(75 days)
No
The summary describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a spinal system intended for immobilization of spinal segments as an adjunct to fusion for treating various spinal instabilities or deformities, which is a therapeutic purpose.
No
The document describes a spinal system intended for providing immobilization of spinal segments, not for diagnosing medical conditions.
No
The device description explicitly details physical components such as screws, set screws, and rods made from titanium alloy and stainless steel, which are hardware implants and instruments. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Picasso II MIS Spinal System is a surgical implant (screws and rods) intended to be surgically implanted into the spine to provide stabilization and aid in fusion. It is a physical device used in vivo (within the body) during surgery.
- Lack of Diagnostic Activity: The description and intended use do not mention any analysis of biological samples or diagnostic testing. The device's function is mechanical support and stabilization.
Therefore, the Picasso II MIS Spinal System falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Picasso II MIS Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso II MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso II MIS Spinal System is intended for noncervical pedicle fixation for the 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 stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the Picasso II MIS Spinal System is intended for noncervical pedicle fixation for the 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 stenosis; curvatures (i.e., scoliosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
Product codes
NKB, MNI, MNH
Device Description
The Picasso II MIS Spinal System is comprised of percutaneous cannulated poly axial screws, a set screw and rods designed to allow for minimally invasive surgery. The screw diameters are 5.5mm, 6.5mm and 7.5mm. The screw length ranges from 30mm in 5mm increments.
The Picasso II system will utilize Ø6.0mm MIS rods. Straight and curved rods are provided with the subiect system. Straight rods are available in 35mm-600mm lengths, and curved rods are available in 35mm-150mm lengths.
The implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. The device specific instrumentation intended for patient contact is manufactured from stainless steel materials that conform to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine; noncervical pedicle
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
The following non-clinical tests were conducted to confirm the results of the engineering analysis:
- Static axial grip, static torsional grip, static cantilever bending and static tulip head disassociation (nominal and extreme angle), conducted in accordance with ASTM F1798-13.
Key Metrics
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.
0
Premarket Notification
APR 1 4 2014
.
·
| SUBMITTED BY | Accel Spine
14901 Quorum Dr. Ste. 125
Dallas, TX 75254 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 3009051471 |
| OWNER/OPERATOR
NUMBER | 10035914 |
| CONTACT PERSON | Lisa Peterson
Kaedon Consulting, LLC
14001 Hunters Pass
Austin, TX 78734
512-507-0746 (phone)
512-266-3364 (fax) |
| DATE PREPARED | April 11, 2014 |
| CLASSIFICATION NAME | Orthosis, spinal pedicle fixation, for degenerative disc
disease (NKB)
Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation
(MNI, MNH) |
| DEVICE CLASS | Class III |
| REGULATION NUMBER | 888.3070 (Product Code NKB, MNI, MNH) |
| COMMON NAME | Pedicle Screw Spinal System |
| PROPRIETARY NAME | Picasso II MIS Spinal System |
| IDENTIFICATION OF PREDICATE
DEVICE(S) | Predicate devices include the following systems:
Accel Spine: Picasso MIS Spinal System (K120714)
Accel Spine: Raphael System (K132365)
- |
| | |
:
.
1
DEVICE DESCRIPTION
The Picasso II MIS Spinal System is comprised of percutaneous cannulated poly axial screws, a set screw and rods designed to allow for minimally invasive surgery. The screw diameters are 5.5mm, 6.5mm and 7.5mm. The screw length ranges from 30mm in 5mm increments.
The Picasso II system will utilize Ø6.0mm MIS rods. Straight and curved rods are provided with the subiect system. Straight rods are available in 35mm-600mm lengths, and curved rods are available in 35mm-150mm lengths.
The implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. The device specific instrumentation intended for patient contact is manufactured from stainless steel materials that conform to ASTM F899.
INDICATIONS
The Picasso II MIS Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso II MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso II MIS Spinal System is intended for noncervical pedicle fixation for the 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 stenosis; curvatures (i.e., scoliosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the Picasso II MIS Spinal System is intended for noncervical pedicle fixation for the following indications: deqenerative 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 stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The purpose of this Special 510/k) is to obtain clearance to market the subject device as the Picasso II MIS Spinal System. The proposed system will utilize a modified version of the perculaneous poly screw housing cleared via K120714 (Picasso MIS Spinal System), and the screw and set screw cleared as part of the Raphael System (K132365).
The fundamental scientific technology and intended use are unchanged from the legally marketed predicate Picasso MIS Spinal System.
DISCUSSION OF NON-CLINICAL TESTING
Results of the engineering analysis provided in support of this premarket notification demonstrate that the modified housing dimensions for the proposed system do not create a worst case construct as compared to the predicate. As the subject device does not create a new worst case, mechanical test results submitted in support of the predicate systems are considered applicable to the subject system.
The following non-clinical tests were conducted to confirm the results of the engineering analysis:
- Static axial grip, static torsional grip, static cantilever bending and static tulip head disassociation (nominal and extreme angle), conducted in accordance with ASTM F1798-13.
CONCLUSIONS
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. Any minor differences do not impact device performance as compared to the predicates and demonstrate that the Accel Spine Picasso II Spinal System is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2014
Accel Spine % Ms. Lisa Peterson Kaedon Consulting, LLC 14001 Hunters Pass Austin, Texas 78734
Re: K140219
Trade/Device Name: Picasso II MIS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: April 7, 2014 Received: April 8, 2014
Dear Ms. Peterson:
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 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 (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 form in the quality by closins (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2.– Ms. Lisa Peterson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140219
Device Name Picasso II MIS Spinal System
Indications for Use (Describe)
The Picasso II MIS Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso II MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso II MIS Spinal System is intended for noncervical pedicle fixation for the 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 stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the Picasso II MIS Spinal System is intended for noncervical pedicle fixation for the 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 stenosis; curvatures (i.e., scoliosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
J Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY - TO BE - THE THE THE Entralian Particle Production Comers (1) Production (1) Production (1) Production (1) Production (1) Production (1) Production (1) Production (1) Production (1) Property (1)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
2014.04.14 09:40:23 -04'00'
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