(93 days)
No
The summary describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any terms related to AI or ML. The performance studies are mechanical tests.
Yes
The device is described as providing "immobilization and stabilization of spinal segments" as an "adjunct to fusion" in the treatment of various spinal conditions, which are therapeutic actions.
No
This device is a surgical implant system designed to provide immobilization and stabilization of spinal segments, not to diagnose a condition.
No
The device description explicitly states it consists of "a variety of rods, pedicle screws, connectors, set screws and other connection components" and "Class 1 manual surgical instruments and cases," which are all physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The DePuy Pulse Thoracolumbar Screw System is described as a system of metallic components (rods, screws, connectors) and surgical instruments used to build a spinal construct for immobilization and stabilization.
- Intended Use: The intended use is to provide mechanical support and stabilization to the spine as an adjunct to fusion. This is a surgical implant, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Pulse Thoracolumbar Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The DePuy Pulse Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Product codes
NKB, MNI, MNH, KWP, KWQ
Device Description
The DePuy Pulse Thoracolumbar Screw System consists of a variety of rods, pedicle screws, connectors, set screws and other connection components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being made for the individual case.
The DePuy Pulse Thoracolumbar Screw System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine.
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)
Non-clinical Test Summary:
The following mechanical tests were conducted:
Static compression bending testing in accordance with ASTM F-1717 Standard 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. The acceptance criteria was/were met. Dynamic compression bending testing in accordance with ASTM F-1717 Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Mode. The acceptance criteria was/were met.
Clinical Test Summary: No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K953915, K033901, K051024, K062174, K063156, K063741, K080313, K081898, K103490
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.
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K113396 Page 1/2
FEB - 8 2012
510(K) SUMMARY
| Submitter: | Medos International Sàrl
Chemin-Blanc 38
Le Locle, CH-NE 2400, Switzerland |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eugene Bang
Regulatory Affairs Associate
DePuy Spine, Inc.
Voice: (508) 977-3966
Fax: (508) 828-3797 |
| Date Prepared: | November 4, 2011 |
| Trade Name: | DePuy Pulse Thoracolumbar Screw System |
| Device Class: | Class III |
| Product Code(s): | NKB, MNI, MNH, KWP, KWQ |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body
Appliance, Fixation, Spinal Interlaminal
Orthosis, Spondyloisthesis Spinal Fixation
Orthosis, Spinal Pedicle Fixation
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
| Classification Name: | Spinal Interlaminal Fixation Orthosis
Spinal Intervertebral Body Fixation Orthosis
Pedicle Screw Spinal System |
| Regulation Number: | 888.3050, 888.3060, 888.3070 |
| Predicate Devices: | Moss Miami System - K953915
Expedium System - K033901, K051024, K062174, K063156, K063741
K080313, K081898, K103490 |
| Device Description: | The DePuy Pulse Thoracolumbar Screw System consists of a variety of
rods, pedicle screws, connectors, set screws and other connection
components used to build a spinal construct. The implant components
can be rigidly locked into a variety of configurations, with each construct
being made for the individual case.
The DePuy Pulse Thoracolumbar Screw System also contains Class 1
manual surgical instruments and cases that are considered exempt from
premarket notification. |
| Indications: | The DePuy Pulse Thoracolumbar Screw System is intended to provide
immobilization and stabilization of spinal segments in skeletally mature patients
as an adjunct to fusion in the treatment of acute and chronic instabilities or
deformities of the thoracic, lumbar and sacral spine.
The DePuy Pulse Thoracolumbar Screw System metallic components are
intended for noncervical pedicle fixation and nonpedicle fixation for fusion for
the following indications: degenerative disc disease (defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and
radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation);
spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor,
pseudoarthrosis; and failed previous fusion in skeletally mature patients. |
| Materials: | Manufactured from ASTM F-136 implant grade titanium alloy. |
| Comparison to
Predicate Device: | The substantial equivalence of the subject device to the predicates indentified
above is based upon the equivalence of intended use, design (fundamental
scientific technology), materials, manufacturing methods, performance, sterility,
biocompatibility, safety and packaging design. |
| Non-clinical Test
Summary: | The following mechanical tests were conducted:
Static compression bending testing in accordance with ASTM F-1717
Standard 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. The
acceptance criteria was/were met. Dynamic compression bending testing in accordance with ASTM F-1717
Standard Test Method for Spinal Implant Constructs in a Vertebrectomy
Mode. The acceptance criteria was/were met. |
| Clinical Test
Summary: | No clinical tests were performed. |
| Conclusion: | Based on the predicate comparison and testing, the subject device DePuy Pulse
Thoracolumbar Screw System is substantially equivalent to the predicate devices. |
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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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medos International, Sarl % DePuy Spine, Inc. Mr. Eugene Bang 325 Paramount Drive Raynham, Massachusetts 02767
FEB - 8 2012
Re: K113396
Trade/Device Name: DePuy Pulse Thoracolumbar Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: January 6, 2012 Received: January 9, 2012
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 I ou may 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 additeration. "Frease 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 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 r tease be advisour and internination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I edital 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 Of ICF at 6077, aboning (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.
3
Page 2 - Mr. Eugene Bang
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you assile spec.fda.gov/AboutFDA/CentersOffices/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 note the 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 Tou thay ovani other generers, 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
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Kil 3396
Device Name: DePuy Pulse Thoracolumbar Screw System
Indications For Use:
The DePuy Pulse Thoracolumbar Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The DePuy Pulse Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
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)
(Diyision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K113396 510(k) Number_