(111 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on physical implants and surgical tools.
Yes
The device is used to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion for various acute and chronic instabilities or deformities, which is a therapeutic purpose.
No
This device is described as a "Spinal System" that provides immobilization and stabilization of spinal segments as an adjunct to fusion. It contains implants and surgical tools, which indicates it is a therapeutic or surgical device, not a diagnostic one.
No
The device description explicitly states that the Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools, indicating it is a hardware-based medical device.
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: The description clearly states the Malibu Spinal System contains "titanium alloy and cobalt alloy implants and surgical tools." These are physical devices intended for surgical implantation and manipulation within the body.
- Intended Use/Indications for Use: The intended use and indications describe the device's purpose in providing "immobilization and stabilization of spinal segments" and treating various spinal conditions through surgical intervention. This involves direct interaction with the patient's anatomy, not the analysis of samples taken from the body.
Therefore, the Malibu Spinal System falls under the category of a surgical implant/device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The intended use for the Malibu Spinal System remains unchanged by the addition of the product line extension and remains as:
The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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.
The indications for use are as follows:
-
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
-
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
-
trauma (i.e., fracture or dislocation),
-
spinal stenosis, ·
-
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
tumor,
-
pseudarthosis, and/or
-
failed previous fusion.
The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows: -
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
-
spondylolisthesis,
-
trauma (i.e., fracture or dislocation),
-
spinal stenosis.
-
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
tumor,
-
pseudarthosis, and/or
-
failed previous fusion.
Product codes
NKB, MNI, MNH, KWP
Device Description
The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, T1-L5, L5-S1 vertebra
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 subjective devices were compared to legally marketed predicated devices in regards to an array of testing per ASTM 1717 (static compressive bending, fatigue compressive bending, static torsion) and ASTM 1798 (static AP) testing and found to be equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072605, K061342, K051942, K051663, K060979, K021623, K053276
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
Malibu Spinal System with the Daytona Deformity System Special 510(k)
| Special 510(k) Summary | DEC 12 2012 | ||
|---|---|---|---|
| Company Name: | SeaSpine, Inc. | ||
| An Integra Life Sciences Company | |||
| 2302 La Mirada Drive | |||
| Vista, CA 92081 | |||
| Contact person: | Nicholas M. Cordaro | ||
| Director, Engineering | |||
| e-mail: nick.cordaro@integralife.com | |||
| Phone: (760) 216-5603, Fax: (760) 477-8260 | |||
| Date prepared: | December 11, 2012 | ||
| Trade name: | Malibu™ Spinal System with the Daytona™ Deformity System | ||
| Common name: | Pedicle Screw System | ||
| Classification name: | Pedicle Screw Spinal System | ||
| MNH (Class II) - 888.3070(b)(1) | |||
| MNI (Class II) - 888.3070(b)(1) | |||
| NKB (Class III) - 888.3070(b)(2) |
Spinal Interlaminal Fixation Orthosis
KWP (Class II) - 888.3050 | | |
| Predicate Device: | Previously cleared Malibu Spinal System 510(k)'s K072605, K061342, K051942, K051663, Xia Spinal System 510(k) K060979, UCR Spinal System 510(k) K021623 and the IST Pedicle Screw System 510(k) K053276. | | |
| Device Description: | The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System. | | |
| Intended use: | The intended use for the Malibu Spinal System remains unchanged by the addition of the product line extension and remains as:
The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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 | | |
1
1
chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The indications for use are as follows:
-
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
-
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
-
trauma (i.e., fracture or dislocation),
-
spinal stenosis, ·
-
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
tumor,
-
pseudarthosis, and/or
-
failed previous fusion.
The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows: -
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
-
spondylolisthesis,
-
trauma (i.e., fracture or dislocation),
-
spinal stenosis.
-
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
tumor,
-
pseudarthosis, and/or
-
failed previous fusion.
Technological Characteristics:
The spinal rod product line extension increases the ultimate strength of the existing cobalt alloy spinal rods while the varying uni-planar pedicle screws combine the features of the current pedicle screws including cannulated and non-cannulated with variable and limiting angles. These line item extensions to the system do not alter the fundamental scientific technologies of the previously cleared system; these devices have substantially equivalent technological characteristics as the predicate devices. These Malibu rods and pedicle screws are housed within the Daytona™ Deformity sterilization tray. A re-validation to updated standards is included.
Performance Testing:
The subjective devices were compared to legally marketed predicated devices in regards to an array of testing per ASTM 1717 (static compressive bending, fatigue compressive bending, static torsion) and ASTM 1798 (static AP) testing and found to be equivalent.
2
:
:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
.
100 - 100 - 100 -
| Declaration of
Substantial Equivalence: | All verification and validation activities related to the design features,
conducted risk analysis, and mitigation activities (e.g. performance testing)
showed that the submitted devices are substantially equivalent to predicate
devices. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The manufacturing facility is in conformance with the design control
procedure requirements as specified in 21 CFR §820.30 and the records are
available for review. |
.
.
:
and the comments of the comments of
.
.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is oriented to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: December 12, 2012
SeaSpine, Incorporated % Mr. Nicholas M. Cordaro Director, Engineering 2302 La Mirada Drive Vista, California 92081
Re: K122571
Trade/Device Name: Malibu™ Spinal System with the Daytona™ Deformity System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: November 1, 2012 Received: November 19, 2012
Dear Mr. Cordaro:
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
4
Page 2 - Mr. Nicholas M. Cordaro
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health ·
Enclosure
5
Indications for Use Statement
510(k) Number: K122571
Device Name: Malibu™ Spinal System with the Daytona™ Deformity System
Indications for Use:
The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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.
The indications for use are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- : severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- spinal tumor,
- pseudoarthrosis, and/or
- failed previous fusion.
Prescription Use
AND/OR
Over-The-Counter-Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122571
Page 1 of 2
6
510{k} Number: K122571
Device Name: Malibu™ Spinal System with the Daytona™ Deformity System
Indications for Use (Continued):
The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudarthosis, and/or
- failed previous fusion.
Prescription Use
AND/OR
Over-The-Counter-Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Summary: K122571