(412 days)
The Precice Intramedullary Limb Lengthening System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatic patients (greater than 12 years old).
The predicate system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The purpose of submission is to add the treatment of pediatric patients (greater than 12 years old) to this the Precice Intramedullary Limb Lengthening System indications for use. The Precice Intramedullary Limb Lengthening System includes the same devices as within the predicate Precice System (K172628) : nail, cortical screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, in K113219; ERC 2P, in K131490; or ERC 3P, in K170169; or ERC 4P, in K191336). The configurations of sets and geometry of previously cleared Precice System devices remain unchanged. The following system description is herein repeated from K172628: Precice Nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and thread styles. The ERC is available in several compatible models, including the ERC 1, ERC 2P, ERC 3P and ERC 4P. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice IMLL nail is implanted using locking screws and reusable surgical instruments.
The provided text describes a 510(k) submission for the Precice Intramedullary Limb Lengthening System, primarily focusing on expanding its indications for use to include pediatric patients (greater than 12 years old). It does not contain information about an AI/ML-driven medical device, an MRMC comparative effectiveness study, or details related to establishing ground truth by a panel of experts for a test set. Therefore, I cannot fully address all the points in your request.
However, I can extract information related to the device's acceptance criteria, study design, and performance data as presented for its 510(k) clearance. The "acceptance criteria" here are not explicitly stated in numerical thresholds, but are demonstrated through substantial equivalence to predicate devices and performance data from clinical literature and a retrospective study.
Here's a breakdown of the available information structured to best fit your request:
Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through comparison with predicate devices and clinical outcomes from two pediatric datasets (literature review and retrospective study) and one adult literature dataset. The implied acceptance criteria are that the device performs comparably or acceptably for limb lengthening, with acceptable rates of adverse events and bone healing.
Table of Reported Device Performance
Since this is not an AI/ML device with specific classification metrics, the "acceptance criteria" are implied by the comparison to predicate devices and the clinical outcomes themselves. The table below presents the key performance metrics reported in the submission.
| Metric | Pediatric (Literature Review) | Pediatric (Retrospective Study, 13-20 years) | Adult (Literature) |
|---|---|---|---|
| Demographic Information | |||
| N (bones) | 227 (253) | 59 (59) | 136 (189) |
| Age, mean (range) | 14.4 (3-21) | 15.8 (13-20) | 36.1 (21-74) |
| Gender, male/female, % | 52.5/47.5 | 54.2/45.8 | 69.7/30.4 |
| Limb Lengthening Outcomes | |||
| Limb Length Discrepancy, cm | 5.3 | 4.9 | 4.9 |
| Target Length, cm | 6.2 | 4.9 | 4.7 |
| Achieved Length, mean, cm | 5.5 | 4.6 | 5.4 |
| Achieved Length/Target, overall, % | 93.0 | 93.9 | 119.5 |
| Achieved Length/Target, femoral, % | 114.6 | 94.1 | 127.5 |
| Achieved Length/Target, tibial, % | 93.0 | 90.7 | 110.0 |
| Bone Healing Rate, % | 100.0 | 100.0 | 94.3 |
| Adverse Events | |||
| Device-related Adverse Events | 6.7% | 6.8% | 22.2% |
| Lengthening-related Adverse Events | 16.6% | 34.7% | 8.5% |
| Joint Loss of ROM* | 6.2% | 3.4% | 2.9% |
| Joint Subluxation/Dislocation* | 4.0% | 3.4% | 0.0% |
| Angular Malalignment* | 2.8% | 1.7% | 0.0% |
| Radiographic - Premature Consolidation | 1.8% | 3.4% | 2.2% |
| Radiographic - Delayed Union | 2.6% | 16.9% | 8.1% |
| Radiographic - Partial Union | 0.0% | 3.4% | 0.0% |
| Radiographic - Nonunion | 0.9% | 5.1% | 5.1% |
| *Clinically significant events, i.e., those requiring major surgical treatments. |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Pediatric Literature Review: 227 patients with 253 lengthened bones (188 femur, 53 tibia, 12 humerus). Data provenance not specified beyond "clinical literature analysis of pediatric patients." It is a retrospective summary of published data.
