(399 days)
No
The device description and performance studies focus on mechanical properties and surgical use of non-powered hand-held tools, with no mention of AI or ML.
No
The device is described as a nonpowered hand-held surgical instrument used for bone cutting and drilling to prepare for screw insertion, indicating a surgical tool rather than a therapeutic device that treats a disease or condition.
No
Explanation: This device is described as a nonpowered hand-held tool for cutting and drilling bone, preparing it for screw insertion, which are surgical functions, not diagnostic ones.
No
The device description clearly states that the device is a nonpowered hand-held device manufactured from stainless steel and other physical components, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium." This describes a surgical instrument used directly on a patient's body.
- Device Description: The description details a physical tool (taps) made of materials suitable for surgical use, designed to prepare bone for screw insertion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
The device described is a surgical instrument, specifically a bone tap, used in orthopedic/neurosurgical procedures.
N/A
Intended Use / Indications for Use
Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium.
The taps may be used to prepare cranial bone to insert bone fixation screws.
Product codes
HBG
Device Description
Taps are used to drill a hole and simultaneously create threads in order to accommodate a Rapid Resorbable Fixation System bone screw. The self-drilling fixed-stop taps are manufactured from Stainless Steel 440A which conforms to ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments and ASTM A276 Specification for Stainless Steel Bars and Shapes. The adjustable-length taps (final assembly) are assembled from three components; the adjustable tap (Stainless Steel 440A), the locking collar (Makrolon Rx2530 W/1118 Tint), and the stop collar (Stainless Steel 316L with an aluminum titanium nitride coating).
DePuy Synthes Taps for Resorbable Screws can be used with the following handles: 311.01.98 Handle, with mini quick coupling 311.03 Handle, with mini quick coupling, small 311.005 Screwdriver Handle with hex coupling, small 311.006 Screwdriver Handle with hex coupling, medium 311.007 Screwdriver Handle with hex coupling, large
The DePuy Synthes Taps for Resorbable Screws can be used with the DePuy Synthes Rapidsorb® Rapid Resorbable Fixation System (K062789) screws [1.5mm, 2.0mm, 2.5mm (Emergency) diameters] and plates (1.5 mm and 2.0mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium, skull
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
Mechanical Testing:
- Simulated Use/Bioskills Lab: A representative range of the subject devices was selected. The lab was conducted to validate various aspects of the device design such as torque resistance, length, and screw size diameter. The validation lab consisted of 5 individual participants. There were 4 cadaveric cephalises selected to represent a range of patients (young male and female, and elderly male and female). The users were independent from the design of the subject device. Results: The results indicated full validation of the subject device. All acceptance criteria were met.
- Sawbones Lab - RapidSorb Instruments: The objective was to validate that the subject taps are able to self-drill in normal density bone. A representative range of the subject device was selected to represent the entire range of taps, including all diameters and the longest length of each tap, representing worst-case in regard to torque resistance. Results: The acceptance criteria were met in that all four users were able to use each of the three subject taps to create three separate tapped holes that will accommodate the corresponding screw (36 total insertions).
- Mechanical Test - Torsional Testing of RapidSorb Taps: Objective was to demonstrate that the failure torque of RapidSorb self-drilling taps is above the torque at which the same diameter taps will bottom-out in the testing substrate. Two separate tests were performed: Failure Torque Test and Stripping Torque Test. Results: The results indicated that the RapidSorb failure torque is superior to the Bottoming or Stripping torque (p=0.000 for all three sizes: 1.5, 2.0, and 2.5mm), satisfying acceptance criteria.
- Mechanical Test - RapidSorb Self-Drilling Tap Axial Load at Strip Out: The objective was to demonstrate that the axial force required to cause the adjustable stop on the adjustable length taps (311.100, 311.101, 311.102, 311.110, 311.111, 311.112) to unintentionally move is greater than the axial force generated by the strip out torque of each tap. Results: The axial load required to move the adjustable stop was statistically superior to the axial load at strip-out in all cases (p=0.000 for 1.5, 2.0, and 2.5mm), satisfying acceptance criteria.
