(30 days)
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is intended to treat cervical disc degeneration and/or cervical spinal instability, which are medical conditions, and aims to facilitate fusion and provide surgical stabilization of the spine. These uses align with the definition of a therapeutic device.
No
This device is a cervical interbody system intended for fusion and stabilization of the spine, not for diagnosing conditions. It is used to treat cervical disc degeneration and instability, which are confirmed by imaging studies, but the device itself does not perform the diagnosis.
No
The device description clearly states that the ZSFab Cervical Interbody System includes "additively manufactured interbody fusion devices for cervical implantation," which are physical implants, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The ZSFab Cervical Interbody System is an implantable device designed to be surgically placed within the cervical spine. It does not analyze or test biological samples.
- The intended use is for surgical fusion. The purpose of this device is to provide structural support and facilitate bone fusion in the cervical spine, not to diagnose a condition based on in vitro testing.
- The device description details a physical implant. The description focuses on the material, design, and dimensions of the interbody fusion device, which is a physical implant.
The information provided clearly describes a surgical implant used for spinal fusion, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine. Implants having a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation.
Product codes
ODP
Device Description
The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 500-920μm and maior axis length of 810-1390μm. Each interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographs, CT, MRI
Anatomical Site
C2-T1
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 of the worst case ZSFab Cervical Interbody System was relied upon in support of the original ZSFab Cervical Interbody System clearance. The testing included static and dynamic axial compression and static and dynamic torsion according to ASTM F2077, subsidence according to ASTM F2267 and expulsion. An engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case. Sterilization validations were successfully performed to meet AAMI ST79 parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ZSFab Cervical Interbody System (ZSFab Inc. - K202488), Cascadia™ Interbody System (K2M Inc. – K160125), INTEGRATE™-C Interbody Fusion System (HAPPE Spine - K222004)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 18, 2023
ZSFab Inc. % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K232150
Trade/Device Name: ZSFab Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 18, 2023 Received: July 19, 2023
Dear Dr. Warden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232150
Device Name
ZSFab Cervical Interbody System
Indications for Use (Describe)
The ZSFab Cervical Interbody System is interior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical sping a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Type of Use (Select one or both, as applicable)
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Section 7 – 510(k) Summary
| Date: | 18 July 2023 |
|---|---|
| Sponsor: | ZSFab Inc. |
| 96 Clematis Ave, Suite 2F | |
| Waltham, MA 02453 | |
| Office: 617.468.8665 | |
| Sponsor Contact: | Xuewei Ma, R&D Director |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | ZSFab Cervical Interbody System |
| Common Name: | Cervical interbody fusion device |
| Regulatory Class: | Class II |
| Regulation Name: | Intervertebral fusion device with bone graft, cervical |
| Regulation Number: | 21 CFR 888.3080 |
| Product Code: | ODP |
| Submission Purpose: | The subject 510(k) adds sizes to the ZSFab Cervical Interbody System. |
| Device Description: | The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 500-920μm and maior axis length of 810-1390μm. Each interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. |
| Indications for Use: | The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine. Implants having a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation. |
| Materials: | The ZSFab Cervical Interbody System implants are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F3001). |
| Primary Predicate: | ZSFab Cervical Interbody System (ZSFab Inc. - K202488) |
| Additional Predicates: | Cascadia™ Interbody System (K2M Inc. – K160125), INTEGRATE™-C Interbody Fusion System (HAPPE Spine - K222004) |
| Performance Data: | Mechanical testing of the worst case ZSFab Cervical Interbody System was relied upon in support of the original ZSFab Cervical Interbody System clearance. The testing included static and dynamic axial compression and static and dynamic torsion according to ASTM F2077, subsidence according to ASTM F2267 and expulsion. An engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case. Sterilization validations were successfully performed to meet AAMI ST79 parameters. |
| Technological Characteristics: | The ZSFab Cervical Interbody System possesses the same technological characteristics as one or more of the predicate devices. These include: intended use (as described above) basic design (additively manufactured structure), material (titanium alloy) and sizes (dimensions are comparable to those offered by the predicate systems)The ZSFab Cervical Interbody System is the same as previously cleared devices. |
| Conclusion: | The ZSFab Cervical Interbody System possesses the same intended use and technological characteristics as the predicate devices. Therefore the ZSFab Cervical Interbody System is substantially equivalent for its intended use. |
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