(84 days)
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No
The summary describes a mechanical implant and its associated nonclinical testing, with no mention of AI or ML capabilities.
Yes
The device is indicated for intervertebral body fusion procedures for patients with degenerative disc disease, which involves treating a disease and restoring function.
No
The provided text describes the Exceed™ Biplanar Expandable Interbody System as a fusion device used in surgical procedures, not a tool for diagnosing medical conditions. It is indicated for treatment of degenerative disc disease, not for its diagnosis.
No
The device description explicitly states it is fabricated from titanium alloy and is an implantable device, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that the Exceed™ Biplanar Expandable Interbody System is an implantable device used in surgical procedures on the lumbar spine. It is not used to test or analyze samples like blood, urine, or tissue.
- The purpose of this device is structural support and fusion. Its function is to provide stability and facilitate bone growth between vertebrae, not to diagnose a condition or provide information about a patient's health status through in vitro testing.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Exceed™ Biplanar Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Exceed™ Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. The Exceed™ Biplanar Expandable Interbody System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Product codes
MAX
Device Description
The Exceed™ Biolanar Expandable Interbody System is a lumbar intervertebral body fusion device fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implant is provided unexpanded with a nose tapered in both the lateral and vertical planes, and is expanded in situ using the Exceed™ Inserter. The implant has a microscopic roughened surface with micro and nano-scale features on the superior and inferior surfaces for resistance to migration and to facilitate fusion. The implant is provided in different heights, lengths, and lordotic angles to accommodate the anatomical needs for a range of patients, and is designed to accommodate autogenous and/or allogenic bone graft material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L2-S1
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
Nonclinical testing was performed on the Exceed™ Biplanar Expandable Interbody System to support substantial equivalence to the predicate device. The following testing was performed:
- . Static and dynamic axial compression testing per ASTM F2077
- Static and dynamic compression shear testing per ASTM F2077 ●
- Subsidence testing per ASTM F2267 ●
- . Particulate and wear analysis per ASTM F1877
Key Metrics
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.
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July 25, 2023
Spine Wave, Inc. Ronald K. Smith Executive VP, Quality, Regulatory & Clinical Affairs 3 Enterprise Drive Shelton, Connecticut 06484
Re: K231275
Trade/Device Name: Exceed™ Biplanar Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 2, 2023 Received: May 2, 2023
Dear Mr. Smith:
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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K231275
Device Name
ExceedTM Biplanar Expandable Interbody System
Indications for Use (Describe)
The Exceed™ Biplanar Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Exceed™ Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. The Exceed™ Biplanar Expandable Interbody System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
| 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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Image /page/3/Picture/1 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The words are black, and there is a blue wave-like design underneath the word "Wave". The wave design appears to be a stylized representation of a spine.
510(k) Summary Exceed™ Biplanar Expandable Interbody System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1846 |
| Contact: | Ronald K. Smith |
| Date Prepared: | May 2, 2023 |
2. Device Information
| Trade Name: | Exceed™ Biplanar Expandable Interbody System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | Class II per 21 CFR 888.3080 |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumba |
| Product Code: | MAX |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new intervertebral body fusion device.
4. Predicate Device Information
The Exceed™ Biplanar Expandable Interbody System described in this submission is substantially equivalent to the following predicates:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Leva® Spacer System | Spine Wave, Inc. | K153222 |
| Additional Predicate Device | Manufacturer | 510(k) No. |
| DualX® Expanding Titanium Posterior | ||
| Lumbar Interbody Fusion System | Amplify Surgical, | |
| Inc. | K222203 |
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5. Device Description
The Exceed™ Biolanar Expandable Interbody System is a lumbar intervertebral body fusion device fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implant is provided unexpanded with a nose tapered in both the lateral and vertical planes, and is expanded in situ using the Exceed™ Inserter. The implant has a microscopic roughened surface with micro and nano-scale features on the superior and inferior surfaces for resistance to migration and to facilitate fusion. The implant is provided in different heights, lengths, and lordotic angles to accommodate the anatomical needs for a range of patients, and is designed to accommodate autogenous and/or allogenic bone graft material.
6. Indications for Use
The Exceed™ Biplanar Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Exceed™ Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. The Exceed™ Biplanar Expandable Interbody System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
7. Comparison of Technological Characteristics
The substantial equivalence of the Exceed™ Biplanar Expandable Interbody System to the predicate is shown by similarity in intended use, indications for use, materials, and performance.
8. Performance Data
Nonclinical testing was performed on the Exceed™ Biplanar Expandable Interbody System to support substantial equivalence to the predicate device. The following testing was performed:
- . Static and dynamic axial compression testing per ASTM F2077
- Static and dynamic compression shear testing per ASTM F2077 ●
- Subsidence testing per ASTM F2267 ●
- . Particulate and wear analysis per ASTM F1877
9. Conclusion
The indications for use, technological characteristics, and performance testing show that the Exceed™ Biplanar Expandable Interbody System is substantially equivalent to the predicate device and does not present any new issues of safety or effectiveness.