- Validation of Hex Coupling for RapidSorb Adjustable Taps: The objective was to validate the compatibility of the Hex coupling on the proximal end of the RapidSorb Adjustable length taps. All tested parts were to couple with designated hex handles and be fully inserted into 40 lbs/cf polyurethane foam with no slippage or visible damage. Results: All participants were able to drive all 12 taps with a combination of the 3 specified handles with no visible damage to the proximal coupling end of the tap.
- Biocompatibility Testing - Cytotoxicity: An in vitro study was conducted following ANSI/AAMI/ISO 10993-5 guidelines. Results: The test articles extract showed no reactivity of causing cell lysis or toxicity. All test method acceptance criteria were met. Patient contacting components are manufactured from Stainless Steel 440A, conforming to ASTM F899.
Clinical studies were not necessary.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories
(a)
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.(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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
Synthes (USA) Products, LLC Ms. Susan Lewandowski Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K153587
Trade/Device Name: Taps for Resorbable Screws Regulation Number: 21 CFR 882.4300 Regulation Name: Manual Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBG Dated: December 22, 2016 Received: December 23, 2016
Dear Ms. Lewandowski:
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Michael J. Hoffmann -S
for 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) K153587
Device Name Taps for Resorbable Screws
Indications for Use (Describe)
Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium.
The taps may be used to prepare cranial bone to insert bone fixation screws.
Type of Use (Select one or both, as applicable)
| 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
Image /page/3/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, black letters on the right. There is a line underneath the word "SYNTHES".
| Date Prepared: | January 18, 2017 |
|---|---|
| Submitter: | Synthes USA Products, LLC |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact: | Susan Lewandowski |
| slewand2@its.jnj.com | |
| Telephone 610-719-5852 | |
| Facsimile 484-356-9682 |
DEVICE
| Device Name: | Taps for Resorbable Screws |
|---|---|
| Classification Name: | Drills, burrs, trephines, and accessories (Manual) |
| Review Panel: | Neurology |
| Regulatory Class: | II |
| Product Code: | HBG (Manual cranial drills, burrs, trephines, and their accessories) |
| 21 CFR 882.4300 |
PREDICATE DEVICE
Medtronic Sofamor Danek POWEREASE™ System K123270 is the primary predicate.
Synthes Dental Bone Cutting Instruments K150796 is used as a reference device in support of this submission.
DEVICE DESCRIPTION
Taps are used to drill a hole and simultaneously create threads in order to accommodate a Rapid Resorbable Fixation System bone screw. The self-drilling fixed-stop taps are manufactured from Stainless Steel 440A which conforms to ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments and ASTM A276 Specification for Stainless Steel Bars and Shapes. The adjustable-length taps (final assembly) are assembled from three components; the adjustable tap (Stainless Steel 440A), the locking collar (Makrolon Rx2530 W/1118 Tint), and the stop collar (Stainless Steel 316L with an aluminum titanium nitride coating).
DePuy Synthes Taps for Resorbable Screws can be used with the following handles: 311.01.98 Handle, with mini quick coupling 311.03 Handle, with mini quick coupling, small 311.005 Screwdriver Handle with hex coupling, small 311.006 Screwdriver Handle with hex coupling, medium 311.007 Screwdriver Handle with hex coupling, large
The DePuy Synthes Taps for Resorbable Screws can be used with the DePuy Synthes Rapidsorb® Rapid Resorbable Fixation System (K062789) screws [1.5mm, 2.0mm, 2.5mm (Emergency) diameters] and plates (1.5 mm and 2.0mm).
4
Image /page/4/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. The circular symbol appears to be a stylized representation of a medical device or implant. A registered trademark symbol is located to the right of the word "SYNTHES".
INDICATIONS FOR USE
Taps for Resorbable Screws
Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium. The taps may be used to prepare cranial bone to insert bone fixation screws.
Medtronic Sofamor Danak POWEREASE System (Primary Predicate)
IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC® POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
Discussion
Both the subject taps and the primary predicate Medtronic Sofamor Danek POWEREASE System K123270 are intended for use in neurosurgical procedures to drill or cut into the skull. There is a difference in the assigned FDA product codes:
- The subject taps are manual instruments, with a corresponding product code of . HBG (Drills, burrs, trephines, and their accessories - manual).
