(150 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal fixation system components, with no mention of AI or ML technology.
Yes.
The device is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients to provide rigid fixation and stability for various spinal conditions, which is clearly a therapeutic purpose.
No
This device is a surgical implant system designed for spinal fixation and fusion, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of titanium alloy and stainless steel, which are hardware.
Based on the provided information, the Kentrospine PSS Pedicle Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details physical components like screws, rods, and connectors made of titanium alloy, designed to be implanted during surgery.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Kentrospine system does not perform any such function.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Kentrospine PSS Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenoss; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
Product codes
NKB
Device Description
The Kentrospine PSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of PSS Pedicle Screws (Monoaxial, polyaxial), PSS Rods, PSS Locking Cap, and a PSS Crosslink Connectors. The Kentrospine PSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Kentrospine PSS Pedicle Screw System components are supplied non-sterile, single use and are made from medical grade. biocompatible Titanium alloy (Ti6Al4V ELI) conforming to ASTM F136-13(2021)- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. Various sizes of these implants are available. The PSS Pedicle Screws are available in diameters from Ø4.50mm to Ø7.00mm and in lengths of 25mm to 55mm. PSS Rods are straight, made from titanium and available in 05.50mm diameter with length from 45mm, 55mm, 65mm, 75mm, 85mm, 100mm, 125mm, 200mm, 250mm, 300mm, 350mm, 450mm and 500mm. Specialized instruments are available for the application and removal of the Kentrospine PSS Pedicle Screw System. The instruments are made from SAE 316L stainless steel which is complied with ASTM F899 - 20 Standard Specification for Wrought Stainless Steels for Surgical Instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation
Indicated Patient Age Range
skeletally mature 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance: The following tests have been conducted on the Kentrospine PSS Pedicle Screw System and the device performance has been demonstrated against following applicable standards:
- Static compression bending testing (ASTM F 1717-21)
- Static Torsional Testing (ASTM F 1717-21)
- Static Tension bending Testing (ASTM F 1717-21)
- Fatigue Compression testing (ASTM F 1717-21)
The results of this non-clinical testing shows that the strength and performance of the Kentrospine PSS Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Clinical Performance Data/Information: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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July 22, 2022
Rivarp Medical Private Limited Sushma N.R Manager - RA No.34, Azeez Sait Industrial Town, 6th Mile, Mysore Road,Nayandahalli. Bangalore, Karnataka 560039 India
Re: K220486
Trade/Device Name: Kentrospine PSS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 29, 2022 Received: July 6, 2022
Dear Sushma N.R:
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
1
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 (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 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
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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Indications for Use
510(k) Number (if known) K220486
Device Name Kentrospine PSS Pedicle Screw System
Indications for Use (Describe)
The Kentrospine PSS Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenoss; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
| 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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510(k) SUMMARY
Premarket Notification 510(k) Summary as required by Section 21 CFR 807.92
General Company Information as required by 807.92 (a)
| Submitter's Name /
Contact details: | Rivarp Medical Pvt.Ltd.,
34, Azeez Sait Industrial Town, 6th Mile
Mysore Road, Nayandahalli,
Bangalore -560039, INDIA
+91 80 2339 1136
info@rivarpmedical.com
www.rivarpmedical.com | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Details:
Sushma N.R
Manager- Regulatory affairs
+91 80 2339 1136 | |
| Summary preparation
date: | 20th July 2022 | |
| Device name and
classification: | Proprietary/ trade name:
Common or Usual Name:
Classification Name:
Product Code(s):
Device Class:
Regulation Number:
Review Panel: | Kentrospine PSS Pedicle Screw System
Pedicle Screw System
Thoracolumbosacral Pedicle Screw System
NKB
Class II
21 CFR Section 888.3070
Orthopedic |
| Variants/Types: | Kentrospine PSS Pedicle Screw System consists of following
components.
• PSS Monoaxial Pedicle Screw
• PSS Polyaxial Pedicle Screw
• PSS Locking Cap
• PSS Crosslink Connector
• PSS Rod | |
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The identified primary predicate device within this submission is as follows: Identification of the predicate device: CD HORIZON® Spinal System (K091442) manufactured by Medtronic Sofamor Danek USA, dated July 15 2009. The design features, material and indications for use of the Kentrospine PSS Pedicle Screw System are substantially equivalent to the predicate CD HORIZON® Spinal System.
The purpose of this Traditional 510(k) submission is to obtain market clearance Device Description: for the Kentrospine PSS Pedicle Screw System. The Kentrospine PSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of PSS Pedicle Screws (Monoaxial, polyaxial), PSS Rods, PSS Locking Cap, and a PSS Crosslink Connectors.
The Kentrospine PSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Kentrospine PSS Pedicle Screw System components are supplied non-sterile, single use and are made from medical grade. biocompatible Titanium alloy (Ti6Al4V ELI) conforming to ASTM F136-13(2021)- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. Various sizes of these implants are available.
The PSS Pedicle Screws are available in diameters from Ø4.50mm to Ø7.00mm and in lengths of 25mm to 55mm. PSS Rods are straight, made from titanium and available in 05.50mm diameter with length from 45mm, 55mm, 65mm, 75mm, 85mm, 100mm, 125mm, 200mm, 250mm, 300mm, 350mm, 450mm and 500mm.
Specialized instruments are available for the application and removal of the Kentrospine PSS Pedicle Screw System. The instruments are made from SAE 316L stainless steel which is complied with ASTM F899 - 20 Standard Specification for Wrought Stainless Steels for Surgical Instruments.
Indications for use:
The Kentrospine PSS Pedicle Screw System is intended for posterior, noncervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with following indications: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed studies): Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis and/or lordosis); Tumor; Pseudarthritis; and/or failed previous fusion.
5
| Comparison to
Technological
Characteristics: | The Kentrospine PSS Pedicle Screw System is equivalent to the predicate
device with respect to intended use, device design and material. All the
necessary performance test to determine the mechanical characteristics have
been performed on the Kentrospine PSS Pedicle Screw System |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data:
1.Non-clinical
Performance: | The following tests have been conducted on the Kentrospine PSS Pedicle
Screw System and the device performance has been demonstrated against
following applicable standards, |
| | 1. Static compression bending testing (ASTM F 1717-21)
2. Static Torsional Testing (ASTM F 1717-21)
3. Static Tension bending Testing (ASTM F 1717-21)
4. Fatigue Compression testing (ASTM F 1717-21) |
| | The results of this non-clinical testing shows that the strength and performance
of the Kentrospine PSS Pedicle Screw System is sufficient for its intended use
and is substantially equivalent to legally marketed predicate devices. |
| | Following are the applicable material standards considered for Kentrospine
PSS Pedicle Screw System:
- ASTM F136-13(2021)-Standard Specification for Wrought Titanium-
6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI) for
Surgical Implant Applications. - ASTM F899 – 20 Standard Specification for Wrought Stainless Steels for
Surgical Instruments. |
| 2. Clinical
Performance
Data/Information: | No clinical studies were performed. |
| Conclusion: | The Kentrospine PSS Pedicle Screw System is equivalent to the identified
primary predicate device. From the data available we can justify that the
Kentrospine PSS Pedicle Screw System has the same indications for use
and similar technological characteristics as the legally marketed predicate
device. Hence Kentrospine PSS Pedicle Screw System can be considered
substantially equivalent to the predicate. |