(94 days)
Not Found
No
The device description and intended use focus on mechanical components for spinal fixation and bone cement. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies are related to the usability and properties of the bone cement and screws, not algorithmic performance.
Yes
The device is intended to immobilize spinal segments, treat various spinal instabilities and deformities, and restore spinal column integrity, all of which are therapeutic actions.
No
The PERLA® TL system is a surgical implant designed for spinal immobilization as an adjunct to fusion or to restore spinal column integrity. Its components, such as screws and rods, are used to treat various spine conditions, not to diagnose them.
No
The device description explicitly states that the PERLA® TL System consists of a range of physical components like screws, rods, set screws, hooks, rod connectors, and cross-connectors, manufactured from medical grade titanium alloy and cobalt chromium. It also mentions the use of bone cement. This indicates it is a hardware-based medical device, not software-only.
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 implant system (screws, rods, etc.) used to stabilize the spine and an associated bone cement for augmenting the screws or treating vertebral fractures. These are physical devices used in vivo (within the body) for structural support and repair.
- Device Description: The description details the components of the system (screws, rods, etc.) and the materials they are made from (titanium alloy, cobalt chromium, PMMA-based bone cement). This aligns with the description of a surgical implant and bone cement.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or conditions. This device is a surgical implant and bone cement used for treatment and stabilization within the body.
N/A
Intended Use / Indications for Use
The PERLA® TL system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- · degenerative disc disease;
- · spondylolisthesis;
- · fracture;
- · dislocation;
- scoliosis;
- · kyphosis;
- spinal tumor:
- · and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical pedictic patients, the PERLA® TL system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used in conjunction with TEKTONA® HV US bone cement system, the PERLA®TL system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time, in patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors. The PERLA@TL 35mm to 60mm lengths Screws augmented used with TEKTONA® HV US bone cement system are intended to be used at spinal levels where the structural integrity is not severely compromised.
TEKTONA® HV US Bone Cement is indicated for the treatment of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
When used in conjunction with PERLA®TL system, TEKTONA® HV US Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. PERLA®TL Screws augmented with TEKTONA® HV US Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes (comma separated list FDA assigned to the subject device)
PML, NKB, KWP
Device Description
The PERLA® TL System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537.
The PERLA® TL System is identical to the previously cleared version, however this submission includes the additional option to use bone cement with the fenestrated screws.
Mendec Spine HV System (TEKTONA HV US Bone Cement) is highly viscous, radio-opaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device that serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The device is sold disposable and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; vertebral body
Indicated Patient Age Range
skeletally mature patients; pediatric patients; adolescent; patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors
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)
Bone cement usability testing (Usability Testing, Cement Injection Time Testing, and Cement Flow, Bolus Formation, and Screw Removal from Bone Cement Testing) was conducted to validate the use of the Perla® TL System used with bone cement.
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.
TEKTONA HV US Bone Cement (K122175), PERLA®TL Posterior Osteosynthesis System (K213470), KYPHON HV-R® Fenestrated Screw Cement, CD Horizon® Fenestrated Screw Set (K152604), NEO Pedicle Screw SystemTM (K212489), G21 Cement VADER® pedicle System (K200596)
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
§ 888.3027 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
June 23, 2023
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.
