(74 days)
Not Found
No
The summary describes a physical implant and surgical instrumentation, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device is an intervertebral body fusion device and is intended to provide mechanical support and promote fusion. It is not designed to treat a disease but rather to aid in a surgical procedure for spinal fusion.
No
This device is designed to provide mechanical support for intervertebral fusion and is used with bone grafts and supplemental fixation systems. Its purpose is to aid in spinal fusion, not to diagnose a condition.
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 medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a lumbar interbody fusion device used for surgical implantation in the spine to aid in fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and design of a physical implant intended for surgical placement. It does not describe a test, reagent, or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
This device is a surgical implant used in a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Duo™ Lumbar Interbody Fusion Device 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Duo™ Lumbar Interbody Fusion Device 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. The Duo implant is available in varying lengths and heights with two lordotic configurations, and is provided sterile. The device is designed with a porous central cavity for graft containment, rounded nose to aid implant insertion, and ridged teeth to resist migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic studies
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:
Duo Implantable Devices: New performance testing was not required to support the modifications to the Duo implantable device.
- A review of the design changes to the Duo implantable device was performed and confirmed that these modifications do not alter the primary device design, introduce new technological characteristics, or alter the intended use of the device.
- A risk assessment was performed and confirmed that the modifications to the Duo implant do not alter the risk profile for the device or present new issues of safety or effectiveness.
Duo Surgical Instrumentation: Where applicable, verification testing was performed to support modifications to the Duo surgical instrumentation.
- A review of the design changes to the Duo surgical instrumentation was performed and confirmed that these modifications do not present new technological characteristics or alter the intended use of these devices.
- For surgical instruments which are intended to interface with the Duo implant, the implant/instrument remained unchanged.
- The design changes included modifications to maintain or improve surgical instrument ergonomics and usability but do not alter the primary control mechanism or operating principle of the instrument.
- A risk assessment was performed and confirmed that the modifications to the Duo surgical instruments do not alter the risk profile for the device or present new issues of safety or effectiveness.
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
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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August 18, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Spineology, Inc. Ms. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street N.. Suite 600 St. Paul. Minnesota 55128
St. Paul, Minne
Re: K171660 Trade/Device Name: Duo™ Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 21, 2017 Received: July 24, 2017
Dear Ms. Hauge:
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. 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 (reporting of medical device-
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K171660
Device Name Duo™ Lumbar Interbody Fusion Device
Indications for Use (Describe)
The Duo™ Lumbar Interbody Fusion Device 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 sketally mature and 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Spineology, 44 | |
|---|---|
| ---------------- | -- |
| Date Prepared: | July 20, 2017 |
|---|---|
| Submitter: | Spineology Inc. |
| 7800 3rd Street North | |
| Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Jacqueline A. Hauge |
| Regulatory Affairs Manager | |
| Phone: 651.256.8534 | |
| Fax: 651.256.8505 | |
| Email: jhauge@spineology.com | |
| Device Name and Classification | |
| Trade Names: | Duo™ Lumbar Interbody Fusion Device |
| Common Name: | Intervertebral body fusion device |
| Product Code: | MAX |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3080 |
| Panel: | Orthopedic |
| Primary Predicate Device: | K160074 Rampart™ D Lumbar Interbody Fusion Device |
| (Spineology Inc.) |
A. Purpose of Submission
The purpose of this submission is to obtain FDA clearance for the following modifications to the Duo Lumbar Interbody Fusion Device (formerly known as Rampart D Lumbar Interbody Fusion Device):
- Name change ●
- Updated surgical instrumentation
- Updated product labeling (no change to indications or contraindications) ●
- Minor modifications to the Duo implant
- . Shelf life extension
B. Device Description
The Duo Lumbar Interbody Fusion Device 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. The Duo implant is available in varying lengths and heights with two lordotic configurations, and is provided sterile. The device is designed with a porous central cavity for graft containment, rounded nose to aid implant insertion, and ridged teeth to resist migration.
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C. Indications for Use
The Duo™ Lumbar Interbody Fusion Device 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.
D. Comparison to Predicate
When compared to the predicate device, the modified Duo System has the same or equivalent:
- Intended Use
- Indications for Use
- . Fundamental Scientific Technology
- Principle of Operation
E. Non-Clinical Testing
Duo Implantable Devices: New performance testing was not required to support the modifications to the Duo implantable device.
- . A review of the design changes to the Duo implantable device was performed and confirmed that these modifications do not alter the primary device design, introduce new technological characteristics, or alter the intended use of the device.
- A risk assessment was performed and confirmed that the modifications to the Duo implant do ● not alter the risk profile for the device or present new issues of safety or effectiveness.
Duo Surgical Instrumentation: Where applicable, verification testing was performed to support modifications to the Duo surgical instrumentation.
- . A review of the design changes to the Duo surgical instrumentation was performed and confirmed that these modifications do not present new technological characteristics or alter the intended use of these devices.
- . For surgical instruments which are intended to interface with the Duo implant, the implant/instrument remained unchanged.
- . The design changes included modifications to maintain or improve surgical instrument ergonomics and usability but do not alter the primary control mechanism or operating principle of the instrument.
- . A risk assessment was performed and confirmed that the modifications to the Duo surgical instruments do not alter the risk profile for the device or present new issues of safety or effectiveness.
F. Conclusion
Based on individual and collective review of the modifications to the Duo implant and surgical instruments, Spineology has demonstrated that the modified Duo System is substantially equivalent to the predicate device.
- Device Design
- Materials of Construction
- Risk Profile