(91 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data processing.
No
The device is designed to provide cranial access and secure sensors for intracranial monitoring, not to treat a disease or condition.
No
The device is described as an access and securing device for intracranial monitoring sensors, not a sensor itself or a device that performs diagnostic functions. It facilitates data collection but does not interpret or analyze that data for diagnostic purposes.
No
The device description explicitly lists multiple hardware components (cranial bolt, drill bit, scalpel, sensor introducer, fittings, connectors) made of various materials, and the performance studies focus on the mechanical properties and functionality of these hardware components.
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 interacting directly with the patient's body (accessing the skull and placing sensors within).
- Device Description: The device is a cranial bolt and associated tools for surgical access and sensor placement. These are physical devices used in vivo (within a living organism).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the Hemedex Cranial Bolt is a surgical device used for in vivo monitoring, not an IVD.
N/A
Intended Use / 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.
Product codes
GWM, HBG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
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
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: Torque required to insert the cranial bolt. Results: 7 - 8 in-lbs maximum torque required. Conclusion: Easily inserted. Met the predetermined specification.
- Test: Axial tension required to pull the cranial bolt out. Results: Greater than 40 lbf. Conclusion: Acceptably secured in the bone. Met the predetermined specification.
- Test: Torque required to tighten the Touhy Borst compression cap to seal the sensors. Results: Less than 1 in-lb torque required. Conclusion: Easy to secure the sensors. Met the predetermined specification.
- Test: Tension required to pull the sensors out of the Touhy Borst. Results: Approximately 1.3 lbf. Conclusion: Sensors secure. Met the predetermined specification.
- Test: Leak testing. Results: No leaking at 185 mm Hg pressure for 14 days. Conclusion: Easily meets the predetermined sealing specifications.
- Test: Axial tensile strength of the "pig tails". Results: 19 - 37 lbf depending on pigtail diameter. Conclusion: Strong connections. Met the predetermined specification.
- Test: Axial tensile strength of the introducer. Results: 3.7 - 4.4 lbf. Conclusion: Acceptable. Met the predetermined specification.
- Test: Axial tensile strength of the pigtail extension. Results: 16.6 - 20.6 lbf. Conclusion: Strong connections. Met the predetermined specification.
- Test: Drill bit dimensional and cutting functionality. Results: Burr hole diameter 0.209" Easily cut through bone. Conclusion: 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 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: Torque required to insert the cranial bolt. Results: The Hemedex Quad Lumen Bolt required 38% to 64% less in-lbs of torque to fully insert, depending on the predicate or reference device. Conclusion: Substantially equivalent or better than the predicate & reference devices.
- Test: Axial tension required to pull the cranial bolt out of the skull. Results: 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. Conclusion: Substantially equivalent or better than the predicate & reference devices.
- Test: Leak testing. Results: 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. Conclusion: Substantially equivalent or better than the predicate & reference devices.
- Test: Drill bit dimensional and cutting functionality. Results: 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. Conclusion: Substantially equivalent to the predicate & reference devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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)
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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.