(169 days)
No
The device description focuses on mechanical components and an external remote controller, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia, which are all therapeutic interventions for medical conditions.
No
This device is not a diagnostic device as it is indicated for fracture fixation, pseudoarthrosis, mal-unions, non-unions, or limb lengthening of the tibia. Its purpose is therapeutic intervention, not diagnosis.
No
The device description explicitly lists multiple hardware components including a nail, locking screws, end cap, surgical instruments, and an external remote controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia." This describes a surgical implant used to treat bone conditions, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a mechanical implant (nail, screws, etc.) and associated instruments and controller. It does not mention any components or processes related to analyzing biological specimens.
- Performance Studies: The performance studies listed (sterilization, shelf life, biocompatibility, mechanical testing, pyrogen testing) are typical for implantable medical devices, not IVDs. IVD performance studies would focus on analytical and clinical performance metrics like sensitivity, specificity, accuracy, etc., when testing samples.
IVDs are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The PRECICE UNYTE CoCr System is a surgical implant used directly on the patient's bone.
N/A
Intended Use / Indications for Use
The PRECICE UNYTE CoCr System is indicated for open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The PRECICE UNYTE CoCr System is composed of the PRECICE UNYTE CoCr Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC). The nail is available in tibia models with various diameters and lengths to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and configurations (fully and partially threaded). The PRECICE CoC's Nail and end cap are supplied sterile by gamma radiation while the locking screws and surgical 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 supplied either pre-distracted by 10 mm to allow for compression fracture reduction techniques or fully retracted for limb lengthening applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 201 Subpart D)
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)
Testing of the PRECICE UNYTE CoCr System included sterilization validation, shelf life testing for packaging and device functionality, biocompatibility testing, and testing to ASTM F1264 for intramedullary rods. Pyrogen testing was also performed on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices.
The following specific tests have been performed in order to establish equivalence to the predicate device:
- PRECICE, Static Four Point Bend (ASTM F1264-14)
- PRECICE, Dynamic Four Point Bend (ASTM F1264-14)
- PRECICE, Static Torque to Failure (ASTM F1264-14)
- 25 Month Shelf Life Packaging Validation (I.S. EN ISO 11607-1)
- Standard Guide for Accelerated Aging of Sterile Medical Device Packages (ASTM F1984-07)
- Standard Test Method for Seal Strength of Flexible Barrier Materials (ASTM F88/F88M-09)
- Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM D4169-16)
- Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing (ASTM D4332-14)
- Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection (ASTM F 1886/F 1886M-15)
- Packaging for terminally sterilized medical devices Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods (BS EN 868-5)
- Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose (IS/EN/ISO 11137-2)
- Biocompatibility (ISO 10993-1)
- Sterilization of Health Care Products-Moist heat-Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices (ISO 17665-1)
- Sterilization of Health Care Products-Moist heat-Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 (ANSI/AAMI/ISO TIR17665-2:2009)
- Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers (AAMI TIR12:2010)
- Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2010&A4:2013)
- Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices (AAMI TIR39:2009)
- Pyrogenicity - LAL (Kinetic Turbidimetric Assay Pyrogen Test) (ANSI/AAMI ST72:2011 - Bacterial Endotoxins - Test Methods, Routine Monitoring, and Alternatives to Batch Testing)
Conclusions can be drawn from the testing performed that the PRECICE UNYTE CoCr System is substantially equivalent to the predicate device.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NuVasive Specialized Orthopedics, Inc. Cora Sim Sr. Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
April 6, 2017
Re: K162927
Trade/Device Name: PRECICE UNYTE CoCr System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 17, 2016 Received: October 19, 2016
Dear Cora Sim:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162927
Device Name PRECICE UNYTE CoCr System
Indications for Use (Describe)
The PRECICE UNYTE CoCr System is indicated for open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)
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 silver graphic on the left, followed by the company name in silver lettering. Below the company name, the words "SPECIALIZED ORTHOPEDICS, INC." are written in purple.
510(k) Summary PRECICE® UNYTE CoCr System 510(k) Summary - K162927 March 2, 2017
-
- NuVasive Specialized Orthopedics, Inc. Company: 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
Contact: Cora Sim Sr. Regulatory Affairs Specialist Phone: (949) 544-6478 Fax: (949) 837-3664
- NuVasive Specialized Orthopedics, Inc. Company: 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
Date of Submission: March 2, 2017
-
- Proprietary Trade Name: PRECICE UNYTE CoCr System
-
- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
-
- Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
- ട്. Product Description: The PRECICE UNYTE CoCr System is composed of the PRECICE UNYTE CoCr Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC). The nail is available in tibia models with various diameters and lengths to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and configurations (fully and partially threaded). The PRECICE CoC's Nail and end cap are supplied sterile by gamma radiation while the locking screws and surgical 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 supplied either pre-distracted by 10 mm to allow for compression fracture reduction techniques or fully retracted for limb lengthening applications.