- Pediatric Retrospective Study: 59 patients (59 bones) treated in the United States with the Precice Intramedullary Limb Lengthening System. This is a retrospective study.
- Adult Literature: 136 patients with 189 bones. Data provenance not specified beyond "clinical literature analysis." This is a retrospective summary of published data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study involves a medical device for limb lengthening, not an AI/ML-driven diagnostic or image analysis tool requiring expert ground truth for a test set in the traditional sense of AI/ML validation. The "ground truth" for success/failure or adverse events would be derived from clinical outcomes and medical records.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the type of device and study described. Clinical outcomes are typically recorded directly from patient follow-ups and medical records, not through an adjudication process of interpretations by multiple experts.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI/ML-assisted diagnostic devices, which is not the case for the Precice Intramedullary Limb Lengthening System.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical intramedullary limb lengthening system, not an algorithm. Its performance is directly tied to its use in patients by surgeons.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is based on clinical and radiographic outcomes data from patients treated with the device, derived from both retrospective studies and aggregated literature. This includes achieved limb length, bone healing rates, and the incidence of various adverse events.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "evidence" presented supports the expansion of indications based on existing clinical data and the device's similarity to predicate devices.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI/ML model.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 15, 2023
NuVasive Specialized Orthopedics, Inc. Madison Heffron Sr. Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
Re: K220234
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 Dated: March 6, 2023 Received: March 9, 2023
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
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 (OS) 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,
Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2023.03.15
17:11:59-04'00'
For Jiping Chen, MD, Ph.D., M.P.H. Division Director DHT6A:Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
Precice Intramedullary Limb Lengthening System
Indications for Use (Describe)
The Precice Intramedullary Limb Lengthening System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatic patients (greater than 12 years old).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 on the left, followed by the word "NUVASIVE" in silver, block letters. Below the company name, the words "SPECIALIZED ORTHOPEDICS, INC." are written in smaller, red letters.
Precice Intramedullary Limb Lengthening System 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 Senior Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (203) 885-2438 Email: mheffron@nuvasive.com
Date Prepared: March 15, 2023
B. Device Name
Trade or Proprietary Name: Precice Intramedullary Limb Lengthening System
Common or Usual Name: Rod, Fixation, Intramedullary and Accessories Classification Name: Intramedullary Fixation Rod Device Class: Class II Classification: 21 CFR § 888.3020 Product Code: HSB
Common or Usual Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener. Device Class: Class II Classification: 21 CFR § 888.3040 Product Code: HWC
C. Predicate Devices
The subject Precice Intramedullary Limb Lengthening System is substantially equivalent to the following predicate devices:
For indications in an adult population, the Precice Intramedullary Limb Lengthening System is substantially equivalent to the predicate device Precice System (K172628).
For indications in a pediatric population (greater than 12 years old), the Precice Intramedullary Limb Lengthening System is substantially equivalent to the predicate device FITBONE® TAA (K203399).
Device Description D.
The predicate system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The purpose of
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray, and the words "SPECIALIZED ORTHOPEDICS, INC." in purple below. The logo is clean and modern, with a focus on the company's name and specialization.
submission is to add the treatment of pediatric patients (greater than 12 years old) to this the Precice Intramedullary Limb Lengthening System indications for use. The Precice Intramedullary Limb Lengthening System includes the same devices as within the predicate Precice System (K172628) : nail, cortical screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, in K113219; ERC 2P, in K131490; or ERC 3P, in K170169; or ERC 4P, in K191336). The configurations of sets and geometry of previously cleared Precice System devices remain unchanged. The following system description is herein repeated from K172628: Precice Nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and thread styles. The ERC is available in several compatible models, including the ERC 1, ERC 2P, ERC 3P and ERC 4P. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice IMLL nail is implanted using locking screws and reusable surgical instruments.
