HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

• K Number: K032337
• Device Name: HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
• Manufacturer: HEMEDEX INCORPORATED
• Date Cleared: 2003-10-21 ( 84 days)
• Product Code: GWM
• Regulation Number: 882.1620
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K992591 , K974088 , K002765

Intended Use

The Hemedex Single and Double Lumen Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.

Device Description

The Hemedex Cranial Bolts are stainless steel threaded cranial access devices with standard tuohy borst compression fittings.

AI/ML Overview

The Hemedex Cranial Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring. Bench testing was conducted to demonstrate that this device meets the requirements of its intended use and meets the specified performance criteria. The Hemedex Cranial Bolts and the predicate devices use identical technology and materials.

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Meet requirements of intended use	Bench testing demonstrated the device meets these requirements
Meet specified performance criteria	Bench testing demonstrated the device meets these criteria
Identical technology to predicate devices	Confirmed as identical
Identical materials to predicate devices	Confirmed as identical

Study Information:

1. Sample size used for the test set and the data provenance: Not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was bench testing.
3. Adjudication method: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: No.
5. Standalone performance study: Yes, bench testing was conducted.
6. Type of ground truth used: Bench testing results against specified performance criteria and intended use requirements.
7. Sample size for the training set: Not applicable, as this was bench testing for a physical device.
8. How the ground truth for the training set was established: Not applicable.

Regulation Number and Section

§ 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).