(159 days)
No
The device description and performance studies focus on the mechanical properties and materials of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an intervertebral body fusion device intended for spinal fusion procedures for treating cervical degenerative disc discogenic pain, which is a therapeutic purpose.
No.
The device is described as an intervertebral body fusion device intended to provide structural stability following discectomy procedures, not to diagnose a condition.
No
The device description clearly states it consists of a PEEK cage and bone screws, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a spinal system for intervertebral body fusion. This is a surgical implant used to provide structural stability in the spine.
- Device Description: The description details the physical components of the device (PEEK cage, bone screws) and the materials used. These are all components of a surgical implant.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the ArcadiusXP C Spinal System does not mention any interaction with bodily specimens for diagnostic purposes.
- Performance Studies: The performance studies described are focused on the mechanical and structural integrity of the implant, which is typical for a surgical device, not an IVD.
Therefore, the ArcadiusXP C Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies) using autograft bone.
Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The Arcadius X C spinal system is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy procedures. The system consists of a PEEK cage and two bone screws. The PEEK cages are manufactured from a radiolucent material medical grade LT1 polyetheretherketone (PEEK) per ASTM F2026, with a titanium layer and a vacuum titanium plasma spray coating (PlasmaporeXP). The Arcadius N C implants are offered in various heights and geometrical options to fit the anatomical needs of a wide variety of patients. The Arcadius C implant is available in two footprints. The wide central opening holds optimal graft material. The screws are 4mm in diameter and offered in three lengths. The fixation screws and radiographic markers are manufactured of titanium alloy, (Ti6Al4V) according to ISO 5832/3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine from the C2/C3 disc space to the C7/T1 disc space
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)
Non-clinical testing was performed to demonstrate that the AIS Arcadius C Spinal System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic torsion per ASTM F2077
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic shear compression testing per ASTM F2077
- Subsidence per ASTM F2267
- Wear Debris per ASTM F1877
- Expulsion per ASTM Draft Standard F-04.25.02.02
Additional non-clinical testing recommended in the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post-market Surveillance Requirements" was also performed:
- Microstructure of the coating per ASTM F1854
- Static Tensile Strength per ASTM F1147
- Static Shear Strength per ASTM F1044
- Shear Fatigue Test per ASTM F1160
- Abrasion Resistance per ASTM F1978
Key results: The results of these tests showed that the Arcadius X C Spinal System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
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.
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.
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
Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
Aesculap Implant Systems, Incorporated Ms. Lisa Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K153629
Trade/Device Name: Arcadius C Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: April 25, 2016 Received: April 26, 2016
Dear Ms. Boyle:
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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K153629
Device Name ArcadiusXP C Spinal System
Indications for Use (Describe)
The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space for the treatment of cervical degenerative disc discogenic pain with degeneration ofthe disc confirmed by history and radiographic studies) using autograft bone.
Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap® Implant Systems (AIS) – Arcadius*P C Spinal System May 18, 2016
| COMPANY: | Aesculap®Implant Systems, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle
610-984-9274 (phone)
610-791-6882 (fax) |
| TRADE NAME: | ArcadiusXP C Spinal System |
| COMMON NAME: | Intervertebral Body Fusion Device |
| CLASSIFICATION NAME: | Intervertebral Fusion Device with Integrated Fixation
Cervical |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | OVE |
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the Arcadius C Spinal System.
DEVICE DESCRIPTION
The Arcadius X C spinal system is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy procedures. The system consists of a PEEK cage and two bone screws. The PEEK cages are manufactured from a radiolucent material medical grade LT1 polyetheretherketone (PEEK) per ASTM F2026, with a titanium layer and a vacuum titanium plasma spray coating (PlasmaporeXP). The Arcadius N C implants are offered in various heights and geometrical options to fit the anatomical needs of a wide variety of patients. The Arcadius C implant is available in two footprints. The wide central opening holds optimal graft material. The screws are 4mm in diameter and offered in three lengths. The fixation screws and radiographic markers are manufactured of titanium alloy, (Ti6Al4V) according to ISO 5832/3.
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INDICATIONS FOR USE
The Arcadius C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies) using autograft bone.
Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Arcadius C Spinal System.
SUBSTANTIAL EQUIVALENCE
The Arcadius XX C Spinal System is substantially equivalent to the predicates in design, material, function and performance. Based on test results and additional supporting documentation provided. Aesculap believes that the subject device demonstrates substantial equivalence.
PERFORMANCE DATA
As recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device non-clinical testing was performed to demonstrate that the AIS Arcadius C Spinal System is substantially equivalent to other predicate devices. The following testing was performed:
- · Static and dynamic torsion per ASTM F2077
- · Static and dynamic axial compression per ASTM F2077
- Static and dynamic shear compression testing per ASTM F2077
- · Subsidence per ASTM F2267
- · Wear Debris per ASTM F1877
- · Expulsion per ASTM Draft Standard F-04.25.02.02
In addition to FDA's Spine Guidance, Aesculap has also completed non-clinical testing recommended in the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post-market Surveillance Requirements." The following tests were performed:
- · Microstructure of the coating per ASTM F1854
- · Static Tensile Strength per ASTM F1147
- · Static Shear Strength per ASTM F1044
- · Shear Fatigue Test per ASTM F1160
- Abrasion Resistance per ASTM F1978
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The results of these tests showed that the Arcadius X C Spinal System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
PRIMARY PREDICATE
Elite Surgical Supplies: Biolign Stand Alone Cervical Cage (STACC) ACIF System – K130274
REFERENCE DEVICES
Centinel Spine: Stalif C® – K150053 / K142079 Aesculap Implant Systems: SIBD XP Spinal System – K111122