(98 days)
Not Found
No
The summary describes a mechanical fixation device and does not mention any AI or ML components or functionalities.
Yes
The description explicitly states "fixation during the healing process" and "stabilizing the syndesmosis during healing", indicating its role in supporting the body's natural healing mechanisms for injury repair.
No
The device is described as an adjunct for fracture repair and for stabilizing the syndesmosis during healing, indicating a therapeutic or supportive function rather than one involved in diagnosing a condition. Its function is to provide fixation, not to detect or identify a disease or condition.
No
The device description clearly states it consists of physical components (buttons and suture made from titanium and UHMWPE) and is intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in vivo (within the body) for fracture repair and syndesmosis fixation. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implantable device (buttons and suture) made of titanium and UHMWPE, designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or any other components typically associated with IVD devices.
Therefore, the Parcus Synd-EZ Ti is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Parcus Synd-EZ Ti 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 Ti is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HTN
Device Description
The Parcus Synd-EZ Ti 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 GFS Ultimate, the Synd-EZ Ti is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium 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 (syndesmosis disruptions) in connection with Weber B and Weber C ankle 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)
The Synd-EZ Ti was evaluated and testing was conducted on the worst case configurations. Devices were assembled to test blocks and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.
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.
Parcus GFS Ultimate, K162198, Arthrex Tightrope™ Syndesmosis Device, K043248
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243
Re: K191783
Trade/Device Name: Parcus Synd-EZ Ti Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HTN Dated: September 9, 2019 Received: September 10, 2019
Dear Mr. Vagts:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K191783
Device Name
Parcus Synd-EZ Ti
Indications for Use (Describe)
The Parcus Synd-EZ Ti 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 Ti is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis disruptions) in connection with Weber B 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is in large, blue, sans-serif font, with a red square to the left of the word. Below the word "PARCUS" is the phrase "MEDICAL, LLC." in a smaller, blue, sans-serif font.
Surgical Innovation | Customer Driven
| 510(k) Summary – K191783 | |
|---|---|
| 510(k) Owner & Submitter: | Parcus Medical, LLC |
| 6423 Parkland Dr | |
| Sarasota, FL 34243 | |
| Company Contact: | Paul Vagts |
| Phone: (941)755-7965 | |
| Fax: (941)755-6543 | |
| Date Prepared: | September 9th, 2019 |
| Device Trade Name: | Synd_EZ Ti |
| Common Name: | Fastener, Fixation, Non-Degradable, Soft Tissue |
| Device Class: | Class II |
| Classification Name: | 21 CFR 888.3040 - Product Code MBI |
| Predicate Device: | Parcus GFS Ultimate, K162198, cleared 11/18/16, |
| Arthrex Tightrope™ Syndesmosis Device, K043248, | |
| 2/16/2005 |
Device Description:
The Parcus Synd-EZ Ti 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 GFS Ultimate, the Synd-EZ Ti is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium and UHMWPE suture and is provided sterile.
Intended Use:
The Parcus Synd-EZ Ti 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 Ti 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.
Substantial Equivalence Summary:
The Synd-EZ Ti is very similar to the predicate Parcus Medical GFS Ultimate in that it is comprised of the same materials, intended for the same indications and utilizes similar designs. LAL testing was conducted on a representative device and it was concluded that the Synd-EZ Ti does not raise any additional concerns regarding pyrogenicity.
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Image /page/4/Picture/0 description: The image shows the logo for "PARCUS MEDICAL, LLC.". The word "PARCUS" is in large, bold, blue font. To the left of the word is a red square with a white line running through it. Below the word "PARCUS" is the phrase "MEDICAL, LLC." in a smaller, blue font.
Surgical Innovation | Customer Driven
Summary Performance Data:
The Synd-EZ Ti was evaluated and testing was conducted on the worst case configurations. Devices were assembled to test blocks and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.