(264 days)
No
The device description and performance studies focus on mechanical properties and instrumentation for a surgical procedure, with no mention of AI or ML.
Yes.
The device is used for the reduction and fixation of fractures and the creation of a void in cancellous bone in the spine using balloon kyphoplasty, which is a therapeutic procedure aiming to stabilize and restore vertebral body height after compression fractures.
No
The text describes the device as a system of instruments for performing kyphoplasty, a surgical procedure to treat spinal fractures, rather than for diagnosing conditions.
No
The device description explicitly states it is a "system of instruments" and lists physical components like balloon catheters, inflation devices, and curettes, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's spine to treat fractures and create voids in bone. This is a therapeutic intervention, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device description details instruments used for a surgical procedure (balloon kyphoplasty), including catheters, balloons, and tools for creating access channels. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device is used directly on the patient's bone.
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
The Joline® Kyphoplasty System Allevo is intended to be used for the reduction of fixation of fractures and or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacy late (PMMA) bone cements).
Product codes
HRX, NDN
Device Description
The Joline® Kyphoplasty System Allevo is a sterile, single-use system of instruments that facilitates balloon kyphoplasty. The subject device includes both single and double balloon catheter options that allows the introduction of one, or two balloons, into each pedicle at a time, for a total of two or four balloons per vertebrae. The balloons can be expanded or deflated separately using contrast medium, a balloon adapter, and an inflation device. The Joline® Kyphoplasty System Allevo includes instruments and accessories that facilitate the kyphoplasty procedure, including devices and curettes for creation of access channels within the bone. Subsequent to creating the cavities within the vertebral bone, the vertebral body is stabilized with an FDA cleared PMMA bone cement that cures within a few minutes. The Joline Kyphoplasty System Allevo is offered in kits that are comprised of various combinations of instruments that address surgeon preference and specific clinical condition of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, vertebral bone, vertebral body
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 following tests were performed in support of the substantial equivalence determination:
- Balloon Burst Pressure: Acceptance Criteria: Burst pressure (pburst) ≥ 27 bar (~ 400 psi)
- Balloon Burst Volume: Acceptance Criteria: Burst volume (Vburst) ≥ 3 ml
- Balloon Inflation Behavior: Acceptance Criteria: Inflated with 6 ml, the average diameter of the balloon should be 16 mm
- Tensile Force Balloon-Shaft: Acceptance Criteria: Minimum tensile strength (Fballoon-shaft) ≥ 15 N
- Tensile Force Hub-Shaft: Acceptance Criteria: Minimum tensile strength (Fhub-shaft) ≥ 15 N
- Balloon Repeated Inflation: Acceptance Criteria: The balloon must not burst within 3 inflation/deflation cycles
- Balloon Deflation Time: Acceptance Criteria: Deflation time (tdef) ≤ 3 s
Key Results: The results of the non-clinical tests show that the inflatable bone tamp of the Joline Kyphoplasty System Allevo meets or exceeded all performance requirements. The device was found to be equivalent to the predicate device in Balloon Burst Pressure and Volume, Tensile Force Balloon - Shaft, Tensile Force Hub – Shaft, Tensile Force Luer Lock, and Balloon Inflation Behavior.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
May 27, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a stylized image of a human figure. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
Joline GmbH & Co. KG % Robert Poggie President BioVera Inc. 65 Promenade Saint Louis Notre-Dame-del-L'Ile-Perrot, CA J7V 7P2 QC
Re: K192449
Trade/Device Name: Joline® Kyphoplasty System Allevo Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope; Cement, Bone Vertebroplasty Regulatory Class: Class II Product Code: HRX, NDN Dated: April 24, 2020 Received: April 27, 2020
Dear Dr. Poggie:
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
1
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 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
Jesse Muir, Ph.D. Acting 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Joline® Kyphoplasty System Allevo
Indications for Use (Describe)
The Joline Kyphoplasty System Allevo is intended to be used for the reduction of fixation of fractures and or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacy late (PMMA) bone cements).
