(267 days)
The MILI System is intended for posterior, non-cervical pedicle fixation of the spine. It is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of one or more of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolithesis (Grade I/II) with objective evidence of neurological impairment, fracture, dislocation, scoliosis (one level), kyphosis, spinal tumor, failed previous fusion (pseudarthrosis),
The MILI System, when used as a pedicle screw fixation system, is indicated for use in patients: a) who are receiving fusion using autogenous graft only; b) who are having the device fixed or attached to the thoracolumbar or sacral spine; and c) who are having the device removed after the development of a solid fusion mass.
The MILI System is indicated only for one-level or adjacent two-level procedures.
The Aesculap Implant Systems (AIS) MILI System is a minimally invasive posterior plating system for the thoracolumbar spine. This system is intended for posterior, non-cervical pedicle fixation. The AIS MILI System consists of plates and cannulated screws. The components are available in a variety of lengths in order to accommodate patient anatomy. The AIS MILI System is manufactured from Titanium/Titanium Alloy and will be provided non-sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MILI (Minimally Invasive Lumbar Implant) System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Equivalence: Proposed device demonstrates similar performance to legally marketed predicate systems in biomechanical testing. | "Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications." |
| Safety and Effectiveness: Mechanical testing demonstrates the device is safe and effective. | "Mechanic testing demonstrates that Aesculap's MILI System is safe and effective comparable to other predicate systems currently on the market." |
| Surgical Implantation Feasibility: The device can be successfully implanted according to the specified minimally invasive surgical technique. | "In addition, cadaver testing confirms that the MILI System can successfully be implanted according to the specified minimally invasive surgical technique." |
| Compliance with Guidance Documents: All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" and "Spinal System 510(k)s" are met where applicable/relevant. | "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where relevant." |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: The document explicitly mentions "cadaver testing," which indicates a biological, non-human live subject sample. However, the exact number of cadavers used is not specified.
- Data Provenance: The document does not specify the country of origin for the biomechanical or cadaver testing. It also doesn't indicate if the data was retrospective or prospective, though cadaver testing would inherently be prospective for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- The document does not provide information on the number or qualifications of experts used to establish a "ground truth" for the test set in the context of expert consensus or clinical outcomes. The cadaver testing focuses on surgical implantation feasibility, which would likely be assessed by surgeons or anatomists, but their specific roles and numbers are not detailed.
4. Adjudication Method (Test Set)
- The document does not specify an adjudication method. For cadaver testing, methods like 2+1 or 3+1 are typically for clinical outcome or image interpretation, which isn't the focus here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The evaluations are focused on the device's physical and mechanical properties and surgical feasibility, not human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. The MILI System is a physical implant, not an AI algorithm. Therefore, there is no standalone (algorithm-only) performance study described.
7. Type of Ground Truth Used
- The ground truth in this context is primarily established through mechanical/physical testing results demonstrating equivalence to predicate devices and observational assessment (cadaver testing) of the device's ability to be implanted successfully according to its intended technique. It is not based on expert consensus for clinical diagnosis, pathology, or long-term outcomes data in live patients for these performance tests.
8. Sample Size for the Training Set
- Not applicable. As the MILI System is a physical medical device (implant) and not an AI/machine learning algorithm, there is no "training set" in the context of data-driven model development. The design and manufacturing process for the device would have involved engineering design, material testing, and rapid prototyping, but these are not considered a "training set" in the same way as for AI.
9. How Ground Truth for the Training Set Was Established
- Not applicable. Refer to point 8. There is no training set in the AI sense for this device. The "ground truth" for its design and performance would be established through engineering principles, material science, biomechanical standards, and iterative design and testing.
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K083004
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510(k) SUMMARY (as required by 21 CFR 807.92) B.
MILI (Minimally Invasive Lumbar Implant) System
June 5, 2009
| COMPANY: | Aesculap Implant Systems, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 |
|---|---|
| CONTACT: | Lisa M. Boyle800-258-1946 (phone)610-791-6882 (fax) |
| TRADE NAME: | MILI |
| COMMON NAME: | Minimally Invasive Lumbar Implant (MILI) System |
| CLASSIFICATION NAME: | Non-cervical, Pedicle System (MNH, MNI, NKB) |
REGULATION NUMBER: 888.3070
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems (AIS), Inc., believes that the MILI System is substantially equivalent to the S4 Lumbar Spinal System (also known as Revolution) (K032219), and the Ascend Spinal Fixation System with the Shadow Spinal System (K013196).
DEVICE DESCRIPTION
The Aesculap Implant Systems (AIS) MILI System is a minimally invasive posterior plating system for the thoracolumbar spine. This system is intended for posterior, non-cervical pedicle fixation. The AIS MILI System consists of plates and cannulated screws. The components are available in a variety of lengths in order to accommodate patient anatomy. The AIS MILI System is manufactured from Titanium/Titanium Alloy and will be provided non-sterile.
INDICATIONS FOR USE
The MILI System is intended for posterior, non-cervical pedicle fixation of the spine. It is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of one or more of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolithesis (Grade I/II) with objective evidence of neurological impairment, fracture,
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K083004
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dislocation, scoliosis (one level), kyphosis, spinal tumor, failed previous fusion (pseudarthrosis),
The MILI System, when used as a pedicle screw fixation system, is indicated for use in patients: a) who are receiving fusion using autogenous graft only; b) who are having the device fixed or attached to the thoracolumbar or sacral spine; and c) who are having the device removed after the development of a solid fusion mass.
The MILI System is indicated only for one-level or adjacent two-level procedures.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
The AIS MILI System is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the "Spinal System 510(k)s" was completed where relevant. Mechanic testing demonstrates that Aesculap's MILI System is safe and effective comparable to other predicate systems currently on the market.
In addition, cadaver testing confirms that the MILI System can successfully be implanted according to the specified minimally invasive surgical technique.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 an abstract symbol resembling an eagle or bird with stylized wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- JUL - 2 2009
Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K083004
Trade/Device Name: Minimally Invasive Lumbar Implant (MILI) System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNI, and MNH Dated: June 3, 2009 Received: June 4, 2009
Dear Ms. Boyle:
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.
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
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Вавваевинер
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. INDICATIONS FOR USE STATEMENT
16083004 510(k) Number:
Device Name: MILI (Minimally Invasive Lumbar Implant) System
Indications for Use:
The MILI System is intended for posterior, non-cervical pedicle fixation of the spine. It is a pedicle screw system intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of one or more of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolithesis (Grade I/II) with objective evidence of neurological impairment, fracture, dislocation, scoliosis (one level), kyphosis, spinal tumor, failed previous fusion (pseudarthrosis),
The MILI System, when used as a pedicle screw fixation system, is indicated for use in patients: a) who are receiving fusion using autogenous graft only: b) who are having the device fixed or attached to the thoracolumbar or sacral spine; and c) who are having the device removed after the development of a solid fusion mass.
The MILI System is indicated only for one-level or adjacent two-level procedures,
Prescription Use and/or Over-the-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
EXT for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_KO&3004
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.