(366 days)
Not Found
No
The summary describes a physical interbody fusion device and its materials, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are mechanical testing, not related to data analysis or AI/ML performance.
Yes
The device is an interbody fusion device used to treat degenerative disc disease in the cervical spine by promoting fusion, which is a therapeutic intervention.
No
The device is an interbody fusion device (Manta Ray TDF Spacer) used for surgical treatment of degenerative disc disease, not a device designed to diagnose the condition. Its purpose is to facilitate fusion, not to identify or assess a medical condition.
No
The device description clearly states it is a physical interbody fusion device manufactured from PEEK, tantalum, and NanoMetalene, and includes instruments for placement. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Manta Ray TDF Spacer Function: The Manta Ray TDF Spacer is an implantable surgical device used to facilitate bone fusion in the cervical spine. It is a physical device placed within the body, not used to analyze samples taken from the body.
The description clearly outlines its purpose as an interbody fusion device for surgical implantation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
Product codes
ODP
Device Description
The Manta Ray TDF Spacer features a cervical interbody cage that engages the entire disc space, including the uncovertebral joints, during the fusion process. This engagement between the lateral wings and the uncovertebral joints is intended to further reduce subsidence by increasing the mating surface area. The interbody spacer is manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) markers for radiographic visualization, and NanoMetalene®, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. Each spacer has a central graft window for receiving autograft and/or allogenic bone graft material and is offered in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy. The Manta Ray TDF Spacer is intended for use with supplemental fixation.
The instruments provided with the Manta Ray TDF Spacer facilitate the placement, adjustment, and removal, if necessary, of the interbody spacer. The spacer is provided sterile packaged, whereas the instruments are provided in system-specific trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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
Non-Clinical Testing: The Manta Ray TDF Spacer has demonstrated equivalent mechanical performance to the predicate devices through mechanical testing in static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, and subsidence per ASTM F2267.
Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics
Not Found
Predicate Device(s)
K183083, K212904, K101363, K151496
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 3, 2023
SeaSpine Orthopedics Corporation Ms. Jesse Albright Associate Manager, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K220296
Trade/Device Name: Manta Ray TDF Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 23, 2023 Received: January 24, 2023
Dear Ms. Albright:
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.
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
1
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 medical devices and radiation-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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Indications for Use
510(k) Number (if known) K220296
Device Name Manta Ray TDF Spacer
Indications for Use (Describe)
The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Contact Details
Device Class:
| Applicant Name:
Address:
Phone number:
Fax number:
Contact Person:
Date Prepared: | SeaSpine Orthopedics Corporation
5770 Armada Drive, Carlsbad, CA 92008
(760) 216-5176
(760) 683-6874
Jesse Albright, Associate Manager, Regulatory Affairs
February 1, 2023 |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | |
| Trade Name:
Common Name:
Classification Name:
Product Code(s): | Manta Ray TDF Spacer
Intervertebral Body Fusion Device
Intervertebral Fusion Device With Bone Graft, Cervical (21 CFR 888.3080)
ODP |
Legally Marketed Predicate Devices
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| 510(k) Number | Product Code(s) | Trade Name | Manufacturer | |
|---|---|---|---|---|
| Primary Predicate Device | ||||
| K183083 | OVE, ODP | Shoreline Cervical | ||
| Interbody RT System | SeaSpine Orthopedics | |||
| Corporation | ||||
| Additional Predicate Device(s) | ||||
| K212904 | OVE, ODP | SeaSpine WaveForm C | ||
| Interbody System | SeaSpine Orthopedics | |||
| Corporation | ||||
| K101363 | ODP | Vu cPOD Intervertebral | ||
| Body Fusion Device | SeaSpine Orthopedics | |||
| Corporation | ||||
| K151496 | ODP | Latitude-C Cervical | ||
| Interbody Spacer System | DeGen Medical |
Device Description
The Manta Ray TDF Spacer features a cervical interbody cage that engages the entire disc space, including the uncovertebral joints, during the fusion process. This engagement between the lateral wings and the uncovertebral joints is intended to further reduce subsidence by increasing the mating surface area. The interbody spacer is manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) markers for radiographic visualization, and NanoMetalene®, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. Each spacer has a central graft window for receiving autograft and/or
4
allogenic bone graft material and is offered in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy. The Manta Ray TDF Spacer is intended for use with supplemental fixation.
The instruments provided with the Manta Ray TDF Spacer facilitate the placement, adjustment, and removal, if necessary, of the interbody spacer. The spacer is provided sterile packaged, whereas the instruments are provided in system-specific trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for Use
The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.
Summary of Technological Characteristics
The Manta Ray TDF Spacer and the cited predicate devices have the same operational principle; they act as a disc spacer and hold bone graft. The subject device is also similar to the cited predicate devices in regard to intended use/indications for use, device description, technological characteristics (e.g., design, components, materials, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., mechanical testing).
Compared to the predicate counterparts, the Manta Ray TDF Spacer is used to treat the same conditions, has essentially the same precautions and contraindications for use, and represents a basic design concept in terms of safety and effectiveness, differing only in design details and not functionality.
The subject and predicate devices are based on the following similar technological elements:
- . Spacer Heights
- Spacer Footprints
- . Spacer Lordotic Angles
Non-Clinical Testing
The Manta Ray TDF Spacer has demonstrated equivalent mechanical performance to the predicate devices through mechanical testing in static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, and subsidence per ASTM F2267.
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Clinical Testing
Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the Manta Ray TDF Spacer is substantially equivalent to the cited legally marketed predicates.