(80 days)
The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
The DePuy PULSE Anterior Cervical In-Line 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 bone screws using an anterior approach. The DePuy PULSE Anterior Cervical In-Line Plate System consists of an assortment of implantable titanium alloy plates and screws in various sizes.
The provided text describes a 510(k) summary for the DePuy PULSE™ Anterior Cervical In-Line Plate System, which is a medical device for anterior screw fixation of the plate to the cervical spine. The "study" proving the device meets acceptance criteria refers to non-clinical mechanical tests, as no clinical tests were performed.
Here's the breakdown of the information requested, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static compression bending testing (in accordance with ASTM F-1717) | The acceptance criteria was/were met. | The acceptance criteria was/were met. |
| Static torsion testing (in accordance with ASTM F-1717) | The acceptance criteria was/were met. | The acceptance criteria was/were met. |
| Dynamic compression bending testing (in accordance with ASTM F-1717) | The acceptance criteria was/were met. | The acceptance criteria was/were met. |
Note: The document states that the "acceptance criteria was/were met" for all tests without providing the specific numerical values of the acceptance criteria themselves.
Study Details (Non-Clinical Mechanical Testing)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The tests are described as "mechanical tests," implying they were conducted in a laboratory setting. The text does not provide information about the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM F-1717) and measurements from the testing equipment, not by human expert consensus or clinical assessment.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. Mechanical test results are typically objective measurements, not subjective evaluations requiring adjudication.
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:
- MRMC Study: No. The device is an Anterior Cervical Plate System, a physical implant, not an AI-assisted diagnostic tool.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for this device's performance is based on engineering standards and measurements from mechanical testing equipment, specifically in accordance with ASTM F-1717 for spinal implant constructs in a vertebrectomy model.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a physical implant, and the "study" concerns non-clinical mechanical safety and performance, not machine learning model training.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
In summary, the provided document focuses on the non-clinical mechanical testing of a physical medical implant (an anterior cervical plate system) to demonstrate its substantial equivalence to predicate devices. It does not involve AI, human expert readings, or clinical studies.
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510(K) SUMMARY
Submitter:
Medos International Sàrl Chemin-Blanc 38 Le Locle, CH-NE 2400, Switzerland
Contact Person:
Eugene Bang Regulatory Affairs Associate Voice: (508) 977-3966 (508) 828-3797 Fax:
October 8, 2012
Class II
KWQ
888.3060
Date Prepared: Trade Name: Device Class: Product Code(s): Common Name: Classification Name: Regulation Number:
Predicate Devices:
Device Description:
AcroPlate Anterior Cervical Plate System (DePuy Spine) - K914362 Uniplate Anterior Cervical Plate System (DePuy Spine) - K042544 Skyline Anterior Cervical Plate System (DePuy Spine) - K 103491 PULSE Anterior Cervical Plate System (DePuy Spine) - K112724
DePuy PULSETM Anterior Cervical In-Line Plate System
Appliance, Fixation, Spinal Intervertebral Body
Spinal Intervertebral Body Fixation Orthosis
The DePuy PULSE Anterior Cervical In-Line 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 bone screws using an anterior approach. The DePuy PULSE Anterior Cervical In-Line Plate System consists of an assortment of implantable titanium alloy plates and screws in various sizes.
DEC 2 8 2012
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| Indications: | The DePuy PULSE Anterior Cervical In-Line Plate System is intended foranterior cervical intervertebral body fixation. This system is indicated for patientsin which stability is desired following anterior cervical fusion for the indicationslisted below. The intended levels for treatment range from C2 to T1. |
|---|---|
| Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined asdiscogenic pain with degeneration of the disc confirmed by history andradiographic studies), spinal stenosis, re-operation for failed fusion, or instabilityfollowing surgery for the above indications. | |
| Materials: | Manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F-136. |
| 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 VertebrectomyModel. The acceptance criteria was/were met.• Static torsion testing in accordance with ASTM F-1717 Standard TestMethod for Spinal Implant Constructs in a Vertebrectomy Model. Theacceptance criteria was/were met.• Dynamic compression bending testing in accordance with ASTM F-1717Standard Test Method for Spinal Implant Constructs in a VertebrectomyModel. 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 In-Line Plate System is substantially equivalent to thepredicate devices. |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized lines forming its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: December 28, 2012
Medos International, Sarl % John & Johnson Company Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K123167
Trade/Device Name: DePuy PULSE™ Anterior Cervical In-Line Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 08, 2012 Received: October 09, 2012
Dear Mr. Bang:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewe 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, de noos that have been 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 manier the Act include requirements for annual registration, listing of I ho general bonators proving practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition: Triouse noter, 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 may be subject to additions, 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 I least of advisou that I Drivice and sever device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I ederal statures and regimments, including, but not limited to: registration and listing (21 Comply with an the Act 8 require mart 801); medical device reporting (reporting of medical CITY att 6077, laboring (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Eugene Bang
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/ReportalProblem/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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K123167
Device Name: DePuy PULSE™ Anterior Cervical In-Line Plate System
Indications For Use:
The DePuy PULSE Anterior Cervical In-Line Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
Prescription Use __ X
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(Part 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)
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(Division Sign-Off) Division of Orthopedic Devices 510(K) Number: K123167
§ 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.