- The primary predicate is a powered instrument with the corresponding product code of HBE (drills, burrs, trephines, and accessories - simple, powered).
Additionally, the subject taps defined herein as Class II product code HBG are the same instruments currently marketed by Synthes as Class I product code LXH (Orthopedic manual surgical instruments). Thus, the subject taps include the intended uses of both product codes (i.e. cranial bone-cutting and general orthopedic bone cutting).
The reference device Synthes Dental Bone Cutting Instruments K150796 does not have the same intended use as the subject taps since the dental bone cutting instruments are intended for trauma, reconstruction, or orthognathic procedures to drill or cut into the upper or lower jaw. The reference device product code is DZJ (Driver, wire, and Bone Drill Manual). Since taps for general orthopedic bone-cutting would typically be considered Class I Exempt instruments, the identified reference device is included to show that taps have been previously cleared within premarket notification submissions.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Primary Predicate
DePuy Synthes considers the subject taps equivalent to the Medtronic Sofamor Danek Sofamor Danek POWEREASE™ System K123270, as well as the Synthes Dental Bone Cutting Instruments K150796.
5
Image /page/5/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small "R" in a circle is located to the right of the word "SYNTHES", indicating that it is a registered trademark.
Technological Similarities of Taps to the Primary Predicate
- Both instruments are used for drilling a hole in preparation for a bone screw ●
- . Both are used in the skull
- Both can be used manually
- The Medtronic POWEREASE™ System consists of a hand piece and ● attachments; the subject taps consist of the instruments and handles based on the coupling
Technological Differences of Taps to Primary Predicate
- The Medtronic POWEREASE™ System is used for drilling, tapping and driving . screws as well as for the placement or cutting of screws, posts and rods; the tap is used to drill a hole and simultaneously create threads in order to receive a bone screw
- The Medtronic POWEREASE™ System can be used manually or with power; the ● subject taps are manual instruments only
- The Medtronic IPC® and POWEREASE™ Systems (K123270) are used in ● Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures; the subject taps are intended for neurosurgical procedures only
Impact on Safety and Effectiveness
There is no impact to safety and effectiveness. The subject devices have a limited intended use compared to the predicate device; the POWEREASE System is used for drilling, tapping, and driving screws while the taps are used to cut bone in preparation of receiving a bone screw. The subject devices are basic handheld instruments compared to the predicate; the tap is connected to a handle (dependent on the coupling feature) while the predicate device consists of a handpiece and multiple attachments. The subject devices are used manually while the predicate can be used either manually or with power.
Reference Device
Both the subject taps and the reference Dental Bone Cutting Instruments (K150796) are generally intended to be used during surgery for cutting into bone. The reference device is included to show that taps have been cleared within premarket submissions.
Technological Similarities of Taps to the Reference Device
- Both devices are intended to be used to prepare bone for placement of a screw
- Both devices are operated manually ●
- Both are manufactured from stainless steel (440A) .
Technological Differences of Taps to the Reference Device
- The subject taps are intended for use in fracture repair and reconstructive procedures of the cranium (covered under a Neurology product code); the Dental Bone Cutting Instruments are intended for use in oral/maxillofacial surgery (covered under a Dental product code).
6
Image /page/6/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the word "SYNTHES". A horizontal line is located underneath the logo.
Impact on Safety and Effectiveness
There is no impact to safety and effectiveness. The subject taps are intended for use in fracture repair and reconstructive procedures of the cranium (Neurology); the Dental Bone Cutting Instruments are intended for use in oral/maxillofacial surgery (Dental). Regardless of specific intended use, all taps are used to cut bone in preparation of receiving a bone screw. The reference device was included to provide evidence that taps have been cleared within premarket notification submissions.
