(262 days)
The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications: Foot/ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament and Tendon Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Plantar Plate Repair
The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes in one size and is provided attached to a needle.
The provided text describes the 510(k) premarket notification for the Paratrooper™ Plantar Plate Repair System. It is a medical device, specifically an all-suture soft tissue fixation device used for tissue-to-tissue and tissue-to-bone fixation. The information provided is primarily for regulatory clearance and does not detail a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy study.
Therefore, many of the requested categories related to AI/ML or comparative effectiveness studies (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document. This document focuses on demonstrating substantial equivalence to predicate devices through performance testing, biocompatibility, and sterilization, rather than clinical efficacy or diagnostic accuracy.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as numerical values, but implied by testing) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device performs as intended for tissue fixation. (Implied by pullout testing) | Characterized via pullout testing. (Results not quantified in this document) |
| Material Safety | Biocompatible and non-pyrogenic. | Biocompatibility and pyrogenicity testing performed. (Results not quantified in this document) |
| Sterility | Sterilization effective. | Sterilization testing performed. (Results not quantified in this document) |
| Substantial Equivalence | Equivalence to predicate devices (Stryker ICONIX All Suture Anchor System and Ziptek ZipE® Knotless Tissue Repair and Attachment Device) in indications for use, technical characteristics, and function. | Performance testing demonstrates substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests. The document only states that "All necessary testing has been performed on representative Paratrooper™ Plantar Plate Repair System components."
- Data Provenance: Not applicable in the context of clinical data. The testing mentioned appears to be bench testing on the device components themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method for the test set:
- Not applicable.
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. This is not an AI/ML device or a diagnostic device, so an MRMC comparative effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device.
7. The type of ground truth used:
- Not applicable in the conventional sense of ground truth for a diagnostic study. The "ground truth" for this device's performance would be the established engineering and biological standards for mechanical strength, biocompatibility, and sterility, which are verified through the specified tests.
8. The sample size for the training set:
- Not applicable.
9. How the ground truth for the training set was established:
- Not applicable.
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January 24, 2020
Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E, STE 280 Englewood, Colorado 80112
Re: K191227
Trade/Device Name: Paratrooper™ Plantar Plate Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 23, 2019 Received: December 23, 2019
Dear Mr. Lintula:
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
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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 (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 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,
for
Laura Rose, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K191227
Device Name
Paratrooper™ Plantar Plate Repair System
Indications for Use (Describe)
The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications:
Foot/ankle:
- · Lateral Stabilization
- · Medial Stabilization
- · Achilles Tendon Repair
- · Metatarsal Ligament and Tendon Repair
- · Hallux Valgus Reconstruction
- Digital Tendon Transfers
- Mid-foot Reconstruction
- · Plantar Plate 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)
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510(k) Summary
| Date: | May 3rd, 2019 |
|---|---|
| 510(k) Number: | K191227 |
| Sponsor: | Paragon 28, Inc.14445 Grasslands Dr.Englewood, Colorado 80112Phone: (888) 728-1888Fax: (888) 728-1220 |
| Sponsor contact: | Eric Lintula, Senior Director of Quality and Regulatory Affairs |
| Trade Name: | Paratrooper™ Plantar Plate Repair System |
| Regulatory Class: | Class II |
| Regulation,Product Code,Classification, andCommon Name: | 888.3040, MBI, Fastener, Fixation, Nondegradable, Soft Tissue |
| DeviceDescription: | The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes inone size and is provided attached to a needle. |
| Indications forUse: | The Paratrooper™ Plantar Plate Repair System is intended forfixation of tissue to bone and tissue to tissue. Specificindications:Foot/ankle:• Lateral Stabilization• Medial Stabilization• Achilles Tendon Repair• Metatarsal Ligament and Tendon Repair• Hallux Valgus Reconstruction• Digital Tendon Transfers• Mid-foot Reconstruction• Plantar Plate Repair |
| Materials: | The Paratrooper™ Plantar Plate Repair System implants aremade from ultra-high-molecular-weight-polyethylene(UHMWPE) co-braid suture, and polyester. All suture meets allsurgical suture requirements established by the USP for non-absorbable surgical sutures except for oversized diameter. Theinstrumentation is manufactured from medical grades ofstainless steel, nitinol, and polymer. |
| PrimaryPredicate: | K133671, Stryker Endoscopy ICONIX All Suture AnchorSystem |
| AdditionalPredicate: | K162429, Ziptek, LLC ZipE® Knotless Tissue Repair andAttachment Device |
| Reference Device: | K181774, Teleflex Medical Force Fiber® Sutures |
| Comparison toPredicateIndications: | The subject Paratrooper™ Plantar Plate Repair System andStryker ICONIX All Suture Anchor are intended to be used fortissue to bone fixation. The subject Paratrooper™ Plantar PlateRepair System and Ziptek ZipE® device are intended to be usedfor tissue to tissue fixation. All indications for the subject deviceare within the indications of the predicate devices. |
| Comparison toPredicateTechnologicalCharacteristics: | The subject Paratrooper™ Plantar Plate Repair Systemcomponents possess the same technological characteristics as thepredicate devices. These include:• performance,• basic design,• material, manufacturing and• sizes (dimensions are comparable to those offered by thepredicate systems).Differences between the Paratrooper™ Plantar Plate RepairSystem implants and the predicate devices were shown not toraise new questions of safety and effectiveness. Therefore, thefundamental scientific technology of the subject Paratrooper™Plantar Plate Repair System components is similar to previouslycleared devices. |
| PerformanceData: | All necessary testing has been performed on representativeParatrooper™ Plantar Plate Repair System components to assuresubstantial equivalence to its predicate and demonstrate thesubject device performs as intended. All testing was performedon finished devices.The device performance was characterized via pullout testing.Additional testing includes pyrogenicity, biocompatibility andsterilization.Clinical data are not needed to support the safety andeffectiveness of the subject device. |
| Conclusion: | Performance testing demonstrates the substantial equivalence ofthe Paratrooper™ Plantar Plate Repair System to the StrykerICONIX All Suture Anchor System and the Ziptek ZipE®Knotless Tissue Repair and Attachment Device. Therefore, theParatrooper™ Plantar Plate Repair System is substantiallyequivalent to the predicate devices with respect to theirindications for use, technical characteristics, and function. |
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§ 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.