(117 days)
Not Found
No
The summary describes a passive spinal implant made of PEEK with tantalum markers, focusing on mechanical properties and surgical approaches. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is used for interbody fusion in patients with degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
The device is an interbody fusion device designed to provide structural support and facilitate bone fusion in patients with degenerative disc disease. It is an implantable therapeutic device, not a diagnostic one used for identifying or characterizing a medical condition.
No
The device description clearly states it is a physical implant made of PEEK with Tantalum markers, and the performance studies are mechanical tests of the physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, not a test performed on biological samples outside the body.
- Device Description: The device is a physical implant made of PEEK and Tantalum, designed to be placed within the body. IVDs are typically reagents, kits, instruments, or software used to analyze samples.
- Performance Studies: The performance studies described are mechanical tests of the implant's strength and durability, not studies evaluating the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions. This device is a therapeutic implant used in surgery.
N/A
Intended Use / Indications for Use
The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The subject CRESCENT™ Spinal System consists of a variety of hollow intervertebral body spacers featuring a bullet-nosed, anatomically shaped design with axial voids designed to hold autogenous bone graft. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices are designed to be implanted through the transforaminal and direct lateral approaches. The devices range from 7mm to 15mm in height and from 25mm to 36mm in length. The devices are manufactured from Medical Grade PEEK (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
Indicated Patient Age Range
skeletally mature
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)
The following mechanical tests of the subject CRESCENT™ Spinal System were performed :
- . static axial compression testing in accordance with ASTM 2077-03:
- dynamic axial compression testing in accordance with ASTM 2077-03; .
- . static compression shear testing in accordance with ASTM 2077-03;
- compression shear fatigue testing in accordance with ASTM 2077-03; and .
- subsidence testing in accordance with ASTM F2267-04. .
Results of mechanical testing indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073291, P970015, P950019, P960025, K052261
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
CRESCENTTM Spinal System 510(k) Summary April 23, 2010
- I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
APR 2 6 2010
| Contact: | Jennifer Hackney |
|---|---|
| Regulatory Affairs Specialist |
Proprietary Trade Name: CRESCENT™ Spinal System II.
Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080) III.
- IV. Product Code: MAX
V. Product Description
The subject CRESCENT™ Spinal System consists of a variety of hollow intervertebral body spacers featuring a bullet-nosed, anatomically shaped design with axial voids designed to hold autogenous bone graft. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices are designed to be implanted through the transforaminal and direct lateral approaches. The devices range from 7mm to 15mm in height and from 25mm to 36mm in length. The devices are manufactured from Medical Grade PEEK (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.
V. Indications
The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
1
VI. Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence
Documentation was provided which demonstrated that the subject CRESCENT™ Spinal System is substantially equivalent to several interbody cages, including the CAPSTONE® Spinal System (K073291, SE 04/24/08), the LT-CAGE® PEEK Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), and the BRANTIGEN I/F CAGE® (DePuy, P960025), as well as to the VERTE-STACK® Spinal System (K052261, SE 10/07/05).
VII. Brief Discussion of the Non-Clinical Tests Submitted
The following mechanical tests of the subject CRESCENT™ Spinal System were performed :
- . static axial compression testing in accordance with ASTM 2077-03:
- dynamic axial compression testing in accordance with ASTM 2077-03; .
- . static compression shear testing in accordance with ASTM 2077-03;
- compression shear fatigue testing in accordance with ASTM 2077-03; and .
- subsidence testing in accordance with ASTM F2267-04. .
VIII. Conclusions Drawn from the Non-Clinical Tests
Results of mechanical testing indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek % Ms. Jennifer Hackney Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
APR 2 6 2010
Re: K094025
Trade/Device Name: CRESCENT™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 15, 2010 Received: April 16, 2010
Dear Ms. Hackney:
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 - Ms. Jennifer Hackney
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 n you don't oper.its aov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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 regardions 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 may 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,
Barbara Buehrn
Mark N. Melke Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K094025
Device Name: CRESCENT™ Spinal System_
Indications for Use:
The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
× Prescription Use (Part 21 CFR 801 Subpart D)
ﺮ
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)
K
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K094025