(82 days)
Not Found
Not Found
No
The summary describes a physical implantable device (spinal fusion/vertebral body replacement) made of PEEK and titanium, secured with screws. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML. The performance studies focus on mechanical testing, not algorithmic performance.
Yes.
The device is intended to replace a vertebral body, restore biomechanical integrity, and achieve anterior decompression of the spinal cord, which are all therapeutic actions to treat a diseased or damaged spinal column.
No
Explanation: The Zuma System is an implantable spinal device designed for fusion and replacement of vertebral bodies. Its purpose is therapeutic (spinal fusion, restoration of height and biomechanical integrity), not to diagnose a medical condition. While it mentions "radiographic studies" to confirm degenerative disc disease, the device itself does not perform the diagnosis.
No
The device description explicitly states that Zuma is an implantable spinal device made from PEEK and titanium, secured with bone screws. This indicates it is a physical hardware device, not software only.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Zuma System is an implantable spinal device used for surgical procedures (spinal fusion and vertebral body replacement). It is physically placed within the patient's body.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient.
- Input Imaging Modality: The input is "Radiographic studies," which are imaging techniques, not laboratory tests on specimens.
Therefore, the Zuma System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the Zuma System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft. Zuma is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
When used as a Vertebral Body Replacement Device, the Zuma System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zuma System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, Zuma is intended for use with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP, OVD
Device Description
Zuma is an implantable spinal device made from polyetheretherketone (PEEK) and titanium with markers for radiographic visualization; it is secured to vertebral bodies with bone screws. The device has an open central area for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (L2-S1), Thoracolumbar spine (T1-L5)
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 results indicated that Zuma possessed appropriate properties for its intended use and is substantially equivalent to predicate devices. Clinical data was not required for this device.
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.
Not Found
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
510(k) Summary
| Company Name: | SeaSpine, Inc.
2302 La Mirada Drive
Vista, CA 92081 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jeff Brittan
Senior Project Engineer
E-mail: jbrittan@seaspine.com
Phone: (760) 727-8399, Fax: (760) 727-8809 |
| Date Prepared: | September 30, 2008 |
| Trade Name: | Zuma™ |
| Common Name: | Interbody Fusion Device
Vertebral Body Replacement Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar
21 CFR 888.3080, Product Code MAX, Class II
Spinal Intervertebral Body Fixation Orthosis
21 CFR 888.3060, Product Code MQP, Class II |
| Review Panel: | Orthopedic |
| Device Description: | Zuma is an implantable spinal device made from polyetheretherketone
(PEEK) and titanium with markers for radiographic visualization; it is
secured to vertebral bodies with bone screws. The device has an open
central area for receiving bone graft material and is offered in a variety
of sizes and geometries to accommodate variations in pathology and
patient anatomy. |
| Intended Use: | When used as an intervertebral body fusion device, the Zuma System is
intended for spinal fusion procedures at one or two contiguous levels
(L2-S1) in skeletally mature patients with degenerative disc disease
(DDD). DDD is defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies.
DDD patients may also have up to Grade 1 spondylolisthesis or
retrolisthesis at the involved level(s). These patients may have had a
previous non-fusion spinal surgery at the involved spinal level(s). These
patients should have had six months of non-operative treatment. The
device is intended to be used with autograft. Zuma is a stand alone
system intended to be used with the bone screws provided and requires
no additional supplementary fixation systems. |
| | collapsed, diseased, damaged or unstable complete or partial vertebral
body due to tumor or trauma/fracture, to achieve anterior
decompression of the spinal cord and neural tissues, and to restore the
height of a collapsed vertebral body. The Zuma System is designed to
restore the biomechanical integrity of the anterior, middle and posterior
spinal column, even in the absence of fusion for a prolonged period.
Additionally, Zuma is intended for use with bone graft. |
| Substantial
Equivalence: | Zuma was shown to be substantially equivalent to predicate
devices through comparison in areas including intended use, design,
materials, and function. |
| Performance Data: | Mechanical testing results indicated that Zuma possessed appropriate
properties for its intended use and is substantially equivalent to
predicate devices. Clinical data was not required for this device. |
When used as a Vertebral Body Replacement Device, the Zuma System is intended for use in the thoracolumbar spine (T1 to L5) to replace a
page 1 of 2
1
2
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 stylized eagle or bird symbol, with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SFP 1.2 201
SeaSpine, Inc. % Mr. Jeff Brittan Senior Project Engineer 2302 La Mirada Drive Vista, California 92084
Re: K082926
Trade/Device Name: Zuma™M Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MOP Dated: September 30, 2008 Received: October 1, 2008
Dear Mr. Brittan:
This letter corrects our substantially equivalent letter of December 22, 2008.
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 (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
3
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/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 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,
Mark A. Milke
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K082926 510(k) Number (if known):
Device Name: Zuma™
Indications for Use:
When used as an intervertebral body fusion device, the Zuma System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft. Zuma is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
When used as a Vertebral Body Replacement Device, the Zuma System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zuma System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, Zuma is intended for use with bone graft.
Prescription Use ਮ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Eva
Daniel Krone for M
(Divis: 198-44)
Division of General, Restoration
Neurological Devices
510 Number K0882926