(78 days)
Not Found
Not Found
No
The summary describes a physical reservoir for accessing cerebral ventricles, with no mention of software, algorithms, or AI/ML terms.
No
The device is described as providing access to cerebral ventricles for drainage or administration of therapeutic agents, but it does not perform a therapeutic action itself.
No
Explanation: The device is used for gaining access to cerebral ventricles for drainage or administration of agents, which are therapeutic or interventional actions, not diagnostic ones.
No
The device description is not found, but the intended use describes a physical reservoir intended for hypodermic puncture and ventricular drainage, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes accessing the cerebral ventricles for drainage and administration of substances. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are performed in vitro (outside the living organism).
- Lack of IVD Characteristics: The description doesn't mention analyzing samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Perf (Ommaya Style) Reservoir, as described, is a medical device used for direct patient intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- The Perf (Ommaya Style) Reservoir is intended as a means of gaining access to the coronal velieres of any and for ventricular drainage by hypodermic puncture.
- The Perf (Ommaya Style) Reservoir may be used to access the ventricles for instillation of chemotherapeutic agents and/or radioisotopes.
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
ventricles, coronal velieres
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/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of a stylized human figure with three profiles overlapping each other. The profiles are facing to the right and are connected to a wing-like shape above them.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UG 0 6 2002
Phoenix Biomedical Corporation Courtney Smith Regulatory Affairs Manager 2495 General Armistead Avenue, P. O. Box 80390 Valley Forge, Pennsylvania 19484
Re: K021644
Trade/Device Name: Perf (Ommaya Style) Reservoir Regulation Number: 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: May 16, 2002 Received: May 20, 2002
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. Iisting 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours
Sincerely yours,
Mark A. Milken
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 : INDICATIONS FOR USE:
Perf (Ommaya Style) Reservoir
Intended Use/ Indications:
- The Perf (Ommaya Style) Reservoir is intended as a means of gaining . The Pen (Onlinaya Stylo) Reber by hypodermic puncture. It may be used access to the coronal velieres of any and for ventricular drainage.
- The Perf (Ommaya Style) Reservoir may be used to access the ventricles . The Perf (Onlinaya Bryto) Resort of chemotherapeutic agents and/or radioisotopes.
(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)
for
| Mark N. Melkers | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices |
510(k) Number_________________________________________________________________________________________________________________________________________________________________