(263 days)
Not Found
No
The document describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "supplemental fixation device" intended for "achieving supplemental fusion" in various spinal conditions. It is used in conjunction with bone graft material to promote healing and provide stability to the spine, which are therapeutic functions.
No
This device is a fusion plate intended for spinal procedures to achieve supplemental fusion. Its purpose is to provide fixation and support, not to diagnose medical conditions.
No
The device description clearly states that the Minuteman G5 is a physical implant made of titanium alloy with a hydroxyapatite coating, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Spinal Simplicity Minuteman G5 MIS Fusion Plate is a surgical implant intended for posterior fixation in the spine to aid in fusion. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The information provided focuses on the mechanical properties, surgical application, and intended anatomical site of the device, all of which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Spinal Simplicity Minuteman G5 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:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- · spondylolisthesis;
- · trauma (i.e., fracture or dislocation); and/or
• tumor.
The Minuteman G5 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 lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
Product codes
PEK
Device Description
The Minuteman G5 consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include gripping features on the boneinterfacing surfaces of each Plate for attachment to the spinous processes. The Minuteman G5 device is available in multiple sizes to accommodate varying patient anatomy. The Minuteman G5 is made from titanium alloy Ti6A14V ELI and has a hydroxyapatite coating on the distal regions of the device.
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
Test data and/or engineering analyses have been provided to describe the performance of the Minuteman G5 in the following test modalities:
- ASTM F1717 Static Axial Compression
- ASTM F1717 Dynamic Axial Compression
- Custom Static Plate Dissociation
- Cadaveric Fatigue Testing
The data demonstrates that the subject Minuteman G5 device presents substantially equivalent mechanical performance compared to the predicate device.
Bacterial endotoxin testing will be performed on all batches of sterile packed devices.
Key Metrics
Not Found
Predicate Device(s)
Spinal Simplicity's HA Posterior Fusion Plate (K212781), Spinal Simplicity's HA Minuteman G3 MIS Fusion Plate (K212781), Spinal Simplicity's HA Minuteman G3-R MIS Fusion Plate (K212781)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 11, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Spinal Simplicity LLC Mr. Adam Rogers Director of Regulatory 6600 College Blvd, Ste 220 Overland Park. Kansas 66211
Re: K211880
Trade/Device Name: Minuteman G5 MIS Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: February 7, 2022 Received: February 8, 2022
Dear Mr. Rogers:
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.
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
1
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,
Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number (if known) K211880
Device Name
Spinal Simplicity Minuteman G5 MIS Fusion Plate
Indications for Use (Describe)
The Spinal Simplicity Minuteman G5 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:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- · spondylolisthesis;
- · trauma (i.e., fracture or dislocation); and/or
• tumor.
The Minuteman G5 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 lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
| 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
Spinal Simplicity's Minuteman G5 MIS Fusion Plate
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Spinal Simplicity LLC 6600 College Blvd Suite 220 Overland Park, KS 66211 Phone: (913) 451-4414 Facsimile: (913) 888-0075
Contact Person: Adam Rogers
Date Prepared: February 7, 2022
Name of Device:
Minuteman G5 MIS Fusion Plate
Common / Classification Name:
Spinous Process Plate, 21 CFR 888.3050, Class II
Product codes: PEK
Predicate Devices:
Spinal Simplicity's HA Posterior Fusion Plate (K212781) - Primary Predicate Spinal Simplicity's HA Minuteman G3 MIS Fusion Plate (K212781) Spinal Simplicity's HA Minuteman G3-R MIS Fusion Plate (K212781)
Intended Use / Indications for Use:
The Spinal Simplicity Minuteman G5 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:
- lumbar spinal stenosis
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
- spondylolisthesis;
4
- trauma (i.e., fracture or dislocation); and/or ●
- tumor. ●
The Minuteman G5 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 lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
Technological Characteristics:
The Minuteman G5 consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include gripping features on the boneinterfacing surfaces of each Plate for attachment to the spinous processes. The Minuteman G5 device is available in multiple sizes to accommodate varying patient anatomy. The Minuteman G5 is made from titanium alloy Ti6A14V ELI and has a hydroxyapatite coating on the distal regions of the device.
Performance Data:
Test data and/or engineering analyses have been provided to describe the performance of the Minuteman G5 in the following test modalities:
- ASTM F1717 Static Axial Compression ●
- ASTM F1717 Dynamic Axial Compression ●
- Custom Static Plate Dissociation ●
- Cadaveric Fatigue Testing o
The data demonstrates that the subject Minuteman G5 device presents substantially equivalent mechanical performance compared to the predicate device.
Bacterial endotoxin testing will be performed on all batches of sterile packed devices.
Substantial Equivalence:
The Spinal Simplicity Minuteman G5 MIS Fusion Plate is as safe and effective as the identified predicate device. The Minuteman G5 has the same intended use, indications for use, and similar technological characteristics and principles of operation as its predicate device. Differences between the subject and predicate devices are minor and do not raise any new issues of safety or effectiveness. Performance data further demonstrate that the Minuteman G5 is substantially equivalent to the predicate device.
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Conclusions:
The information submitted by Spinal Simplicity in this premarket notification demonstrates that the Minuteman G5 performs as intended and is substantially equivalent to the predicate device.