(255 days)
Not Found
No
The document describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as facilitating fusion in the cervical spine for patients with degenerative disc disease, which is a medical condition, and it is used in a therapeutic context with bone graft and supplemental fixation.
No
The device is an intervertebral body fusion device intended to provide mechanical support and facilitate fusion in the cervical spine, not to perform diagnosis.
No
The device description explicitly states the system includes implants manufactured from PEEK and radiopaque markers made from titanium or tantalum, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health.
- This device is an implant. It is surgically placed into the body to provide structural support and facilitate fusion in the cervical spine.
- The intended use clearly describes a surgical procedure and an implanted device. It does not involve the analysis of biological samples.
The information provided describes a medical device used in surgery, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Captiva Spine FuseLOX Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. FuseLOX Cervical IBF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
The Captiva Spine FuseLOX Cervical IBF is intended to provide mechanical support of the cervical spine while biologic fusion occurs. It is intended to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Captiva Spine FuseLOX Cervical IBF System includes various size implants manufactured from implant grade PEEK-OPTIMA™ LT1 conforming to ASTM F2026-12. The devices also have radiopaque markers made from either titanium alloy (Ti6Al4V) per ASTM F136 or tantalum per ASTM F560-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to C7 disc levels
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)
Mechanical testing, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression, Static Compression Shear, Static Torsion, Dynamic Torsion, Expulsion, Dynamic Compression, and Dynamic Compression Shear per ASTM F2077-11 were met. No clinical testing was 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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 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 28, 2015
Captiva Spine Rich Jansen, Pharm. D. Silver Pine Consulting 11821 Bramble Cove Drive Fort Myers, Florida 33905
Re: K142586
Trade/Device Name: Captiva Spine FuseLOX Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 28, 2015 Received: April 29, 2015
Dear Dr. Jansen:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Rich Jansen, Pharm. D.
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/Resourcesfor You/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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (If known) | K142586 | ||
|---|---|---|---|
| Device Name | FuseLox Cervical IBF System | ||
| Indications for Use (Describe) | The Captiva Spine FuseLOX Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. FuseLOX Cervical IBF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation. | ||
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (1/14) | Page 1 of 1 |
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510(k) Summary
| Date Prepared: | April 28, 2015 |
|---|---|
| Submitter: | Dale Mitchell |
| Captiva Spine | |
| 967 Alternate A1A #1 | |
| Jupiter, FL 33477 | |
| 877-772-5571 | |
| 866-318-3224 | |
| Device: | Captiva Spine FuseLOX Cervical IBF System |
| Product Class: | Class II |
| Classification: | 888.3080 Intervertebral Body Fusion Device |
| Product Codes: | ODP |
| Panel Code: | 87 |
Reason for this Submission:
This Traditional 510(k) is to introduce the Captiva Spine FuseLOX Cervical IBF System manufactured from PEEK-OPTIMA'™ LT1.
Predicate Device(s):
I
The Captiva Spine FuseLOX Cervical IBF System is substantially equivalent to the previously cleared primary predicate Transcorp ACIF System found in K092794.
Device Descriptions:
The Captiva Spine FuseLOX Cervical IBF System includes various size implants manufactured from implant grade PEEK-OPTIMA™ LT1 conforming to ASTM F2026-12. The devices also have radiopaque markers made from either titanium alloy (Ti6Al4V) per ASTM F136 or tantalum per ASTM F560-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.
Indications for Use:
The Captiva Spine FuseLOX Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Captiva Spine FuseLOX Cervical implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device must be used with supplemental fixation.
Intended Use:
The Captiva Spine FuseLOX Cervical IBF is intended to provide mechanical support of the cervical spine while biologic fusion occurs. It is intended to be used with supplemental fixation.
4
Performance Standards:
Captiva Spine FuseLOX Cervical IBF System was evaluated to demonstrate equivalence to the predicate device. Mechanical testing, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression, Static Compression Shear, Static Torsion, Dynamic Torsion, Expulsion, Dynamic Compression, and Dynamic Compression Shear per ASTM F2077-11 were met. No clinical testing was performed.
Conclusion:
The results of non-clinical testing demonstrate that the design, function, intended use, and indications for use of the Captiva Spine FuseLOX Cervical IBF System is substantially equivalent to the predicate and raises no new questions of safety or effectiveness.