(47 days)
The PSL Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
The PSL Anterior Cervical Plate (ACP) System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
This document describes a 510(k) premarket notification for the "PSL Anterior Cervical Plate System". It's a medical device, specifically a spinal implant, which means the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and comparison of characteristics, rather than clinical efficacy studies often associated with AI/software devices.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Mechanical Performance (according to ASTM F1717): | |
| Static Compression Bending | Performed "as well as the predicate device" |
| Static Torsion | Performed "as well as the predicate device" |
| Dynamic Compression Bending | Performed "as well as the predicate device" |
| Technological Characteristics: | |
| Intended Use | Identical to predicate device |
| Design (plate-based fixation, self-tapping screws) | Identical to predicate device |
| Material (titanium alloy) | Identical to predicate device |
| Sizes (plate and screw) | Identical to predicate device |
| Fundamental Scientific Technology | Same as previously cleared device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Mechanical Testing: "worst-case, cervical plate construct" - The document does not specify the exact number of constructs tested, but implies a sufficient number for an engineering study to demonstrate performance against the predicate.
- Data Provenance: The mechanical tests were performed by the manufacturer (Precision Surgery Limited) or a contracted lab. This is a prospective engineering study, not involving human data. There is no country of origin of data in the same sense as clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable in the context of this device. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and direct comparison to the predicate device, not by expert medical consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable. This is an engineering study, not a clinical study requiring adjudication of outcomes or diagnoses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size.
No, an MRMC study was not done. This is a spinal implant, not an AI/software device that would typically involve human readers interpreting images.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence was:
- Predicate Device Performance: The established mechanical performance of the legally marketed predicate device (Fixed, Variable & Corpectomy Cervical Plate System (K032815/K073708)).
- ASTM F1717 Standard: The performance criteria defined by the standard for spinal implant mechanical testing.
- Direct Comparison of Characteristics: Comparing the design, materials, intended use, and sizes directly to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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8. 510(k) Summary
FEB 15 2011
| Date: | 29 December 2010 |
|---|---|
| Sponsor: | Precision Surgery Limited |
| 2700 W. 9th Ave, Suite 120 | |
| Oshkosh, WI 54904 | |
| Phone 920-223-0547Fax 920-223-0551 | |
| Contact Person: | Kamaljit S. Paul, MD |
| Proposed TradeName: | PSL Anterior Cervical Plate System |
| Device Classification | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation: | 888.3060 |
| Device ProductCode: | KWQ |
| Device Description: | The PSL Anterior Cervical Plate (ACP) System comprises plate andscrew components in a variety of sizes and lengths. Three styles ofplate, including fixed, variable and corpectomy, are available.Primary, self-drilling primary and rescue screws are offered. |
| Intended Use: | The PSL Anterior Cervical Plate System is intended for anteriorscrew fixation of the cervical spine (C2-C7). These implants havebeen designed to provide stabilization as an adjunct to cervicalfusion. Indications for the use of this implant system are:degenerative disc disease defined as neck pain of discogenic originwith the degeneration of the disc confirmed by history andradiographic studies, spondylolisthesis, trauma, spinal stenosis,deformity, tumor, pseudarthrosis or failed previous fusion.WARNING: The PSL Anterior Cervical Plate System is not intendedfor screw attachment or fixation to the posterior elements (pedicles)of the cervical, thoracic or lumbar spine. |
| Materials: | The PSL ACP System components are manufactured from titaniumalloy (Ti-6Al-4V per ASTM F136). The screw-retaining central rail ismanufactured from nickel titanium alloy (NiTi per ASTM F2063). |
| Predicate Device: | Fixed, Variable & Corpectomy Cervical Plate System(K032815/K073708) |
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Technological The PSL ACP System is identical to the predicate Fixed, Variable & Corpectomy Cervical Plate System, only the system name has Characteristics: changed. Therefore, the system possesses the same technological characteristics as the predicate. These include: . intended use (as described above), design (plate-based fixation system having self-tapping screws in .
- various sizes),
- . material (titanium alloy) and
- sizes (plate and screw sizes are the same as those offered by . the predicate system).
The fundamental scientific technology of the PSL ACP is the same as the previously cleared device.
Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that the PSL ACP performs as well as the predicate device.
The PSL Anterior Cervical Plate System is substantially equivalent to the devices referenced above and is therefore safe and effective for its intended use.
Performance Data:
Conclusion:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Precision Surgery, Ltd. % BackRoads Consulting, Inc. Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026
FEB 15 201
Re: K103819
Trade/Device Name: PSL Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: December 29, 2010 Received: December 30, 2010
Dear Dr. Warden:
. ·
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 - Karen E. Warden, Ph.D.
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 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.
A. Sig. B. R2A
for
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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7. Indications for Use Statement
510(k) Number: K103819
Device Name: PSL Anterior Cervical Plate System
Indications for Use:
The PSL Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stablization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The PSL Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumber spine.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use
(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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K103819 - -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.