E. Indications for Use
The Precice Intramedullary Limb Lengthening System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).
F. Comparison of Technological Characteristics with the Predicate Device
As was established in this submission, for adult patients, the subject Precice Intramedullary Limb Lengthening System is substantially equivalent to the predicate. Precice System (K172628) previously cleared by the FDA for commercial distribution in the United States. For pediatric patients greater than 12 years old, the subject device is substantially equivalent to the FITBONE® TAA (K203399). The subject device has been shown to be substantially equivalent and have equivalent technological characteristics to the predicates through comparison in areas including clinical use, labeling/intended use, material composition. The subject device is intended for use with pediatric (greater than 12 years old) and adult patients. Safety and effectiveness for limb lengthening of intended patient population of subject device can be determined by the device's ability to perform as intended demonstrated within the submission through a retrospective study and a clinical literature analysis of pediatric patients.
The following table describes the summary comparison of technological characteristics of the subject device with the predicate devices:
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo consists of a stylized purple and gray graphic to the left of the company name. The company name is written in a simple, sans-serif font, with "NUVASIVE" in a larger font than "SPECIALIZED ORTHOPEDICS, INC."
| Subject Device | K172628 Predicate | K203399 Predicate | |
|---|---|---|---|
| Indications for Use | The Precice IntramedullaryLimb Lengthening System isindicated for limblengthening, open and closedfracture fixation,pseudarthrosis, malunions,nonunions, or bone transportof long bones in patients age18 years and older andindicated for limblengthening of the femur andtibia in pediatric patients(greater than 12 years old). | The Precice IntramedullaryLimb Lengthening System isindicated for limblengthening, open and closedfracture fixation,pseudoarthrosis, mal-unions,non-unions, or bone transportof long bones in patients 18years and older. | The WITTENSTEIN intens GmbHFITBONE TAA intramedullarylengthening system is intended forlimb lengthening of the femur andtibia.The FITBONE TAAintramedullary lengthening systemis indicated for adult and pediatric(greater than 12 through 21 yearsof age) patients. |
| Predicates | Precice System (K172628)(Primary – patients 18 yearsand older)FITBONE® TAA (K203399)(Primary – pediatric patientsgreater than 12 years old) | ||
| Explanation ofdifferences inIndications forUse | The subject device isindicated for use in patients18 years and older andpediatric patients (greaterthan 12 years old) patients. | The predicate device isindicated for use in all longbones of patients 18 yearsand older. | The predicate device is indicatedfor use in the femur and tibia inadult and pediatric (greater than 12through 21 years of age) patients. |
| Summary ofthe technologysimilarities tothe predicatedevice | Principle of Operation:Distraction osteogenesis. Material Composition:Titanium. Design: Identical toprimary predicatePrecice System(K172628). Use of External RemoteController (ERC). Distraction andcompression. | Principle of Operation:Distraction osteogenesis. Material Composition:Titanium. Use of External RemoteController (ERC). Distraction andcompression. | Principle of Operation:Distraction osteogenesis. Material Composition:Stainless Steel. |
| Summary ofthe technologydifferences tothe predicatedevice | Identical to K172628. | No design changes havebeen introduced as partof this submission. | Use of an implanted receiverto receive energy from acontroller. Distraction only device (noability for compression). |
G. Performance Data
The Precice Intramedullary Limb Lengthening System is substantially equivalent to perform limb lengthening demonstrated by predicate device testing identical to the precice System (K172628). There have been no design changes introduced as part of this submission. The
{6}------------------------------------------------
Image /page/6/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.
purpose of this submission is to expand the indications for use of the Precice Intramedullary Limb Lengthening System to include its use in the treatment of pediatric patients (greater than 12 years old).
