(154 days)
No
The summary describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML use.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and degenerative scoliosis by promoting fusion in the lumbar spine. This directly addresses medical conditions to restore function or relieve symptoms.
No
The text describes an intervertebral body fusion device used for treatment, not for diagnosing medical conditions. It mentions "radiographic studies" as a diagnostic method for DDD, but the device itself is a treatment implant, not a diagnostic tool.
No
The device description explicitly states it is comprised of interbody implant cages, surgical instruments, and sterilization trays, all of which are physical hardware components.
Based on the provided information, 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.
- Device Description and Intended Use: The Deploy™ Expandable Interbody System is a surgical implant designed to be placed within the human body (in the lumbar spine) to aid in spinal fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Deploy™ Expandable Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L2-S1). 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 I spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.
Product codes
MAX
Device Description
The Deploy™ Expandable Interbody System is comprised of the interbody implant cages, surgical instruments which include trial instruments to aid in the selection of the appropriate implant size for the patient's anatomy, and sterilization trays. The implants are manufactured from titanium alloy Ti-6AI-4V (ASTM F136, ASTM F3001) and are offered with various heights and shapes for different patient anatomy. Each implant is designed to be inserted and then rotate in-situ, providing immediate fixation and the arm deployed for the graft containment area. Ridges on the superior and inferior surfaces of the titanium implants contact the endplates to resist expulsion forces. The implants are designed to be used in conjunction with supplemental spinal fixation instrumentation. The surgical instruments are manufactured from stainless steel (ASTM F899. ISO 7153-1). The implants and surgical instruments are provided non-sterile and require sterilization prior to use within sterilization trays following validated sterilization parameters as provided within the Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-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)
The biocompatibility risk assessment was completed as directed by FDA guidance under ISO 10993-1 and Parts 5 biocompatibility requirements. Cytotoxicity testing was completed to demonstrate and support justification that the known biocompatible materials, Titanium Alloy (Ti6Al4V ELI) per ASTM F136 and ASTM 3001 standards, maintained compliance through manufacturing processes and cleaning and sterilization validated for the final implants and instruments. The Deploy™ Expandable Interbody System was tested in static axial compression (ASTM F2077), static compressive shear (ASTM F2077), dynamic axial compression (ASTM F2077), dynamic compressive shear (ASTM F2077), static subsidence (ASTM F2267), and wear debris testing (ASTM F1877).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151322, K163364, K171097, K072791
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
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November 16, 2021
Southern Spine LLC % Julie Stephens President/Consultant Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, Georgia 30004
Re: K211845
Trade/Device Name: Deploy™ Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 21, 2021 Received: July 22, 2021
Dear Ms. Stephens:
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.
1
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 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, 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)
Device Name Deploy™ Expandable Interbody System
Indications for Use (Describe)
The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with degenerative disease (DDD) at one level or two contiguous levels of the lumbar spine (L2-S1). 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 I spondylolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.
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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3
Southern Spine LLC Traditional 510(k): K211845 - Deploy™ Expandable Interbody System
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
| Submitted By: | Southern Spine LLC
487 Cherry Street – Third Street Tower
Macon, GA 31201
Phone: (478) 745-0000 |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant
Regulatory Resources Group, Inc. - Phone: (678) 513-0693 |
| Date Submitted: | November 12, 2021 |
Device Name and Classification:
| Trade/Proprietary Name: | Deploy™ Expandable Interbody System |
|---|---|
| Common Name: | Intervertebral body fusion device |
| Regulation Number: | 21 CFR 888.3080 |
| Regulation Name: | Intervertebral fusion device with bone graft, lumbar |
| Class: | II |
| Product Code: | MAX |
Legally Marketed Predicate Devices:
Primary Predicate: Amendia Interbody Fusion Devices [Zeus] - 510(k) # K151322 Additional Predicate: MOJAVE Expandable Interbody System - 510(k) # K163364 and K171097 Additional Predicate: Synthes OPAL Spacer/Cage - 510(k) # K072791
None of the predicates have been subject to a design-related recall.
Device Description:
The Deploy™ Expandable Interbody System is comprised of the interbody implant cages, surgical instruments which include trial instruments to aid in the selection of the appropriate implant size for the patient's anatomy, and sterilization trays. The implants are manufactured from titanium alloy Ti-6AI-4V (ASTM F136, ASTM F3001) and are offered with various heights and shapes for different patient anatomy. Each implant is designed to be inserted and then rotate in-situ, providing immediate fixation and the arm deployed for the graft containment area. Ridges on the superior and inferior surfaces of the titanium implants contact the endplates to resist expulsion forces. The implants are designed to be used in conjunction with supplemental spinal fixation instrumentation. The surgical instruments are manufactured from stainless steel (ASTM F899. ISO 7153-1). The implants and surgical instruments are provided non-sterile and require sterilization prior to use within sterilization trays following validated sterilization parameters as provided within the Instructions for Use.
Indications for Use:
The Deploy™ Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative
4
Southern Spine LLC Traditional 510(k): K211845 - Deploy™ Expandable Interbody System
510(k) Summarv
disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L2-S1). 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 I spondvlolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have at least six months of non-operative treatment prior to being treated with this system. Additionally, the Deploy™ implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Deploy™ implants are intended to be used with supplemental spinal fixation systems that are cleared for use in the lumbosacral spine.
Technological Characteristics:
The Deploy™ Expandable Interbody System and the predicate devices have the same principles of operation as interbody fusion devices in patients at one level or two contiquous levels from L2 to S1. The Deploy™ Expandable Interbody System have the same or similar technological characteristics as its predicate devices through comparison of characteristics including design, intended use, material composition, and function. The proposed implants are classified as permanent implants (more than 30 days), single patient use only, and have validated instructions for cleaning and sterilization.
Summary of Testing:
The biocompatibility risk assessment was completed as directed by FDA guidance under ISO 10993-1 and Parts 5 biocompatibility requirements. Cytotoxicity testing was completed to demonstrate and support justification that the known biocompatible materials, Titanium Alloy (Ti6Al4V ELI) per ASTM F136 and ASTM 3001 standards, maintained compliance through manufacturing processes and cleaning and sterilization validated for the final implants and instruments. The Deploy™ Expandable Interbody System was tested in static axial compression (ASTM F2077), static compressive shear (ASTM F2077), dynamic axial compression (ASTM F2077), dynamic compressive shear (ASTM F2077), static subsidence (ASTM F2267), and wear debris testing (ASTM F1877).
Substantial Equivalence Conclusions:
Deploy™ Expandable Interbody System was shown to be substantially equivalent to predicate systems in terms of indications for use, design, function, material composition, range of sizes, and mechanical performance.