(88 days)
Not Found
Not Found
No
The device description and intended use focus on physical components for pressure monitoring and fluid drainage, with no mention of AI/ML processing or analysis of the data.
No.
The device is indicated for monitoring intracranial pressure and CSF drainage, not for treating a disease or condition.
Yes
Explanation: The device is used for "direct intracranial pressure (ICP) monitoring," which is a diagnostic activity to assess a patient's condition.
No
The device description clearly lists multiple hardware components, including a catheter, stylet, sensor, connector, suture clip, and tunneling trocar.
Based on the provided information, the CODMAN® MICROSENSOR™ Ventricular Catheter Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for direct intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage. This involves monitoring a physiological parameter within the body and managing a bodily fluid from the body.
- Device Description: The components are all designed for insertion into the body (catheter, stylet, sensor, tunneling trocar) and managing fluids or connections related to that insertion.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens outside the body (in vitro) to provide information about a patient's health. This device does not involve the analysis of samples in a laboratory setting.
Therefore, the CODMAN® MICROSENSOR™ Ventricular Catheter Kit is a medical device used for in vivo monitoring and drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use of the CODMAN® MICROSENSOR™ Ventricular Catheter Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid (CSF) drainage applications.
Product codes (comma separated list FDA assigned to the subject device)
GWM, HCA
Device Description
The CODMAN® MICROSENSOR™ Ventricular Catheter Kit consists of the following components:
- Ventricular Catheter Triple-lumen catheter with a center drainage lumen (1) and dedicated lumens for the stylet and MICROSENSOR™ ICP Sensor,
- Stylet Preloaded stylet sued for catheter insertion and placement, (2)
- MICROSENSOR™ ICP Sensor Intracranial pressure (ICP) sensor (3) embedded in a dedicated lumen with direct CSF access,
- Y -Connector Connection component allowing the catheter to be either (4) connected to an external drainage system or capped,
- (૨) Suture Clip - Catheter anchoring clip, and
- Tunneling Trocar with TEFLON® Tubing Trocar with sheath designed (6) to allow the catheter to be tunneled under the scalp to the craniotomy site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraventricular
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)
This submission relied on appropriate testing in accordance with ISO 10993-1 "Biological Testing of Medical and Dental Materials and Devices, Part 1: Guidance on Selection of Tests" and the "Tripartite Biocompatibility Guidelines for Medical Devices" as well as material characteristics of the silicone elastomer as furnished by the material supplier. All testing supports the device for its intended use.
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.
Not Found
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
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).
0
99/222
510(k) Summary for the CODMAN® MICROSENSOR™ Ventricular Catheter Kit
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person
James M. Flaherty, Jr., RAC Regulatory Affairs Specialist Telephone Number: (508) 880-8404 Fax Number: (508) 828-3212
Name of Device
| Proprietary Name: | CODMAN® MICROSENSOR™ Ventricular Catheter Kit |
|---|---|
| Common Name: | Intracranial pressure (ICP) monitoring/cerebrospinal fluid |
| (CSF) drainage catheter kit | |
| Classification Name: | • Intracranial pressure monitoring device |
| • Ventricular catheter |
Device Classification
This device has been placed in Class II for intracranial pressure monitoring devices per 21 CFR § 882.1620 (84GWM) as well as for ventricular catheters per 21 CFR § 882.4100 (84HCA).
Statement of Substantial Equivalence
The CODMAN® MICROSENSOR™ Ventricular Catheter Kit is substantially equivalent to both the CODMAN® MICROSENSOR™ Catheter Kit and the CAMINO NeuroCare™, Inc. VentrixTM Ventricular Tunneling Pressure Monitoring Kit based on the subject device's similarity to the predicate devices in intended use, materials, design, and principles of operation.
Indications for Use
Use of the CODMAN® MICROSENSOR™ Ventricular Catheter Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid (CSF) drainage applications.
1
Physical Description
The CODMAN® MICROSENSOR™ Ventricular Catheter Kit consists of the following components:
- Ventricular Catheter Triple-lumen catheter with a center drainage lumen (1) and dedicated lumens for the stylet and MICROSENSOR™ ICP Sensor,
- Stylet Preloaded stylet sued for catheter insertion and placement, (2)
- MICROSENSOR™ ICP Sensor Intracranial pressure (ICP) sensor (3) embedded in a dedicated lumen with direct CSF access,
- Y -Connector Connection component allowing the catheter to be either (4) connected to an external drainage system or capped,
- (૨) Suture Clip - Catheter anchoring clip, and
- Tunneling Trocar with TEFLON® Tubing Trocar with sheath designed (6) to allow the catheter to be tunneled under the scalp to the craniotomy site.
Device Testing
This submission relied on appropriate testing in accordance with ISO 10993-1 "Biological Testing of Medical and Dental Materials and Devices, Part 1: Guidance on Selection of Tests" and the "Tripartite Biocompatibility Guidelines for Medical Devices" as well as material characteristics of the silicone elastomer as furnished by the material supplier. All testing supports the device for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1999
Mr. James M. Flaherty, Jr., RAC Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K991222
Trade Name: Codman Microsensor Ventricular Catheter Kit Regulatory Class: II Product Code: GWM Dated: April 9, 1999 Received: April 12, 1999
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, Drug, 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 (OS) 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.
3
Page 2 - Mr. James M. Flaherty, Jr., RAC
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) 594-4595. 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,
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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510(k) Number (if known) Device Name
CODMAN® MICROSENSOR™ Ventricular Catheter Kit
Indications For Use:
Use of the CODMAN® MICROSENSOR™ Ventricular Catheter Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid (CSF) drainage applications.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✗
| (Per 21 CFR §801.109) | OR | Over-the-Counter Use __ |
|---|---|---|
| --------------------------------------------- | ---- | ------------------------- |
(Optional Format 1-2-96)
at Restorative Devices K991222