(79 days)
The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus ATLAS is indicated for adjunct fixation of the 1st and 2nd metacarpals in CMC arthroplasty.
The Parcus Actiflip Naked, Actiflip Cinch, and Actiflip Whip are used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, pectoralis repair (minor), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
The Parcus Synd-EZ Ti are 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 are 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.
The Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6AI4V ELI, and may also include an UHMWPE polyblend suture component. Each device is provided sterile.
This document is a 510(k) Premarket Notification from Parcus Medical, LLC for several orthopedic fixation devices. It is a submission to the FDA for market clearance, asserting substantial equivalence to previously cleared predicate devices. The primary focus of the performance data in this submission is related to MR Conditional safety, as the devices themselves are largely unchanged from their predicates.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implicit for MR Conditional) | Reported Device Performance |
|---|---|---|
| Magnetically Induced Force | Devices should not pose a significant hazard due to magnetic forces in specified MR environments. | Evaluated; worst-case devices selected for testing; results used to establish MR system conditions for safe use. |
| Magnetically Induced Torque | Devices should not pose a significant hazard due to magnetic torque in specified MR environments. | Evaluated; worst-case devices selected for testing; results used to establish MR system conditions for safe use. |
| Heating by RF Fields | Devices should not heat to an unsafe level in specified MR environments. | Evaluated; worst-case devices selected for testing; results used to establish MR system conditions for safe use. |
| Image Artifact | Devices should produce acceptable levels of image artifact in specified MR environments, allowing for diagnostic interpretation where relevant. | Evaluated; results used to establish MR system conditions for safe use. |
| Biocompatibility | Should be biocompatible as per predicate devices. | Unchanged from predicate devices. |
| Packaging | Should have appropriate packaging as per predicate devices. | Unchanged from predicate devices. |
| Shelf-life | Should have appropriate shelf-life as per predicate devices. | Unchanged from predicate devices. |
| Sterilization Process | Should have an effective sterilization process as per predicate devices. | Unchanged from predicate devices. |
| LAL Testing (Endotoxin) | Endotoxin levels within acceptable limits. | Tested on representative samples; concluded no additional concern. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "worst-case devices were selected for testing" for the MR environment evaluation. It does not provide a specific number for the sample size.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It implies the testing was conducted by or for Parcus Medical, LLC, which is based in Sarasota, Florida, USA. The testing was likely prospective for the specific purpose of this submission (determining MR Conditional status).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is based on objective physical measurements of the devices' interaction with an MR environment and chemical testing (LAL), not on expert subjective interpretation or clinical outcomes. The evaluation against standards like the "FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards" serves as the "ground truth" criteria.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective physical and chemical testing against established standards, not on expert consensus or adjudication of subjective data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms, not for the safety assessment of orthopedic implants.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is for medical devices (implants), not for an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation in this submission is based on:
- Physical measurements and compliance with established standards: For MR Conditional safety, this refers to measurements of magnetic force, torque, and heating in MR environments, assessed against the "FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards."
- Chemical testing results: For LAL (Limulus Amebocyte Lysate) testing, the ground truth is the measured endotoxin level against a defined acceptable limit.
- Predicate device characteristics: For biocompatibility, packaging, shelf-life, and sterilization, the "ground truth" is that these aspects remain unchanged and were previously deemed acceptable based on predicate devices.
8. The Sample Size for the Training Set
This is not applicable. This submission is for medical devices (implants) and does not involve an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reason stated above.
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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 Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 28, 2020
Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243
Re: K202259
Trade/Device Name: Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 31, 2020 Received: August 10, 2020
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.
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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 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 (OS) 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 medical devices and radiation-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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Indications for Use
510(k) Number (if known)
K202259
Device Name
Parcus GFS II and GFS Mini. GFS Naked. GFS Ultimate. GFS BTB. ATLAS. Actiflip Cinch. Actiflip Whip. GFS Ultimate Hip and Synd-EZ Ti.
Indications for Use (Describe)
The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair
The Parcus ATLAS is indicated for adjunct fixation of the 1st and 2nd metacarpals in CMC arthroplasty.
