(134 days)
No
The document describes surgical screws and their sterilization, with no mention of AI or ML technology.
Yes
The device is intended for medical purposes such as limb lengthening and fracture fixation, which directly treat or manage specific medical conditions.
No
The device is described as screws used with systems for limb lengthening and fracture fixation, indicating a therapeutic or structural purpose rather than a diagnostic one.
No
The device description explicitly states it is introducing a sterile option for "Precice Screws" and describes physical characteristics like lengths, materials, and thread styles, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures involving bone fixation and lengthening (limb lengthening, fracture fixation, pseudoarthrosis, mal-unions, non-unions, bone transport). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as screws made of various materials and designs, intended to be used with specific surgical systems. This aligns with a surgical implant or fixation device.
- Lack of Diagnostic Function: 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.
- Performance Studies: The performance studies described focus on sterilization and packaging validation, which are relevant for sterile surgical implants, not IVDs.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a physical implant used in surgical procedures.
N/A
Intended Use / Indications for Use
The Precice® Screws are provided sterile and intended to be used with the systems below:
The Precice® Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Stryde System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Bone Transport Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones for pediatrics and small stature adult patients.
Product codes
HSB, KTT, HRS, HWC
Device Description
The Precice Screws accompanying previously cleared Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181) are available in a variety of lengths, materials and thread styles. The screws are offered in lengths between 10-100mm and styles including pegs, partially threaded and fully threaded shaft designs.
The purpose of this submission is to introduce a sterile option of previously cleared screws as part of the Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181).
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
pediatrics and small stature adult patients
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
Gamma sterilization validation, sterile packaging validation, and integrity of the sterile barrier over time validation are performed to qualify new packaging and sterilization method for the Precice Screws.
The results demonstrate that the subject Precice Screws are substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
K172628, K180503, K182170, K192181
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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May 8, 2020
NuVasive Specialized Orthopedics, Inc. Madison Heffron Regulatory Affairs Specialist 101 Enterprise. Suite 100 Aliso Viejo, California 92656
Re: K193617
Trade/Device Name: Precice Screws Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, KTT, HRS, HWC Dated: April 7, 2020 Received: April 9, 2020
Dear Madison Heffron:
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
1
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 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 medical devices and radiation-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,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K193617
Device Name
The Precice® Screws
Indications for Use (Describe)
The Precice® Screws are provided sterile and intended to be used with the systems below:
The Precice® Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Stryde System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Bone Transport Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones for pediatrics and small stature adult patients.
| 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® Screws 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:
Madison Heffron Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo. CA 92656 Telephone: (949) 532-7868
Date Prepared: May 7th, 2020
B. Device Name
| Trade or Proprietary Name: | Precice® Screws |
|---|---|
| Common or Usual Name: | Screw, Fixation, Bone |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3020, 888.3030, and 888.3040 |
| Product Code: | HSB, KTT & HRS, and HWC |
C. Predicate Devices
The subject Precice® Screws are substantially equivalent to the predicate device the Precice® System (K172628) and additional predicates, Precice® Stryde System (K180503), Precice® Bone Transport (K182170), and Precice® Plate System (K192181).
D. Device Description
The Precice Screws accompanying previously cleared Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181) are available in a variety of lengths, materials and thread styles. The screws are offered in lengths between 10-100mm and styles including pegs, partially threaded and fully threaded shaft designs.
The purpose of this submission is to introduce a sterile option of previously cleared screws as part of the Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181).
E. Indications for Use
The Precice® Screws are provided sterile and intended to be used with the systems below:
4
The Precice® System is indicated for limb lengthening, open and closed fracture fixation. pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Stryde System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The Precice® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones for pediatrics and small stature adult patients.
Technological Characteristics F.
As was established in this submission, the subject Precice Screws are substantially equivalent to other predicate devices 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 device through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
Gamma sterilization validation, sterile packaging validation, and integrity of the sterile barrier over time validation are performed to qualify new packaging and sterilization method for the Precice Screws.
The results demonstrate that the subject Precice Screws are substantially equivalent to the predicate.
H. Conclusions
The subject Precice Screws have been shown to be substantially equivalent to the legally marketed predicate devices.