The QFlow 500™ Titanium Bolt Quad Lumen Kit is used to achieve cranial access and to introduce and secure up to four sensors in place for intracranial monitoring. The kit contains a cranial bolt, drill bit, scalpel, sensor introducer with stylet, Touhy Borst fittings and connectors. The cranial bolt contains four lumens with its primary materials being titanium, polyphenylsulfone, polyvinyl chloride and polycarbonate. The primary materials of the sensor introducer are polyether block amide and polycarbonate. The primary materials of the other components in the kit are stainless steel, titanium nitride, acrylonitrile butadiene styrene, polyphenylsulfone, polyvinyl chloride and polycarbonate.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This device is not an AI/ML powered device, The current response contains information derived from the provided document.

Test	Acceptance Criteria (Predetermined Specification)	Reported Device Performance (Hemedex QFlow 500™ Titanium Bolt Kit, Quad Lumen)
Torque required to insert the cranial bolt	Not explicitly stated (implied to be easy)	7 - 8 in-lbs maximum torque required. In comparative testing, required 38% to 64% less in-lbs of torque to fully insert compared to predicate/reference devices.
Axial tension required to pull the cranial bolt out	Greater than 40 lbf	Greater than 40 lbf. In comparative testing, the Hemedex Quad Lumen Bolt pull out force was greater than 40 lbf, whereas predicate and reference devices could not reach this threshold without incurring damage.
Torque required to tighten the Touhy Borst compression cap to seal the sensors	Less than 1 in-lb torque required	Less than 1 in-lb torque required.
Tension required to pull the sensors out of the Touhy Borst	Not explicitly stated (implied to be secure)	Approximately 1.3 lbf.
Leak testing	No leaking at 185 mm Hg pressure for 14 days	No leaking at 185 mm Hg pressure for 14 days. In comparative testing, the Hemedex Quad Lumen Bolts incurred less leaking at increasing intervals of insertion replicating different skull thicknesses at 185 mm Hg pressure.
Axial tensile strength of the "pig tails"	Not explicitly stated (implied to be strong)	19 - 37 lbf depending on pigtail diameter.
Axial tensile strength of the introducer	Not explicitly stated (implied to be acceptable)	3.7 - 4.4 lbf.
Axial tensile strength of the pigtail extension	Not explicitly stated (implied to be strong)	16.6 - 20.6 lbf.
Drill bit dimensional and cutting functionality	Burr hole diameter 0.209"	Burr hole diameter 0.209". Easily cut through bone. Depth collars remained secure. In comparative testing, the Hemedex drill bit meets specification. Predicate (K002765) and reference device specifications are unknown for diameter. All tested drill bits easily cut through bone; depth collars remained secure.

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing, which typically involves laboratory-controlled experiments rather than human or animal subjects. Therefore, the concept of "sample size used for the test set" in the context of human data or "data provenance" (country of origin, retrospective/prospective) as it relates to clinical data is not applicable here. The tests were performed on the device components themselves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this type of performance testing (mechanical and functional bench tests) is based on engineering specifications and physical measurements, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human adjudication of results; it's a series of physical and mechanical bench tests performed according to engineering protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a mechanical cranial bolt, not an AI/ML system that would involve human readers interpreting output.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance tests described are standalone in the sense that they evaluate the device's physical properties and function without human interaction beyond operating the test equipment.

7. The Type of Ground Truth Used

The ground truth for the bench testing was based on:

Predetermined Engineering Specifications: These are quantifiable targets for mechanical properties (e.g., torque, tension, leak rates, dimensions).
Measurable Physical Properties: Direct measurements of the device's behavior under specific test conditions (e.g., actual torque required, actual pull-out force, actual leakage).
Comparison to Predicate Devices: Performance was also evaluated relative to the performance of existing legally marketed predicate devices (K032337, K002765) and a reference device (K992591) to demonstrate substantial equivalence or improvement.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2014

Hemedex Inc. Dean Honkonen VP, Regulatory Affairs and Quality Assurance 222 3rd St Suite 0123 Cambridge, Massachusetts 02142

Re: K141869 Trade/Device Name: OFlow 500 Titanium Bolt Kit, Quad Lumen Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM, HBG Dated: July 8, 2014 Received: July 14, 2014

Dear Mr. Honkonen,

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141869

Device Name QFlow 500 Titanium Bolt Kit, Quad Lumen

Indications for Use (Describe)

The Hemedex Cranial Bolt is designed to achieve cranial access and to introduce and secure one to four sensors in place for intracranial monitoring.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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HEMEDEX QFLOW 500™ TITANIUM BOLT KIT

510K Summary

Submitter's Name and Address

Hemedex, Inc. 222 Third Street, Suite 0123 Cambridge, MA 02142

Date

October 9, 2014

Contact Person

Dean Honkonen VP, Regulatory Affairs and Quality Assurance Telephone (617) 577-1759 Fax (617) 577-9328

Name of Device

Proprietary Name:	QFlow 500™ Titanium Bolt Kit, Quad Lumen
Common Name:	Intracranial Bolt
Classification Name:	Intracranial pressure monitoring device
Product Codes:	GWM, HBG
Regulations:	882.1620, 882.4300
Class:	II
Panel:	Neurology

Statement of Substantial Equivalence

The QFlow 500™ Titanium Bolt Kit is substantially equivalent in intended use, function and design to the Hemedex Single and Dual Lumen Cranial Bolts (K032337), as well as the Integra Licox Brain Monitoring System, PN IM1, IM2, IM3 (K002765).

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Purpose

This submission covers design changes to predicate device cranial bolt K032337 that adds two lumens to the dual lumen bolt for a total of four lumens. New kit components are added to accommodate the additional sensors and for ease of use.

