(88 days)
The SpineFrontier Indus™ ACP System (Indus™ Invue™, Indus™ Invue™2, Indus Inset") is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.
The SpineFrontier Indus™ ACP System consists of a variety of shapes and sizes of plates, screws, and associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The screws come as self tapping or self drilling in various lengths and diameters. The SpineFrontier Indus™ ACP System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V El.I) that conforms to ASTM F 136.
The provided text describes a medical device, the SpineFrontier Indus™ ACP System, and its clearance process through a 510(k) premarket notification. This type of submission relies on demonstrating "substantial equivalence" to a predicate device, primarily through non-clinical performance data. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like accuracy, sensitivity, etc.) is not applicable here.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from device guidance) | Reported Device Performance (as demonstrated) |
|---|---|
| Substantial equivalence to predicate devices in: | Substantially equivalent to predicate devices in: |
| - Indications for Use | - Indications for Use |
| - Function | - Function |
| - Operating Principles | - Operating Principles |
| - Materials | - Materials (Titanium alloy - Ti-6Al-4V El.I) |
| - Performance (Mechanical Testing) | - Performance (Mechanical testing per ASTM Standard F1717) |
The document explicitly states: "The SpineFrontier Indus™ ACP System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing). Clinical data was not required for this device."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This device clearance was based on mechanical testing, not clinical studies with human participants or data.
- Data Provenance: Not applicable. The "data" refers to the results of mechanical tests, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of expert consensus on patient data, is not relevant to mechanical testing.
4. Adjudication method for the test set
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (spinal implant) and not an AI/software device that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used
- The "ground truth" for this medical device would be adherence to the specifications for materials and the established performance standards set by ASTM F1717 for spinal implant constructs. These are objective, rather than expert-derived, measures.
8. The sample size for the training set
- Not applicable. There is no AI component or training set involved in the clearance of this physical medical device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The SpineFrontier Indus™ ACP System demonstrated its acceptance criteria by performing mechanical testing in accordance with ASTM Standard F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This testing allowed the manufacturer to show that the device's performance, along with its indications for use, function, operating principles, and materials, was substantially equivalent to legally marketed predicate devices (K093776, K050588, K073275, K030866).
The FDA guidance "Spinal System 510(k)s, May 3, 2004" dictated that clinical data was not required for this device, emphasizing the reliance on non-clinical, mechanical performance data for clearance. The successful completion of this mechanical testing, demonstrating equivalence to the predicate devices, served as the "study" proving the device met the required regulatory "acceptance criteria" for substantial equivalence.
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JUL
3 2012
5.0 510(k) Summary
1. Sponsor
SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915
| Primary Contact: | Fredy H. Varela, RACRegulatory Affairs Specialist |
|---|---|
| Telephone: | 1-978-232-3990 |
| Date Prepared: | April 3, 2012 |
2. Device Name and Classification:
SpineFrontier Indus™ ACP System Proprietary Names:
Common/Usual Name: Spinal Intervertebral Body Fixation Orthosis
Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060), Class II
KWQ Product Code:
3. Predicate Devices
K093776- SpineFrontier - Indus™ Anterior Cervical Plate System K050588- Innovative Spinal - Verteview ACP System K073275- NuVasive - Helix Mini ACP System K030866- Synthes - Anterior CSLP System
4. Device Description
The SpineFrontier Indus™ ACP System consists of a variety of shapes and sizes of plates, screws, and associated instruments. The plates are available in four levels to accommodate one to four levels of fixation. The screws come as self tapping or self drilling in various lengths and diameters. The SpineFrontier Indus™ ACP System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V El.I) that conforms to ASTM F 136.
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This submission is being provided for design changes to the previously cleared Indus™ Anterior Cervical Plate System (K093776).
5. Intended Üse
The SpineFrontier Indus" ACP System (Indus™ Invue™, Indus™ Invue "2, Indus™ Inset™) is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above. indications.
6. Technological Characteristics
The SpineFrontier Indus" ACP System System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles and materials.
The SpineFrontier Indus™ ACP System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing). Clinical data was not required for this device.
7. Basis for Substantial Equivalence
The SpineFrontier Indus" ACP System was evaluated in accordance with FDA Document, Guidance for Industry and FDA Staff' - Spinal System 510(k)s, May 3, 2004, and has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing). Clinical data was not required for this device. Mechanical testing includes performance assessments per the following recognized test methods:
- ASTM Standard F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
Special 510(k) Premarket Notification
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SpineFrontier, Inc. % Fredy H. Varela, RAC Regulatory Affairs Specialist 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915
3 2012 JUL
Re: K121060
Trade/Device Name: Indus ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 2, 2012 Received: June 7, 2012
Dear Mr. Varela:
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.
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Page 2- Fredy H. Varela, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised hite i Dri bisean.to vour device complies with other requirements of the Act that i Dri has made a aved regulations administered by other Federal agencies. You must or any I catal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the rece 31equiremansmally, medical device reporting (reporting of medical CI it i art 007), laboring (DF CFR 803); good manufacturing practice requirements as set de vice-related daverse ovenis) (2 regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 11 you desire specific ad resources offices/CDRH/CDRHOffices/ucm115809.htm for go to hap. W. W. Madiological 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 I ou may 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 yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indications for Use Statement
510(k) Number (if Known):
Device Name: SpineFrontier Indus™ ACP System
Indications For Use:
The SpineFrontier Indus™ ACP System (Indus™ Invue™, Indus™ Invue™2, Indus Inset") is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.
Prescription Use: X
OR
Over-The-Counter Use: (Part 21 CFR 807.109)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Diffsion of Surgical, Orthopedic, And Restorative Devices
K121060 510(k) Number_
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.