The Parcus Synd-EZ SS is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

The Parcus Synd-EZ SS is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

Device Description

The Parcus Synd-EZ SS consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus Synd-EZ Ti, the Synd-EZ SS is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium, stainless steel and UHMWPE suture and is provided sterile.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for a medical device called "Parcus Synd-EZ SS." This document is a regulatory filing that demonstrates substantial equivalence to a predicate device, and as such, it does not contain acceptance criteria or detailed study information for new device performance.

The primary purpose of this 510(k) is a labeling change for MR conditional parameters, indicating that the design, materials, and manufacturing processes of the device itself have not changed since its previous clearance (K192964). Therefore, the document explicitly states: "No new testing was completed, apart from the testing required to support MR Conditional parameters that was provided in this submission."

Given this, I cannot extract the information you requested about acceptance criteria and proof of device performance for the medical functions of the Parcus Synd-EZ SS from this document. The document primarily focuses on the MR Conditional testing.

However, I can provide the available information regarding the MR Conditional testing:

Regarding MR Conditional Testing:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Conditional Parameters):

Acceptance Criteria (MR Conditional)	Reported Device Performance
Magnetically induced force	Device was tested for magnetically induced force and the results were used to establish MR system conditions suitable for safe use. (Specific values or thresholds not provided in the summary).
Magnetically induced torque	Device was tested for magnetically induced torque and the results were used to establish MR system conditions suitable for safe use. (Specific values or thresholds not provided in the summary).
Heating by RF fields	Device was tested for heating by RF fields and the results were used to establish MR system conditions suitable for safe use. (Specific values or thresholds not provided in the summary). Note: The document indicates "The Synd-EZ SS was evaluated for use in the MR Environment and were determined to fit the definition of MR Conditional." This implies it met the relevant safety thresholds.
Image artifact	Device was tested for image artifact and the results were used to establish MR system conditions suitable for safe use. (Specific values or thresholds not provided in the summary).

2. Sample size used for the test set and the data provenance:

Sample Size: "worst-case device was selected for testing." The exact number of devices tested is not specified, but it implies a single representative device or a small number to characterize the "worst-case."
Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by Parcus Medical, LLC (or a contracted lab) to comply with FDA guidance and ASTM standards. This would be prospective testing specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for MR Conditional testing. MR Conditional testing relies on standardized physical measurements and engineering evaluations against defined limits, not expert clinical consensus on a "ground truth" derived from patient data.

4. Adjudication method for the test set:

Not applicable. MR Conditional testing involves objective measurements rather than adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to MR Conditional testing of a physical implant.

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

Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used:

For MR Conditional testing, the "ground truth" is defined by the safety limits and thresholds established in regulatory guidance (FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment) and applicable ASTM standards.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

In summary, this document is a regulatory submission focused on demonstrating substantial equivalence and providing MR Conditional labeling. It does not provide detailed performance data or clinical study results for the device's primary indications, as those would have been covered in the original 510(k) clearances (K191783 and K192964) to which this device is substantially equivalent.

Summary

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July 26, 2022

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Parcus Medical, LLC Vasavi Vora Regulatory Affairs Specialist II 6423 Parkland Drive Sarasota, Florida 34243

Re: K221502

Trade/Device Name: Parcus Synd-EZ SS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 24, 2022 Received: May 25, 2022

Dear Vasavi Vora:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No . 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221502

Device Name Parcus Synd-EZSS

Indications for Use (Describe)

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.

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Image /page/3/Picture/1 description: The image shows a document with the text "K221502 Page 1 of 2" at the top. Below that is the logo for "PARCUS MEDICAL, LLC." The text "Parcus Medical has joined Anika" is at the bottom of the image.

510(k) Summary
510(k) Owner & Submitter:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Vasavi VoraPhone: 781-457-9237Fax: 781-305-9720
Date Prepared:	July 26th 2022
Device Trade Name:	Parcus Synd-EZ SS
Common Name:	Fastener, Fixation, Non-Degradable, Soft Tissue
Device Class:	Class II
Classification Name:	21 CFR 888.3040 - Product Code MBI

Predicate Device:

K191783 (cleared October 9, 2019) - Parcus Synd-EZ Ti Secondary Predicate Device: K192964 - Parcus Synd-EZ SS

Device Description:

Intended Use:

PARCUS MEDICAL, LLC.

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Substantial Equivalence Summary:

The Synd-EZ SS is very similar to the predicate Parcus Medical Synd-EZ Ti in that they are both utilize titanium and UHMWPE suture, are intended for the same indications and both utilize the same design. LAL testing was conducted on a representative device comprised of similar materials and it was concluded that the Synd-EZ SS does not raise any additional concerns reqarding pyrogenicity.

As the purpose of this submission is limited to a labeling change for MR conditional parameters, there is no change to device design, materials or manufacturing processes. Because there was no change to the device, there was no resulting requirement to complete additional sterilization, shelf-life, biocompatibility or mechanical performance tests.

Summary Performance Data:

The Synd-EZ SS was evaluated for use in the MR Environment and were determined to fit the definition of MR Conditional. This implant was evaluated based on the FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards, and worstcase device was selected for testing. The device was tested for magnetically induced force, magnetically induced torque, heating by RF fields, and image artifact. The results of this testing have been used to establish the MR system conditions suitable for safe use when this implant is present.

No new testing was completed, apart from the testing required to support MR Conditional parameters that was provided in this submission.

Regulation Number and Section

§ 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.