(90 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional screw design, with no mention of AI/ML or related concepts.
No
This device is for fracture fixation, which is a structural repair, not a therapeutic treatment.
No
Explanation: The device description and intended use clearly state that it is for "fracture fixation" using "screws and instruments," which are therapeutic rather than diagnostic. The "Summary of Performance Studies" describes mechanical testing of the screws, not diagnostic accuracy.
No
The device description explicitly states it is comprised of screws and instruments, which are physical hardware components. The performance studies also focus on mechanical testing of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is comprised of "screws and instruments" for "fracture fixation of small bones and small bone fragments." This is a surgical implant and associated tools used directly on the patient's body.
- Intended Use: The intended use is for "fracture fixation," which is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided describes a surgical device used for orthopedic procedures, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
For fracture fixation of small bones and small bone fragments including odontoid fractures.
Product codes
HWC
Device Description
DePuy Synthes Spine Dens Access System is comprised of screws and instruments. The screws are available in multiple lengths and will be offered non-sterile. The screws feature self-drilling, self-tapping tips, reverse cutting flutes and cancellous threads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small bone fragments including odontoid fractures.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was provided in order to provide data to support a substantial equivalence determination. These tests were performed to characterize the properties and functionality of the screw, as well as to allow comparison with established acceptance criteria.
The following mechanical tests were conducted on the screw:
Torque to failure test Cantilever bend test Pull-out strength test Insertion torque test
No clinical data was necessary to demonstrate substantial equivalence, nor safety and effectiveness of this system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes 4.0mm Cannulated Screw - K963192, HBS Headless Bone Screw - K020791, Headless Compression Screw - K112672
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K132910
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Page 1 of 2
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510(k) Summary
| Submitter: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 | DEC 16 2013 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Eugene Bang
Regulatory Affairs Associate
Telephone: (508) 977-3966
Fax: (508) 828-3797 | |
| Date Prepared: | November 25, 2013 | |
| Trade Name: | DePuy Synthes Spine Dens Access System | |
| Device Class: | Class II | |
| Product Code(s): | HWC | |
| Common Name: | Screw, Fixation, Bone | |
| Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener | |
| Regulation Number: | 21 CFR 888.3040 | |
| Predicate Devices: | Synthes 4.0mm Cannulated Screw - K963192
HBS Headless Bone Screw - K020791
Headless Compression Screw - K112672 | |
| Device Description: | DePuy Synthes Spine Dens Access System is comprised of screws and
instruments. The screws are available in multiple lengths and will be
offered non-sterile. The screws feature self-drilling, self-tapping tips,
reverse cutting flutes and cancellous threads. | |
| Indications: | For fracture fixation of small bones and small bone fragments including
odontoid fractures. | |
| Materials: | Manufactured from Titanium-6Aluminum-7Niobium Alloy conforming
to ASTM F-1295 | |
. .
. .
.
.
1
K132910
. . . . .
.
and the comments of the comments of the comments of
and the comments of the comments of
:
| Comparison to
Predicate Device: | The substantial equivalence of the subject device to the predicates indentified
above is based upon the equivalence of intended use, design (fundamental
scientific technology), materials, performance, sterility, and biocompatibility. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical Test
Summary: | Mechanical testing was provided in order to provide data to support a
substantial equivalence determination. These tests were performed to
characterize the properties and functionality of the screw, as well as to
allow comparison with established acceptance criteria. |
| | The following mechanical tests were conducted on the screw: |
| | Torque to failure test Cantilever bend test Pull-out strength test Insertion torque test |
| Clinical Test
Summary: | No clinical data was necessary to demonstrate substantial equivalence, nor
safety and effectiveness of this system. |
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
December 16, 2013
Synthes (USA) Products, LLC Mr. Eugene Bang Regulatory Affairs Associate 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K132910
Trade/Device Name: DePuy Synthes Spine Dens Access System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 23, 2013 Received: September 24, 2013
Dear Mr. Bang:
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. Drue. 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 111 (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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Eugene Bang
ﺍﻟﻤﺎﻟﻴﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﻘﺎﺑﻠﺔ ﻭﺍﻟﻘﺎﺑﻠﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/Safetv/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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.
Ronald院剑ean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- 1135-17 1944 1994 1994 1994 1999 1999 11
Indications for Use Statement
510(k) Number (if known): K132910
Device Name: DePuy Synthes Spine Dens Access System
Indications For Use:
For fracture fixation of small bones and small bone fragments including odontoid fractures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
Х
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
DePuy Synthes Spine Dens Access System