Device Description

Indications for Use

The Hemedex Cranial Bolt is designed to achieve cranial access and to introduce and secure one to four sensors in place for intracranial monitoring.

The QFlow 500™ Titanium Bolt Quad Lumen indications for use differ from predicate devices K032337 and K002765, in that the Quad Lumen Bolt allows for one to two additional sensors to be inserted. This difference does not change the use of the device as it is still used to introduce and secure sensors in place for intracranial monitoring. The Quad Lumen Bolt improves safety and effectiveness as in cases were more than two sensors are to be placed in a patient, only one burr hole of 5.3 mm in diameter is necessary. Currently, in the case where the physician decides to place four sensors, two burr holes must be drilled for the placement of two dual lumen bolts, or a three lumen bolt combined with a single lumen bolt. Two burr holes drilled into the patient's skull increase the risk of infection and trauma to the patient. Predicate device K002765, Integra Licox Brain Monitoring System, allows for up to three devices to be inserted through one burr hole, requiring a second burr hole and single lumen bolt to be inserted, thus increasing the risk to the patient.

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Comparison of Technological Characteristics

	Hemedex Quad LumenIntracranial Bolt	HemedexIntracranial BoltK032337	Integra Licox Brain OxygenMonitoring SystemK002765 (P/N IM1, IM2, IM3)
Indicationsfor Use	The Hemedex Cranial Bolt isdesigned to achieve cranialaccess and to introduce andsecure one to four sensors inplace for intracranialmonitoring.	The Hemedex Single andDouble Lumen Bolts aredesigned to achieve cranialaccess and to introduce andsecure a sensor in place forintracranial monitoring.	The Licox measuresintracranial oxygen andtemperature and is indicatedas an adjunct monitor of trendsof these parameters, indicatingthe perfusion status of cerebraltissue local to the sensorplacement. Licox systemsvalues are relative within anindividual and should not beused as the sole basis fordecisions as to diagnosis ortherapy. It is intended toprovide data additional to thatobtained by current clinicalpractice in cases wherehypoxia or ischemia are aconcern.
Components	Titanium BoltBolt wingCompression fitting (cap,body, gasket and washer)Luer tubesCap, Non-vented, Male LuerLockExtension fittingStyletIntroducerDrill bitHex wrenchScalpel	Stainless steel Bolt with wingshapeCompression fitting (cap,grommet and washer)Piercing deviceCap, Non-vented, Male LuerLockSealing WasherStylet	Stainless steel BoltBolt wingCompression fitting (cap,grommet and washer)Luer tubesStyletIntroducerDrill BitHex WrenchPiercing needle
Configuration	Quadruple Lumen	Single and Double Lumen	Single, Double & Triple lumen
Bolt SizeLength	4.7

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Performance Testing

Bench testing was conducted to demonstrate that this device meets the requirements of its intended use and meets the specified performance criteria. Bench testing performed was as follows:

Test	Results	Conclusion
Torque required to insertthe cranial bolt	7 - 8 in-lbs maximumtorque required	Easily inserted. Met thepredetermined specification
Axial tension required topull the cranial bolt out	Greater than 40 lbf	Acceptably secured in thebone. Met the predeterminedspecification
Torque required to tightenthe Touhy Borstcompression cap to sealthe sensors	Less than 1 in-lb torquerequired	Easy to secure the sensors.Met the predeterminedspecification
Tension required to pull thesensors out of the TouhyBorst	Approximately 1.3 lbf	Sensors secure. Met thepredetermined specification
Leak testing	No leaking at 185 mm Hgpressure for 14 days	Easily meets thepredetermined sealingspecifications
Axial tensile strength of the"pig tails"	19 - 37 lbf depending onpigtail diameter	Strong connections. Met thepredetermined specification
Axial tensile strength of theintroducer	3.7 - 4.4 lbf	Acceptable. Met thepredetermined specification
Axial tensile strength of thepigtail extension	16.6 - 20.6 lbf	Strong connections. Met thepredetermined specification
Drill bit dimensional andcutting functionality	Burr hole diameter 0.209"Easily cut through bone	Easy to create the correctsize burr hole. Strongconnections. Met thepredetermined specification

Bench testing was also conducted to demonstrate that this device is substantially equivalent or better than predicate devices K032337, K002765 and a reference device

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K992591. The tests selected assess the performance of the devices with regards to their interaction with the patient and user. Bench testing performed was as follows:

Test	Results	Conclusion
Torque requiredto insert thecranial bolt	The Hemedex Quad Lumen Bolt required38% to 64% less in-lbs of torque to fullyinsert, depending on the predicate orreference device	Substantially equivalentor better than thepredicate & referencedevices
Axial tensionrequired to pullthe cranial boltout of the skull	The Hemedex Quad Lumen Bolt pull outforce was greater than 40 lbf.The predicate and reference devicescould not reach the 40lbf thresholdwithout incurring damage.	Substantially equivalentor better than thepredicate & referencedevices
Leak testing	The bolts were tested at increasingintervals of insertion replicating differentskull thicknesses at 185 mm Hg pressure.In all cases the Hemedex Quad LumenBolts incurred less leaking.	Substantially equivalentor better than thepredicate & referencedevices
Drill bitdimensional andcuttingfunctionality	The Hemedex Burr hole diameter 0.209"meets specification. Predicate (K002765)and reference device specifications areunknown.All the tested drill bits easily cut throughbone.Depth collars remained secure.	Substantially equivalentto the predicate &reference devices

Conclusion

The Hemedex QFlow 500™ Titanium Bolt Kit, Quad Lumen is substantially equivalent to or better than the predicate devices.

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).