(128 days)
Not Found
No
The 510(k) summary describes a mechanical pedicle screw system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not algorithm validation.
Yes
The device is described as providing "immobilization and stabilization of spinal segments" as an "adjunct to fusion in the treatment of acute and chronic instabilities or deformities." This description aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is described as a "pedicle screw fixation system" that provides "immobilization and stabilization of spinal segments as an adjunct to fusion." Its intended use is for treating various spinal instabilities or deformities, not for diagnosing them.
No
The device description explicitly states it is a "surgically implantable device" and a "polyaxial pedicle screw system," indicating it is a physical hardware device, not software.
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 surgically implanted device used to provide immobilization and stabilization of spinal segments. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as a "surgically implantable device."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the R&D Innovation Pedicle Screw 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, NKB
Device Description
The R&D Innovation Pedicle Screw System is a polyaxial pedicle screw system with straight or precontoured crosslink to provide optimal supporting structure for the spinal bodies. The pedicle screw system is a surgically implantable device which is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine (T1-S1), thoracic, lumbar, and sacral spine
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)
The R&D Innovation Pedicle Screw System has been shown to the following standards, practices, and guidance:
STERILIZATION
- ANSI/AAMI/ ST79:2006 and ANSI/AAMI ST79/A1:2009, Comprehensive guide to steam . sterilization and sterility assurance in health care facilities
BIOCOMPATIBILITY
- ASTM F136:2008, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium . ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
MECHANICAL INTEGRITY
The device also underwent static compression bending, static torsion, and dynamic compression bending testing per the following standard to ensure that performance requirements were met.
- ASTM F1717–11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy . Model
CLINICAL STUDIES
Clinical data is not necessary for this application because the standard mechanical testing results supported the substantial equivalence of the R&D Innovation Pedicle Screw System with predicate devices. The R&D Innovation Pedicle Screw System and the predicates have similar indication for use, intended us, principles of operation, and specifications in materials.
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.
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
§ 888.3070 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
K 120091
5.510(K) SUMMARY
MAY 1 8 2012
| Submitter's Name: | R&D Innovation |
|---|---|
| Submitter's Address: | 30 Town & Country Dr, Ste 104 |
| Danville, CA 94526-3930 | |
| Submitter's Telephone: | Phone (925) 699-7960 or (925) 400-3010 |
| Fax (925) 648-4331 or (925) 362-1045 | |
| Contact Name: | Robert Rovner |
| Date Summary was Prepared: | 12/15/2011 |
| Trade or Proprietary Name: | R&D Innovation Pedicle Screw System |
| Common or Usual Name: | Pedicle Screw Spinal System |
| Classification: | Class III per 21 CFR §888.3070 |
| Product Codes: | MNI, 21 CFR 888.3070, Pedicle screw spinal system |
| MNH, 21 CFR 888.3070, Pedicle screw spinal system | |
| NKB, 21 CFR 888.3070, Pedicle screw spinal system | |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Device Names: |
| ACME Spinal System, 510(K) Number: K071824 | |
| Moss Miami and Expedium Spinal System, 510(K) Number: | |
| K103490 & K955348 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The R&D Innovation Pedicle Screw System is a polyaxial pedicle screw system with straight or precontoured crosslink to provide optimal supporting structure for the spinal bodies. The pedicle screw system is a surgically implantable device which is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine.
INDICATIONS FOR USE
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the R&D Innovation Pedicle Screw 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).
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TECHNICAL CHARACTERISTICS
The intended use and technological features of the R&D Innovation Pedicle Screw System do not substantially differ from the legally marketed predicate devices which are the ACME Spinal System, now marketed a Spine 360 Talon Pedicle Screw System, (K071824) and DePuy Moss Miami and Expedium (K103490 & K955348). The R&D Innovation pedicle screw system and the predicate devices have similar indication for use and methods of operation.
PERFORMANCE DATA
The R&D Innovation Pedicle Screw System has been shown to the following standards, practices, and guidance:
STERILIZATION
- ANSI/AAMI/ ST79:2006 and ANSI/AAMI ST79/A1:2009, Comprehensive guide to steam . sterilization and sterility assurance in health care facilities
BIOCOMPATIBILITY
- ASTM F136:2008, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium . ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
MECHANICAL INTEGRITY
The device also underwent static compression bending, static torsion, and dynamic compression bending testing per the following standard to ensure that performance requirements were met.
- ASTM F1717–11 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy . Model
CLINICAL STUDIES
Clinical data is not necessary for this application because the standard mechanical testing results supported the substantial equivalence of the R&D Innovation Pedicle Screw System with predicate devices. The R&D Innovation Pedicle Screw System and the predicates have similar indication for use, intended us, principles of operation, and specifications in materials.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The indications for use and principles of operation of the R&D Innovation Pedicle Screw System are similar to the predicate devices cited in this application. The materials used in R&D Innovation Pedicle Screw System and the predicate share the same requirements in chemical, mechanical, and metallurgical properties in accordance to ASTM F136 standard, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. Performance testing under the guidance of ASTM F1717 standard, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, demonstrates that the R&D Innovation Pedicle Screw System is functionally equivalent to the predicate devices.
CONCLUSION
R&D Innovation Pedicle Screw System
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The overall technology characteristics and mechanical performance data lead to the conclusion that R&D Innovation Pedicle Screw System is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 18 2012
R and D Innovation, LLC % Empirical Testing Corporation Ms. Meredith May 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K120091
Trade/Device Name: R & D Innovation Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: December 15, 2011 Received: April 17, 2012
Dear Ms. May:
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. 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
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Page 2 - Ms. Meredith May
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
Device Name: R&D Innovation Pedicle Screw System .
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the R&D Innovation Pedicle Screw 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | 11120091 |
|---|---|
| --------------- | ---------- |
R&D Innovation Pedicle Screw System
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