Non-clinical testing was presented to demonstrate substantial equivalence for the subject Precice Intramedullary Limb Lengthening System. The following testing was performed:
- · Biocompatibility evaluation per ISO 10993-1, including chemical characterization per ISO 10993-18 and toxicological risk assessment per ISO 10993-17
- · Wear Debris Testing
- · Mechanically Assisted Crevice Corrosion (MACC) Testing
As the subject Precice Intramedullary Limb Lengthening System (K220234) device is identical to the predicate Precice Intramedullary Limb Lengthening System (K172628) device in design, material, and manufacturing, there are no new or increased risks related to biocompatibility of the subject device when compared to the predicate.
Additionally, a retrospective study and a clinical literature analysis of pediatric patients treated with the subject devices were performed. The Precice pediatic literature included 227 patients with 253 lengthened bones (188 femur, 53 tibia, 12 humerus) with a mean age of 14.4 years (range: 3.5-21.3 years). The retrospective study data provided clinical and radiographic data from 59 patients treated in the United States with the Precice Intramedullary Limb Lengthening System. The study population included 32 boys and 27 girls, with a mean age of 15.8 years (range: 12-20 years). There were 59 patient ages 13-20 years, with 43 femoral and 16 tibial lengthenings. Any potential hazards of the changes introduced as part of this submission have been evaluated and controlled through risk management activities, and any relevant information, have been addressed in the subject device labeling, after all control measures have been implemented.
| Population | Pediatric | Adult | |
|---|---|---|---|
| Data Source | Literature | Retrospective Study | Literature |
| Group | All | 13-20 years | All |
| Demographic Information | |||
| N (bones) | 227 (253) | 59 (59) | 136 (189) |
| Age, mean (range) | 14.4 (3-21) | 15.8 (13-20) | 36.1 (21-74) |
| Gender, male/female, % | 52.5/47.5 | 54.2/45.8 | 69.7/30.4 |
| Etiology: congenital/acquired, % | 52.9/47.1 | 86.4/13.6 | 11.6/88.4 |
| Limb length discrepancy, cm | 5.3 | 4.9 | 4.9 |
| Target length, cm | 6.2 | 4.9 | 4.7 |
| Achieved length, mean, cm | 5.5 | 4.6 | 5.4 |
| Achieved length/target, overall, % | 93.0 | 93.9 | 119.5 |
| Achieved length/target, femoral, % | 114.6 | 94.1 | 127.5 |
| Achieved length/target, tibial, % | 93.0 | 90.7 | 110.0 |
| Bone healing rate, % | 100.0 | 100.0 | 94.3% |
| Adverse Events | |||
| Device-related adverse events | 6.7% | 6.8% | 22.2% |
| Lengthening-related adverse events | 16.6% | 34.7% | 8.5% |
| Joint loss of ROM* | 6.2% | 3.4% | 2.9% |
| Joint subluxation/dislocation* | 4.0% | 3.4% | 0.0% |
| Angular malalignment* | 2.8% | 1.7% | 0.0% |
| Radiographic - premature consolidation | 1.8% | 3.4% | 2.2% |
| Table 1. Pediatric Literature Review | |
|---|---|
| -------------------------------------- | -- |
{7}------------------------------------------------
Image /page/7/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 a smaller font below the name.
| Population | Pediatric | Adult | |
|---|---|---|---|
| Data Source | Literature | Retrospective Study | Literature |
| Group | All | 13-20 years | All |
| Radiographic – delayed union | 2.6% | 16.9% | 8.1% |
| Radiographic – partial union | 0.0% | 3.4% | 0.0% |
| Radiographic – nonunion | 0.9% | 5.1% | 5.1% |
- Clinically significant events, i.e., those requiring major surgical treatments.
H. Conclusions
The subject Precice Intramedullary Limb Lengthening System has been shown to be substantially equivalent to the legally marketed predicate devices for its intended use.
§ 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.