(198 days)
Not Found
No
The device description and intended use focus on a physical catheter kit for draining CSF. There is no mention of software, algorithms, or any technology that would suggest AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is designed to reduce increased intracranial volume and pressure by draining cerebrospinal fluid, which is a therapeutic intervention.
No
The device is designed to drain cerebrospinal fluid (CSF) to reduce intracranial volume and pressure, which is a therapeutic action, not a diagnostic one. It is used for "temporary access" and "drains cerebrospinal fluid," indicating intervention rather than diagnosis.
No
The device description clearly outlines multiple physical components including a catheter, needle, guidewire, connector, and suture tab, indicating it 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 is to drain cerebrospinal fluid (CSF) from the lumbar subarachnoid region to reduce intracranial volume and pressure. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device components are designed for accessing and draining fluid from the body, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be performed on a sample outside of the patient's body for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to directly interact with the patient's anatomy for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Lumbar Drainage Catheter Kit is indicated for temporary access to the lumbar subarachnoid region and, when used with other Codman devices, is designed to drain cerebrospinal fluid (CSF) as a means of reducing increased intracranial volume and pressure.
Product codes (comma separated list FDA assigned to the subject device)
84JXG
Device Description
The Lumbar Drainage Catheter Kit consists of an 80cm lumbar catheter having an inner diameter of .76mm. The catheter has 13 tantalum location markings to assist the surgeon. The initial mark is located at 11.4 cm with a mark every 1cm thereafter for 10cm, and additional marks at 15cm and 20cm. Also included are a cm-marked 14 gauge thin wall Touhy needle with optional stabilizing wings; a 100 cm Teflon coated, flexible tip guidewire with an outer diameter of 0.5mm; a plastic female Luer-Lok connector, with barbed end and plastic Luer-Lok cap, that is installed on the distal end of the catheter in preparation for connection to monitoring equipment or fluid collection equipment; and a soft suture tab for holding the catheter in position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar subarachnoid region
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Summary of Safety and Effectiveness Data for the Lumbar Drainage Catheter Kit
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person
Deana M. Boushell Associate Regulatory Affairs Specialist Phone: (508) 828-3107 Fax: (508) 828-3212
Name of Device
| Proprietary Name: | CODMAN Lumbar Drainage Catheter Kit |
|---|---|
| Common Name: | Lumbar Drainage Catheter Kit |
| Classification Name: | Central nervous system fluid shunt and component |
| Regulatory Class: | Class II by 21 CFR §882.5550 |
| Product Code No.: | 84JXG |
| Owner/Operator No.: | 9001269 |
Device Classification_________________________________________________________________________________________________________________________________________________________
This device has been placed in Class II for Central nervous system fluid shunt and components per 21 CFR § 882.5550.
Statement of Substantial Equivalence _________________________________________________________________________________________________________________________________________
The Lumbar Drainage Catheter Kit is substantially equivalent to the Cordis Lumbar Catheter Accessory Kit currently marketed in the United States under #K855058.
The subject device is composed of similiar materials to the Cordis Lumbar Catheter Accessory Kit. Further, the intended use, design, and manufacture of the Lumbar Drainage Catheter Kit are substantially equivalent to the currently distributed. Additionally, the packaging and method of sterilization utilized for the Lumbar Drainage Catheter Kit are the same as those used for the Lumbar Catheter Accessory Kit
Indications for Use___________________________________________________________________________________________________________________________________________________________
The Lumbar Drainage Catheter Kit has the same indications for use as the Cordis Lumbar Catheter Accessory Kit. They are both indicated for use in conjunction with other devices to drain cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing increased intracranial volume and pressure.
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Physical Description
The Lumbar Drainage Catheter Kit consists of an 80cm lumbar catheter having an inner diameter of .76mm. The catheter has 13 tantalum location markings to assist the surgeon. The initial mark is located at 11.4 cm with a mark every 1cm thereafter for 10cm, and additional marks at 15cm and 20cm. Also included are a cm-marked 14 gauge thin wall Touhy needle with optional stabilizing wings; a 100 cm Teflon coated, flexible tip guidewire with an outer diameter of 0.5mm; a plastic female Luer-Lok connector, with barbed end and plastic Luer-Lok cap, that is installed on the distal end of the catheter in preparation for connection to monitoring equipment or fluid collection equipment; and a soft suture tab for holding the catheter in position.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James M. Flaherty, Jr. Associate Requlatory Affairs Specialist JUN 2 5 1997 Johnson & Johnson Professional, Inc. 325 Paramount Drive --------Raynham, Massachusetts 02767-0350
Re : K964923 CODMAN® Lumbar Drainage Catheter Kit Trade Name: Requlatory Class: II Product Code: 84JXG Dated: March 31, 1997 Received: April 3, 1997
Dear Mr. Flaherty:
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, Druq, and Cosmetic Act (Act). 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 (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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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 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 - Mr. James M. Flaherty, Jr.
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callah an, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Lumbar Drainage Catheter Kit
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Indications for Use
The Lumbar Drainage Catheter Kit is indicated for temporary access to the lumbar subarachnoid region and, when used with other Codman devices, is designed to drain cerebrospinal fluid (CSF) as a means of reducing increased intracranial volume and pressure.
Prescription Use (Per 21 CFR 801.109)
Thomas J. Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K964923