(31 days)
No
The document describes a bone graft substitute and associated delivery system, with no mention of AI or ML technology.
Yes
The device is a bone graft substitute intended to facilitate the healing process by filling bone voids and being replaced by new bone, which aligns with the definition of a therapeutic device.
No
The device is described as a bone graft substitute intended to fill bone voids and provide temporary support during surgical procedures, not to diagnose medical conditions.
No
The device is a bone graft substitute provided as a paste and kit with surgical instruments, clearly indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a bone graft substitute to be injected or packed into bone voids/gaps. It is used in vivo (within the body) to aid in bone healing.
- Device Description: The description details the components of the bone graft substitute and the tools for mixing and delivery. It does not mention any components or processes related to testing samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a medical device used for surgical intervention and bone repair, not for diagnostic testing.
N/A
Intended Use / Indications for Use
PRO-STIM™ resultant paste 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 surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-STIM™ 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-STIM™ is provided sterile for single use only.
For the PRO-STIM™ Core Decompression Procedure Kit:
The PRO-STIM™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-STIM™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
Product codes
MOV, MBP
Device Description
PRO-STIM is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ via hydration reactions. The subject implant kits consist of pre-measured surgical grade calcium sulfate and calcium phosphate, demineralized bone matrix, pre-measured mixing solution, and the tools necessary to mix the components into a paste and inject the material into the defect site. When the implant components are mixed according to the instructions, an injectable paste is formed.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Dissolution, vicat set time, and diametral tensile strength (DTS) testing showed that the new syringe mixing and delivery systems produced a resultant graft that met all the material specification of the current PRO-STIM graft. Pyrogenicity testing was also performed. The subject 14 mL and 40 mL syringe mixing and delivery systems are acceptable methods for the preparation of the PRO-STIM Injectable Bone Graft.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083270 - WMT Composite DBM, K181255 - PRODENSE™ Bone Graft Substitute
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
March 14, 2019
Wright Medical Technology, Inc. Rachel Roberts Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K190283
Trade/Device Name: PROSTIM™ Injectable Inductive Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: February 8, 2019 Received: February 11, 2019
Dear Ms. Roberts:
We have reviewed vour 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Laurence D. Coyne -S
For 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190283
Device Name PROSTIM™ Injectable Inductive Graft
Indications for Use (Describe)
PRO-STIM™ resultant paste 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 surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-STIM™ 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-STIM™ is provided sterile for single use only.
For the PRO-STIM™ Core Decompression Procedure Kit:
The PRO-STIM™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-STIM™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
| 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
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 PRODENSE™ 2.0 Bone Graft Substitute.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|----------------------------------------------------------------------------------------------------|
| Date: | February 8, 2019 |
| Contact Person: | Rachel Roberts
Regulatory Affairs Specialist
Office - (901) 867-9708
Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | PRO-STIM™ Injectable Inductive Graft |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | 21 CFR 888.3045 - Class II |
| Device Product Code, Device Panel: | MQV, Orthopedic |
| (a)(3). Predicate Device: | K083270 - WMT Composite DBM
K181255 - PRODENSE™ Bone Graft
Substitute |
(a)(4). Device Description
PRO-STIM is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ via hydration reactions. The subject implant kits consist of pre-measured surgical grade calcium sulfate and calcium phosphate, demineralized bone matrix, pre-measured mixing solution, and the tools necessary to mix the components into a paste and inject the material into the defect site. When the implant components are mixed according to the instructions, an injectable paste is formed.
(a)(5). INTENDED USE
PRO-STIM resultant paste 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 surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
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The PRO-STIM 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-STIM paste is provided sterile for single use.
PRO-STIM Core Decompression Procedure Kit
The PRO-STIM Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-STIM Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
(a)(6). Technological Characteristics Comparison
The subject implant is identical to that of the predicate. The subject includes an updated mixing and delivery system for the implant material as well as new size configurations for the kits. The subject accessories include two sizes of syringe mixers (14 mL and 40 mL); a spindle drive for mechanical assist, a larger delivery syringe, and associated cannulas and adaptors.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Dissolution, vicat set time, and diametral tensile strength (DTS) testing showed that the new syringe mixing and delivery systems produced a resultant graft that met all the material specification of the current PRO-STIM graft. Pyrogenicity testing was also performed. The subject 14 mL and 40 mL syringe mixing and delivery systems are acceptable methods for the preparation of the PRO-STIM Injectable Bone Graft.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices.