(307 days)
Not Found
No
The summary describes a 3D printed lumbar interbody fusion system, a physical implant. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on mechanical testing of the implant.
Yes.
The device is indicated for intervertebral body fusion procedures for patients with degenerative disc disease of the lumbar spine, which aims to treat a medical condition and alleviate pain.
No
Explanation: The MiRus™ 3D Printed Lumbar Interbody Fusion System is an implant used for intervertebral body fusion procedures, not for identifying or diagnosing a medical condition.
No
The device description explicitly states that the device consists of implants manufactured from titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, a procedure performed in vivo (within the body). IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor conditions.
- Device Description: The device is described as an implant made of titanium alloy, designed to be surgically placed in the lumbar spine. This is consistent with a medical device for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the MiRus™ 3D Printed Lumbar Interbody Fusion System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MiRus™ 3D Printed Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The MiRus™ 3D Printed Lumbar Interbody Fusion System consist of implants manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001-14 and are offered in four configurations of various sizes to accommodate different patient anatomy and the surgical approaches listed; Posterior Lumbar Approach (PLIF), Transforaminal Lumbar Approach (TLIF), Lateral Lumbar Approach (LLIF), and Anterior Lumbar Approach (ALIF). The implants are provided sterile and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L1-L2 to L5-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)
The mechanical performance profile of the MiRus™ 3D Printed Lumbar Interbody Fusion System was assessed through static and fatigue construct testing in accordance with the following test methods:
- Static and dynamic compression testing (ASTM F2077-17)
- . Static and dynamic compression shear testing (ASTM F2077-17)
- Subsidence testing (ASTM F2267-04)
- Expulsion testing .
Performance data demonstrate that the MiRus™ 3D Printed Lumbar Interbody Fusion System is substantially equivalent to legally marketed predicate systems.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 18, 2020
MiRus, LLC Mr. Jordan Bauman Director of Regulatory Affairs and Ouality 2150 Newmarket Parkway Marietta, Georgia 30067
Re: K191906
Trade/Device Name: MiRus™ 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto™ 3D Printed PLIF, HYPERION™ 3D Printed TLIF, CALYPSO™ 3D Printed LLIF, and ANTARESTM 3D Printed ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 22, 2020 Received: April 23, 2020
Dear Mr. Bauman:
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 (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known) Not Known
Device Name
MiRus™ 3D Printed Lumbar Interbody Fusion System consisting of the CALLISTO™ 3D Printed PLIF, HYPERION™ 3D Printed TLIF, CALYPSO™ 3D Printed LLIF, and ANTARES™ 3D Printed ALIF
Indications for Use (Describe)
The MiRus™ 3D Printed Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17) Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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K191906 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| I. SUBMITTER | MiRus™, LLC
2150 Newmarket Parkway SE
Suite 108
Marietta, Georgia 30067
Tel: (678)-324-6272
Fax: (678) 401-5607 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL
CORRESPONDENT | Jordan Bauman
Director of Regulatory Affairs and Quality
MiRus™, LLC
2150 Newmarket Parkway SE
Suite 108
Marietta, Georgia 30067
Tel: (678)-324-6272
Fax: (678) 401-5607 |
| III. DATE PREPARED | July 15, 2019 |
| IV. DEVICE
Name of Device | MiRus™ 3D Printed Lumbar Interbody Fusion System
consisting of the CALLISTO™ 3D Printed PLIF,
HYPERION™ 3D Printed TLIF, CALYPSO™ 3D
Printed LLIF, and ANTARES™ 3D Printed ALIF |
| Common Name | Intervertebral body fusion device |
| Classification Name | 21 CFR 888.3080 |
| Regulatory Class | Class II |
| Product Codes | MAX |
| Submission Type | Traditional 510(k) |
| V. PREDICATE DEVICE | Primary Predicate
MiRus Lumbar Interbody Fusion System
(K182920)
Additional Predicates
EIT Cellular Titanium® Lumbar Cage (K172888, K181644) |
VI. DEVICE DESCRIPTION
The MiRus™ 3D Printed Lumbar Interbody Fusion System consist of implants manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001-14 and are offered in four configurations of various sizes to accommodate different patient anatomy and the surgical approaches listed; Posterior Lumbar Approach (PLIF), Transforaminal Lumbar Approach (TLIF), Lateral Lumbar Approach (LLIF), and Anterior Lumbar Approach (ALIF). The implants are provided sterile and are intended for single use only.
K191906 510k Summary Page 1 of 2
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VII. INDICATIONS FOR USE
The MiRus™ 3D Printed Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiquous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
VIII. PREDICATE DEVICE COMPARISON
The MiRus™ 3D Printed Lumbar Interbody Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, sizes, and materials.
IX. PERFORMANCE DATA
The mechanical performance profile of the MiRus™ 3D Printed Lumbar Interbody Fusion System was assessed through static and fatigue construct testing in accordance with the following test methods:
- Static and dynamic compression testing (ASTM F2077-17) ●
- . Static and dynamic compression shear testing (ASTM F2077-17)
- Subsidence testing (ASTM F2267-04) ●
- Expulsion testing .
X. CONCLUSONS
The MiRus™ 3D Printed Lumbar Interbody Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, sizes, and materials. Performance data demonstrate that the MiRus™ 3D Printed Lumbar Interbody Fusion System is substantially equivalent to legally marketed predicate systems.