PERFORMANCE DATA
Mechanical Testing
The performance data provided in support of substantial equivalence of the proposed devices are as follows:
- Simulated Use/Bioskills Lab ●
- Sawbones Lab ●
- Torsional Testing of RapidSorb Taps
- . RapidSorb Self-Drilling Tap Axial Load at Strip Out
- Validation of Hex Coupling for RapidSorb Adjustable Taps ●
- Biocompatibility Testing - Cytotoxicity
| Performance Testing - Bench | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Simulated Use/Bioskills Lab - | ||
| RapidSorb Instruments | A representative range of the | |
| subject devices will be selected to | ||
| represent the entire range of taps. | ||
| The lab will be conducted to | ||
| validate various aspects of the | ||
| device design such as torque | ||
| resistance, length and screw size | ||
| diameter. The validation lab will | ||
| consist of 5 individual | ||
| participants. There will be 4 | ||
| cadaveric cephalises. The heads | ||
| (cephalises) will be selected to | ||
| represent a range of patients (a | ||
| young male and female, and | ||
| elderly male and female). The | ||
| users are independent from the | ||
| design of the subject device. | The results indicated full | |
| validation of the subject device. | ||
| All acceptance criteria were met. | ||
| Saw Bones Lab - RapidSorb | ||
| Instruments | The objective of the lab is to | |
| validate that the subject taps are | ||
| able to self-drill in normal density | ||
| bone. A representative range of | ||
| the subject device will be selected | ||
| to represent the entire range of | ||
| taps. The range includes all | ||
| diameters and the longest length | ||
| of each tap. These represent | ||
| worst case in regard to torque | ||
| resistance. | The acceptance criteria was met | |
| in that all four users were able to | ||
| use each of the three subject taps | ||
| to create three separate tapped | ||
| holes that will accommodate the | ||
| corresponding screw (36 total | ||
| insertions). |
7
Image /page/7/Picture/0 description: The image shows the logo for Synthes. The logo consists of a stylized symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the right of the word "SYNTHES". A horizontal line is located underneath the logo.
| Performance Testing - Bench | ||||||
|---|---|---|---|---|---|---|
| Test | Test Method Summary | Results | ||||
| Mechanical Test - Torsional | ||||||
| Testing of RapidSorb Taps | The objective of this test is to | |||||
| demonstrate that the failure | ||||||
| torque of RapidSorb self-drilling | ||||||
| taps is above the torque at which | ||||||
| the same diameter taps will | ||||||
| bottom-out in the testing | ||||||
| substrate. Two separate tests will | ||||||
| be performed, Failure Torque | ||||||
| Test and Stripping Torque Test. | The results of this testing indicate | |||||
| that when the failure torque of all | ||||||
| three sizes of RapidSorb Self | ||||||
| Drilling Taps (1.5, 2.0, and 2.5 | ||||||
| mm) are compared to their | ||||||
| respective bottoming or stripping | ||||||
| torque, the resulting p-values | ||||||
| were all 0.000. There is | ||||||
| sufficient evidence to reject the | ||||||
| null hypothesis in favor of the | ||||||
| alternate, that in all cases the | ||||||
| RapidSorb failure torque is | ||||||
| superior to the Bottoming or | ||||||
| Stripping torque (as specified). | ||||||
| This satisfies the acceptance | ||||||
| criteria. | ||||||
| Mechanical Test - RapidSorb | ||||||
| Self-Drilling Tap Axial Load at | ||||||
| Strip Out | The objective of this test was to | |||||
| demonstrate that the axial force | ||||||
| required to cause the adjustable | ||||||
| stop on the adjustable length taps | ||||||
| (311.100, 311.101, 311.102, | ||||||
| 311.110, 311.111, 311.112) to | ||||||
| unintentionally move is greater | ||||||
| than the axial force that is | ||||||
| generated by the strip out torque | ||||||
| of each tap. | As can be seen in all comparisons | |||||
| (1.5, 2.0, and 2.5mm) the | ||||||
| resulting p-value was 0.000, | ||||||
| which is sufficient evidence to | ||||||
| reject the null hypothesis in favor | ||||||
| of the alternate that the Axial | ||||||
| load required to move the | ||||||
| adjustable stop was superior to | ||||||
| the axial load at strip-out in all | ||||||
