(63 days)
No
The summary describes a mechanical system for limb lengthening and bone fixation, with no mention of AI or ML components or functions.
Yes
The intended use explicitly states therapeutic applications such as limb lengthening, fracture fixation, and treatment of malunions and non-unions, which are direct treatments for medical conditions.
No
This device is used for treatment (limb lengthening, fracture fixation, etc.) and not for diagnosing a medical condition.
No
The device description explicitly lists hardware components such as the PRECICE Nail, locking screws, end cap, surgical instruments, and an external remote controller (ERC).
Based on the provided information, the PRECICE System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical procedures involving bone lengthening, fracture fixation, and bone transport of long bones. This is a therapeutic and structural intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device components are implants (nail, screws, end cap) and surgical instruments used to perform the procedure. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
Therefore, the PRECICE System falls under the category of a surgical implant and associated instruments, not an in vitro diagnostic device.
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 screwhole 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
NuVasive Specialized Orthopedics, Inc. Lance Justice Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
December 1, 2017
Re: K173129
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: November 14, 2017 Received: November 15, 2017
Dear Lance Justice:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name PRECICE System
Indications for Use (Describe)
The PRECICE System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of long bones.
| 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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PRECICE System 510(k) Summary - K173129
Company: NuVasive Specialized Orthopedics, Inc. 1. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
Contact: Lance Justice Regulatory Affairs Specialist Phone: (949) 544-6540 Fax: (949) 837-3664
Date Prepared: November 14, 2017
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- Proprietary Trade Name: PRECICE System
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- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
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Product Code: HSB (Rod, Fixation, Intramedullary and Accessories) 4.
HCW (Screw, Fixation, Bone) -
Product Description: The PRECICE System is composed of the PRECICE Nail, locking ട്. screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole 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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Indications for Use: The PRECICE System is indicated for limb lengthening, open and 6. closed fracture fixation, pseudoarthrosis, mal-unions, or bone transport of long bones.
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- Substantial Equivalence: The subject PRECICE System is substantially equivalent to the most recently cleared PRECICE System (K172628). Substantial equivalence is based on
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indications for use, technological characteristics, and principles of operation. In addition, the Cannulated Screw System (K003496) by Pioneer is designated as a reference device to further substantiate equivalence of the material change to include stainless steel Biodur 108.
Substantial equivalence is based on identical indications for use, design, technological characteristics, principles of operations, and fundamental scientific principles. The Risk Management file was updated to include the material modification and no new risks were identified.
Other than the material change described in the submission, there are no changes to the design of the devices. The additional stainless steel PRECICE nails are available in the same application, screwhole configurations, stroke lengths, and overall lengths. The additional stainless steel locking screws are also available in the same thread styles, lengths, and diameters. The additional stainless steel end caps are available in the same sizes. No changes are being made to the design, technological characteristics or principles of operation as a result of this premarket notification. Both devices are inserted into the intramedullary canal of the long bones and secured with locking screws. Both devices are adjusted non-invasively by the External Remote Controller. The differences between the subject device and the predicate device are as follows:
- Extension of the product offering to include PRECICE Nails, locking screws, . and end caps composed of stainless steel
- . Material change of the patient contacting components of the PRECICE Nail to stainless steel (Biodur 108).
- Material change of the locking screws to stainless steel (Biodur 108). .
- Material change of the end caps to stainless steel (Biodur 108). ●
There are no changes being made to the ERCs or PRECICE surgical instruments as a result of this submission.
The subject PRECICE System and the predicate device have the same indications for use. Specifically, both systems are indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The subject PRECICE System has the same technological characteristics and the same principles of operation as that of the predicate system. The technological characteristics and design of the subject PRECICE Nails, end cap, instruments, and External Remote Controllers are identical to the predicate device. All testing previously performed on these components of the predicate system (i.e. PRECICE Nail, end cap, and External Remote
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Controllers) are applicable to this submission. The difference between the two systems is a change in material to include intramedullary nails, locking screws, and end caps composed of stainless steel.
Conclusions can be drawn from these comparisons that the subject PRECICE System is substantially equivalent to the predicate device.