms. Courtney Smith Regulatory Affairs Manager Phoenix Biomedical Corporation P.O. Box 80390 Valley Forge, Pennsylvania 19484
Re: K030468
Trade/Device Name: Acura Elite Gravity Compensating Reservoir Regulation Number: 21 CFR 882.5550) Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: August 18, 2003 Received: August 18, 2003
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) that do not require 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 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 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.
1
Page 2 - Ms. Courtney Smith
This letter will allow you to begin marketing your device as described in your Section 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), please contact 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 Manufacturers, 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.
Mark A. Millman
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
2
Page of
510(k) NUMBER (IF KNOWN) : DEVICE NAME : Accura Elite Gravity Compensating Reservoir INDICATIONS FOR USE:
Accura Elite Gravity Compensating Reservoir
Intended Use/ Indications:
This device is intended for implantation over either right or left frontal horn, in This device is miended for implantation over shirt system for use as a means of conjunction with a ventricles for the purpose of diagnostic studies, therapeutic drug access to the cord/or diversion of cerebrospinal fluid.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
510(k) Number K030468