- Indications: The PRECICE UNYTE CoCr System is indicated for open and closed fracture 6. fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia.
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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic to the left of the company name. The company name is written in silver, with the words "SPECIALIZED ORTHOPEDICS, INC." written in purple below the name.
-
- Substantial equivalence: A detailed comparison to the predicate device demonstrates that the PRECICE UNYTE CoCr System is substantially equivalent to the following 510(k) cleared device:
| Trade Name: | PRECICE® Trauma Nail System |
|---|---|
| Common Name: | Intramedullary Fixation Rod |
| 510(k) Clearance Number: | K160267 |
In addition, the PRECICE UNYTE CoCr System designates the following 510(k) cleared reference device:
| Trade Name: | PRECICE® Intramedullary Limb Lengthening System |
|---|---|
| Common Name: | Intramedullary Fixation Rod |
| 510(k) Clearance Number: | K160325 |
Substantial equivalence is based on indications for use, technological characteristics, principles of operation, and on in vitro testing performed.
The PRECICE UNYTE CoCr Nail System subject to this 510(k) and the predicate device have similar indications for use. Specifically, both systems are indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of the tibia. This 510(k) is intended to include additional implant sizes utilizing cobalt chromium alloy (CoCr) material and to expand the indications to include limb lengthening.
The PRECICE UNYTE CoCr System has the same technological characteristics and the same principles of operation as that of the predicate. Both devices are inserted into the intramedullary canal of the tibia and secured with locking screws. Both devices are adjusted non-invasively by the External Remote Controller (ERC).
The PRECICE UNYTE CoCr Nail has similar design features as that of the predicate. Both the PRECICE UNYTE CoCr Nail and the predicate are intramedullary nails with a telescoping portion that can adjust the length of the implant. Both devices are inserted into the intramedullary canal of the tibia and secured with locking screws. Both devices are adjusted non-invasively by the external remote controller (ERC). The overall length of the PRECICE UNYTE CoCr Nail is similar to the overall length of the predicate.
Testing of the PRECICE UNYTE CoCr System included sterilization validation, shelf life testing for packaging and device functionality, biocompatibility testing, and testing to ASTM F1264 for intramedullary rods. Pyrogen testing was also performed on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices.
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Image /page/5/Picture/0 description: The image is the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a purple and gray abstract shape on the left. To the right of the shape is the word "NUVASIVE" in gray, and below that is the text "SPECIALIZED ORTHOPEDICS, INC." in purple.
The following specific tests have been performed in order to establish equivalence to the predicate device:
| Test Description | Applicable Test Standard |
|---|---|
| PRECICE, Static Four Point Bend | ASTM F1264-14 |
| PRECICE, Dynamic Four Point Bend | ASTM F1264-14 |
| PRECICE, Static Torque to Failure | ASTM F1264-14 |
| 25 Month Shelf Life Packaging Validation | I.S. EN ISO 11607-1 |
| Standard Guide for Accelerated Aging of Sterile Medical Device Packages | ASTM F1984-07 |
| Standard Test Method for Seal Strength of Flexible Barrier Materials | ASTM F88/F88M-09 |
| Standard Practice for Performance Testing of Shipping Containers and Systems | ASTM D4169-16 |
| Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing | ASTM D4332-14 |
| Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection | ASTM F 1886/F 1886M-15 |
| Packaging for terminally sterilized medical devices Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods | BS EN 868-5 |
| Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose | IS/EN/ISO 11137-2 |
| Biocompatibility | ISO 10993-1 |
| Sterilization of Health Care Products-Moist heat-Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | ISO 17665-1 |
| Sterilization of Health Care Products-Moist heat-Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 | ANSI/AAMI/ISO TIR17665-2:2009 |
| Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers | AAMI TIR12:2010 |
| Comprehensive guide to steam sterilization and sterility assurance in health care facilities | ANSI/AAMI ST79:2010&A4:2013 |
| Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices | AAMI TIR39:2009 |
| Pyrogenicity - LAL (Kinetic Turbidimetric Assay Pyrogen Test) | ANSI/AAMI ST72:2011 - Bacterial Endotoxins - Test Methods, Routine Monitoring, and Alternatives to Batch Testing |
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Image /page/6/Picture/0 description: The image is a logo for "NUVASIVE SPECIALIZED ORTHOPEDICS, INC.". The logo features a stylized purple and gray graphic on the left, resembling an abstract leaf or curved 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.
There are no changes to the design of the ERC being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE Trauma Nail System for the ERC are applicable.
Conclusions can be drawn from the testing performed that the PRECICE UNYTE CoCr System is substantially equivalent to the predicate device.