(33 days)
No
The device description and summary of performance studies focus on mechanical components and standard sterilization/testing procedures, with no mention of AI or ML technologies.
Yes
The device is indicated for "limb lengthening of the tibia and femur," which is a therapeutic intervention. It is designed to treat a medical condition (limb length discrepancy) through direct physical modification.
No
The device is described as an intramedullary limb lengthening system used for physically lengthening the tibia and femur, not for diagnosing a 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 or ERC 2P). This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "limb lengthening of the tibia and femur." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components are physical implants (nail, screws, end cap) and surgical instruments used for the procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples for diagnostic purposes. This device is used in vivo (inside the body) for a therapeutic purpose (limb lengthening).
N/A
Intended Use / Indications for Use
The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HWC
Device Description
The PRECICE Intramedullary Limb Lengthening (IMLL) System is composed of the PRECICE Nail. locking screws, end cap, surgical instruments, and an External Remote Controller (ERC or ERC 2P). The nail is available in tibial and femoral models; with 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, lengths, and thread styles. The PRECICE Nail is supplied sterile by gamma radiation; the locking screws and surgical instruments are supplied non sterile, and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia and femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical testing was performed on the locking screws previously performed on the same screws used in the reference device system (K160267) according to the methods outlined in ASTM F1264-14 and ASTM F543-13.
Pyrogen testing was performed per ANSI/AAMI ST72:2011 – Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices.
Conclusions can be drawn from these tests that the subject PRECICE IMLL 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2017
Nuvasive Specialized Orthopedics, Inc. Lance Justice Regulatory Affairs Specialist 101 Enterprise. Suite 100 Aliso Viejo, California 92656
Re: K170346
Trade/Device Name: Precice Intramedullary Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: February 1, 2017 Received: February 2, 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 (reporting of medical device-
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
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related 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.
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | K170346 Page 1 of 1
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------- |
|---|
510(k) Number (if known)
K170346
Device Name
Device Name
PRECICE Intramedullary Limb Lengthening System
Indications for Use (Describe)
Indications for Use (Describe)
The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.
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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3
Image /page/3/Picture/1 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.
PRECICE Intramedullary Limb Lengthening System 510(k) Summary
-
- Company: NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
- Contact: Lance Justice Regulatory Affairs Specialist Phone: (949) 544-6540 Fax: (949) 837-3664
Date Prepared: February 27, 2017
- Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System 2.
- Classification: 888.3020, 888.3040 3.
-
- Product Code: HSB, HWC
- Product Description: The PRECICE Intramedullary Limb Lengthening (IMLL) System ട. is composed of the PRECICE Nail. locking screws, end cap, surgical instruments, and an External Remote Controller (ERC or ERC 2P). The nail is available in tibial and femoral models; with 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, lengths, and thread styles. The PRECICE Nail is supplied sterile by gamma radiation; the locking screws and surgical instruments are supplied non sterile, and must be sterilized prior to use.
- Indications for Use: The PRECICE Intramedullary Limb Lengthening System is indicated 6. for limb lengthening of the tibia and femur.
- Substantial equivalence: The subject PRECICE IMLL System is substantially equivalent 7. to the most recently cleared PRECICE IMLL System (K160325). Substantial equivalence is based on indications for use, technological characteristics, and principles of operation. In addition, the PRECICE Trauma Nail System (K160267) and Zimmer Natural Nail System (K083497) are designated as a reference devices to further substantiate equivalence of the new screws to be added to the system.
The subject PRECICE IMLL System and the predicate device have the same indications for use. Specifically, both systems are indicated for limb lengthening of the tibia and the femur.
4
Image /page/4/Picture/1 description: The image shows the logo for "NUVASIVE SPECIALIZED ORTHOPEDICS, INC.". The logo consists of a stylized leaf-like shape in purple and gray on the left, followed by the company name in silver. Below the company name, "SPECIALIZED ORTHOPEDICS, INC." is written in a smaller, purple font.
The subject PRECICE IMLL System has similar technological characteristics and the same principle of operation as that of the predicate system. The technological characteristics of the subject PRECICE Nails, end cap, instruments, and External Remote Controller (ERC and ERC 2P) 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 Controller) are applicable to this submission. The difference between the two systems is the addition of two screw thread styles (partially threaded and fully threaded) to the currently available peg style screws of the predicate system.
There are no technological or performance changes to the PRECICE IMLL Nail being made as a result of this submission, therefore all testing previously performed on the predicate PRECICE Nail are applicable.
The assessment of substantial equivalence is based upon mechanical testing previously performed on the same screws used in the reference device system (K160267). Mechanical testing on the locking screws were previously performed according to the methods outlined in ASTM F1264-14 and ASTM F543-13.
Pyrogen testing was performed per ANSI/AAMI ST72:2011 – Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices.
Conclusions can be drawn from these tests that the subject PRECICE IMLL System is substantially equivalent to the predicate device.