(238 days)
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.
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.
This document is a 510(k) summary for the Zuma-C™ interbody fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and pre-clinical testing for mechanical performance, rather than clinical efficacy or diagnostic accuracy. Therefore, many of the requested categories related to clinical studies, ground truth establishment, and expert involvement are not applicable or not detailed in this submission.
Here's the information extracted and categorized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as criteria, but implied and "worst case Performance Data" were used) | Reported Device Performance (Results were found to be substantially equivalent to legally marketed devices) |
|---|---|---|
| Mechanical Performance | Static and Dynamic Axial Compression (per ASTM F2077) | Substantially equivalent to predicate devices. |
| Static and Dynamic Compression Shear (per ASTM F2077) | Substantially equivalent to predicate devices. | |
| Static and Dynamic Torsion (per ASTM F2077) | Substantially equivalent to predicate devices. | |
| Subsidence (per ASTM F2267) | Substantially equivalent to predicate devices. | |
| Wear Testing (per ASTM F2077) | Substantially equivalent to predicate devices. | |
| Wear Debris Characterization (per ASTM F1714 and ASTM F1877) | Substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. The studies performed were pre-clinical (benchtop) tests on device constructs, not data from a patient test set.
- Data Provenance: The data provenance is pre-clinical testing conducted by the manufacturer, SeaSpine, Inc. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for diagnostic or prognostic devices with expert review is not relevant for this type of pre-clinical mechanical performance assessment. The "ground truth" here is adherence to established ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication is not relevant for pre-clinical mechanical performance testing.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical device for spinal fusion, not an AI-powered diagnostic or decision support tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these pre-clinical studies is defined by the performance requirements and testing methodologies outlined in the referenced ASTM standards (ASTM F2077, ASTM F2267, ASTM F1714, ASTM F1877). The goal was to show "substantial equivalence" to legally marketed predicate devices under these conditions.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The "samples" would be the physical device constructs tested in the pre-clinical studies, but the concept of a "training set" doesn't apply.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model was used.
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K092521 Page 1 of 2
510(k) Summary
. .
| Company Name: | SeaSpine, Inc.2302 La Mirada DriveVista, CA 92081 |
|---|---|
| APR 1 3 2010 | |
| Contact Person: | Ethel BernalRegulatory Affairs ManagerE-mail: ebernal@seaspine.comPhone: (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 Device21 CFR 888.3080, Product Code ODP, Class IIOrthopedic Review Committee |
| Device Description: | Zuma-C is a stand-alone interbody fusion device composed of PEEK andtitanium alloy with radiopaque markers, titanium screws and a lockingcover. The screws are inserted through the device into adjacentvertebral bodies and the locking cover mates with the device, coveringthe screws. The device has an open central area for receiving bone graftmaterial and is offered pre-assembled in a variety of heights andgeometries to accommodate variations patient anatomy. |
| Intended Use: | Zuma-C is a stand-alone anterior cervical interbody fusion deviceintended for use as an adjunct to fusion at one level (C3-C7) in skeletallymature patients with degenerative disc disease (defined as discogenicneck pain with degeneration of the disc confirmed by history andradiographic studies). Patients should have received at least six weeksof non-operative treatment prior to treatment with the device. Zuma-Cis to be packed with autogenous bone graft and implanted via an open,anterior approach. Zuma-C is intended to be used with the bone screwfixation provided and requires no additional fixation. |
| Predicate Devices: | K082309 Cambria™ (SeaSpine, Inc.)K082926 Zuma™ (SeaSpine, Inc.)K072981 Zero-P™ (Synthes Spine) |
| TechnologicalCharacteristics: | Zuma-C was shown to be substantially equivalent to predicatedevices through comparison in areas including intended use, design,materials, function and ranges of sizes. |
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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.
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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 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
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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/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
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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_
Page 1 of 1
§ 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.