(55 days)
Not Found
No
The summary describes a mechanical implant device and its material properties and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for supplemental fusion in various conditions, including degenerative disc disease, spondylolisthesis, trauma, and tumor, which are medical conditions that it aims to alleviate or treat.
No
This device is a posterior, non-pedicle supplemental fixation device, intended for surgical implantation to achieve supplemental fusion in the non-cervical spine. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implant made of titanium with a hydroxyapatite coating, intended for surgical implantation.
No, 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 provided text clearly describes a surgical implant (a fusion plate) intended to be surgically implanted into the spine to provide structural support and aid in bone fusion. It is a physical device used in vivo (within the body), not a test performed in vitro (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.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
- spondylolisthesis;
- trauma (i.e., fracture or dislocation); and/or ●
- tumor.
The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).
Product codes (comma separated list FDA assigned to the subject device)
PEK
Device Description
The HA Minuteman G3 MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spikes at the ends of each Plate for attachment to the spinous processes. The HA Minuteman G3 device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3 is made from Ti6Al4V (per ASTM F1472) and Ti6Al4V ELI (per ASTM F136) and has a hydroxyapatite coating (per ASTM F1185) at the distal regions of the plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1)
Indicated Patient Age Range
Not Found
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 HA powder was characterized to determine its particle size. Ca/P ratio, elemental analysis, solubility, dissolution products and rates, XRD pattern (per ASTM F2024), and FTIR spectra. The HA coating was characterized to determine its porosity, thickness (via SEM), Ca/P ratio, elemental analysis, static shear strength (per ASTM F1160), static tensile strength (per ASTM 1147), solubility, dissolution products and rates, XRD pattern (per ASTM F2024), and FTIR spectra.
In all instances, the subject device functioned as intended and the results observed were as expected. Further, engineering rationales and modified performance testing per ASTM F1717 demonstrated that the HA Minuteman G3 presents substantially equivalent mechanical strength compared to the predicate device.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/1 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
Spinal Simplicity, LLC % Ms. Janice M. Hogan Hogans Lovells US, LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K151741
Trade/Device Name: HA Minuteman G3 MIS Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: June 26, 2015 Received: June 26, 2015
Dear Ms. Hogan:
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-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.
1
Page 2 - Ms. Janice M. Hogan
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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
HA Minuteman G3 MIS Fusion Plate
Indications for Use (Describe)
The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/atto spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
- spondylolisthesis: ●
- trauma (i.e., fracture or dislocation); and/or
- tumor. ●
The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
区Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Spinal Simplicity's HA Minuteman G3 MIS Fusion Plate
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Spinal Simplicity LLC 10995 Quivira Road Overland Park, KS 66210 Phone: (913) 451 4414 Facsimile: (913) 888 0075
Contact Person: Julie McKee, J.D.
Date Prepared: August 18, 2015
Name of Device
HA Minuteman G3 MIS Fusion Plate
Common / Classification Name
Spinous Process Plate, 21 CFR 888.3050, Class II Product codes: PEK
Predicate Device
Spinal Simplicity's Spinous Process Fusion Plate (K140046)
Intended Use / Indications for Use
The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
- spondylolisthesis;
- trauma (i.e., fracture or dislocation); and/or ●
- tumor.
The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).
Device Description
The HA Minuteman G3 MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spikes at the ends of each Plate for attachment to the spinous processes. The HA
4
Minuteman G3 device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3 is made from Ti6Al4V (per ASTM F1472) and Ti6Al4V ELI (per ASTM F136) and has a hydroxyapatite coating (per ASTM F1185) at the distal regions of the plate.
Performance Data
The HA powder was characterized to determine its particle size. Ca/P ratio, elemental analysis, solubility, dissolution products and rates, XRD pattern (per ASTM F2024), and FTIR spectra. The HA coating was characterized to determine its porosity, thickness (via SEM), Ca/P ratio, elemental analysis, static shear strength (per ASTM F1160), static tensile strength (per ASTM 1147), solubility, dissolution products and rates, XRD pattern (per ASTM F2024), and FTIR spectra.
In all instances, the subject device functioned as intended and the results observed were as expected. Further, engineering rationales and modified performance testing per ASTM F1717 demonstrated that the HA Minuteman G3 presents substantially equivalent mechanical strength compared to the predicate device.
Substantial Equivalence
The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is as safe and effective as the identified predicate device. The Spinal Simplicity HA Minuteman G3 has the same intended use and indications for use, and similar technological characteristics and principles of operation as its predicate device. The subject device differs from the predicate in the addition of a hydroxyapatite coating at the distal regions of the plate, which does not raise any new issues of safety or effectiveness. Performance data demonstrate that the HA Minuteman G3 is substantially equivalent to the predicate device.
Conclusions
Therefore, the information submitted by Spinal Simplicity in this premarket notification demonstrates that the HA Minuteman G3 MIS Fusion Plate performs as intended and is substantially equivalent to the predicate device.