(65 days)
No
The provided text describes a bone void filler made of demineralized bone matrix and glycerol. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is indicated as a bone void filler that remodels into the recipient's skeletal system, addressing defects and providing a therapeutic effect by aiding in the repair and integration of bone.
No
Explanation: The device is a bone void filler intended for structural support and remodeling within the skeletal system, not for diagnosing conditions or diseases. Its purpose is therapeutic.
No
The device description clearly states it is a "human bone allograft product consisting of demineralized bone matrix fibers combined with USP grade glycerol/glycerin" and is "pre-filled in a 3cc or 14cc delivery syringe". This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, 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 void filler" to be placed into bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details a "human bone allograft product" consisting of demineralized bone matrix fibers and glycerol/glycerin. This is a material intended for implantation or filling, not for testing samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is applied directly to the skeletal system, not used to test samples taken from the body.
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
PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.
Product codes
MBP, MOV
Device Description
PliaFX® Flo Flowable Demineralized Fibers is a sterile, freeze-dried, human bone allograft product consisting of demineralized bone matrix fibers combined with USP grade glycerol/glycerin. The subject device is pre-filled in a 3cc or 14cc delivery syringe based on product volume. The 3cc syringe configuration also includes an optional female luer cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g., the extremities, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility and non-clinical performance testing included in this submission, including mechanical extrusion testing, leak testing, verification of plunger fit in barrel, and formative evaluation of extrusion force, unscrewing torque, and delivered volume, confirm that the proposed device does not raise different questions of safety or effectiveness.
The submitted data demonstrates that the delivery syringe is capable of storing and delivering the bone void filler.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 21, 2024
Image /page/0/Picture/1 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 logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
LifeNet Health Brittany Beasley Sr. Manager, Global Regulatory Affairs 1864 Concert Drive Virginia Beach, Virginia 23453
Re: K242799
Trade/Device Name: PliaFX Flo Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MBP, MOV Dated: September 16, 2024 Received: September 17, 2024
Dear Brittany Beasley:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
2
Sincerely,
Digitally signed by JESSE JESSE MUIR -S Date: 2024.11.21 14:18:01 -05'00'
Jesse Muir, 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
3
Indications for Use
510(k) Number (if known) K242799
Device Name PliaFX® Flo
Indications for Use (Describe)
PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.
| 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)
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Image /page/4/Picture/0 description: The image shows the logo for LifeNet Health. The logo consists of a blue and green circular graphic to the left of the company name. The words "LifeNet" are in dark blue, while the word "Health" is in light green. There is a registered trademark symbol to the right of the word "Health".
510(k) Summary
Submitter Information:
| Company: | LifeNet Health |
|---|---|
| Address: | 1864 Concert Drive |
| Virginia Beach, Virginia 23453 | |
| Contact: | Brittany Beasley |
| Sr. Manager, Global Regulatory Affairs | |
| Phone: | (757) 609-4201 |
| Email: | brittany_beasley@lifenethealth.org |
| Date Prepared: | November 20, 2024 |
| Device Information: | |
| Trade Name: | PliaFX® Flo |
| Common Name: | Flowable Demineralized Fibers |
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void filler device |
| Regulatory Class: | Class II |
| Product Code: | MBP; MQV |
| Proposed Panel: | Orthopedic |
| Predicate Device: |
Name:
K053098, Optium DBM
Device Description:
PliaFX® Flo Flowable Demineralized Fibers is a sterile, freeze-dried, human bone allograft product consisting of demineralized bone matrix fibers combined with USP grade glycerol/glycerin. The subject device is pre-filled in a 3cc or 14cc delivery syringe based on product volume. The 3cc syringe configuration also includes an optional female luer cap.
Indications for Use:
PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.
Comparison of Technological Characteristics with the Predicate:
The subject device is similar in materials, composition, packaging system configuration, and sterility to the predicate device. The differences in technological characteristics requiring 510(k) clearance include a change to the immediate container from a PETG jar to a pre-filled syringe,
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Image /page/5/Picture/0 description: The image shows the logo for LifeNet Health. The logo consists of a blue and green circular graphic to the left of the company name. The words "LifeNet" are in blue, while the word "Health" is in green, and there is a registered trademark symbol to the right of the word "Health".
minor differences in packaging, and a smaller product volume option. The biocompatibility and non-clinical performance testing included in this submission, including mechanical extrusion testing, leak testing, verification of plunger fit in barrel, and formative evaluation of extrusion force, unscrewing torque, and delivered volume, confirm that the proposed device does not raise different questions of safety or effectiveness.
Conclusions:
The submitted data demonstrates that the delivery syringe is capable of storing and delivering the bone void filler. Any differences between the subject device and the predicate device are minor and do not raise different questions concerning safety or effectiveness. Based on the indications for use, technological characteristics, and non-clinical data submitted, LifeNet Health has determined that the proposed device is substantially equivalent to the predicate device.