(132 days)
No
The description focuses on mechanical and electrical components for limb lengthening and fracture fixation, with no mention of AI or ML capabilities. The submission is for a new generation of the external remote controller, which appears to be a control interface, not an AI/ML processing unit.
Yes
The device is indicated for limb-lengthening, fracture fixation, and addressing conditions like pseudoarthrosis, mal-unions, non-unions, and bone transport of long bones, which are all therapeutic interventions.
No
The PRECICE® System is described as a device for limb-lengthening, fracture fixation, bone transport, and to address mal-unions or non-unions of long bones. Its components, such as the nail, screws, and external remote controller, are designed for internal fixation and adjustment of bone length, which are therapeutic functions. There is no mention of the device collecting or analyzing data to diagnose a condition.
No
The device description explicitly details hardware components including a nail, locking screws, end cap, surgical instruments, and an external remote controller (ERC). The submission also includes nonclinical testing for electrical safety, electromagnetic compatibility, shock and vibration, and ingress protection, which are typical for hardware devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "limb-lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions or bone transport of long bones." This describes a surgical procedure and the treatment of musculoskeletal conditions.
- Device Description: The device is a system of implants (nail, screws, end cap) and an external controller used to mechanically adjust the length of bones. This is a physical intervention, not a diagnostic test performed on biological samples.
- No mention of biological samples: The description does not mention the collection or analysis of blood, urine, tissue, or any other biological specimen, which is a hallmark of IVD devices.
- Performance Studies: The performance studies listed are related to electrical safety, electromagnetic compatibility, mechanical testing, and usability, which are typical for implantable and external medical devices used in surgery. There are no studies related to the accuracy or performance of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PRECICE® System is indicated for limb-lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions or bone transport of long bones.
Product codes
HSB, HWC
Device Description
The PRECICE® System is composed of the PRECICE® Nail, locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE® Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is offered in pre-distracted and non-predistracted models. Pre-distracted models are supplied pre-distracted by 10 mm (femur and, tibia models), 15 mm and 20 mm (humeral model), to allow for compression fracture reduction techniques.
The PRECICE® Stryde System includes the PRECICE® Stryde Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Stryde nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE® Stryde Nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Stryde Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Stryde Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.
The reason for this submission is to introduce some design modifications to the third generation of the External Remote Controller (ERC 3P) cleared under K170169. The subject device, ERC 4P, is fourth generation of ERC component of the PRECICE® System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
Indicated Patient Age Range
Not Found
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 testing was performed to demonstrate that the subject PRECICE® System is substantially equivalent to predicate devices. Following testing have been included in the submission to show substantial equivalence to the predicate device.
Test: Electrical Safety, Applicable standard: IEC 60601-1 (3rd edition): 2005
Test: Electromagnetic Compatibility and Interference, Applicable standard: IEC 60601-1-2: 2014
Test: Minimum rated voltage testing, Applicable standard: Not Found
Test: Shock and Vibration Testing, Applicable standard: IEC 60601-1-11:2015
Test: Ingress protection, Applicable standard: Not Found
Test: Magnet Safety Analysis, Applicable standard: N/A
Test: Usability Study, Applicable standard: N/A
Test: Labeling Readability, Applicable standard: N/A
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
NuVasive Specialized Orthopedics, Inc. Aditya Sharma Sr. Regulatory Affairs Specialist 101 Enterprise. Suite 100 Aliso Viejo, California 92656
Re: K191336
Trade/Device Name: PRECICE System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: August 29, 2019 Received: August 30, 2019
Dear Aditya Sharma:
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 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
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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 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.
For Shumava Ali, M.P.H. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative 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) K191336
Device Name PRECICE® System
Indications for Use (Describe)
The PRECICE® System is indicated for limb-lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions or bone transport of long bones.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray graphic element on the left, resembling an abstract shape. To the right of the graphic is the word "NUVASIVE" in a silver, sans-serif font. Below "NUVASIVE" is the text "SPECIALIZED ORTHOPEDICS, INC." in a smaller, purple font.
510 (k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
A. Submitted by:
Aditya Sharma Sr. Regulatory Affairs Specialist Nu Vasive Specialized Orthopedics Incorporated 101 Enterprise. Suite 100 Aliso Viejo. California, 92656 Telephone: (949) 837-3600.
Date Prepared: August 29, 2019
B. Device name
| Proprietary Name: | PRECICE® System |
|---|---|
| Common or Usual Name: | Intramedullary Fixation Rod, Smooth or threaded metallic bone fixation fastener |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
| Regulation Number: | 21 CFR § 888.3020, 21 CFR 888.3040 |
| Classification: | Class II |
| Product Code (primary): | HSB |
| Product Code (subsequent): | HWC |
C. Predicate Devices
The subject PRECICE® System is substantially equivalent to the primary predicate device, PRECICE® Intramedullary Limb Lengthening System (K170169) and additional predicate devices, PRECICE® System (K173129) and PRECICE® Stryde (K180503).
D. Device Description
The PRECICE® System is composed of the PRECICE® Nail, locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE® Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is offered in pre-distracted and non-predistracted models. Pre-distracted models are supplied pre-distracted by 10 mm (femur and, tibia models), 15 mm and 20 mm (humeral model), to allow for compression fracture reduction techniques.
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The PRECICE® Stryde System includes the PRECICE® Stryde Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Stryde nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE® Stryde Nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Stryde Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Stryde Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.
The reason for this submission is to introduce some design modifications to the third generation of the External Remote Controller (ERC 3P) cleared under K170169. The subject device, ERC 4P, is fourth generation of ERC component of the PRECICE® System.
E. Indications for Use
The PRECICE® System is indicated for limb-lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions or bone transport of long bones.
F. Technological Characteristics
As was established in this submission, the subject PRECICE® System is substantially equivalent to the predicate device cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and functions.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject PRECICE® System is substantially equivalent to predicate devices. Following testing have been included in the submission to show substantial equivalence to the predicate device.
| Test | Applicable standard |
|---|---|
| Electrical Safety | IEC 60601-1 (3rd edition): 2005 |
| Electromagnetic Compatibility and | |
| Interference | IEC 60601-1-2: 2014 |
| Minimum rated voltage testing | |
| Shock and Vibration Testing | IEC 60601-1-11:2015 |
| Ingress protection |
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Image /page/5/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, and the words "SPECIALIZED ORTHOPEDICS, INC." in purple below it. The logo is clean and modern, with a focus on the company's name and specialization.
| Test | Applicable standard |
|---|---|
| Magnet Safety Analysis | N/A |
| Usability Study | N/A |
| Labeling Readability | N/A |
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate device, the subject PRECICE® System has been shown to be substantially equivalent to legally marketed predicate device.