(89 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of implants and wires, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as being used for reconstructive purposes (craniofacial reconstruction, repair of craniofacial trauma), soft tissue approximation, and ligation, indicating it is used to treat or manage a medical condition.
No
The device descriptions and intended uses clearly state that these are implants and wires used for surgical reconstruction, repair, and approximation of tissues. There is no mention of these devices being used to diagnose conditions or diseases.
No
The device description clearly states that the devices are physical implants and wires made of porous polyethylene and titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use of the DePuy Synthes Porous Polyethylene Implants and Titanium Wire clearly indicate they are implantable devices used for surgical reconstruction and repair within the body. They are not used to analyze samples taken from the body.
Therefore, this device falls under the category of surgical implants and instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
The Depuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
FTM, GAQ
Device Description
The DePuy Synthes Porous Polyethylene Implants consist of porous/smooth implant sheets with or without titanium.
The DePuy Synthes Titanium Wire is a nonabsorbable, monofilament, sterile surgical wire composed of commercially pure titanium wire is available in a length of 500mm with different gauge sizes, and is available with or without a permanently attached stainless steel needle.
The DePuy Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm, and has a permanently attached stainless steel needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Craniofacial
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)
Non-clinical testing results are provided to support the conditional safety of the DEPUY SYNTHES POROUS POLYETHYLENE IMPLANT AND TITANIUM WIRE PORTFOLIO in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14), torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07).
The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051879, K040364, K952677, K832283, K022665, K041333, K042606
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.
March 13, 2019
Synthes (USA) Products LLC Fredy Varela Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K183472
Trade/Device Name: DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio - MR Conditional Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, GAQ Dated: December 11, 2018
Received: December 14, 2018
Dear Mr. Varela:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by David Krause -David Krause -S Date: 2019.03.13 13:12:50 -04'00'
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K183472
Device Name
DEPUY SYNTHES POROUS POLYETHYLENE IMPLANTS - MR CONDITIONAL
Indications for Use (Describe)
The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
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
Indications for Use
510(k) Number (if known)
K183472
Device Name
DEPUY SYNTHES TITANIUM WIRE - MR CONDITIONAL
Indications for Use (Describe)
The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
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."
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K183472
Device Name
DEPUY SYNTHES TITANIUM WIRE WITH BARB - MR CONDITIONAL
Indications for Use (Describe)
The DePuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
| 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."
5
510(k) Summary 1.
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact:
Fredy Varela Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-5883 Email: fvarela2@its.jnj.com
Alternate Contact:
Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Name of Device: DEPUY SYNTHES POROUS POLYETHYLENE IMPLANTS – MR Conditional
Classification Name(s): Surgical Mesh
Regulatory Class: Class II; 878.3300
Product Code(s): FTM
Predicate Devices 1.3.
- K051879 Synthes Porous Polythylene Implants
- K040364 Medpor Craniofacial Implants with Embedded Titanium
- K952677 Medpor Barrier Surgical Implant Biomaterial
- K832283 Medpor Surgical Implants
- K022665 ePor Porous HDPE Surgical Implants
Device Description 1.4.
The DePuy Synthes Porous Polyethylene Implants consist of porous/smooth implant sheets with or without titanium.
6
1.5. Indications for Use
The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DEPUY SYNTHES POROUS POLYETHYLENE IMPLANTS. The intended use and technological characteristics of the devices remain unchanged.
1.7. Performance Testing
Non-clinical testing results are provided to support the conditional safety of the DEPUY SYNTHES POROUS POLYETHYLENE IMPLANT AND TITANIUM WIRE PORTFOLIO in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14), torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07).
Conclusion 1.8.
The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
7
1. 510(k) Summary
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact: Fredy Varela Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-5883 Email: fvarela2@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Name of Device: DEPUY SYNTHES TITANIUM WIRE – MR Conditional
Classification Name(s): Suture, Nonabsorbable, Steel, Monofilament and Multifilament, Sterile
Regulatory Class: Class II; 878.4495
Product Code(s): GAQ
1.3. Predicate Devices
K041333 - Synthes Titanium Wire Ethilon™ Nylon Suture
Device Description 1.4.
The DePuy Synthes Titanium Wire is a nonabsorbable, monofilament, sterile surgical wire composed of commercially pure titanium wire is available in a length of 500mm with different gauge sizes, and is available with or without a permanently attached stainless steel needle.
Indications for Use 1.5.
DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
8
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DEPUY SYNTHES TITANIUM WIRE. The intended use and technological characteristics of the devices remain unchanged.
1.7. Performance Testing
Non-clinical testing results are provided to support the conditional safety of the DEPUY SYNTHES POROUS POLYETHYLENE IMPLANT AND TITANIUM WIRE PORTFOLIO in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14), torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07).
Conclusion 1.8.
The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
9
1. 510(k) Summary
Date Prepared: March 7, 2019
Submitter 1.1.
Primary Contact:
Fredy Varela Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-5883 Email: fvarela2@its.jnj.com
Alternate Contact:
Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Name of Device: DEPUY SYNTHES TITANIUM WIRE WITH BARB – MR Conditional
Classification Name(s): Suture, Nonabsorbable, Steel, Monofilament and Multifilament, Sterile
Regulatory Class: Class II; 878.4495
Product Code(s): GAQ
1.4. Device Description
The DePuy Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm, and has a permanently attached stainless steel needle.
1.5. Indications for Use
The Depuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
10
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DEPUY SYNTHES TITANIUM WIRE WITH BARB. The intended use and technological characteristics of the devices remain unchanged.
Performance Testing 1.7.
Non-clinical testing results are provided to support the conditional safety of the DEPUY SYNTHES POROUS POLYETHYLENE IMPLANT AND TITANIUM WIRE PORTFOLIO in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14), torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07).
Conclusion 1.8.
The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.