(65 days)
Not Found
No
The summary describes a physical implant (cervical cage) and manual surgical instruments. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests of the implant.
Yes
The device is indicated for use as an intervertebral body fusion device to treat degenerative disc disease and facilitate fusion in the cervical spine, which is a therapeutic purpose.
No
The DePuy Pulse Cervical Cage System is described as an intervertebral body fusion device and is intended to facilitate fusion in the cervical spine. It is a surgical implant, not a device used for diagnosis.
No
The device description explicitly states that the system includes implant devices made from PEEK and tantalum, as well as manual surgical instruments and cases, indicating it is a hardware-based medical device.
Based on the provided information, the DePuy Pulse Cervical Cage System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The DePuy Pulse Cervical Cage System is an implantable surgical device. Its purpose is to facilitate fusion in the cervical spine by being surgically placed within the body.
- The description focuses on the physical characteristics of the device, its intended surgical use, and mechanical testing. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the DePuy Pulse Cervical Cage System falls under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2 - T1) and are placed via an anterior approach using autogenous bone. DePuy Pulse Cervical Cage System implants are intended to be used with supplemental internal fixation system.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The DePuy Pulse Cervical Cage System is designed for use as a cervical intervertebral body fusion device. The implant devices are available in various geometries and sizes to accommodate patient anatomy. The implant devices are manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 and also contain tantalum wires per ASTM F-560. The DePuy Pulse Cervical Cage 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
cervical spine (C2 - T1)
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
No clinical tests were performed.
Description of the test set, sample size, data source, and annotation protocol
No clinical tests were performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following mechanical tests were conducted:
Static and dynamic compression testing in accordance with ASTM F-2077 Standard Test Method for Intervertebral Body Fusion Devices. The acceptance criteria was/were met. Static and dynamic torsion testing in accordance with ASTM F-2077 Standard Test Method for Intervertebral Body Fusion Devices. The acceptance criteria was/were met. Static and dynamic compression shear testing in accordance with ASTM F-2077 Standard Test Method for Intervertebral Body Fusion Devices. The acceptance criteria was/were met. Subsidence testing in accordance with ASTM F-2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. The acceptance criteria was/were met.
No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K081917, K103488, P960025, K091088
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
KI20217
APR 2 6 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: | February 17, 2012 |
| Trade Name: | DePuy Pulse Cervical Cage System |
| Device Class: | Class II |
| Product Code(s): | ODP |
| Common Name: | Intervertebral Fusion Device with Bone Graft, Cervical |
| Classification Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 888.3080 |
| Predicate Devices: | Bengal System - K081917, K103488
Concorde System - K081917
Lumbar I/F Cage System - P960025'
LDR Spine Cervical Interbody Fusion System - K091088 |
| Device Description: | The DePuy Pulse Cervical Cage System is designed for use as a cervical
intervertebral body fusion device. The implant devices are available in
various geometries and sizes to accommodate patient anatomy. The
implant devices are manufactured from medical grade
polyetheretherketone (PEEK OPTIMA® LT1) per ASTM F-2026 and
also contain tantalum wires per ASTM F-560.
The DePuy Pulse Cervical Cage System also contains Class 1 manual
surgical instruments and cases that are considered exempt from
premarket notification. |
| Indications: | The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral
body fusion device in skeletally mature patients with degenerative disc disease
(defined as discogenic neck pain with degeneration of the disc confirmed by
patient history and radiographic studies) at one level of the cervical spine with
accompanying radicular symptoms. Patients should have six weeks of non-
operative treatment prior to surgery. The DePuy Pulse Cervical Cage System
implants are used to facilitate fusion in the cervical spine (C2 - T1) and are
placed via an anterior approach using autogenous bone. DePuy Pulse Cervical
Cage System implants are intended to be used with supplemental internal fixation
system. |
| Materials: | Manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LTI)
per ASTMF F-2026 and tantalum wires per ASTM F-560. |
| 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 and dynamic compression testing in accordance with ASTM F-2077
Standard Test Method for Intervertebral Body Fusion Devices. The
acceptance criteria was/were met. Static and dynamic torsion testing in accordance with ASTM F-2077
Standard Test Method for Intervertebral Body Fusion Devices. The
acceptance criteria was/were met. Static and dynamic compression shear testing in accordance with ASTM F-
2077 Standard Test Method for Intervertebral Body Fusion Devices. The
acceptance criteria was/were met. Subsidence testing in accordance with ASTM F-2267 Standard Test Method
for Measuring Load Induced Subsidence of Intervertebral Body Fusion
Device Under Static Axial Compression. 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
Cervical Cage System is substantially equivalent to the predicate devices. |
1 This device was re-classified from a Class III (PMA) device to a Class II (510K) device via petition approved on 2007
1
队120517
Pg 2 of 2
2
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 features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medos International Sarl % Mr. Eugene Bang DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
APR 2 6 2012
Re: K120517
Trade/Device Name: DePuy Pulse Cervical Cage System Regulation Number: 21 CFR 8880.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 17, 2012 Received: February 21, 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 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 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
3
Page 2 - Mr. Eugene Bang
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 yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
12051
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K120517
Device Name: DePuy Pulse Cervical Cage System
Indications For Use:
The DePuy Pulse Cervical Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. The DePuy Pulse Cervical Cage System implants are used to facilitate fusion in the cervical spine (C2 - T1) and are placed via an anterior approach using autogenous bone. DePuy Pulse Cervical Cage System implants are intended to be used with supplemental internal fixation system.
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)
Division Sign Off
(Division Sign-Off) Diyision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120517