(64 days)
Not Found
No
The document describes a mechanical implant for fracture repair and syndesmosis stabilization. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes.
The device is intended to provide fixation during the healing process following syndesmotic trauma, which directly contributes to the repair and restoration of bodily function.
No
Explanation: The device is described as an adjunct in fracture repair and for stabilizing the syndesmosis during healing, indicating it is a therapeutic or fixation device, not one used for diagnosis.
No
The device description explicitly states that the device consists of physical components made from medical grade titanium, stainless steel, and UHMWPE suture. It is a physical implant for fracture repair.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for fracture repair and stabilization within the body (specifically, the syndesmosis in ankle fractures). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical implantable device (buttons with suture) designed to provide mechanical fixation. This is consistent with a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
syndesmosis, ankle
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)
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.
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.
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
§ 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
July 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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
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/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
2
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)
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 C and Weber C ankle fractures.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for the company "Anika". The logo consists of a blue circular icon with a white design inside, followed by the word "ANIKA" in large, blue, sans-serif letters. The icon is on the left, and the word "ANIKA" is on the right.
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, LLC |
| 6423 Parkland Dr | |
| Sarasota, FL 34243 | |
| Company Contact: | Vasavi Vora |
| Phone: 781-457-9237 | |
| Fax: 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:
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.
Intended Use:
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.
PARCUS MEDICAL, LLC.
4
Image /page/4/Picture/0 description: The image shows the logo for Anika Therapeutics. The logo consists of a blue circular graphic on the left and the word "ANIKA" in blue capital letters on the right. The graphic appears to be a stylized letter "A" inside of a circle.
Image /page/4/Picture/1 description: The image shows a logo for Parcus Medical, LLC, along with the text "K221502 Page 2 of 2". The logo is blue and white and features the word "PARCUS" in a stylized font. Below the logo, the text "Parcus Medical has joined Anika" is visible. The image appears to be a page from a document.
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.