(63 days)
The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The DePuy Pulse Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The DePuy Pulse Anterior Cervical Plate System consists of an assortment of implantable titanium alloy plates and screws in various sizes.
The DePuy Pulse Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes the DePuy Pulse Anterior Cervical Plate System, a spinal fixation device, and its non-clinical testing. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Compression Bending | "The acceptance criteria was/were met." | "The acceptance criteria was/were met." |
| Static Torsion | "The acceptance criteria was/were met." | "The acceptance criteria was/were met." |
| Dynamic Compression Bending | "The acceptance criteria was/were met." | "The acceptance criteria was/were met." |
Note: The specific numerical or qualitative acceptance criteria for each test (e.g., maximum deflection, load before failure, cycles to failure) are not provided in this summary. The summary only states that the criteria were met.
2. Sample Size Used for the Test Set and Data Provenance:
The document states "No clinical tests were performed." Therefore, there is no test set in the context of clinical data, as this device's submission relied on non-clinical mechanical testing and substantial equivalence to predicate devices. The mechanical tests themselves involve physical samples of the device components. The sample sizes for these mechanical tests are not explicitly stated in the provided text. The data provenance is non-clinical mechanical testing, likely conducted in a laboratory setting by the manufacturer or contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable, as no clinical studies were performed, and thus no expert ground truth was established for a test set of clinical data.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical studies were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as stated by "No clinical tests were performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable, as this device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used:
For the non-clinical mechanical tests, the "ground truth" would be the engineering specifications and performance standards defined by ASTM F-1717 and internal requirements, which the device's performance was measured against. This is essentially engineering specifications/standards compliance.
8. The Sample Size for the Training Set:
Not applicable, as this device is a physical medical implant and does not involve AI/machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as this device is a physical medical implant and does not involve AI/machine learning algorithms that require a training set and corresponding ground truth.
In summary, this submission relies entirely on non-clinical mechanical testing to demonstrate substantial equivalence, rather than clinical studies or AI algorithm performance.
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K112724
page 1 of 2
510(K) SUMMARY
| Submitter: | Medos Internation SàrlChemin-Blanc 38Le Locle, CH-NE 2400, Switzerland |
|---|---|
| Contact Person: | Eugene BangRegulatory Affairs AssociateDePuy Spine, Inc.Voice: (508) 977-3966Fax: (508) 828-3797 |
| Date Prepared: | September 16, 2011 |
| Trade Name: | DePuy Pulse Anterior Cervical Plate System |
| Device Class: | Class II |
| Product Code(s): | KWQ |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Regulation Number: | 888.3060 |
| Predicate Devices: | Skyline Anterior Cervical Plate System - K103491Slim-Loc Anterior Cervical Plate System - K013877Uniplate Anterior Cervical Plate System - K082273 |
| Device Description: | The DePuy Pulse Anterior Cervical Plate System is intended foranterior screw fixation of the plate to the cervical spine. The fixationconstruct consists of a cervical plate that is attached to the vertebral bodyof the cervical spine with self-tapping bone screws using an anteriorapproach. The DePuy Pulse Anterior Cervical Plate System consists ofan assortment of implantable titanium alloy plates and screws in varioussizes.The DePuy Pulse Anterior Cervical Plate System also contains Class 1manual surgical instruments and cases that are considered exempt frompremarket notification. |
| Indications: | The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization ofthe cervical spine from C2 to T1 employing unicortical screw fixation at theanterior face of the vertebral bodies. Specific clinical indications for anteriorplating include: instability caused by trauma; instability associated withcorrection of cervical lordosis and kyphosis deformity; instability associated withpseudoarthrosis as a result of previously failed cervical spine surgery; instabilityassociated with major reconstructive surgery for primary tumors or metastaticmalignant tumors of the cervical spine; instability associated with single ormultiple level corpectomy in advanced degenerative disc disease, spinal canalstenosis and cervical myelopathy. |
| Materials: | Manufactured from ASTM F-136 implant grade titanium alloy. |
| Comparison toPredicate Device: | The substantial equivalence of the subject device to the predicates indentifiedabove is based upon the equivalence of intended use, design (fundamentalscientific technology), materials, manufacturing methods, performance, sterility,biocompatibility, safety and packaging design. |
| Non-clinical TestSummary: | The following mechanical tests were conducted:Static compression bending testing in accordance with ASTM F-1717Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Mode The acceptance criteria was/were met. Static torsion testing in accordance with ASTM F-1717 Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Mode . Theacceptance criteria was/were met. Dynamic compression bending testing in accordance with ASTM F-1717Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Mode . The acceptance criteria was/were met. |
| Clinical TestSummary: | No clinical tests were performed. |
| Conclusion: | Based on the predicate comparison and testing, the subject device DePuy PulseAnterior Cervical Plate System is substantially equivalent to the predicatedevices. |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 2 1 2011
Medos International, Sarl % DePuy Spine, Inc. Mr. Eugene Bang 325 Paramount Drive Raynham, Massachusetts 02767
Re: K112724
Trade/Device Name: DePuy Pulse 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: September 16, 2011 Received: September 19, 2011
Dear Mr. Bang:
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 - Mr. Eugene Bang
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 (OS) 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 yours,
for Poffro
N.A
N.A
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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INDICATIONS FOR USE STATEMENT
510(k) Number: K112724
Device Name: DePuy Pulse Anterior Cervical Plate System
Indications For Use:
The DePuy Pulse Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to T1 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII2724 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.