(224 days)
The Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine 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/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Spinal Stenosis; 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 6. Tumor; 7. Pseudoarthrosis and/or failed previous fusion
The subject system (Pitkar Spinal Pedicle Screw) attaches to the spine through screw, rod, and crosslink components. Furthermore, the system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. All implants are manufactured from Ti-alloy per ASTM F136.
This submission is for a medical device (Pitkar Spinal Pedicle Screw System), not a software or AI device. Therefore, the requested information on acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable and is not present in the provided text.
The document describes the regulatory review and clearance of a Pitkar Spinal Pedicle Screw System, a physical medical device. The clearance is based on its substantial equivalence to existing legally marketed predicate devices.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical and material testing, not clinical trials or AI/software performance studies.
Here's a breakdown of what is available in the document regarding how the device meets its "acceptance criteria" (which in this case are related to safety and performance through substantial equivalence):
Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for this physical device are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant ASTM standards for mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
There is no specific table of "acceptance criteria" with numerical performance metrics provided in the document for the device itself. Instead, the performance is demonstrated by:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "The technological design features of the subject system (Pitkar Spinal Pedicle Screw System) are substantially equivalent to the primary predicate (K043578), additional predicates (K082572, K060648, K190471, K180226, and K201457), and reference device (K192619)." |
| Mechanical Performance (demonstrated against applicable standards) | "The device performance of Pitkar Spinal Pedicle Screw System has been demonstrated against applicable standards ASTM F1717- Standard Test Methods For Spinal Implant Constructs In A Vertebrectomy Model:"- Static Compression Bending Test- Dynamic Compression Bending Test- Static Torsion Test"The submitted mechanical testing data demonstrates that the proposed device is substantially equivalent to that of the predicate device for the desired indications." |
| Material Composition | "All implants are manufactured from Ti-alloy per ASTM F136." |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For a physical device, this would typically refer to the number of device samples tested in laboratory settings, not patient data sets. The provenance would be the testing facility.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable for this type of device submission. Ground truth here is established by engineering and materials science principles and adherence to standards.
4. Adjudication Method for the Test Set:
Not applicable for this type of device submission. Adjudication methods are typically for clinical data or expert reviews, not mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:
Not applicable. This is a physical implant device, not a software algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's safety and effectiveness is established through:
- Mechanical Testing Results: Performance against established ASTM standards (ASTM F1717 for static compression bending, dynamic compression bending, and static torsion).
- Material Compatibility and Specifications: Conformance to ASTM F136 for Ti-alloy.
- Substantial Equivalence: Comparison of design features, intended use, indications for use, and function to existing cleared predicate devices.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no "training set" in the context of this physical device.
In summary, the provided document is a 510(k) clearance letter for a Class II spinal implant device. The "proof" it meets "acceptance criteria" lies in demonstrating substantial equivalence to predicate devices and adherence to relevant ASTM mechanical testing standards.
