(46 days)
No
The summary describes a mechanical spinal osteosynthesis system and its components, with no mention of AI or ML technology.
Yes
The device is intended to immobilize spinal segments and treat various medical conditions such as degenerative disc disease, scoliosis, and fractures, which aligns with the definition of a therapeutic device.
No
The device is described as an osteosynthesis system intended to provide immobilization of spinal segments as an adjunct to fusion, comprised of mechanical components like screws, rods, and connectors. There is no mention of it being used to diagnose conditions or gather diagnostic information.
No
The device description clearly states it consists of physical components like screws, rods, and surgical instruments made of titanium alloy and cobalt chromium, which are hardware.
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 for stabilizing the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a spinal implant system (screws, rods, etc.) and their materials. This aligns with a surgical device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical properties (compression, torsion), which are relevant to the structural integrity of an implant, not diagnostic accuracy.
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 PERLA® TL posterior osteosynthesis system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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 posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP
Device Description
The PERLA® TL posterior osteosynthesis 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 posterior osteosynthesis implants are delivered either non sterile or sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. The subject product line extension of the PERLA® TL Posterior Osteosynthesis System manufactured by Spineart (K193396) consists of addition of cannulatec screws (various models), fenestrated screws (various models), percutaneous rods and associated surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients; pediatric patients (for adolescent idiopathic scoliosis)
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)
Static compression bending, static torsion and dynamic compression bending testing were conducted in conformance to in conformance to ASTM F1717. Results demonstrate at least comparable mechanical properties to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM by Spineart (K081165), PERLA® TL Posterior Osteosynthesis System by Spineart (K193396), ROMEO Posterior Osteosynthesis System by Spineart (K093936), CD HORIZON by Medtronic (K152457, K170347)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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January 15, 2021
Image /page/0/Picture/1 description: The image shows the logo for 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 Franck Pennesi Chief Technical Officer 3 chemin du pré Fleuri Plan Les Ouates, Geneva 1228 Switzerland
Re: K203506
Trade/Device Name: PERLA® TL posterior osteosynthesis system Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: November 25, 2020 Received: November 30, 2020
Dear Franck Pennesi:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 (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 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,
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
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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) K203506
Device Name
PERLA® TL posterior osteosynthesis system
Indications for Use (Describe)
The PERLA® TL posterior osteosynthesis system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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 posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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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FORM FDA 3881 (7/17)
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Traditional 510k Perla® TL Posterior Osteosynthesis System Perla® TL MIS Extension line
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510(k) SUMMARY
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | Product Line Extension of the Perla® TL system previously cleared (K193396) |
| Submitted by | SPINEART |
| 3 Chemin du Pré Fleuri | |
| 1228 PLAN LES OUATES | |
| GENEVA SWITZERLAND | |
| Contacts | Franck PENNESI Chief Technical Officer |
| Phone: +41 22 570 1200 Fax: +41 22 594 8306 | |
| Mail: fpennesi@spineart.com | |
| Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | |
| Date Prepared | January 11, 2021 |
| Common Name | Pedicle screw spinal system |
| Trade Name | PERLA® TL posterior osteosynthesis system |
| Classification Name | Thoracolumbosacral pedicle screw system |
| Class | II |
| Product Code | NKB |
| Subsequent codes | KWP |
| CFR section | 888.3070 , 888.3050 |
| Device panel | ORTHOPEDIC |
| Legally marketed | |
| predicate devices | Primary predicate: ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM by |
| Spineart (K081165) | |
| Additional predicates: PERLA® TL Posterior Osteosynthesis System by Spineart | |
| (K193396) ROMEO Posterior Osteosynthesis System by Spineart (K093936) and CD | |
| HORIZON by Medtronic (K152457, K170347) | |
| Indications for use | The PERLA® TL posterior osteosynthesis system is intended to provide |
| immobilization and stabilization 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 posterior | |
| osteosynthesis system is indicated as an adjunct to fusion to treat adolescent | |
| idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to | |
| be used with autograft and/or allograft. Pediatric pedicle screw fixation is limitec | |
| to a posterior approach. | |
| Description of the device | The PERLA® TL posterior osteosynthesis 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 posterior osteosynthesis implants are delivered either non sterile | |
| or sterile (gamma sterilization) and supplied with dedicated surgical instruments. | |
| Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity | |
| testing to achieve the Endotoxin limit of 20 EU / device. | |
| The subject product line extension of the PERLA® TL Posterior Osteosynthesis | |
| System manufactured by Spineart (K193396) consists of addition of cannulatec | |
| screws (various models), fenestrated screws (various models), percutaneous rods | |
| and associated surgical instruments. | |
| Technological | |
| characteristics | |
| compared to the | |
| predicate devices | As was established in this submission, the PERLA® TL added components are |
| substantially equivalent and have the same technological characteristics to | |
| predicate devices in areas including indications for use, function, material | |
| composition, design, range of sizes and mechanical performance. | |
| The safety and effectiveness of PERLA® TL fenestrated screws have not been | |
| established when used in conjunction with bone cement or for use in patients with | |
| poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to | |
| be used with saline or radiopaque dye. | |
| Discussion of Testing | Static compression bending, static torsion and dynamic compression bending |
| testing were conducted in conformance to in conformance to ASTM F1717. Results | |
| demonstrate at least comparable mechanical properties to the predicate devices. | |
| Conclusion | Based on the design features, technological characteristics, feature comparisons, |
| indications for use, and non-clinical performance testing, the added components | |
| to the PERLA® TL posterior osteosynthesis system has demonstrated substantial | |
| equivalence to the identified predicate devices | |
4