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510(k) Data Aggregation

    K Number
    K191057
    Device Name
    Park's Pectus System
    Manufacturer
    TDM Co. Ltd.
    Date Cleared
    2020-03-19

    (332 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K171808,K190391,K061384
    Why did this record match?
    Device Name :

    Park's Pectus System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities

    Device Description

    Park's Pectus System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest. This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.

    Park's Pectus System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.

    AI/ML Overview

    The provided text does not contain information about an AI device or a study proving its performance against acceptance criteria. It discusses the "Park's Pectus System," which is a medical device for correcting pectus excavatum, comprising pectus bars and stabilizers. The document is an FDA 510(k) premarket notification and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study against acceptance criteria typically associated with AI/software devices.

    Therefore, many of the requested details, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set information, and ground truth establishment for an AI device, are not applicable to this document.

    However, I can extract the acceptance criteria and performance information as presented for the Park's Pectus System in relation to its predicate device. This will be based on the substantial equivalence discussion.

    Here's a summary of the information available in the document, framed as acceptance criteria and reported performance in the context of substantial equivalence to a predicate device:

    Acceptance Criteria and Reported Device Performance (Park's Pectus System vs. Predicate Device)

    The "acceptance criteria" for the Park's Pectus System, as presented in this 510(k) summary, are its features and performance demonstrating substantial equivalence to the predicate device, Lorenz Pectus Support Bar System (K061384), and reference devices (TDM Plate and Screw System K171808/K190391).

    Acceptance Criteria (Comparison to Predicate)Reported Device Performance (Park's Pectus System)Conclusion on Equivalence
    Indication for Use: Intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities. (Identical to predicate)Substantial Equivalence
    Indication: Congenital deformity of the sternum and anterior chest wall.Congenital deformity of the sternum and anterior chest wall. (Identical to predicate)Substantial Equivalence
    Contraindications: - Patients with mental/neurological conditions unwilling/incapable of following instructions. - Patients with metal sensitivity reactions. - Patients with insufficient quantity or quality of bone/fibrous tissue. - Infection.- Patients with mental or neurological conditions who are unwilling or incapable of following instructions. - Patients presenting metal sensitivity reactions. - Patients with insufficient quantity or quality of bone or fibrous tissue to allow remodeling. - Infection. (Identical to predicate)Substantial Equivalence
    Raw Material: Titanium Alloy (ASTM F136), Stainless Steel (ASTM F138 & ASTM F139).Titanium Alloy (ASTM F136), Stainless Steel (ASTM F138 & ASTM F139). (Identical or comparable to predicate; predicate lists ASTM F138). Materials are also identical to cleared TDM plate and screw systems (K171808/K190391).Substantial Equivalence
    Features (Key aspects): Rounded ends/blunt edges for minimal tissue destruction, variety of lengths (7-17 inches for predicate), instruments for Nuss Procedure simplicity, container size, specialized bars for nickel allergies, special/pre-bent bars.- Rounded ends and blunt edges to minimize tissue destruction. - Variety of lengths (6-17 inches). - Instruments designed for Nuss Procedure simplicity. - Container in two sizes. - Specialized titanium bars/stabilizers for nickel allergies. - Includes special sized and pre-bent bars based on CT scans. (Comparable to predicate; Pectus Bar length range slightly different: 6-17 inch vs. 7-17 inch for predicate).Substantial Equivalence (differences in length range considered acceptable based on overall equivalence and testing)
    Surgical Procedure: MIRPE (Minimally Invasive Repair of Pectus Excavatum).MIRPE (Minimally Invasive Repair of Pectus Excavatum). (Identical to predicate)Substantial Equivalence
    Single Use: Yes.Yes. (Identical to predicate)Substantial Equivalence
    Non-Sterile Packaging: Yes.Yes. (Identical to predicate)Substantial Equivalence
    Target Population: Patients with congenital deformity of the sternum and anterior chest wall.Patients with congenital deformity of the sternum and anterior chest wall. (Identical to predicate)Substantial Equivalence
    Anatomical Site: Sternum and anterior chest wall.Sternum and anterior chest wall. (Identical to predicate)Substantial Equivalence
    Location of Use: Use only by professional orthopedists.Use only by professional orthopedists. (Identical to predicate)Substantial Equivalence
    Biocompatibility: All user-directly contacting materials comply with ISO10993 requirements.All user directly contacting materials are compliance with ISO10993 requirements. Additionally, materials are identical to previously cleared TDM plate and screw systems (K171808/K190391) and literature review shows no conclusive evidence of carcinogenesis for these materials.Substantial Equivalence
    Mechanical Performance: Equivalent mechanical properties to predicate for relevant tests (e.g., 4-point bending, fatigue, vertical tensile) based on worst-case scenarios.Non-clinical performance tests (4-point bending, 4-point bending fatigue, vertical tensile) were performed. The selection rationale was based on the worst-case scenario (longest and thinnest bar: 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick). Both stainless and titanium bars, and both rounded and serrated end bars were tested. Tests demonstrate comparable performance to the predicate device.Substantial Equivalence (tests comparing performance to predicate were conducted and demonstrated comparable results, supporting substantial equivalence)

    Study Information (Non-AI device context):

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

      • Test set: The document refers to "worst case scenario" samples for mechanical testing: a pectus bar with dimensions of 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick. Both stainless and titanium pectus bars were tested, as were pectus bars with rounded and serrated ends.
      • Data provenance: Not explicitly stated, but these were non-clinical, in-vitro tests conducted by the manufacturer (TDM Co. Ltd.) to compare its device against the predicate.

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

      • Not applicable. This device is not an AI/diagnostic software. The "ground truth" for non-clinical performance refers to established engineering standards (e.g., ASTM F382-14) and direct comparison to the predicate device under specific test conditions.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • Not applicable. This is not a clinical study involving human readers or interpretation.

    4. 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:

      • Not applicable. This is not an AI device.

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

      • Not applicable. This is not an AI device.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • For material properties and biocompatibility: Compliance with ISO10993 requirements, use of well-established medical-grade materials (ASTM F136, ASTM F138 & F139), and equivalence to previously cleared devices (K171808/K190391).
      • For mechanical performance: Comparison to a legally marketed predicate device (Lorenz Pectus Support Bar System, K061384) under specific ASTM-standardized mechanical tests (ASTM F382-14 for metallic bone plates). The "ground truth" is that the new device performs comparably to the predicate under these conditions.

    7. The sample size for the training set:

      • Not applicable. This is not an AI device, so there is no training set in the AI sense.

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

      • Not applicable.
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