(256 days)
No
The device description and performance studies focus solely on the mechanical properties and components of an external fixation system, with no mention of AI or ML.
Yes
The device is intended to provide stabilization of fractures and help in bone reconstruction procedures, which are therapeutic interventions.
No
This device is an external fixation system used for the stabilization of fractures and other orthopedic conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the system consists of implants and instrumentation for external fixation, including Schanz Screws, clamps, and rods, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Para-Fix External Fixation System is a surgical device intended for the mechanical stabilization of bone fractures and deformities. It is implanted externally to the body and does not involve the analysis of biological specimens.
The description clearly indicates it's a system of implants and instrumentation for external fixation of bones, which falls under the category of surgical or orthopedic devices, not IVDs.
N/A
Intended Use / Indications for Use
The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The specific indications for the Para-Fix External Fixation System include:
· Bone fracture fixation
· Osteotomy
· Arthrodesis
· Correction of deformity
· Revision procedure where other treatments or devices have been unsuccessful
· Bone reconstruction procedures
Product codes
LXT, KTT
Device Description
The New Paradigm Biomedical (NPB) Para-Fix External Fixation System is intended for use in external fixation of various long bone fractures, including tibial, femoral, pelvic, and humeral fractures in adults. The Para-Fix system consists of implants, & instrumentation for external fixation. The system features implants (Schanz Screws) in various diameters (05 – 6mm) and lengths (120 – 300mm) to accommodate different anatomic sizes of patients. Schanz Screws are manufactured from medical grade stainless steel per ASTM F138. Para-Fix frame components include Clamps are available in Combination (pin to rod, rod to rod) or Multi-Pin clamps are manufactured from stainless steel. Ø11mm rods are available in lengths ranging from 65 – 500mm and are manufactured from carbon fiber. The Para-Fix system is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibial, femoral, pelvic, and humeral fractures
Indicated Patient Age Range
adults
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
Nonclinical (mechanical) testing per ASTM F1541-17 (Standard Specification and Test Methods for External Skeletal Fixation Devices) was performed by Element Materials Technology (Fairfield, OH) and NexTek Innovations (Logan, UT). The following tests were performed on subject and predicate/reference (5tryker Hoffmann II MRI and Stryker Apex Pin) Compression Connector Testing (ASTM F1541-17 A2), Static Axial Compression Subassembly Testing (ASTM F1541-17 A6), Static Torsion Full Construct Testing (ASTM F1541-17 A7), Static Axial Compression Testing (ASTM F1541-17 A7), and Fatigue (Multi-Cycle) Axial Compression/ Tension Full Construct Testing (ASTM F1541-17 A7).
Mechanical testing was performed according to ASTM F1541-17 and conclusively shows that the subject device performed substantially equivalent to the primary predicate device in all full construct test modalties. The subject device has been shown to be as safe and effective and perform as well as the primary predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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). 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 and the words "U.S. FOOD & DRUG ADMINISTRATION".
September 22, 2023
New Paradigm Biomedical John Wixted Co-Founder 163 Highland Ave #1144 Needham, Massachusetts 02494
Re: K230067
Trade/Device Name: Para-Fix External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: LXT, KTT Dated: December 21, 2022 Received: January 9, 2023
Dear John Wixted:
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.
1
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 (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.
Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Para-Fix External Fixation System
Indications for Use (Describe)
The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The specific indications for the Para-Fix External Fixation System include:
- · Bone fracture fixation
- · Osteotomy
- · Arthrodesis
- · Correction of deformity
- · Revision procedure where other treatments or devices have been unsuccessful
- · Bone reconstruction procedures
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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3
| 510(k) #: K230067 | 510(k) Summary | Prepared on: 2023-09-21 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | New Paradigm Biomedical | |
| Applicant Address | 163 Highland Ave #1144 Needham, MA 02494 United States | |
| Applicant Contact Telephone | 1-781-549-9008 | |
| Applicant Contact | Mr. John Wixted | |
| Applicant Contact Email | john.wixted@npbortho.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Para-Fix External Fixation System | |
| Common Name | Single/multiple component metallic bone fixation appliances and | |
| accessories | ||
| Classification Name | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, | |
| Metal Composite | ||
| Regulation Number | 888.3030 | |
| Product Code | LXT, KTT | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K051306 | Hoffmann II MRI External Fixation System | LXT |
| K111786 | Hoffmann 3 Modular External Fixation System | KTT |
| Device Description Summary | 21 CFR 807.92(a)(4) |
Device Description Summary
The New Paradigm Biomedical (NPB) Para-Fix External Fixation System is intended for use in external fixation of various long bone fractures, including tibial, femoral, pelvic, and humeral fractures in adults. The Para-Fix system consists of implants, & instrumentation for external fixation. The system features implants (Schanz Screws) in various diameters (05 – 6mm) and lengths (120 – 300mm) to accommodate different anatomic sizes of patients. Schanz Screws are manufactured from medical grade stainless steel per ASTM F138. Para-Fix frame components include Clamps are available in Combination (pin to rod, rod to rod) or Multi-Pin clamps are manufactured from stainless steel. Ø11mm rods are available in lengths ranging from 65 – 500mm and are manufactured from carbon fiber. The Para-Fix system is provided non-sterile.
21 CFR 807.92(a)(5)
Intended Use/Indications for Use
The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The specific indications for the Para-Fix External Fixation System include:
· Bone fracture fixation
· Osteotomy
· Arthrodesis
· Correction of deformity
· Revision procedure where other treatments or devices have been unsuccessful
4
· Bone reconstruction procedures
Indications for Use Comparison
The indications for use of the subject device are consistent with those of the primary and secondary predicate external fixation systems.
Technological Comparison
21 CFR 807.92(a)(6)
The subject device has similar technological characteristics as the predicate devices. Subject and predicate/reference devices include implants manufactured from stainless steel in similar diameters and predicate devices include frame components consisting of clamps (manufactured from stainless steel in the subject device, material not disclosed in the primary predicate device), and rods manufactured from carbon fiber. Subject device rods are Ø11mm and primary predicate device rods are Ø8mm. The principles of operation are identical for subject and predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Nonclinical (mechanical) testing per ASTM F1541-17 (Standard Specification and Test Methods for External Skeletal Fixation Devices) was performed by Element Materials Technology (Fairfield, OH) and NexTek Innovations (Logan, UT). The following tests were performed on subject and predicate/reference (5tryker Hoffmann II MRI and Stryker Apex Pin) Compression Connector Testing (ASTM F1541-17 A2), Static Axial Compression Subassembly Testing (ASTM F1541-17 A6), Static Torsion Full Construct Testing (ASTM F1541-17 A7), Static Axial Compression Testing (ASTM F1541-17 A7), and Fatigue (Multi-Cycle) Axial Compression/ Tension Full Construct Testing (ASTM F1541-17 A7).
Mechanical testing was performed according to ASTM F1541-17 and conclusively shows that the subject device performed substantially equivalent to the primary predicate device in all full construct test modalties. The subject device has been shown to be as safe and effective and perform as well as the primary predicate device.