(119 days)
Not Found
No
The summary describes a physical intervertebral fusion device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an intervertebral fusion device intended for spinal fusion procedures in patients with degenerative disc disease, which clearly indicates its purpose in treating a medical condition.
No
The device is an intervertebral fusion device intended for spinal fusion procedures, meaning it is used for treatment (fusion) rather than diagnosis.
No
The device description explicitly states the device is an intervertebral fusion device manufactured from PEEK with tantalum and titanium alloy radiographic markers, and includes instruments for placement. This indicates a physical implant and associated hardware, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Reef TH System is for spinal fusion procedures. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an intervertebral fusion device made of PEEK, tantalum, and titanium alloy. This is a physical implant used to facilitate bone fusion, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on mechanical properties (compression, shear, subsidence, wear) and sterilization, which are relevant to a surgical implant, not a diagnostic device.
In summary, the Reef TH System is a surgical implant used in spinal fusion procedures, not a device intended for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Reef TH 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The SeaSpine Reef TH 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 implant is manufactured from PEEK (ASTM F2026) with tantalum (ASTM F560) and titanium alloy (ASTM F136) radiographic markers. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile-packed. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays 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
One or two contiguous levels (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical performance in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), and wear testing (ASTM F1877) was performed for the Reef TH System. An engineering analysis of expulsion, packaging, shipping and sterilization tests was also conducted to validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
No additional coating characterization testing was conducted in this submission due to coating being identical to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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SeaSpine Orthopedics Corporation Aly Alvarez Sr. Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 98008
Re: K193636
Trade/Device Name: SeaSpine Reef TH System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 23, 2020 Received: March 25, 2020
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 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
April 24, 2020
1
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 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,
for
Brent Showalter, Ph.D. Assistant Director (Acting) 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)
K193636 Page 1 of 1
Device Name SeaSpine Reef TH System
Indications for Use (Describe)
The Reef TH 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)
| ☑ 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 | ||
| (760) 216-5622 | |||
| (760) 683-6874 | |||
| Contact person: | Aly Alvarez, Sr. Regulatory Affairs Specialist | ||
| Date Prepared: | December 26, 2019 | ||
| Device Name | |||
| Trade Name: | SeaSpine Reef TH System | ||
| Common Name: | Intervertebral Body Fusion Device | ||
| Classification Name: | Intervertebral fusion device with bone graft, lumbar | ||
| (21 CFR 888.3080) | |||
| Class: | II |
Legally Marketed Predicate Devices
MAX
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K082310 | MAX | SeaSpine Spacer System - | |
| Pacifica | SeaSpine Orthopedics | ||
| Corporation | |||
| Additional Predicate Devices | |||
| K192132 | MAX | SeaSpine Beachside System | SeaSpine Orthopedics |
| Corporation |
Device Description
Product Code:
The SeaSpine Reef TH 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 implant is manufactured from PEEK (ASTM F2026) with tantalum (ASTM F560) and titanium alloy (ASTM F136) radiographic markers. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile-packed. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are
4
placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for Use
The Reef TH 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 Reef TH System is identical or similar to the cited predicate devices 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 performance in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), and wear testing (ASTM F1877) was performed for the Reef TH System. An engineering analysis of expulsion, packaging, shipping and sterilization tests was also conducted to validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
No additional coating characterization testing was conducted in this submission due to coating being identical to the predicate.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrates that the SeaSpine Reef TH System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate.