(58 days)
Not Found
No
The 510(k) 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. The performance studies are mechanical tests, not evaluations of algorithmic performance.
Yes
The device is described as a "posterior, non-pedicle supplemental fixation device" intended for "achieving supplemental fusion" in the spine, which clearly indicates its use in treating medical conditions.
No
The device is a posterior, non-pedicle supplemental fixation device intended for fusion in the non-cervical spine, serving as an implant for structural support rather than for diagnosis.
No
The device description clearly states it is a physical implant made of Ti6Al4V and Ti6Al4V ELI with a hydroxyapatite coating, and the performance studies are mechanical tests on the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a plate and body/post) intended to be surgically implanted into the spine for fixation and fusion. It is a physical device used within the body, not a test performed on samples outside the body.
The description focuses on the mechanical properties, materials, and surgical application of the device, which are characteristic of an implantable medical device, not an IVD.
N/A
Intended Use / Indications for Use
The HA Minuteman G3-R 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 radiographic studies);
- spondylolisthesis;
- . trauma (i.e., fracture or dislocation); and/or
- . tumor.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The HA Minuteman G3-R MIS Fusion Plate may be implanted via a minimally invasive lateral approach (L1-S1).
Product codes
PEK
Device Description
The HA Minuteman G3-R MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates. The Plate components include several spikes on the face of each Plate for attachment to the spinous processes. The HA Minuteman G3-R device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3-R is made from Ti6Al4V and Ti6Al4V ELI and has a hydroxyapatite coating on a portion of the implant.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests have been performed on the HA Minuteman G3-R MIS Fusion Plate to evaluate the mechanical performance of the device:
- Static Axial Compression Test ●
- o Static Torsion Test
- Dynamic Axial Compression Test
- Static Axial Pull-Out Test ●
- Static Plate Dissociation Test ●
- Simulated Deployment Testing
- Custom Body Connection Feature Tests (Torque Test, Axial Locking Feature Test, ● Axial Disengagement Test)
- . Cadaveric Insertion Testing
In all instances, the HA Minuteman G3-R MIS Fusion Plate functioned as intended and the results observed were as expected.
Bacterial endotoxin testing will also be performed on all batches of sterile packed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, repeated three times to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Febraury 2, 2017
Spinal Simplicity Mr. Douglas B. Snell Director of Engineering, Quality, and Regulatory 10995 Quivira Road Overland Park, Kansas 66210
Re: K163428
Trade/Device Name: HA Minuteman G3-R MIS Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: January 6, 2017 Received: January 9, 2017
Dear Mr. Snell:
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 devicerelated 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
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/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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known) K163428
Device Name
HA Minuteman G3-R MIS Fusion Plate
Indications for Use (Describe)
The HA Minuteman G3-R 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 radiographic studies);
- spondylolisthesis;
- . trauma (i.e., fracture or dislocation); and/or
- . tumor.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The HA Minuteman G3-R MIS Fusion Plate may be implanted via a minimally invasive lateral approach (L1-S1).
| 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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FORM FDA 3881 (8/14)
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510(k) SUMMARY Spinal Simplicity's HA Minuteman G3-R MIS Fusion Plate
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
- Spinal Simplicity 10995 Quivira Road Overland Park, KS 66210 Phone: (913) 451 4414 Facsimile: (913) 888 0075 Contact Person: Douglas B Snell Date Prepared: January 6th, 2016
Name of Device
HA Minuteman G3-R MIS Fusion Plate
Common or Usual Name
Spinous Process Plate, 21 CFR 888.3050, Class II Product Code PEK
Primary Predicate Device
Spinal Simplicity HA Minuteman G3 MIS Fusion Plate (K151741)
Indications for Use
The HA Minuteman G3-R 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 radiographic studies);
- . spondylolisthesis;
- o trauma (i.e., fracture or dislocation); and/or
- o tumor.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The HA Minuteman G3-R MIS Fusion Plate may be implanted via a minimally invasive lateral approach (L1-S1).
4
Technological Characteristics
The HA Minuteman G3-R MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates. The Plate components include several spikes on the face of each Plate for attachment to the spinous processes. The HA Minuteman G3-R device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3-R is made from Ti6Al4V and Ti6Al4V ELI and has a hydroxyapatite coating on a portion of the implant.
Purpose of 510(k)
The purpose of this 510(k) is to:
- Introduce a two-part Body/Post component that allows for reduction of the non-load ● bearing lateral profile of the implant remaining in the patient. The outer threaded portion of the Body/Post remains nearly identical to the Body/Post of the predicate device, with the exception of several geometric features that allow the two halves of the Body/Post to be reversibly locked together.
- Introduce a feature that joins the Spike Plate and Hex Nut together as a single unit. ● This allows the user to hold the implant vertically with the nose of the device pointing towards the ground without the Spike Plate sliding down the Body/Post. This makes loading bone graft material into the device easier, as the user does not need to hold the Spike Plate out of the way.
- Update Wing geometry for manufacturing and to improve Wing profile in the closed ● and open positions.
- . Make minor instrumentation updates.
Performance Data
The following tests have been performed on the HA Minuteman G3-R MIS Fusion Plate to evaluate the mechanical performance of the device:
- Static Axial Compression Test ●
- o Static Torsion Test
- Dynamic Axial Compression Test
- Static Axial Pull-Out Test ●
- Static Plate Dissociation Test ●
- Simulated Deployment Testing
- Custom Body Connection Feature Tests (Torque Test, Axial Locking Feature Test, ● Axial Disengagement Test)
- . Cadaveric Insertion Testing
In all instances, the HA Minuteman G3-R MIS Fusion Plate functioned as intended and the results observed were as expected.
Bacterial endotoxin testing will also be performed on all batches of sterile packed devices.
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Substantial Equivalence
The HA Minuteman G3-R MIS Fusion Plate has the same indications and similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the HA Minuteman G3-R MIS Fusion Plate and its predicate device do not raise different issues of safety or effectiveness, as confirmed through risk analysis and design control activities. Thus, we believe the HA Minuteman G3-R MIS Fusion Plate is substantially equivalent.
Conclusions
The HA Minuteman G3-R MIS Fusion Plate is substantially equivalent to the predicate device.