Spineart % Michael Coladonato Senior Associate, Spine Regulatory Affairs Mcra LLC 803 7th Street Northwest Third Floor Washington, District of Columbia 20001
Re: K230774
Trade/Device Name: PERLA® TL System; TEKTONA® HV US Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: PML, NKB, KWP Dated: May 26, 2023 Received: May 26, 2023
Dear Michael Coladonato:
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
1
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,
Image /page/1/Picture/5 description: The image contains the text "Colin O'neill -S" on the left side of the image. On the right side of the image is the letters "FDA" in a light blue color. The text is arranged in two lines, with "Colin" on the first line and "O'neill -S" on the second line. The text is in a simple, sans-serif font.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230774
Device Name Perla® TL System
Indications for Use (Describe)
The PERLA® TL system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- · degenerative disc disease;
- · spondylolisthesis;
- · fracture;
- · dislocation;
- scoliosis;
- · kyphosis;
- spinal tumor:
- · and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical pedictic patients, the PERLA® TL system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used in conjunction with TEKTONA® HV US bone cement system, the PERLA®TL system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time, in patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors. The PERLA@TL 35mm to 60mm lengths Screws augmented used with TEKTONA® HV US bone cement system are intended to be used at spinal levels where the structural integrity is not severely compromised.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K230774
Device Name TEKTONA® HV US Bone Cement
Indications for Use (Describe)
TEKTONA® HV US Bone Cement is indicated for the treatment of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
When used in conjunction with PERLA®TL system, TEKTONA® HV US Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. PERLA®TL Screws augmented with TEKTONA® HV US Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Type of Use (Select one or both, as applicable)
| ü Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K230774
Page 1 of 4
510(k) Summary
| Device Trade Name: | PERLA® TL System
TEKTONA® HV US Bone Cement |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Spineart
3 Chemin de Pré Fleuri
1228 Plan Les Ouates
Geneva, Switzerland
+41 22 570 1200 |
| Contact: | Franck Pennesi
Chief Technical Officer
+41 22 570 1200
fpennesi@spineart.com |
| Prepared by: | MCRA, LLC
803 7th Street, NW, 3rd Floor
Washington, DC 20001
Office: 202.552.5800 |
| Date Prepared: | March 20, 2023 |
| Classifications: | 21 CFR 888.3027 |
| Class: | II |
| Product Codes: | PML
NKB
KWP |
| Primary Predicate: | KYPHON HV-R® Fenestrated Screw Cement, CD Horizon®
Fenestrated Screw Set (K152604) |
| Additional Predicates: | PERLA®TL Posterior Osteosynthesis System (K213470),
TEKTONA HV US Bone Cement (K122175), NEO Pedicle
Screw SystemTM (K212489), G21 Cement & VADER Pedicle
Screw System
(K200596) |
5
Indications For Use:
PERLA® TL System
The PERLA® TL system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- · degenerative disc disease:
- spondylolisthesis;
- · fracture;
- dislocation;
- scoliosis:
- kyphosis;
- spinal tumor:
- · and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used in conjunction with TEKTONA® HV US bone cement system, the PERLA®TL system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time, in patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors. The PERLA®TL 35mm to 60mm lengths Screws augmented used with TEKTONA® HV US bone cement system are intended to be used at spinal levels where the structural integrity is not severely compromised.
TEKTONA® HV US Bone Cement
TEKTONA® HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
When used in conjunction with PERLA®TL system, TEKTONA® HV US Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. PERLA®TL Screws augmented with TEKTONA® HV US Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
6
Device Description:
The PERLA® TL System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537.
The PERLA® TL System is identical to the previously cleared version, however this submission includes the additional option to use bone cement with the fenestrated screws.
Mendec Spine HV System (TEKTONA HV US Bone Cement) is highly viscous, radio-opaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device that serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The device is sold disposable and sterile.
Predicate Device:
Spineart submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, PERLA® TL System is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:
| Primary Predicate: | TEKTONA HV US Bone Cement (K122175) |
|---|---|
| Additional Predicate: | PERLA®TL Posterior Osteosynthesis System |
| KYPHON HV-R® Fenestrated Screw Cement, CD Horizon® | |
| Fenestrated Screw Set (K152604) | |
| NEO Pedicle Screw System™ (K212489) | |
| G21 Cement VADER® pedicle System (K200596) |
Performance Testing Summary:
Bone cement usability testing (Usability Testing, Cement Injection Time Testing, and Cement Flow, Bolus Formation, and Screw Removal from Bone Cement Testing) was conducted to validate the use of the Perla® TL System used with bone cement.
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to the predicates cited in the table above with respect to indications, design materials, function, manufacturing, and performance. The non-clinical tests performed by the company included bone cement usability testing and screw removal testing was conducted to validate the use of the Perla® TL System used with bone cement.
Conclusion:
The subject device and the predicate(s) devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in
7
this submission demonstrate substantial equivalence to the predicate devices listed above. PERLA® TL System is as safe, as effective, and performs as well as, or better, than the predicate devices.