(82 days)
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.
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.
The provided text describes the 510(k) summary for the Zuma™ Interbody Fusion Device/Vertebral Body Replacement Device. It indicates that the device was deemed substantially equivalent to predicate devices based on comparisons in intended use, design, materials, and function. The only performance data mentioned is related to mechanical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Appropriate properties for intended use (mechanical strength, durability) for both interbody fusion and vertebral body replacement applications. | "Mechanical testing results indicated that Zuma possessed appropriate properties for its intended use and is substantially equivalent to predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The performance data mentioned is mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The submission states "Clinical data was not required for this device," and the performance data provided is mechanical testing, which typically does not involve expert ground truth for a test set in the same way clinical studies do.
4. Adjudication Method for the Test Set
- Not Applicable. As no clinical test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. A MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical data was not required for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical medical implant, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance mentioned is related to its mechanical properties.
7. The Type of Ground Truth Used
- The ground truth for the mechanical performance testing would be established by engineering standards and specifications for interbody fusion devices and vertebral body replacement devices. These standards define the acceptable mechanical properties (e.g., strength, stiffness, fatigue life) that the device must meet for its intended use.
8. The Sample Size for the Training Set
- Not Applicable/Not provided. This information is typically relevant for AI/ML models. For a physical medical device, there isn't a "training set" in the same sense. The device design and materials are developed based on engineering principles and preclinical testing, but a "training set" is not a concept explicitly applied here.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable/Not provided. Similar to point 8, this concept does not directly apply to the development of a physical medical device. The "ground truth" for the device's design and materials would be founded on established biomechanical and materials science principles, industry standards, and requirements for spinal implants.
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510(k) Summary
| Company Name: | SeaSpine, Inc.2302 La Mirada DriveVista, CA 92081 |
|---|---|
| Contact Person: | Jeff BrittanSenior Project EngineerE-mail: jbrittan@seaspine.comPhone: (760) 727-8399, Fax: (760) 727-8809 |
| Date Prepared: | September 30, 2008 |
| Trade Name: | Zuma™ |
| Common Name: | Interbody Fusion DeviceVertebral Body Replacement Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar21 CFR 888.3080, Product Code MAX, Class IISpinal Intervertebral Body Fixation Orthosis21 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 issecured to vertebral bodies with bone screws. The device has an opencentral area for receiving bone graft material and is offered in a varietyof sizes and geometries to accommodate variations in pathology andpatient anatomy. |
| Intended Use: | When used as an intervertebral body fusion device, the Zuma System isintended 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 withdegeneration of the disc confirmed by history and radiographic studies.DDD patients may also have up to Grade 1 spondylolisthesis orretrolisthesis at the involved level(s). These patients may have had aprevious non-fusion spinal surgery at the involved spinal level(s). Thesepatients should have had six months of non-operative treatment. Thedevice is intended to be used with autograft. Zuma is a stand alonesystem intended to be used with the bone screws provided and requiresno additional supplementary fixation systems. |
| collapsed, diseased, damaged or unstable complete or partial vertebralbody due to tumor or trauma/fracture, to achieve anteriordecompression of the spinal cord and neural tissues, and to restore theheight of a collapsed vertebral body. The Zuma System is designed torestore the biomechanical integrity of the anterior, middle and posteriorspinal column, even in the absence of fusion for a prolonged period.Additionally, Zuma is intended for use with bone graft. | |
| SubstantialEquivalence: | Zuma was shown to be substantially equivalent to predicatedevices through comparison in areas including intended use, design,materials, and function. |
| Performance Data: | Mechanical testing results indicated that Zuma possessed appropriateproperties for its intended use and is substantially equivalent topredicate 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
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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
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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
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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
§ 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.