(29 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an intervertebral implant designed to provide mechanical support as an adjunct to fusion for treating degenerative disc disease, which explicitly states a therapeutic purpose.
No
The Duo™ Expandable Interbody Fusion System is an intervertebral implant designed to provide mechanical support and facilitate fusion, not to diagnose medical conditions.
No
The device description clearly states it is an intervertebral implant made of physical materials (PEEK, titanium, PET, tantalum) and is provided sterile, indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for intervertebral body fusion in the lumbar spine. This is a surgical implant used in vivo (within the body) to provide structural support and facilitate bone fusion.
- Device Description: The description details a physical implant made of various materials designed to be placed within the spine.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or other substances to perform tests.
IVDs are used to perform tests outside the body on samples taken from the body. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Duo™ Expandable Interbody Fusion System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Duo Expandable Interbody Fusion System is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum or OsteoSync™ titanium, titanium alloy, and PET. The Duo implant is available in varying lengths, widths, heights, lordotic angles and is provided sterile. The implant is designed with a porous central cavity for graft containment, a rounded nose to aid in implant insertion, and rigid teeth to resist migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to L5
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 was conducted to support the subject Duo Ti Implants and Implant Trials confirming function and performance and to demonstrate substantial equivalence.
- A review of the design changes was performed and confirmed that these modifications do not alter the intended use or present new technological characteristics.
- The design changes do not alter the primary control mechanism or operating principle.
- Benchtop mechanical construct and performance ASTM testing and comparison confirmed that the subject implants perform as intended in comparison to the predicate devices.
- A risk assessment was performed and confirmed that the modifications introduced do not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate devices.
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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February 19, 2021
Spineology Inc. Andrew Adams Group Director of Regulatory & Quality Affairs 7800 3rd Street North Suite 600 Saint Paul, Minnesota 55128
Re: K210155
Trade/Device Name: DuoTM Expandable Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 20, 2021 Received: January 21, 2021
Dear Mr. Adams:
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.
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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)
K210155
Device Name Duo™ Expandable Interbody Fusion System
Indications for Use (Describe)
The Duo™ Expandable Interbody Fusion System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar 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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Duo™ Expandable Interbody Fusion System
| Spineology 510(k) Summary | |
|---|---|
| Date Prepared: | February 17, 2021 |
| Submitter: | Spineology Inc. |
| 7800 3rd Street North | |
| Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Andrew Adams |
| Group Director of Regulatory & Quality Affairs | |
| Phone: 651.256.8500 | |
| Fax: 651.256.8505 | |
| Email: aadams@spineology.com | |
| Device Name and Classification | |
| Trade Name: | Duo™ Expandable Interbody Fusion System |
| Classification Name: | Intervertebral Body Fusion Device |
| Product Code: | MAX |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3080 |
| Panel: | Orthopedic |
Predicate Devices
| Primary: | K190055 | Duo™ Lumbar Interbody Fusion Device |
|---|---|---|
| Additional: | K183705 | IdentiTi™ Porous Ti Interbody System |
1. Purpose
The purpose of this premarket notification is to obtain FDA clearance for a line extension of Implants and Implant Trials to the Duo Expandable Interbody Fusion System. The subject Duo Ti Implants incorporate spacer blocks that are wider and constructed of OsteoSync™ porous titanium.
2. Device Description
The Duo Expandable Interbody Fusion System is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum or OsteoSync™ titanium, titanium alloy, and PET. The Duo implant is available in varying lengths, widths, heights, lordotic angles and is provided sterile. The implant is designed with a porous central cavity for graft containment, a rounded nose to aid in implant insertion, and rigid teeth to resist migration.
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3. Indications for Use
The Duo™ Expandable Interbody Fusion System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
4. Technological Characteristics
When compared to the predicate devices, the subject Duo Ti Implants and Implant Trials have the same intended use and the same, or equivalent, technological characteristics, including:
- Indications for Use ●
- Primary Design Features .
- Materials of Construction ●
- . Function / Performance
- . Fundamental Scientific Technology
- Device Design ●
- Principle of Operation ●
- Risk Profile ●
- . Use with Supplemental Fixation Systems
5. Non-Clinical Testing
Non-clinical testing was conducted to support the subject Duo Ti Implants and Implant Trials confirming function and performance and to demonstrate substantial equivalence.
- A review of the design changes was performed and confirmed that these modifications do not alter the intended use or present new technological characteristics.
- The design changes do not alter the primary control mechanism or operating principle.
- Benchtop mechanical construct and performance ASTM testing and comparison ● confirmed that the subject implants perform as intended in comparison to the predicate devices.
- A risk assessment was performed and confirmed that the modifications introduced do ● not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate devices.
6. Conclusion
Based on the intended use, technological characteristics, and comparison to the predicate devices, the Duo Ti Expandable Interbody Fusion System has been shown to be substantially equivalent to the legally marketed predicate devices.