(66 days)
No
The description focuses on the material composition and delivery system of a bone cement for vertebral augmentation, with no mention of AI/ML capabilities or functions.
Yes
The device is indicated for "fixation of pathological fractures of the vertebral body using vertebroplasty procedures" and addresses "painful vertebral compression fractures". These uses indicate a therapeutic purpose.
No
The VK100® system is used for the fixation of pathological fractures and cures in situ to form a non-resorbable polymer. This describes a therapeutic, not diagnostic, function.
No
The device description clearly outlines physical components (cartridge, dispensing system, material components) and a chemical process (curing in situ), indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the VK100® system is for the "fixation of pathological fractures of the vertebral body using vertebroplasty procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a material that is injected into the vertebrae and cures in situ. This is a therapeutic device, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The VK100® system does not perform this function.
The information about radiographic image review and performance studies relates to evaluating the outcome of the surgical procedure and the safety and effectiveness of the implanted material, not to diagnosing a condition using a sample from the patient.
N/A
Intended Use / Indications for Use
The VK100® Percutaneous Vertebral Augmentation System is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).
Product codes
NDN
Device Description
Like the predicate devices. VK100® is provided as a two-component system with barium sulfate as a radiopacifier. VK100® is a polydimethylsiloxane material. The VK100® System consists of a cartridge containing the two VK100® material components and a dispensing system which blends the two components for injection into the injured vertebrae. The material cures in situ to form a non-resorbable polymer.
The VK100® material is supplied in a pre-filled cartridge:
The 2-cylinder cartridge keeps each component separate until administration, when both components are extruded through a mix element, which blends the mixture at a 1:1 ratio.
Each dose (cartridge of VK100® material) consists of:
- Reinforced Dimethyl Methylvinyl Siloxanes
- . Barium Sulfate powder
- Methylhydrogensiloxane Crosslinker
- . Platinum catalyst,
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
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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 ADMINISTRATION" in blue text.
BŌNWRx Ltd % Connie Oiu Regulatory Consultant M Squared Associates, Inc. 575 8th Avenue, Suite 1212 New York, New York 10018
Re: K192403
Trade/Device Name: VK100® Percutaneous Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: August 22, 2019 Received: September 3, 2019
Dear Ms. Oiu:
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
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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 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 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).
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 Quality 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) K192403
Device Name
VK100® Percutaneous Vertebral Augmentation System
Indications for Use (Describe)
The VK100® Percutaneous Vertebral Augmentation System is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Number: K192403 Date Submitted: September 3, 2019
Image /page/3/Picture/1 description: The image shows the Bonwrx logo with the text "K192403 Page 1 of 3" above it. The logo is in gray and blue, with the letters "BONWRX" in a stylized font. The logo has a gray bar above and below the letters. The text "K192403 Page 1 of 3" is in black and is located in the upper right corner of the image.
510(k) Summary
510(k) Summary as required by section 21 CFR 807.92(c)
| Submitter/Owner: | Ralph W. Carmichael |
|---|---|
| Chairman & Chief Executive Officer | |
| BŌNWRx Ltd | |
| 924 Terminal Rd | |
| Lansing, MI 48906 | |
| Telephone (623) 580-9500 | |
| Fax (623) 580-9720 |
| Official Correspondent: | Connie Qiu
Regulatory Consultant
M Squared Associates, Inc.
575 8th Avenue, Suite 1212
New York, NY 10018
Telephone: 703-562-9800 |
| ------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Device Name and Classification
| Trade Name of Device: | VK100® |
|---|---|
| Common or Usual Name: | Percutaneous Vertebral Augmentation Device |
| Classification Name: | Cement, Bone, Vertebroplasty |
| Product Code: | NDN |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21CFR Sec. 888.3027 |
| Device Class: | Class II |
Substantial Equivalence
VK100® is substantially equivalent to the following medical devices in commercial distribution:
| Predicate Device | Manufacturer | 510(k) Number |
|---|---|---|
| KyphX® HV-R | ||
| TM Bone Cement | Kyphon, Inc. | K041584 |
| Reference Devices | Manufacturer | 510(k) Number |
| KyphonTM HV-RTM Bone Cement | Medtronic | K180700 |
| Spine-Fix® Biomimetic Bone Cement | Teknimed S.A. | K043593 |
| F20 Bone Cement | Teknimed S.A. | K103433 |
| SpineplexTM Radiopaque Bone Cement | Stryker | K032945 |
924 Terminal Rd ▪ Lansing ▪ Michigan ▪ 48906
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Substantial Equivalence
VK100® has the same intended use and indications, similar technological and handling characteristics, and similar principles of operation as its predicate and reference devices. The differences between VK100® and its predicate device raise no new issues of safety or effectiveness. Performance and clinical data demonstrate that VK 100® is as safe and effective as its predicate and reference devices. Thus, VK100® is substantially equivalent.
Device Description
Like the predicate devices. VK100® is provided as a two-component system with barium sulfate as a radiopacifier. VK100® is a polydimethylsiloxane material. The VK100® System consists of a cartridge containing the two VK100® material components and a dispensing system which blends the two components for injection into the injured vertebrae. The material cures in situ to form a non-resorbable polymer.
The VK100® material is supplied in a pre-filled cartridge:
The 2-cylinder cartridge keeps each component separate until administration, when both components are extruded through a mix element, which blends the mixture at a 1:1 ratio.
Each dose (cartridge of VK100® material) consists of:
- Reinforced Dimethyl Methylvinyl Siloxanes ●
- . Barium Sulfate powder
- Methylhydrogensiloxane Crosslinker
- . Platinum catalyst,