(233 days)
Not Found
No
The summary describes a bone graft substitute material and its physical properties and performance, with no mention of AI or ML technology.
Yes.
The device is a bone graft substitute intended to fill bone voids and facilitate bone regeneration, which directly relates to the treatment and restoration of natural bodily functions.
No.
This device is a bone graft substitute used to fill bone voids and support bone fragments during surgical procedures, not to diagnose a medical condition.
No
The device is a physical bone graft substitute made of calcium sulfate and calcium phosphate, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PRO-DENSE™ LoVisc Bone Graft Substitute's Intended Use: The intended use clearly states that this device is a bone graft substitute injected or packed into open bone voids/gaps within the skeletal system. It is used in vivo (within the living body) to fill defects and support bone healing.
- Device Description: The description details a composite material mixed and injected into the body, not a test performed on a sample outside the body.
Therefore, PRO-DENSE™ LoVisc Bone Graft Substitute is a medical device used for surgical implantation and bone repair, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
PRO-DENSE™ LoVisc Bone Graft Substitute is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. PRO-DENSE™ LoVisc Bone Graft Substitute resorbs and is replaced with bone during process.
PRO-DENSE™ LoVisc Bone Graft Substitute cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during process.
PRO-DENSE™ LoVisc Bone Graft Substitute is provided sterile for single use only.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
PRO-DENSE™ LoVisc Bone Graft Substitute is a composite of calcium sulfate and calcium phosphate. The formulation consists of a powder component and aqueous mixing solutions. When the two component types are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities and pelvis)
Indicated Patient Age Range
adults and pediatric patients ≥ 6 years old
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench top testing was used to characterize and evaluate the chemical, and mechanical properties of the implant. Testing included Fourier Transform Infrared Spectroscopy, X-ray Diffraction Analysis, Dissolution, Porosity, Density, Maximum Exothermic Temperature, Dilute Slurry pH, Vicat and Gilmore Set Time, Injectability, DTS, hardware interaction, sterilization, biocompatibility, pyrogenicity and LAL testing. The characterization testing showed that the subject material is chemically equivalent to the predicate and the bench top testing showed the graft performs within the range of the predicates.
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.
Not Found
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
§ 888.3045 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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October 21, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.
Wright Medical Technology, Inc. Rachel Roberts Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117
Re: K200507
Trade/Device Name: PRO-DENSE™ LoVisc Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: February 26, 2020 Received: March 2, 2020
Dear Ms. Roberts:
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
1
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.
for
Laura C. Rose. Ph.D. 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)
Device Name
PRO-DENSE™ LoVisc Bone Graft Substitute
Indications for Use (Describe)
PRO-DENSE™ LoVisc Bone Graft Substitute is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. PRO-DENSE™ LoVisc Bone Graft Substitute resorbs and is replaced with bone during process.
PRO-DENSE™ LoVisc Bone Graft Substitute cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during process.
PRO-DENSE™ LoVisc Bone Graft Substitute is provided sterile for single use only.
| 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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Image /page/3/Picture/1 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red, sans-serif font. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray, sans-serif font.
1023 Cherry Road Memphis, TN 38117 wright.com
510(k) SUMMARY
In accordance with the Food and Drug Administration rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PRO-DENSE Bone Graft Substitute.
(a)(1) MANUFACTURER IDENTIFICATION
| Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|-----------------|---------------------------------------------------------------------------------------------------|
| Date: | October 15, 2020 |
| Contact Person: | Rachel Roberts
Sr Regulatory Affairs Specialist
Office: (901)867-9708
Fax: (901)867-4190 |
(a)(2) SUBJECT DEVICE INFORMATION
| Proprietary Name: | PRO-DENSE™ LoVisc Bone Graft Substitute |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Name & Reference: | 21 CFR 888.3045 – Class II |
| Device Product Code & Panel: | MQV – Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
| PRO-DENSE Bone Graft Substitute | K181255/K182823 |
|---|---|
| PROSTIM Injectable Inductive Graft | K190283 |
(a)(4) DEVICE DESCRIPTON
PRO-DENSE™ LoVisc Bone Graft Substitute is a composite of calcium sulfate and calcium phosphate. The formulation consists of a powder component and aqueous mixing solutions. When the two component types are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.
4
(a)(5) INTENDED USE
PRO-DENSE™ LoVisc Bone Graft Substitute is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The cured paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-DENSE™ LoVisc Bone Graft Substitute paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
PRO-DENSE™ LoVisc Bone Graft Substitute is provided sterile for single use only.
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
PRO-DENSE™ LoVisc Bone Graft Substitute was developed to provide surgeons with the option of a less viscous version of the predicate PRODENSE bone graft substitute. The additional liquid in the implant creates a bone graft material that can be more easily injected into bone voids. The testing showed the set implant to be equivalent to the predicate. The characteristics of the subject device are within the range of the predicate characteristics apart from set time and injectability. The indications for use and the fundamental technology of the subject remain identical to the predicate. The accessories included in the kit are composed of the identical accessories included in the predicate kit.
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
Bench top testing was used to characterize and evaluate the chemical, and mechanical properties of the implant. Testing included Fourier Transform Infrared Spectroscopy, X-ray Diffraction Analysis, Dissolution, Porosity, Density, Maximum Exothermic Temperature, Dilute Slurry pH, Vicat and Gilmore Set Time, Injectability, DTS, hardware interaction, sterilization, biocompatibility, pyrogenicity and LAL testing. The characterization testing showed that the subject material is chemically equivalent to the predicate and the bench top testing showed the graft performs within the range of the predicates.
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness. The subject device can be expected to perform at least as well as the predicate systems and are substantially equivalent.