(59 days)
Not Found
No
The document describes a physical interbody fusion device and its associated components and instruments. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The testing described is mechanical performance testing, not software validation.
Yes
The device is indicated for use as an adjunct to fusion in patients with degenerative disc disease, treating a medical condition and restoring function.
No
This device is an interbody fusion device, designed to be implanted in the spine as an adjunct to fusion in patients with degenerative disc disease. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states that the device consists of physical implants made from titanium alloy and associated instruments for placement. It does not describe any software component as the primary medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant used in surgical procedures for spinal fusion in patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is described as an intervertebral body fusion device made of titanium alloy, designed to be implanted into the spine. This is a physical implant, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- No mention of diagnostic testing: The text focuses entirely on the surgical application and mechanical properties of the implant. There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a surgical implant used to treat a condition.
N/A
Intended Use / Indications for Use
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone. The SeaSpine WaveForm A Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
No-profile Implants w/ Screws:
The SeaSpine WaveForm A System No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.
No-profile Implants w/ Inline Fixation Anchors:
The SeaSpine WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine WaveForm A Noprofile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine WaveForm A System Interbody assembled with the Anterior Plate, when used with Screws, an Arterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.
Product codes
MAX, OVD
Device Description
The WaveForm A Interbody System consists of anterior intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic configurations to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized.
The WaveForm A Interbody can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile Interbody configurations. Fixation implants include Anterior Plates, Spin Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Non-Clinical Testing: The WaveForm A Interbody System demonstrated substantially equivalent mechanical performance to the predicate systems through axial compression-shear (ASTM F2077), wear evaluation (ASTM F1877), and subsidence (ASTM F2267) testing.
Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 contains 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
November 7, 2022
SeaSpine Orthopedics Corporation Jesse Albright Associate Manager, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K222732
Trade/Device Name: WaveForm A Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX. OVD Dated: September 7, 2022 Received: September 9, 2022
Dear Jesse 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,
Katherine D.Kavlock -S
for
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
2
Indications for Use
510(k) Number (if known) K222732
Device Name WaveForm A Interbody System
Indications for Use (Describe)
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone. The SeaSpine WaveForm A Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
No-profile Implants w/ Screws:
The SeaSpine WaveForm A System No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.
No-profile Implants w/ Inline Fixation Anchors:
The SeaSpine WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine WaveForm A Noprofile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine WaveForm A System Interbody assembled with the Anterior Plate, when used with Screws, an Arterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.
Type of Use (Select one or both, as applicable)
X 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
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | 5770 Armada Drive, Carlsbad, CA 92008 |
| (760) 216-5176 | |
| (760) 683-6874 | |
| Contact Person: | Jesse Albright, Associate Manager, Regulatory Affairs |
| Date Prepared: | September 7, 2022 |
Device Name
| Trade Name: | WaveForm A Interbody System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device With Bone Graft, Lumbar (21 CFR 888.3080) |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar (21 CFR | |
| 888.3080) | |
| Product Code(s): | MAX, OVD |
| Device Class: | 2 |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code(s) | Trade Name(s) | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K210583 | MAX, OVD | WaveForm A Interbody System | SeaSpine |
| Orthopedics | |||
| Corporation | |||
| Additional Predicate Device(s) | |||
| K220711 | MAX, OVD | Meridian System | SeaSpine |
| Orthopedics | |||
| Corporation | |||
| K213420 | MAX, PHM | WaveForm L Interbody System, | |
| WaveForm TO Interbody System, | |||
| WaveForm TA Interbody System | SeaSpine | ||
| Orthopedics | |||
| Corporation |
5
Device Description
The WaveForm A Interbody System consists of anterior intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic configurations to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized.
The WaveForm A Interbody can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile Interbody configurations. Fixation implants include Anterior Plates, Spin Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
Intended Use/Indications for Use
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine WaveForm A Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
No-profile Implants w/ Screws:
The SeaSpine WaveForm A System No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen
6
of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.
No-profile Implants w/ Inline Fixation Anchors:
The SeaSpine WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine WaveForm A Noprofile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine WaveForm A System Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.
Summary of Technological Characteristics
The WaveForm A Interbody System is identical or similar to the cited predicate systems in regard to intended use/indications for use, device description, technological characteristics (e.g., operating principle, design, components, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., mechanical testing).
Non-Clinical Testing
The WaveForm A Interbody System demonstrated substantially equivalent mechanical performance to the predicate systems through axial compression-shear (ASTM F2077), wear evaluation (ASTM F1877), and subsidence (ASTM F2267) testing.
7
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 WaveForm A Interbody System is substantially equivalent to the cited legally marketed predicates.