(29 days)
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
The SeaSpine Explorer TO System is an intervertebral fusion device with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers are manufactured from Titanium Alloy per ASTM F136 and consist of two different options: an adjustable, expanding spacer and an adjustable, lordotic angle option. All implants and instruments are provided non-sterile in system-specific trays and are to be sterilized by the end user. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary.
The provided document is a 510(k) summary for the SeaSpine Explorer TO System, an intervertebral body fusion device. It details the device's intended use and technological characteristics but does not describe acceptance criteria, a study that proves the device meets those criteria, or any performance metrics, expert involvement, or ground truth information relevant to an AI/ML device.
The document primarily focuses on establishing substantial equivalence to a predicate device (K193418) based on components, device description, intended use, technological characteristics, and mechanical safety. It states that "Mechanical and engineering analysis verified that the subject design changes do not introduce a new worse case nor raise any questions of safety or efficacy." This indicates that the evaluations were likely standard mechanical and engineering tests for an implantable medical device, rather than performance studies typically associated with AI/ML systems.
Therefore, I cannot provide the requested information for the following points as they are not present in the given text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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: Not conducted/described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not conducted/described.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not applicable (this is not an AI/ML device).
- How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).
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September 10, 2021
SeaSpine Orthopedics Corporation Aly Alvarez Assoc. Manager, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K212540
Trade/Device Name: Explorer TO System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 11, 2021 Received: August 12, 2021
Dear Aly Alvarez:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 L. 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
510(k) Number (if known) K212540
Device Name Explorer TO System
Indications for Use (Describe)
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
Type of Use (Select one or both, as applicable)
|XJ 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: | 5770 Armada Drive, Carlsbad, CA 92008 |
| Phone number: | (619) 884-4342 |
| Fax number: | (760) 683-6874 |
| Contact Person: | Aly Alvarez, Assoc. Manager, Regulatory Affairs |
| Date Prepared: | August 11, 2021 |
| Device Name | |
| Trade Name: | Explorer TO System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar (21 CFR 888.3080) |
| Product Code(s): | MAX |
| Device Class: | 2 |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code(s) | Trade Name | Manufacturer |
|---|---|---|---|
| K193418 | MAX | Explorer TO System(formerly SeaSpineSkipjack System) | SeaSpine OrthopedicsCorporation |
Device Description
The SeaSpine Explorer TO System is an intervertebral fusion device with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers are manufactured from Titanium Alloy per ASTM F136 and consist of two different options: an adjustable, expanding spacer and an adjustable, lordotic angle option. All implants and instruments are provided non-sterile in system-specific trays and are to be sterilized by the end user. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary.
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Intended Use/Indications for Use
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
Summary of Technological Characteristics
The SeaSpine Explorer TO System is identical or similar to the cited predicate device in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, manufacturing, etc.) and performance (mechanical safety).
The implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.
Non-Clinical Testing
Mechanical and engineering analysis verified that the subject design changes do not introduce a new worse case nor raise any questions of safety or efficacy.
Conclusions
The submitted data demonstrate that the SeaSpine Explorer TO System is substantially equivalent to the cited legally marketed predicate.
§ 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.