Who is the manufacturer of QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT?

Hemedex Incorporated filed the 510(k) submission for QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT (K141869).

What is the FDA product code for QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT?

GWM. It is classified under 21 CFR 882.1620 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT?

Hemedex Single and Dual Lumen Cranial Bolts (K032337); Integra Licox Brain Monitoring System, PN IM1, IM2, IM3 (K002765).

Who can help prepare an FDA 510(k) submission like QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT

K141869 · Hemedex Incorporated · GWM · Oct 10, 2014 · Neurology

Device Facts

Record ID	K141869
Device Name	QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
Applicant	Hemedex Incorporated
Product Code	GWM · Neurology
Decision Date	Oct 10, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1620
Device Class	Class 2

Intended 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.

Device Story

The QFlow 500 Titanium Bolt Kit is a surgical access device used in clinical settings to facilitate intracranial monitoring. The kit includes a quad-lumen titanium bolt, drill bit, scalpel, and sensor introducer. The physician drills a single 5.3 mm burr hole in the patient's skull and inserts the bolt to provide a secure, sealed pathway for up to four sensors. The device transforms the surgical site into a multi-sensor access point, reducing the need for multiple burr holes compared to using single or dual-lumen bolts. This reduction in surgical trauma and potential infection risk benefits the patient. The device is operated by a physician; output is the physical access and securement of monitoring sensors, which the physician uses to manage intracranial pressure or other physiological parameters.

Clinical Evidence

Bench testing only. Testing included torque requirements for insertion, axial tension for pull-out, Touhy Borst compression cap sealing, leak testing at 185 mm Hg for 14 days, and drill bit functionality. Results showed the device met all predetermined specifications and performed equal to or better than predicate and reference devices in comparative bench studies.

Technological Characteristics

Materials: Titanium, polyphenylsulfone, polyvinyl chloride, polycarbonate, stainless steel, titanium nitride, acrylonitrile butadiene styrene, polyether block amide. Configuration: Quadruple lumen cranial bolt. Sensing/Actuation: Mechanical access/securement. Energy: None. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring intracranial monitoring; allows for the introduction and securement of one to four sensors through a single cranial access point.

Regulatory Classification

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.

Predicate Devices

Hemedex Single and Dual Lumen Cranial Bolts (K032337)
Integra Licox Brain Monitoring System, PN IM1, IM2, IM3 (K002765)

Reference Devices

K992591

Related Devices

K992591 — CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS · Codman & Shurtleff, Inc. · Oct 15, 1999
K032337 — HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 · Hemedex Incorporated · Oct 21, 2003
K981846 — PARENCHYMAL BOLT PRESSURE MONITORING KIT · Camino Neurocare, Inc. · Aug 18, 1998
K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT · Johnson & Johnson Professionals, Inc. · Jul 9, 1999
K974088 — CODMAN INTRACRANIAL BOLT · Johnson & Johnson Professionals, Inc. · Jan 9, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three heads in profile, representing health, humans, and services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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). {4}------------------------------------------------ ### 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 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. #### 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. {5}------------------------------------------------ ## Comparison of Technological Characteristics | | Hemedex Quad Lumen Intracranial Bolt | Hemedex Intracranial Bolt K032337 | Integra Licox Brain Oxygen Monitoring System K002765 (P/N IM1, IM2, IM3) | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 Hemedex Single and Double Lumen Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring. | The Licox measures intracranial oxygen and temperature and is indicated as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to the sensor placement. Licox systems values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern. | | Components | Titanium Bolt Bolt wing Compression fitting (cap, body, gasket and washer) Luer tubes Cap, Non-vented, Male Luer Lock Extension fitting Stylet Introducer Drill bit Hex wrench Scalpel | Stainless steel Bolt with wing shape Compression fitting (cap, grommet and washer) Piercing device Cap, Non-vented, Male Luer Lock Sealing Washer Stylet | Stainless steel Bolt Bolt wing Compression fitting (cap, grommet and washer) Luer tubes Stylet Introducer Drill Bit Hex Wrench Piercing needle | | Configuration | Quadruple Lumen | Single and Double Lumen | Single, Double & Triple lumen | | Bolt Size Length | 4.7 | | | {6}------------------------------------------------ #### 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 insert the cranial bolt | 7 - 8 in-lbs maximum torque required | Easily inserted. Met the predetermined specification | | Axial tension required to pull the cranial bolt out | Greater than 40 lbf | Acceptably secured in the bone. Met the predetermined specification | | Torque required to tighten the Touhy Borst compression cap to seal the sensors | Less than 1 in-lb torque required | Easy to secure the sensors. Met the predetermined specification | | Tension required to pull the sensors out of the Touhy Borst | Approximately 1.3 lbf | Sensors secure. Met the predetermined specification | | Leak testing | No leaking at 185 mm Hg pressure for 14 days | Easily meets the predetermined sealing specifications | | Axial tensile strength of the "pig tails" | 19 - 37 lbf depending on pigtail diameter | Strong connections. Met the predetermined specification | | Axial tensile strength of the introducer | 3.7 - 4.4 lbf | Acceptable. Met the predetermined specification | | Axial tensile strength of the pigtail extension | 16.6 - 20.6 lbf | Strong connections. Met the predetermined specification | | Drill bit dimensional and cutting functionality | Burr hole diameter 0.209" Easily cut through bone | Easy to create the correct size burr hole. Strong connections. Met the predetermined 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 {7}------------------------------------------------ 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 required to insert the cranial bolt | The Hemedex Quad Lumen Bolt required 38% to 64% less in-lbs of torque to fully insert, depending on the predicate or reference device | Substantially equivalent or better than the predicate & reference devices | | Axial tension required to pull the cranial bolt out of the skull | The Hemedex Quad Lumen Bolt pull out force was greater than 40 lbf. The predicate and reference devices could not reach the 40lbf threshold without incurring damage. | Substantially equivalent or better than the predicate & reference devices | | Leak testing | The bolts were tested at increasing intervals of insertion replicating different skull thicknesses at 185 mm Hg pressure. In all cases the Hemedex Quad Lumen Bolts incurred less leaking. | Substantially equivalent or better than the predicate & reference devices | | Drill bit dimensional and cutting functionality | The Hemedex Burr hole diameter 0.209" meets specification. Predicate (K002765) and reference device specifications are unknown. All the tested drill bits easily cut through bone. Depth collars remained secure. | Substantially equivalent to the predicate & reference devices | ### Conclusion The Hemedex QFlow 500™ Titanium Bolt Kit, Quad Lumen is substantially equivalent to or better than the predicate devices.