(98 days)
No
The summary describes a bone void filler made of ceramic granules and collagen. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an implant intended to fill bony voids or gaps and acts as a bone void filler that resorbs and is replaced by bone. While it aids in the healing process, it does not directly manage or treat a disease or condition in a therapeutic manner beyond supporting bone regrowth.
No
The device is described as an implant intended to fill bony voids or gaps, an osteoconductive and resorbable bone void filler. Its function is to facilitate bone healing, not to diagnose a condition.
No
The device description clearly states it is a physical implant consisting of ceramic granules and collagen, intended to fill bony voids. It is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system. This is a therapeutic/surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a bone void filler made of ceramic granules and collagen, designed to be implanted. This is a medical device used in vivo (within the body).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on material characteristics, biocompatibility, and in vivo animal data related to bone healing, not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
AttraX Scaffold is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate in the posterolateral spine. 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 Scaffold resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
The subject AttraX Scaffold, is an osteoconductive and resorbable bone void filler designed for use in the skeletal system. AttraX Scaffold consists of ceramic granules premixed with purified type I bovine collagen. The ceramic granules are identical to those cleared as CuriOs (K090641; herein after referred to by the commercial name as AttraX Granules) and identical to the granules within AttraX Putty (K151584). The collagen binder used in AttraX Scaffold is manufactured from the same source material as that of the primary predicate Formagraft Collagen Bone Graft Matrix (K050789). AttraX Scaffold will be provided sterile in single-use packages. Once hydrated with biological fluids or saline, AttraX Scaffold can be applied directly to bone defects or molded to fit the contours of complex bone defects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., posterolateral spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench-top testing was preformed to evaluate the physicochemical and crystallographic characteristics of AttraX Scaffold. Data to support the substantial equivalence of the AttraX Scaffold to its predicates Formagraft and AttraX Putty, were provided by in vivo animal data in the intended use. The biocompatibility of the AttraX Scaffold is demonstrated by ISO 10993 testing and the long history of clinical use of the collagen/calcium phosphate materials for the same intended use. Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method and showed that the device meets the endotoxin limits of established guidelines.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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November 24, 2017
NuVasive, Incorporated Martin Yahiro, M.D. Director, Medical Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K172497
Trade/Device Name: NuVasive® AttraX® Scaffold Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 6, 2017 Received: November 7, 2017
Dear Dr. Yahiro:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172497
Device Name NuVasive® AttraX® Scaffold
Indications for Use (Describe)
AttraX Scaffold is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate in the posterolateral spine. 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 Scaffold resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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:
Submitted by: A.
Martin Yahiro, M.D. Director, Medical Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: November 6, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® AttraX® Scaffold |
|---|---|
| Common or Usual Name: | Filler, Bone Void, Calcium Compound |
| Classification Name: | Resorbable Calcium Salt Bone Void Filler Device |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3045 |
| Product Code: | MQV |
C. Predicate Devices
The subject NuVasive AttraX Scaffold substantially equivalent to the primary predicate device, NuVasive Formagrafi™ Collagen Bone Graft Matrix (K050789), and additional predicates NuVasive AttraX Putty (K151584) and NuVasive AttraX Granules' (K090641).
D. Device Description
The subject AttraX Scaffold, is an osteoconductive and resorbable bone void filler designed for use in the skeletal system. AttraX Scaffold consists of ceramic granules premixed with purified type I bovine collagen. The ceramic granules are identical to those cleared as CuriOs (K090641; herein after referred to by the commercial name as AttraX Granules) and identical to the granules within AttraX Putty (K151584). The collagen binder used in AttraX Scaffold is manufactured from the same source material as that of the primary predicate Formagraft Collagen Bone Graft Matrix (K050789). AttraX Scaffold will be provided sterile in singleuse packages. Once hydrated with biological fluids or saline, AttraX Scaffold can be applied directly to bone defects or molded to fit the contours of complex bone defects.
1 AttraX Granules is the commercial name for CuriOs™
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E. Indications for Use
AttraX Scaffold is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate in the posterolateral spine. 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 Scaffold resorbs and is replaced with bone during the healing process.
F. Technological Characteristics
As was established in this submission, the subject AttraX Scaffold 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 to 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
Characterization of AttraX Scaffold has been conducted in compliance with Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (Document issued on: June 2, 2003) and the requirements of other applicable standards. Bench-top testing was preformed to evaluate the physicochemical and crystallographic characteristics of AttraX Scaffold. Data to support the substantial equivalence of the AttraX Scaffold to its predicates Formagraft and AttraX Putty, were provided by in vivo animal data in the intended use. The biocompatibility of the AttraX Scaffold is demonstrated by ISO 10993 testing and the long history of clinical use of the collagen/calcium phosphate materials for the same intended use. Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method and showed that the device meets the endotoxin limits of established guidelines.
H. Conclusions
Based on the indications for use, technological characteristics, and performance comparison to its predicate devices, the subject AttraX Scaffold has been shown to be substantially equivalent to the legally marketed predicate devices Formagraft, AttraX Putty, and AttraX Granules.