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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio, focusing on their MR Conditional labeling. It primarily details non-clinical performance testing rather than a clinical study evaluating diagnostic accuracy or algorithmic performance with human readers.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Standard/Method	Specific Criteria/Purpose	Reported Device Performance
MR Conditional Safety	Magnetically Induced Displacement Force	ASTM F2052-14	Assessed in MR environment
	Magnetically Induced Torque	ASTM F2213-06	Assessed in MR environment
	Radio Frequency (RF) Heating	ASTM F2182-11a	Assessed in MR environment
	Image Artifacts	ASTM F2119-07	Assessed in MR environment

Conclusion: The non-clinical performance data demonstrated that the subject devices, when exposed to the MR environment under specific MR conditions of use, did not raise new questions of safety or efficacy.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not detail a "test set" in the context of clinical or algorithmic performance. The testing described is non-clinical performance testing on the devices themselves to assess their safety in an MR environment. Therefore, information about human data provenance, sample size of a test set, etc., is not applicable to this type of study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. As this is non-clinical performance testing for MR safety, there is no "test set" that requires expert ground truth establishment in the traditional sense of medical image analysis or diagnosis. The "ground truth" here is the physical interaction of the device with the MR environment as measured by standardized tests.

4. Adjudication Method for the Test Set

Not Applicable. There is no "test set" requiring adjudication by experts. The performance is measured against established engineering standards for MR safety.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document describes non-clinical performance testing for MR safety of physical implants and wires. It does not involve any AI, human readers, or a comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The document describes non-clinical performance testing of physical medical devices, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on established engineering and safety standards (ASTM standards) for assessing the behavior of medical devices in a Magnetic Resonance (MR) environment. This includes:

ASTM F2052-14 for magnetically induced displacement force.
ASTM F2213-06 for magnetically induced torque.
ASTM F2182-11a for radio frequency (RF) heating.
ASTM F2119-07 for image artifacts.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/algorithm study involving a training set. The descriptions are for non-clinical performance testing of physical devices.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an algorithm, there is no ground truth established in this context.

Summary

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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

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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

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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."

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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.

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."

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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.

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."

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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.

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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.

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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.

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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

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.

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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

1.3. Predicate Devices
K042606 – Synthes Titanium Wire K041333 – Synthes Titanium Wire

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.

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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.

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.

Regulation Number and Section

§ 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.