(201 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the implantable system, with no mention of AI or ML capabilities.
Yes
The ACURA Stabilization System is intended to provide immobilization of spinal segments to aid in fusion for various spinal conditions, directly treating a medical condition.
No
The device is an implantable system (rods, screws, hooks) used for immobilization of spinal segments as an adjunct to fusion, treating acute and chronic spinal instabilities or deformities. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "single use implantable system consisting of connecting members (rods) and fixation members (screws, hooks)" made of medical-grade titanium and cobalt chromium alloy. This indicates 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 states that the ACURA Stabilization System is an implantable system designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details the physical components of the system (rods, screws, hooks, etc.) which are implanted into the patient. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies described are mechanical tests evaluating the strength and stability of the implant, which is relevant for a surgical device. There are no studies related to diagnostic accuracy or performance.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. The ACURA Stabilization System does not fit this definition.
N/A
Intended Use / Indications for Use
ACURA Stabilization System is intended to help provide immobilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- Degenerative spondylolisthesis
-
- Trauma (fracture or dislocation)
-
- Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease)
- న్. Spinal tumours
-
- Spinal Stenosis
-
- Pseudarthrosis
- Previous Failed Fusions 8.
When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft. When used for posterior non-cervical pediation in pediatic patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idionathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP, KWQ
Device Description
The ACURA Stabilization System is a single use implantable system consisting of connecting members (rods) and fixation members (screws, hooks). The hooks are available in different types based on the attachment points on the vertebra such as the Lamina and Transverse Process. The screws are available in multiple diameters and lengths based on variations in the spinal anatomy. Variants in screws are also available based on the surgical procedure requirement such as polyaxial screws, monoaxial screws, uniplanar screws, cannulated screws, fenestrated screws, long tab screws, dual outer diameter screws. Locking caps are available which lock the screw head onto the rods. These devices can be rigidly locked into a variety of configurations as per surgical conditions and are available in a variety of sizes to accommodate individual patient anatomy.
Screws mate with 5.5mm diameter rods. Screws, hooks and cross connectors are intended for posterior use only. Hooks are intended for posterior use only. Similarly, Screws, Rods and Cross-Connectors are intended for both posterior and lateral use.
The devices are made Medical Grade Titanium (Ti6Al4V per ASTM F136), with some rods and polyaxial screw heads also offered as cobalt chromium alloy (Co28Cr6Mo per ASTM F1537).
The safety and effectiveness of this device has 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S2/Ilium (Spinal segments)
Indicated Patient Age Range
skeletally mature patients (including small stature) and for pediatric patients
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
The ACURA Stabilization System has been tested in the following test modes:
- Static compression bending per modified ASTM F1717-18 ●
- Static torsion per ASTM F1717-18 .
- Dynamic compression bending per ASTM F1717-18 ●
- Axial grip testing per ASTM F1798 ●
- . Torsional grip testing per ASTM F1798
The results of this non-clinical testing show that the strength of the ACURA Stabilization System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K142381, K110280, K193365, K180458, K131802, K180210, K133350
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.
0
October 26, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
Indius Medical Technologies Pvt. Ltd. % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K200937
Trade/Device Name: ACURA Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: September 25, 2020 Received: September 29, 2020
Dear Nathan Wright:
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 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
Indications for Use
510(k) Number (if known) K200937
Device Name
ACURA Stabilization System
Indications for Use (Describe)
ACURA Stabilization System is intended to help provide immobilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- Degenerative spondylolisthesis
-
- Trauma (fracture or dislocation)
-
- Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease)
- న్. Spinal tumours
-
- Spinal Stenosis
-
- Pseudarthrosis
- Previous Failed Fusions 8.
When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft. When used for posterior non-cervical pediation in pediatic patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idionathic scoliosis. 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)
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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
5.510(K) SUMMARY
| Submitter's Name: | Indius Medical Technologies Pvt. Ltd. |
|---|---|
| Submitter's Address: | Unit No. 12, Electronic Co-Operative Estate, Pune-Satara |
| Road Pune – 411009, MH, India | |
| Submitter's Telephone: | +91 20 29701607 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | April 9, 2020 |
| Trade or Proprietary Name: | ACURA Stabilization System |
| Common or Usual Name: | Thoracolumbosacral Pedicle Screw System |
| Classification: | Class II per 21 CFR §888.3070 and 21 CFR §888.3050 |
| Product Code: | NKB, KWQ, KWP |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ACURA Stabilization System is a single use implantable system consisting of connecting members (rods) and fixation members (screws, hooks). The hooks are available in different types based on the attachment points on the vertebra such as the Lamina and Transverse Process. The screws are available in multiple diameters and lengths based on variations in the spinal anatomy. Variants in screws are also available based on the surgical procedure requirement such as polyaxial screws, monoaxial screws, uniplanar screws, cannulated screws, fenestrated screws, long tab screws, dual outer diameter screws. Locking caps are available which lock the screw head onto the rods. These devices can be rigidly locked into a variety of configurations as per surgical conditions and are available in a variety of sizes to accommodate individual patient anatomy.
Screws mate with 5.5mm diameter rods. Screws, hooks and cross connectors are intended for posterior use only. Hooks are intended for posterior use only. Similarly, Screws, Rods and Cross-Connectors are intended for both posterior and lateral use.
The devices are made Medical Grade Titanium (Ti6Al4V per ASTM F136), with some rods and polyaxial screw heads also offered as cobalt chromium alloy (Co28Cr6Mo per ASTM F1537).
The safety and effectiveness of this device has 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.
INDICATIONS FOR USE
ACURA Stabilization System is intended to help provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as
4
an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities:
-
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- Degenerative spondylolisthesis
-
- Trauma (fracture or dislocation)
-
- Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease)
-
- Spinal tumours
-
- Spinal Stenosis
-
- Pseudarthrosis
-
- Previous Failed Fusions
When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
TECHNOLOGICAL CHARACTERISTICS
The ACURA Stabilization System is made from titanium alloy per ASTM F136 or cobalt chrome alloy per ASTM F1537. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use
- Technological Characteristics
- Component Styles ●
- Materials ●
- Sizes
- Manufacturing & Biocompatibility
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|--------------------------|-------------------|
| K142381 | Xia® 3 Spinal System | Stryker Spine | Primary |
| K110280 | REVLOK™ Fenestrated
Screw System | Globus Medical Inc. | Additional |
| K193365 | M.U.S.T. Pedicle Screw
System | Medacta International SA | Additional |
Table 5-1 Predicate Devices
5
| K180458 | FOCUS Pedicle Screw
System | Nvision Biomedical
Technologies, LLC | Additional |
|---------|---------------------------------|-----------------------------------------|------------|
| K131802 | EXPEDIUM® Spine System | DePuy Spine, Inc. | Additional |
| K180210 | CREO® Stabilization
System | Globus Medical Inc. | Additional |
| K133350 | REVERE® Stabilization
System | Globus Medical Inc. | Additional |
PERFORMANCE DATA
The ACURA Stabilization System has been tested in the following test modes:
- Static compression bending per modified ASTM F1717-18 ●
- Static torsion per ASTM F1717-18 .
- Dynamic compression bending per ASTM F1717-18 ●
- Axial grip testing per ASTM F1798 ●
- . Torsional grip testing per ASTM F1798
The results of this non-clinical testing show that the strength of the ACURA Stabilization System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the ACURA Stabilization System is substantially equivalent to the predicate device.