(74 days)
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Not Found
No
The summary describes a mechanical device for cranial access and sensor placement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to secure a sensor for intracranial monitoring, which is a diagnostic application rather than a therapeutic one.
No
Explanation: The device is designed to secure sensors for intracranial monitoring, which collects data. It does not perform the diagnosis itself, but rather facilitates the use of other devices that collect diagnostic information.
No
The device description explicitly lists physical components like bolts, sensor introducers, connectors, and drill bits, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to achieve cranial access and secure sensors for intracranial monitoring. This involves direct interaction with the patient's body (invasive procedure) to measure physiological parameters in vivo.
- Device Description: The device description details components for surgical access and securing sensors within the skull. It does not mention any components or processes for analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
Therefore, the CODMAN® Single and Double Lumen Skull Bolt Kits are medical devices used for surgical access and sensor placement for in vivo monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CODMAN® Single Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring applications. The CODMAN® Double Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure sensors in place for intracranial monitoring applications.
Product codes (comma separated list FDA assigned to the subject device)
GWM
Device Description
The CODMAN® Single and Double Lumen Skull Bolt Kits consist of bolts and associated components designed to achieve cranial access and facilitate the introduction and securing of intracranial sensors. Additional accessories supplied in the kits include a sensor introducer, connectors, drill bits, and other associated components supplied for the convenience of the user. All parts and accessories found in the CODMAN® Single and Double Lumen Skull Bolt Kits are manufactured from biocompatible materials suitable for their uses in these kits.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
cranial
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This submission relied on bench testing to demonstrate equivalence of performance characteristics to predicate products. Torque, pullout, and leak testing of both the single and double lumen bolts demonstrated that the devices are appropriate for their 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.
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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.
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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).
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§ 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
510(k) Summary for the CODMAN® Single and Double Lumen Skull Bolt Kits
Codman & Shurtleff, 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
CODMAN® Single and Double Lumen Skull Bolt Kits Proprietary Name: Common Name: Intracranial Bolts Classification Name: Intracranial pressure monitoring devices
Device Classification
These devices have been placed in Class II for intracranial pressure monitoring devices per 21 CFR & 882.1620 (84GWM).
Statement of Substantial Equivalence
The CODMAN® Single and Double Lumen Skull Bolt Kits are substantially equivalent to both the CODMAN® MICROSENSOR™ Skull Bolt Kit and the CAMINO Micro Ventricular Bolt 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
The CODMAN® Single Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring applications.
The CODMAN® Double Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure sensors in place for intracranial monitoring applications.
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Physical Description
The CODMAN® Single and Double Lumen Skull Bolt Kits consist of bolts and associated components designed to achieve cranial access and facilitate the introduction and securing of intracranial sensors. Additional accessories supplied in the kits include a sensor introducer, connectors, drill bits, and other associated components supplied for the convenience of the user. All parts and accessories found in the CODMAN® Single and Double Lumen Skull Bolt Kits are manufactured from biocompatible materials suitable for their uses in these kits.
Device Testing
This submission relied on bench testing to demonstrate equivalence of performance characteristics to predicate products. Torque, pullout, and leak testing of both the single and double lumen bolts demonstrated that the devices are appropriate for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Mr. James Flaherty, Jr., RAC Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K992591
Trade Name: Codman Single and Double Lumen Skull Bolt Kits Regulatory Class: II Product Code: GWM Dated: July 30, 1999 Received: August 2, 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 enclosures) 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.
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Page 2 -- Mr. James Flaherty
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 vour 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,
Colin McWhirter, Ph.D., M.D.
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
K 992591 CODMAN® Single and Double Lumen Skull Bolt Kits
Indications For Use:
The CODMAN® Single Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring applications.
The CODMAN® Double Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure sensors in place for intracranial monitoring applications.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcolle
noral Rastorativa De
Prescription Use (Per 21 CFR §801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)