(148 days)
P960025, P950019, K083661
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as an intervertebral body fusion device used to stabilize spinal segments and promote fusion in patients with degenerative disc disease, which directly addresses a medical condition and aims to restore function.
No
The device is an implant designed for spinal fusion, not for diagnosing medical conditions. Its purpose is treatment, specifically stabilization and promotion of fusion in patients with degenerative disc disease.
No
The device description clearly states it is an "intervertebral body fusion device" made of PEEK-Optima with Tantalum markers, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical 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 Pivotec LIFD implant is an implantable device designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a physical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae. This is a therapeutic intervention, not a diagnostic test.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Pivotec LIFD implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Pivotec LIFD is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The device is made of PEEK-Optima with Tantalum markers and is provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant within the intra-vertebral disc space.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to S1
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)
Mechanical testing of the subject device consisted of static and Functional and dynamic compression, static and dynamic compression shear and Safety Testing: subsidence. All testing was conducted in accordance with ASTM F2077-03 and ASTM F2267-04. The device performed as designed and met, or exceeded, all product specifications.
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.
Lumbar I/F Cage (P960025), Ray Threaded Fusion Cage (TFC)TM (P950019), AVS TL PEEK Spacer (K083661)
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.
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510(k) Summary
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| Submitter: | Captiva Spine, Inc. |
|---|---|
| Contact Person: | Mr. Dale Mitchell, President |
| Captiva Spine, Inc. | |
| 967 Alt. AlA #1 | |
| Jupiter, FL 33477 | |
| Phone: 877-772-5571 | |
| Fax: 866-318-3224 | |
| DEC - 1 2009 | |
| Date Prepared: | July 2, 2009 |
| Trade Name: | Pivotec Lumbar Interbody Fusion Device (LIFD) |
| Classification | |
| Name and Number: | Class II |
| Intervertebral Body Fusion Device | |
| 21 CFR 888.3080 | |
| Product Code: | MAX |
| Predicate Device(s): | The subject device is substantially equivalent to the following |
| devices: | |
| Lumbar I/F Cage (P960025) | |
| Marketed and distributed by DePuy | |
| Ray Threaded Fusion Cage (TFC)TM (P950019) | |
| Marketed and distributed by Stryker (originally approved by | |
| Surgical Dynamics) | |
| AVS TL PEEK Spacer (K083661) | |
| Marketed and distributed by Stryker | |
| Device Description: | The Pivotec LIFD is an intervertebral body fusion device for use |
| with autogenous bone graft in the intervertebral disc space to | |
| stabilize spinal segments and promote fusion. The device is made | |
| of PEEK-Optima with Tantalum markers and is provided in | |
| various configurations and heights, containing a hollow core to | |
| receive bone autograft. Placement is achieved with an insertion | |
| instrument that allows for manipulation of the implant within the | |
| intra-vertebral disc space. |
2
1
Intended Use: The Pivotec LIFD implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Mechanical testing of the subject device consisted of static and Functional and dynamic compression, static and dynamic compression shear and Safety Testing: subsidence. All testing was conducted in accordance with ASTM F2077-03 and ASTM F2267-04. The device performed as designed and met, or exceeded, all product specifications. Conclusion: The documentation provided demonstrates that the Pivotec LIFD is substantially equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in materials, design, indications for use, function and mechanical function.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, composed of three curved lines that suggest movement or flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Captiva Spine, Inc. % Sanacor, LLC Mr. Mike Ensign Director of Engineering P.O. Box 1196 Pleasant Grove, Utah 84062
DEC - 1 2009
Re: K092017
Trade/Device Name: Pivotec Lumbar Interbody Fusion Device (LIFD) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: II Product Code: MAX Dated: July 2, 2009 Received: July 6, 2009
Dear Mr. Ensign:
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.
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 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.
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Page 2 - Mr. Mike Ensign
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Mulkern
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): NA
Device Name: Pivotec Lumbar Interbody Fusion Device (LIFD)
Indications for Use:
The Pivotec LIFD implant is an intervertebral body fusion deviceindicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092017