| cases. This result satisfies the | ||||||
| acceptance criteria. | ||||||
| Validation of Hex Coupling for | ||||||
| RapidSorb Adjustable Taps | The objective of this test was to | |||||
| validate the compatibility of the | ||||||
| Hex coupling on the proximal end | ||||||
| of the RapidSorb Adjustable | ||||||
| length taps. All tested parts will | ||||||
| couple with the designated hex | ||||||
| handles and, then be fully inserted | ||||||
| into 40 lbs/cf polyurethane foam | ||||||
| with no slippage or visible | ||||||
| damage (no magnification) of | ||||||
| taps proximal coupling. | At the conclusion of the testing, | |||||
| all participants were able to drive | ||||||
| all 12 taps with a combination of | ||||||
| the 3 specified handles. This was | ||||||
| done with no visible damage to | ||||||
| the proximal coupling end of the | ||||||
| tap. | ||||||
| Biocompatibility (Cytotoxicity) | An in vitro study was conducted | |||||
| to evaluate for potential cytotoxic | ||||||
| effects, following guidelines of | ||||||
| the ANSI/AAMI/ISO 10993-5, | ||||||
| Biological Evaluation of medical | ||||||
| devices – Part 5: Test for in vitro | ||||||
| cytotoxicity (2009). | At the conclusion of the testing, | |||||
| the test articles extract showed no | ||||||
| reactivity of causing cell lysis or | ||||||
| toxicity. All test method | ||||||
| acceptance criteria were met. | ||||||
| The patient contacting | ||||||
| components of taps are | ||||||
| manufactured from Stainless | ||||||
| Steel 440A which conforms to | ||||||
| the FDA recognized consensus | ||||||
| standard, ASTM F899 - Standard | ||||||
| Specification for Stainless Steel | ||||||
| for Surgical Instruments, | ||||||
| supporting the biocompatibility | ||||||
| of this device. |
8
Image /page/8/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.
Performance testing demonstrates that the mechanical performance of the proposed taps is comparable to that of the primary predicate device (taps) and supports substantial equivalence.
Clinical Studies
Clinical testing was not necessary for the determination of substantial equivalence.
The performance data demonstrate that the mechanical performance of the proposed taps is comparable to that of the primary predicate device and supports substantial equivalence to the primary predicate device for safe and effective bone cutting in the skull.
9
Image /page/9/Picture/0 description: The image shows the logo for SYNTHES. The logo consists of a stylized symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. A registered trademark symbol is located to the right of the word. The logo is black and white.
CONCLUSIONS
The proposed devices have the same intended use as the primary predicate device. The mechanical testing included in this submission demonstrates that:
- Any differences in technological characteristics of the primary predicate and/or . reference device do not raise any new questions of safety and effectiveness.
- . The proposed devices are at least as safe and effective as the primary predicate
It is concluded that the information included in this submission supports substantial equivalence.
10
Image /page/10/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized figure inside. A registered trademark symbol is located to the right of the word.
Device Comparison Table
| | DePuy Synthes Taps for
Resorbable Screws (subject
device) | Medtronic Sofamor Danek
POWEREASE System
K123270
(primary predicate) | DePuy Synthes Dental Bone
Cutting Instruments, e.g. Taps
and Countersinks K150796
(reference device) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Taps are nonpowered hand-held
devices intended for bone
cutting and drilling on a patient's
skull during fracture repair and
reconstructive procedures of the
cranium. The taps may be used
to prepare cranial bone to insert
bone fixation screws. | The IPC System is indicated for
the incision/cutting, removal,
drilling and sawing of soft and
hard tissue and bone, and
biomaterials in Neurosurgical
(Cranial, Craniofacial),
Orthopedic, Arthroscopic,
Spinal, Sternotomy, and General
surgical procedures.
The IPC POWEREASE System
is indicated for drilling, tapping
and driving screws and working
end attachments during spinal
surgery, including open and
minimally invasive procedures.
