(24 days)
Not Found
No
The document describes a physical implant device made of PEEK for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is indicated for use in patients with degenerative disc disease to facilitate fusion in the cervical spine, addressing a medical condition.
No
The device is an intervertebral body fusion system designed to facilitate fusion in the cervical spine for patients with degenerative disc disease, not to diagnose the condition.
No
The device description explicitly states the system includes physical implants made from PEEK, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Captiva Spine FuseLox Cervical IBF System is an implantable device made of PEEK, designed to be surgically placed in the cervical spine to facilitate fusion.
- Intended Use: Its intended use is to treat degenerative disc disease by providing structural support and space for bone graft to fuse the vertebrae. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant used for treatment, not a device used for in vitro testing of biological samples.
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. Captiva Spine FuseLox 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.
Product codes
ODP
Device Description
The Captiva Spine FuseLox Cervical IBF System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. 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 at one disc level (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)
Indicates subject device is substantially equivalent to predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092794 Transcorp ACIF, K081730 Alphatec Novel Spinal Spacer System
Reference Device(s)
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
KII0582
MAR 2 5 2011
Page 1 | |
510(k) Summary
| Submitter: | Captiva Spine
967 Alt A1A Suite 1
Jupiter, FL 33477
Phone: 877-772-5571
Fax: 866-318-322 |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Sanders
Consultant
QualiReg Resources LLC
2361 NW 105th Ln
Sunrise, FL 33322
Phone: 954-993-5581
email: johnsanders@qualireg.com |
| Date Prepared: | February 28, 2011 |
| Trade Name: | Captiva Spine FuseLox Cervical IBF System |
| Classification | Class II |
| Name and Number: | Intervertebral Body Fusion Device
21 CFR 888.3080 |
| Product Code: | ODP |
| Predicate Device(s): | The subject device is substantially equivalent to the following devices:
K092794 Transcorp ACIF
K081730 Alphatec Novel Spinal Spacer System |
| Device Description: | The Captiva Spine FuseLox Cervical IBF System includes various size
implants manufactured from implant grade PEEK conforming to ASTM
F2026-08. The implant is hollow to allow for autogenous bone graft
material. The implant is provided non-sterile. |
| Intended 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 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. |
| Performance Data: | Indicates subject device is substantially equivalent to predicates. |
| Conclusion: | The documentation provided demonstrates that the Captiva Spine FuseLox
Cervical IBF System is substantially equivalent to the predicate devices. |
| Captiva Spine FuseLox Cervical IBF System
510(k) Premarket Notification Page 17 of 103 | |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Captiva Spine, Inc. % QualiReg Resources LLC Mr. John Sanders 2361 NW 105th Lane Sunrise, Florida 33322
MAR 2 5 2011
Re: K110585
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: February 28, 2011 Received: March 01, 2011
Dear Mr. Sanders:
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
2
Page 2 - Mr. John Sanders
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/ReportalProblem/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 N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: KI10585
Device Name: Captiva Spine FuseLox Cervical IBF System
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 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Div/sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110585
Captiva Spine FuseLox Cervical IBF System 510(k) Premarket Notification
Page 15 of 103