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September 9, 2024
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S H Pitkar Orthotools Pvt Ltd. Vivek Mangalwedhekar Head of Firm Plot No. EL 32, J Block, MIDC Bhosari Pune, Maharashtra 411026 India
Re: K240233
Trade/Device Name: Pitkar Spinal Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ Dated: August 7, 2024 Received: August 7, 2024
Dear Vivek Mangalwedhekar:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
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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
for
Enclosure
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Indications for Use
510(k) Number (if known) K240233
Device Name
Pitkar Spinal Pedicle Screw System
Indications for Use (Describe)
The Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine 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/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis;
-
- Trauma (i.e., fracture or dislocation);
- Spinal Stenosis;
-
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- Tumor;
-
- Pseudoarthrosis and/or failed previous fusion
| 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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510(k) Summary
| 1. Submitter: | S H Pitkar Orthotools Pvt Ltd.Plot No. EL 32, J Block, MIDC BhosariPune, Maharashtra 411026, India |
|---|---|
| Contact Person: | Vivek MangalwedhekarHead of FirmTelephone: +912040706464Fax: +912046768107 |
| Date: | 04-September-2024 |
| 2. Device Name: | Pitkar Spinal Pedicle Screw System |
| Common or Usual Name: | Spinal Pedicle screw System |
| Primary Product Code &Classification Name: | NKB- Thoracolumbosacral pedicle screw system (21 CFR888.3070) |
| Secondary Product Code &Classification Name: | KWQ- Spinal Devices Intervertebral Body Fixation Orthosis(21 CFR 888.3060) |
| Regulatory Class: | II |
| 3. Predicate Device(s): | |
| • Primary Predicate Device: | K043578 (4CIS Spinal System and 4CIS Low Back System) |
| • Additional Predicates: | K082572(Synthes USS Polyaxial System, Synthes USSIliosacral System), K090648 (VIPER II System), K190471(4CIS Chiron Spinal Fixation System), K180226 (TREND IISpinal Fixation System- STEP Series), K201457 (AuxeinBrand Vertaux 5.5 mm Pedicle Screw System) |
| • Reference Device | K192619 (Pitkar Locked Plating System) |
| 4. Device Description: | The subject system (Pitkar Spinal Pedicle Screw) attachesto the spine through screw, rod, and crosslink components.Furthermore, the system is intended to help provideimmobilization and stabilization of spinal segments as anadjunct to fusion of the thoracic, lumbar, and/or sacralspine. All implants are manufactured from Ti-alloy perASTM F136. |
| Following is a listing of implant components included in this current submission | |
| Ti Uniloc Poly Pedicle Screw | Ti Unistar Poly Pedicle Screw |
| Ti Uniloc Pedicle Screw | Ti Unistar Pedicle Screw |
| Ti Uniloc Spinal Precut Rod | Ti Unistar Pedicle Reduction Screw |
| Ti Uniloc Pedicle Reduction Screw | Ti Unistar Poly Reduction Screw |
| Ti Trigen Domino Connector | Ti Trigen Poly Screw |
| Ti Uniloc D Connector | Ti Trigen Pedicle Screw |
| Ti Uniloc D Connector Rod | Ti Trigen Precut Rod |
| Ti Uniloc Poly Reduction Screw | Ti Trigen Poly Reduction Screw |
| Ti Elliac Connector | Ti ProMIS Poly Screw |
| Ti Poly Elliac Screw | Ti ProMIS Spinal Pre-Cut Rod |
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Ti ProMIS Spinal Straight Rod
ProMis Tower Screw non-fenestrated
Ti V Locx Pedicle Screw Ti V Locx Poly Screw
Ti Combi Spinal Rod
5. Indications for Use:
The Pitkar Spinal Pedicle Screw System is intended for noncervical posterior and anterolateral fixation of the spine 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/or sacral spine:
- . Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis ●
- Trauma (i.e., fracture or dislocation) ●
- Spinal Stenosis, ●
- Deformities or curvatures (i.e., scoliosis, Kyphosis, ● and/or Lordosis),
- . Tumor,
- Pseudoarthrosis, and failed previous fusion ●
The technological design features of the subject system (Pitkar Spinal Pedicle Screw System) are substantially equivalent to the primary predicate (K043578), additional predicates (K082572, K060648, K190471, K180226, and K201457), and reference device (K192619). The technological design features of the subject system implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent
Non-Clinical Tests:
The device performance of Pitkar Spinal Pedicle Screw System has been demonstrated against applicable standards ASTM F1717- Standard Test Methods For Spinal Implant Constructs In A Vertebrectomy Model
- Static Compression Bending Test ●
- Dynamic Compression Bending Test ●
- Static Torsion Test ●
The Pitkar Spinal Pedicle Screw System is substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness.
The submitted mechanical testing data demonstrates that the proposed device is substantially equivalent to that of the predicate device for the desired indications. Based on the indications for use, technological characteristics, and the summary of data submitted. Pitkar has determined that the proposed device is substantially equivalent to the currently marketed predicate device.
6. Summary of Technological Characteristics:
7. Summary of Performance Data: (Nonclinical and/or Clinical)
8. Conclusion:
§ 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.