It is also used in the placement
or cutting of screws, posts and
rods. | The Dental Bone Cutting
Instruments are nonpowered
hand-held devices intended for
trauma, reconstruction, or
orthognathic procedures to drill
or cut into the upper or lower
jaw and may be used to prepare
bone to insert a wire, pin, or
screw. |
| FDA Product Code | HBG | HBE, HWE, GWF | DZJ |
| 21 CFR | 882.4300 | 882.4310 | 872.4120 |
| Regulation
Description | Manual cranial drills, burrs,
trephines, and their accessories | Powered simple cranial drills,
burrs, trephines, and their
accessories | Bone cutting instrument and
accessories |
| Review Panel | Neurology | Neurology | Dental |
| Device Class | 2 | 2 | 2 |
| Device Description | Taps are used to drill a hole and
simultaneously create threads in
order to accommodate a Rapid
Resorbable Fixation System
bone screw. The taps are
available as self-drilling fixed-
stop taps and self-drilling
adjustable-stop taps. | The POWEREASETM System
Working Ends consists of
instruments such as taps, drill
bits, screwdrivers, post cutter,
set screw break-off tool,
reduction nut driver and sleeves.
The working ends have a manual
alternative. The working ends,
listed above, are compatible with
the CD HORIZON SOLERA
and the TSRH 3Dx Spinal
System implants. Of the working
ends, only the taps, screwdrivers,
drill bits, and sleeves are also
compatible with Medtronic's
NIM-ECLIPSE Spinal System. | Countersinks are intended to
create a countersink feature in
bone to provide a contact surface
for screw heads and to reduce
palpability of the bone screw.
Taps are intended to create
threads in a pre-drilled hole in
order to accomodate a bone
screw. |
| Technological
characteristics: | | | |
| Principles of
function/technology | Taps are designed to be
compatible with corresponding
Synthes screws and/or drill bits.
Taps have cutting threads that
run along the length of the
instrument. The diameter and | The instrument modifications
detailed in this submission have
no impact on the technological
characteristic of the existing
instruments. The working end
Taps are intended for tapping | Countersinks feature cutting
flutes at the working end of the
instrument that continue a
distance up the shaft of the
instrument and a centering pin at
the working end of the |
| | DePuy Synthes Taps for
Resorbable Screws (subject
device) | Medtronic Sofamor Danek
POWEREASE System
K123270
(primary predicate) | DePuy Synthes Dental Bone
Cutting Instruments, e.g. Taps
and Countersinks K150796
(reference device) |
| | thread profile of the tap is
designed to match to the
diameter and thread profile of an
associated screw. | during spinal surgery, including
both open and minimally
invasive procedures. The
working ends are used to
facilitate the placement of the
rods. Like the predicate
POWEREASE System
instruments, the subject
instruments are manufactured
from stainless steel. | instrument. The user will insert
the centering pin into a drilled
pilot hole, ensuring that the
countersink feature is concentric
with the drilled hole.
Taps are designed to be
compatible with corresponding
Synthes screws and/or drill bits.
Taps have cutting threads that
run along the length of the
instrument. The diameter and
thread profile of the tap is
designed to match to the
diameter and thread profile of an
associated screw. |
| Dimensions | | | |
| Stop Depth: | Fixed stop taps: 3mm, 4mm,
5mm, 6mm, 8mm
Adjustable stop taps: 3-8mm
(1mm increments) | Unknown | 20-122mm tapping depths |
| Couplings: | Mini-quick coupling
Hex coupling | Unknown | Hex coupling |
| Compatible
Screws: | Rapidsorb resorbable cortex
screws: 1.5mm, 2.0mm, 2.5mm
diameter | Unknown | Cortex screws: 1.3-3.0mm
diameter |
| Device material(s) | Stainless steel 440A, 316L
Polycarbonate (Makrolon
Rx2530 W/1118 Tint)
Aluminum titanium nitride
coating | Stainless Steel | Stainless steel 440A |
11
Image /page/11/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular icon on the left and the word "SYNTHES" in bold, black letters on the right. The icon features a stylized image of a person or figure within a circle, and a registered trademark symbol is located at the upper right of the word "SYNTHES".
(End of summary)