(95 days)
Not Found
No
The summary describes a passive implant device (lumbar cage) and mechanical testing, with no mention of AI/ML terms, image processing, or data sets for training/testing.
Yes
The device is a lumbar cage system intended for use as an intervertebral body fusion device to facilitate fusion in the lumbar spine for patients with degenerative disc disease, which serves a therapeutic purpose.
No
The device is described as an intervertebral body fusion device and implant, used to facilitate fusion, not to diagnose a condition.
No
The device description explicitly states the device is manufactured from PEEK and tantalum markers, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The DePuy PULSE Lumbar Cage System is an implantable device designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a physical device used in vivo (within the body), not a test performed on a sample in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical components or processes associated with IVDs (reagents, analyzers, test kits, etc.).
Therefore, the DePuy PULSE Lumbar Cage System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The DePuy PULSE Lumbar Cage System is designed for use as a lumbar 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 tantalum markers per ASTM F-560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
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 and dynamic axial 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 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.
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, K101923, K110694, K103034, P950019
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
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: | March 29, 2012 |
| Trade Name: | DePuy PULSE™ Lumbar Cage System |
| Device Class: | Class II |
| Product Code(s): | MAX |
| Common Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 888.3080 |
| Predicate Devices: | Concorde System - K081917, K103488
Concorde Curve System - K101923
Concorde Inline System - K110694
Genesys Spine Interbody Fusion System - K103034
RAY Threaded Fusion Cage - P950019 |
| Device Description: | The DePuy PULSE Lumbar Cage System is designed for use as a
lumbar 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
tantalum markers per ASTM F-560. |
| Indications: | The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral
body fusion devices in skeletally mature patients with degenerative disc disease
(defined as discogenic back pain with degeneration of the disc confirmed by
patient history and radiographic studies) at one or two contiguous levels of the
lumbar spine (L2-S1). Patients should have six months of non-operative
treatment prior to surgery. These implants are used to facilitate fusion in the
lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone.
When used as intervertebral body fusion devices these implants are intended for
use with DePuy Spine supplemental internal fixation products. |
| Materials: | Manufactured from medical grade polyetheretherketone (PEEK OPTIMA® LT1)
per ASTMF F-2026 and tantalum markers 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 axial 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 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
Lumbar Cage System is substantially equivalent to the predicate 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings and a wavy line representing its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medos International Sarl % Depuy Spine, A Johnson & Johnson Company Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
3 2012 JUL
Re: K120966
Trade/Device Name: DePuy PULSE™ Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 08, 2012 Received: June 11, 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.
3
Page 2- Mr. Eugene Bang
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 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.
Evinl Keith
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):
Device Name: DePuy PULSE™ Lumbar Cage System
Indications For Use:
The DePuy PULSE Lumbar Cage System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a PLIF or TLIF approach using autogenous bone. When used as intervertebral body fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use __
(21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(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
510(k) Number K120966