(102 days)
AttraX® Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. posterolateral spine and pelvis) and may be used in combination with autogenous bone. These osseous defects may be surgically created of of traumatic injury to the bone and are not instrinsic to the stability of the bony structure. AttraX Putty resorbs and is replaced with bone during the healing process.
NuVasive AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules. Pressure applied by user manipulation allows the AttraX Putty to be molded into specific shapes, mixed with autograft, or contoured into a bone defect, as desired by the clinician. The subject device is identical to the primary predicate device Progentix AttraX Putty (K151584). No changes to the design, materials, or methods of manufacture have been made for this submission.
The NuVasive AttraX Putty is a resorbable calcium salt bone void filler device. The provided text outlines the 510(k) submission for this device, which aims to expand its indications for use as a bone graft replacement. The primary study presented to support this expansion is a clinical trial evaluating the device's performance in instrumented thoracolumbar posterolateral fusion.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, the study's objective provides the implicit acceptance criterion: non-inferiority to autologous bone graft (iliac crest + local bone) in instrumented posterolateral fusion.
| Acceptance Criteria (Stated Objective) | Reported Device Performance |
|---|---|
| Non-inferiority of AttraX Putty versus autologous bone graft in instrumented posterolateral fusion | "The Level I clinical evidence from this randomized controlled trial demonstrates the non-inferiority of AttraX Putty versus autologous bone graft in instrumented posterolateral spinal fusion." (The text states this conclusion directly, implying the acceptance criterion for non-inferiority was met. Specific metrics like fusion rates or patient outcomes are not detailed in this section.) |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document states "a randomized controlled trial" and "a patient and observer blinded, multicenter, prospective, randomized controlled trial." However, the specific number of patients (sample size) enrolled in this clinical trial is not provided in the given text.
- Data Provenance: The study was a "multicenter, prospective, randomized controlled trial." The country of origin is not specified, but it's reasonable to assume it was conducted with data that would be relevant for FDA submission (likely in the US or with internationally recognized standards).
3. Number of Experts and Qualifications for Ground Truth
The text does not provide information regarding:
- The number of experts used to establish ground truth for the test set.
- The qualifications of those experts.
- How ground truth (e.g., successful fusion) was determined (e.g., by independent radiologists, surgeons assessing outcome).
4. Adjudication Method for the Test Set
The text does not specify an adjudication method (e.g., 2+1, 3+1, none) used for the test set. It mentions the study was "patient and observer blinded," which relates to the methodology but not specifically to the adjudication of outcomes by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted/applicable in this context. This device is a bone void filler, and its effectiveness is determined by clinical outcomes (e.g., successful fusion, absence of complications) rather than the interpretation of medical images by multiple readers. The study was a direct comparison between the device and autologous bone graft for a clinical outcome.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study was not conducted/applicable. This is a medical device, not an AI algorithm. Its performance is evaluated through its clinical efficacy and safety in human subjects, not as an "algorithm only" system.
7. Type of Ground Truth Used
The ground truth used was clinical outcome data from human subjects, specifically focusing on the non-inferiority of the device compared to autologous bone graft in instrumented posterolateral spinal fusion. While not explicitly detailed, ground truth would likely involve assessments of fusion success (e.g., imaging like CT scans reviewed by radiologists, clinical stability assessments by surgeons, patient-reported outcomes). The text refers to "Level I clinical evidence," indicating robust clinical data.
8. Sample Size for the Training Set
This question is not applicable as the device is a medical implant, not an AI algorithm requiring a "training set" in the machine learning sense. The data used for evaluation comes from a clinical trial, which serves as the "test set" for regulatory clearance.
9. How Ground Truth for Training Set Was Established
This question is not applicable for the same reason as #8.
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NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K191974
Trade/Device Name: NuVasive® AttraX® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: October 3, 2019 Received: October 4, 2019
Dear Ms. Leblanc:
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 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
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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 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.
Laurence D. Coyne, Ph.D. Acting Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name NuVasive® AttraX® Putty
Indications for Use (Describe)
AttraX® Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. posterolateral spine and pelvis) and may be used in combination with autogenous bone. These osseous defects may be surgically created of of traumatic injury to the bone and are not instrinsic to the stability of the bony structure. AttraX Putty resorbs and is replaced with bone during the healing process.
| 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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510(k) Summary - K191974
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:
Submitted by: A.
Jessica LeBlanc Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3302
Date Prepared: July 22, 2019
B. Device Name
| Trade or Proprietary Name: | NuVasive ® AttraX ® Putty |
|---|---|
| Common or Usual Name: | Bone void filler |
| Classification Name: | Resorbable calcium salt bone void filler device |
| Device Class: | Class II |
|---|---|
| Regulation: | 21 CFR 888.3045 |
| Product Code: | MQV |
C. Predicate Devices
The subject AttraX Putty is substantially equivalent to multiple predicate devices. Progentix AttraX Putty (K151584) serves as the primary predicate device, CuriOs (AttraX Granules) (K090641). Actifuse Shape (K080736), and the OSferion (K061499) serve as additional predicates.
D. Device Description
NuVasive AttraX Putty is a synthetic, osteoconductive and resorbable bone void filler device consisting of ceramic granules premixed with a polymeric binder that provides cohesion between the granules. Pressure applied by user manipulation allows the AttraX Putty to be molded into specific shapes, mixed with autograft, or contoured into a bone defect, as desired by the clinician. The subject device is identical to the primary predicate device Progentix AttraX Putty (K151584). No changes to the design, materials, or methods of manufacture have been made for this submission.
The purpose of this 510(k) is to expand the indications for use as a bone graft replacement based on animal and clinical data.
E. Indications for Use
AttraX® Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. posterolateral spine and pelvis) and may be used in combination with autogenous bone. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. AttraX Putty resorbs and is replaced with bone during the healing process.
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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf-like shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The logo appears to be for a medical or healthcare-related company.
Technological Characteristics F.
As was established in this submission, the subject AttraX Putty is 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 the same technological characteristics as its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
G. Performance Data
Non-clinical testing data submitted, referenced, or relied upon supports the in vivo safety of AttraX Putty. The data also demonstrates substantial equivalence to the predicate device including chemical composition, physical properties, biocompatibility, and performance characteristics.
In addition, AttraX Putty was clinically evaluated in instrumented thoracolumbar posterolateral fusion in a patient and observer blinded, multicenter, prospective, randomized controlled trial. The objective of the study was to evaluate whether AttraX Putty used alone as a bone void filler is non-inferior to autologous bone graft (iliac crest + local bone) in instrumented posterolateral fusion. The Level I clinical evidence from this randomized controlled trial demonstrates the non-inferiority of AttraX Putty versus autologous bone graft in instrumented posterolateral spinal fusion.
H. Conclusions
Based on the indications for use, non-clinical and clinical data, and comparison to predicate devices, the subject AttraX Putty has been shown to be substantially equivalent to legally marketed predicate devices.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.