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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3
510(k) Summary for the Joline® Kyphoplasty System Allevo
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the Joline® Kyphoplasty System Allevo.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, Notre-Dame-De-L'lle-Perrot, |
| Quebec, J7V 7P2, CANADA | |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (514) 901-0796 |
| Fax Number: | (514) 901-0796 |
| Date of Submission: | April 24, 2020 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Joline GmbH & Co. KG |
|---|---|
| Manufacturer Address: | Neue Rottenburger Strasse 50, 72379 Hechingen, Germany |
| Registration Number: | 3004734264 |
| Contact Name: | Peter Kohlbecher |
| Title: | Director Sales & Marketing |
| Device Trade Name: | Joline® Kyphoplasty System Allevo |
| Device Common Name: | Vertebroplasty System; Inflatable Bone Tamp |
| Classification Names: | Arthroscope; Cement, Bone, Vertebroplasty |
| Classification Codes: | NDN and HRX |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR sections 888.1100 and 888.3027 |
C1. PRIMARY PREDICATE DEVICE
K150607 Osseoflex SB
C2. REFERENCE DEVICE K140937
Osseoflex SB
4
D. DEVICE DESCRIPTION
The Joline® Kyphoplasty System Allevo is a sterile, single-use system of instruments that facilitates balloon kyphoplasty. The subject device includes both single and double balloon catheter options that allows the introduction of one, or two balloons, into each pedicle at a time, for a total of two or four balloons per vertebrae. The balloons can be expanded or deflated separately using contrast medium, a balloon adapter, and an inflation device. The Joline® Kyphoplasty System Allevo includes instruments and accessories that facilitate the kyphoplasty procedure, including devices and curettes for creation of access channels within the bone. Subsequent to creating the cavities within the vertebral bone, the vertebral body is stabilized with an FDA cleared PMMA bone cement that cures within a few minutes. The Joline Kyphoplasty System Allevo is offered in kits that are comprised of various combinations of instruments that address surgeon preference and specific clinical condition of the patient.
E. INDICATIONS FOR USE
The Joline® Kyphoplasty System Allevo is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Joline® Kyphoplasty System Allevo has similar device characteristics and clinical indications for use as the predicate device. The table below compares the technical and performance characteristics of the subject, reference, and predicate devices. The subject and predicate devices are comprised of instruments that facilitate balloon kyphoplasty in the spine, including balloons for creating cavithin bone, cannula to transfer saline, means to deliver FDA cleared bone cement, means to create a channel of access within the bone, and are single use and provided sterile.
| Performance
Characteristic | Requirement
(Joline, Single Balloon 22/16) | Requirement
(Predicate Osseoflex) | Test Result and
Conclusion |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------|
| Balloon Burst
Pressure and Volume
(Constrained) | Burst Pressure ≥ 27 bar
(≈ 400 psi)
Burst Volume ≥ 6 ml | Burst Pressure ≥ 27 atm
(≈ 400 psi)
Burst Volume ≥ 4 ml | Passed all conditions
Equivalent to predicate |
| Tensile Force
Balloon - Shaft | Detachment Force
≥ 15 N | Bond tensile strength
≥ 15 N | Passed all conditions
Equivalent to predicate |
| Tensile Force
Hub – Shaft | Detachment Force
≥ 15 N | Bond tensile strength
≥ 15 N | Passed all conditions
Equivalent to predicate |
| Tensile Force
Luer Lock | Detachment Force
≥ 15 N | Bond tensile strength
≥ 15 N | Passed all conditions
Equivalent to predicate |
| Balloon Inflation
Behavior
(Unconstrained
Balloon Compliance) | Average Diameter
16 mm
Length Change: least possible
Balloon Diameter ≤ 19 mm | Balloon Diameter
≤ 19 mm
Balloon working length
≤ 24 mm | Passed all conditions
Equivalent to predicate |
5
G. PERFORMANCE DATA
The following tests were performed in support of the substantial equivalence determination.
| Test Performed | Acceptance Criteria |
|---|---|
| Balloon Burst Pressure | Burst pressure (pburst) ≥ 27 bar (~ 400 psi) |
| Balloon Burst Volume | Burst volume (Vburst) ≥ 3 ml |
| Balloon Inflation Behavior | Inflated with 6 ml, the average diameter of the balloon should be 16 mm |
| Tensile Force Balloon-Shaft | Minimum tensile strength (Fballoon-shaft) ≥ 15 N |
| Tensile Force Hub-Shaft | Minimum tensile strength (Fhub-shaft) ≥ 15 N |
| Balloon Repeated Inflation | The balloon must not burst within 3 inflation/deflation cycles |
| Balloon Deflation Time | Deflation time (tdef) ≤ 3 s |
The results of the non-clinical tests show that the inflatable bone tamp of the Joline Kyphoplasty System Allevo meets or exceeded all performance requirements.
H. CONCLUSION
The Joline® Kyphoplasty System Allevo is substantially equivalent to the identified predicate device based on the indications for use, materials, design, and performance data presented in this 510(k) notification.