(238 days)
Not Found
No
The summary describes a physical implantable device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an anterior cervical interbody fusion device for patients with degenerative disc disease, with the explicit goal of facilitating fusion and alleviating pain, which aligns with the definition of a therapeutic device.
No
The device description clearly states it is an "interbody fusion device" and its intended use is to act as an "adjunct to fusion" in patients with degenerative disc disease, which indicates a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is composed of PEEK and titanium alloy with radiopaque markers, titanium screws, and a locking cover, indicating it is a physical implantable device, not software.
Based on the provided information, the Zuma-C™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Zuma-C™ Function: The description clearly states that Zuma-C™ is an implantable medical device used in surgery for spinal fusion. It is a physical device inserted into the body to provide structural support and facilitate bone growth.
- Intended Use: The intended use describes a surgical procedure and the device's role in that procedure, not a diagnostic test performed on a sample.
Therefore, Zuma-C™ falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Zuma-C is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP, OVE
Device Description
Zuma-C is a stand-alone interbody fusion device composed of PEEK and titanium alloy with radiopaque markers, titanium screws and a locking cover. The screws are inserted through the device into adjacent vertebral bodies and the locking cover mates with the device, covering the screws. The device has an open central area for receiving bone graft material and is offered pre-assembled in a variety of heights and geometries to accommodate variations patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C3-C7
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)
The following pre-clinical studies were conducted using worst case Performance Data: Zuma-C constructs: 1) static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion per ASTM F2077; 2) subsidence per ASTM F2267; 3) wear testing per ASTM F2077; and 4) wear debris characterization per ASTM F1714 and ASTM F1877. The results of these studies were found to be substantially equivalent to legally marketed devices.
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.
K082309 Cambria™ (SeaSpine, Inc.), K082926 Zuma™ (SeaSpine, Inc.), K072981 Zero-P™ (Synthes Spine)
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
.
K092521 Page 1 of 2
510(k) Summary
. .
| Company Name: | SeaSpine, Inc.
2302 La Mirada Drive
Vista, CA 92081 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APR 1 3 2010 | |
| Contact Person: | Ethel Bernal
Regulatory Affairs Manager
E-mail: ebernal@seaspine.com
Phone: (760) 727-8399, Fax: (760) 727-8809 |
| Date Prepared: | August 14, 2009 |
| Trade Name: | Zuma-C™ |
| Common Name: | Interbody Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device
21 CFR 888.3080, Product Code ODP, Class II
Orthopedic Review Committee |
| Device Description: | Zuma-C is a stand-alone interbody fusion device composed of PEEK and
titanium alloy with radiopaque markers, titanium screws and a locking
cover. The screws are inserted through the device into adjacent
vertebral bodies and the locking cover mates with the device, covering
the screws. The device has an open central area for receiving bone graft
material and is offered pre-assembled in a variety of heights and
geometries to accommodate variations patient anatomy. |
| Intended Use: | Zuma-C is a stand-alone anterior cervical interbody fusion device
intended for use as an adjunct to fusion at one level (C3-C7) in skeletally
mature patients with degenerative disc disease (defined as discogenic
neck pain with degeneration of the disc confirmed by history and
radiographic studies). Patients should have received at least six weeks
of non-operative treatment prior to treatment with the device. Zuma-C
is to be packed with autogenous bone graft and implanted via an open,
anterior approach. Zuma-C is intended to be used with the bone screw
fixation provided and requires no additional fixation. |
| Predicate Devices: | K082309 Cambria™ (SeaSpine, Inc.)
K082926 Zuma™ (SeaSpine, Inc.)
K072981 Zero-P™ (Synthes Spine) |
| Technological
Characteristics: | Zuma-C was shown to be substantially equivalent to predicate
devices through comparison in areas including intended use, design,
materials, function and ranges of sizes. |
1
The following pre-clinical studies were conducted using worst case Performance Data: Zuma-C constructs: 1) static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion per ASTM F2077; 2) subsidence per ASTM F2267; 3) wear testing per ASTM F2077; and 4) wear debris characterization per ASTM F1714 and ASTM F1877. The results of these studies were found to be substantially equivalent to legally marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SeaSpine, Inc. % Ms. Ethel Bernal Regulatory Affairs Manager 2302 La Mirada Drive Vista, California 92081
Re: K092521
Trade/Device Name: Zuma-C™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: February 07, 2010 Received: February 12, 2010
Dear Ms. Bernal:
This letter corrects our substantially equivalent letter of April 13, 2010.
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
SEP 12 2011
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark A. Millkern
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Zuma-C™
Indications for Use
510(k) Number (if known): _ KO 92.621
Device Name: Zuma-C™
Indications for Use:
Zuma-C™ is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and Patients should have received at least six weeks of non-operative radiographic studies). treatment prior to treatment with the device. Zuma-C™ is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C™ is intended to be used with the bone screw fixation provided and requires no additional fixation.
Prescription Use × (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 Evaluation (ODE)
Division Sign-Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KO92521 510(k) Number_
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