The Parcus Actifiip Naked, Actiflip Cinch, and Actifip Whip are used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, pectoralis repair (minor), biceps tendon repair and reattachment (distallproximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
The Parcus Synd-EZ Ti are 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 are 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)
网 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Anika Therapeutics. The logo consists of a blue abstract symbol on the left, followed by the word "ANIKA" in blue, sans-serif capital letters. The abstract symbol appears to be a stylized letter "A" or a geometric shape, and it is positioned to the left of the company name.
Image /page/3/Picture/1 description: The image shows the logo for "Parcus Medical, LLC". The logo is in blue and features a stylized font. Below the logo, the text "Parcus Medical has joined Anika" is written in a smaller, gray font.
| 510(k) Summary | |
|---|---|
| 510(k) Owner & Submitter: | Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243 |
| Company Contact: | Paul VagtsPhone: (941)755-7965Fax: (941)755-6543 |
| Date Prepared: | October 26th, 2020 |
| Device Trade Name: | Parcus GFS II and GFS MiniParcus GFS NakedParcus GFS UltimateParcus GFS BTBParcus ATLASParcus Synd-EZ TiParcus Actiflip Naked, Actiflip Cinch, Actiflip Whip, andGFS Ultimate Hip |
| Common Name: | Fastener, Fixation, Non-Degradable, Soft Tissue |
| Device Class: | Class II |
| Classification Name: | 21 CFR 888.3040 - Product Code MBI |
Predicate Device:
K133757 (cleared February 4, 2014) - Parcus GFS II and GFS Mini K152711 (cleared November 20, 2015) - Parcus GFS Naked K162198 (cleared November 18, 2016) - Parcus GFS Ultimate K183331 (cleared February 7, 2019) - Parcus GFS BTB K190375 (cleared April 24, 2019) - Parcus ATLAS K191783 (cleared October 9, 2019) - Parcus Synd-EZ Ti K192750 (cleared January 16th, 2020) - Parcus Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
Device Description:
The Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6AI4V ELI, and may also include an UHMWPE polyblend suture component. Each device is provided sterile.
PARCUS MEDICAL, LLC.
Page 1 of 3 1-941-755-7965
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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 the logo for Parcus Medical, LLC. The logo is in blue and features the company name in a stylized font. Below the logo, the text "Parcus Medical has joined Anika" is written in a smaller, gray font. The text indicates that Parcus Medical has been acquired by or merged with Anika.
Intended Use:
The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus ATLAS is indicated for adjunct fixation of the 1* and 200 metacarpals in CMC arthroplasty.
The Parcus Actiflip Naked, Actiflip Cinch, and Actiflip Whip are used for fixation of bone to bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
The Parcus Synd-EZ Ti are 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 are 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 Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip are equivalent to the predicate Parcus devices because they are the same devices. No changes from the
PARCUS MEDICAL, LLC. 6423 Parkland Drive Sarasota, FL 34243 www.parcusmedical.com
Page 2 of 3 1-941-755-7965
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Image /page/5/Picture/0 description: The image shows the word "ANIKA" in blue, with a stylized blue circle to the left of the word. The circle contains a white dot and a curved line. The font of the word "ANIKA" is sans-serif and the letters are evenly spaced.
Image /page/5/Picture/1 description: The image shows the Parcus Medical logo. The logo is blue and features the word "PARCUS" in a bold, sans-serif font. Below the word "PARCUS" is the word "MEDICAL, LLC" in a smaller font. Below the logo is the text "Parcus Medical has joined Anika".
existing Parcus Medical devices are proposed except for the inclusion of the MR Conditional parameters into the applicable Instructions for Use. Since the biocompatibility, packaging, shelf-life and sterilization process remain unchanged, no further testing or assessments were needed. LAL testing has been tested on representative samples and it was concluded that the Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip do not raise any additional concern.
Summary Performance Data:
The Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip were evaluated for use in the MR Environment and were determined to fit the definition of MR Conditional. These titanium implants were 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 worst-case devices were selected for testing. Devices were 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 these implants are present.
The Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip have been determined to be substantially equivalent to the predicate devices stated above.
6423 Parkland Drive Sarasota, FL 34243 www.parcusmedical.com
Page 3 of 3 1-941-755-7965
§ 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.