(137 days)
No
The summary describes a mechanical intramedullary nail system for limb lengthening and fracture fixation. There is no mention of AI or ML in the device description, intended use, or performance studies. The device relies on mechanical components and external remote controllers for operation.
Yes
The device is indicated for limb lengthening and fixation of fractures, pseudoarthrosis, mal-unions, and non-unions, which are all therapeutic interventions.
No
The device description clearly states it is for "limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones," which are all therapeutic or reparative functions, not diagnostic ones.
No
The device description explicitly lists hardware components such as nails, endcaps, locking screws, and surgical instruments. It also mentions compatibility with external remote controllers (ERCs), which are also hardware. The performance studies focus on the mechanical properties of these hardware components.
Based on the provided information, the Precice Max System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Precice Max System Function: The description clearly states that the Precice Max System is an implantable device used for surgical procedures involving bone lengthening, fracture fixation, and bone transport. It is a mechanical device that is physically implanted into the patient's body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
The Precice Max System is a surgical implant/device used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Precice Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).
Product codes (comma separated list FDA assigned to the subject device)
HSB, HWC
Device Description
The Precice Max System includes similar devices as within the predicate Precice Intramedullary Limb Lengthening System (K220234): nail, endcaps, locking screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, cleared via K113219; ERC 2P, cleared via K131490; or ERC 3P, cleared via K170169; or ERC 4P, cleared via K202348). The Precice Max intramedullary nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and diameters. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum- 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice Max nail is implanted using locking screws and reusable surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones, femur and tibia
Indicated Patient Age Range
patients age 18 years and older and pediatric patients (greater than 12 years old).
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)
Nonclinical performance verification testing was performed to demonstrate that the subject Precice Max System is substantially equivalent to the predicate device, Precice Intramedullary Limb Lengthening System (K220234). The testing included: Static Compression Bending Strength, Dynamic Compression Bending Strength, Torsion (ASTM F1264 – Standard Specification and Test Methods for Intramedullary Fixation Devices), Dynamic 3-Point Bending, Torque Resistance (ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws), Axial Pullout Strength (ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws), Tensile Strength, Distraction Force, Wear Debris Testing, and Corrosion Testing. The results demonstrate that the subject Precice Max System is substantially equivalent to the predicate.
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.
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.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. The word "ADMINISTRATION" is in a smaller font size than the other words.
NuVasive Specialized Orthopedics, Incorporated Miriam Cervantes Senior Specialist, Regulatory Affairs 101 Enterprise Suite 100 Aliso Viejo, California 92656
Re: K232267
Trade/Device Name: Precice Max System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: November 17, 2023 Received: November 17, 2023
Dear Miriam Cervantes:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
December 15, 2023
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Digitally signed by Farzana Farzana Sharmin -S sha Date: 2023.12.15 12:11:41 -05'00
Farzana Sharmin, PhD 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
510(k) Number (if known) K232267
Device Name Precice Max System
Indications for Use (Describe)
The Precice Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).
| 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) |
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510(k) Summary
In accordance with Title 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Miriam Cervantes Senior Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (909) 229-7836
Date Prepared: July 28, 2023
B. Device Name
| Trade or Proprietary Name: | Precice Max System |
|---|---|
| Common or Usual Name: | Rod, Fixation, Intramedullary and Accessories |
| Classification Name: | Intramedullary Fixation Rod |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3020 / 888.3040 |
| Product Code: | HSB, HWC |
Predicate Devices C.
The subject Precice Max System is substantially equivalent to the Precice Intramedullary Limb Lengthening System (K220234).
Primary Predicate
| Product Name | 510(k) Number | Date of Clearance |
|---|---|---|
| Precice Intramedullary | ||
| Limb Lengthening System | K220234 | 3/15/2023 |
Reference Predicates
| Product Name | 510(k) Number | Date of Clearance |
|---|---|---|
| Precice Ankle Salvage | ||
| System | K200430 | 09/16/2020 |
| Precice Screws | K193617 | 05/08/2020 |
D. Device Description
The subject Precice Max System has identical indications for use as the predicate Precice Intramedullary Limb Lengthening System (K220234), which is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, and bone transport of long bones in bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old). The subject system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The Precice
4
VE Traditional 510(k) Premarket Notification NuVasive Specialized Orthopedics Precice Max System (K232267)
Max System includes similar devices as within the predicate Precice Intramedullary Limb Lengthening System (K220234): nail, endcaps, locking screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, cleared via K113219; ERC 2P, cleared via K131490; or ERC 3P, cleared via K170169; or ERC 4P, cleared via K202348). The Precice Max intramedullary nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and diameters. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum- 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice Max nail is implanted using locking screws and reusable surgical instruments.
E. Indications for Use
The Precice Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).
Technological Characteristics F.
As was established in this submission, the subject Precice Max System is substantially equivalent to the predicate, Precice Intramedullary Limb Lengthening System (K220234) previously cleared by the FDA for commercial distribution in the United States. The subject device has been shown to be substantially equivalent and have equivalent technological characteristics to the predicate through comparison in areas including clinical use, labeling/intended use, material composition, and function.
The following table describes the summary comparison of technological characteristics of the subject device with the predicate device:
| Intended Use | The Precice Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old). |
|---|---|
| Primary Predicate | Precice Intramedullary Limb Lengthening System (K220234) |
| Explanation of | |
| differences in | |
| Intended Use | The subject device, Precice Max System has the identical intended and indications for use as the Precice Intramedullary Limb Lengthening System (K220234). |
| Summary of the | |
| technology | |
| similarities to the | |
| predicate device | Principle of Operation: Distraction osteogenesis. Material Composition: Titanium. Design: Magnetic mechanism |
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| Accessories: Locking screws, end caps, surgical instrumentation and ERC | |
|---|---|
| Summary of the | |
| technology | |
| differences to the | |
| predicate device | Device nail offers a larger nail diameter Device offers larger screw diameter |
Performance Data G.
Nonclinical performance verification testing was performed to demonstrate that the subject Precice Max System is substantially equivalent to the predicate device, Precice Intramedullary Limb Lengthening System (K220234). The following table describes summary testing performed from the predicate device to establish substantial equivalence:
| Testing Description | Explanation of Substantial Equivalence |
|---|---|
| Static Compression Bending Strength | |
| Dynamic Compression Bending Strength | ASTM F1264 – Standard Specification and |
| Torsion | ASTM F1264 – Standard Specification and |
| Test Methods for Intramedullary Fixation | |
| Devices | |
| Dynamic 3-Point Bending | |
| Torque Resistance | ASTM F543 – Standard Specification and Test |
| Axial Pullout Strength | ASTM F543 - Standard Specification and Test |
| Methods for Metallic Medical Bone Screws | |
| Tensile Strength | |
| Distraction Force | N/A |
| Wear Debris Testing | N/A |
| Corrosion Testing | N/A |
The results demonstrate that the subject Precice Max System is substantially equivalent to the predicate.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate device, the subject Precice Max System has been shown to be substantially equivalent to the legally marketed predicate device.