(44 days)
No
The document describes a mechanical spinal fixation system and its components. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making capabilities.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which are therapeutic medical conditions.
No
Explanation: The device description clearly states it is a "multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion." This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description explicitly states it is a "multiple component system comprised of a variety of single use devices" and mentions the materials used for the implants (titanium alloy) and instrumentation (surgical grade stainless steel). This indicates it is a hardware-based medical device, not software-only.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant system used to stabilize the spine. It is implanted directly into the patient's body during surgery.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device's function is mechanical stabilization, not diagnostic testing of bodily fluids or tissues.
Therefore, based on the provided information, the Aesculap's Spine System® Evolution is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.
When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T1 through S1.
Product codes
MNI, KWP, MNH
Device Description
Spine System® Evolution is a multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion. The additional components presented in this submission are pedicle, laminar, thoracic and counter hooks. The spinal implants are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III. The specialized instrumentation used to implant and explant the Spine System® Evolution implants are made from surgical grade stainless steel in accordance to ISO 7153/1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, sacral spine, L5-S1 vertebra, T1 through 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
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the components that comprise Spine System® Evolution were subjected to mechanical testing according to the ASTM Standard F 1717-96 (Static and Fatigue Test Methods for Spinal Implant Constructs in a Corpectomy Model).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K964159, K962708, K961633, K951846, K980447, K955348, K973836, K950099, K940631
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
09/29/98
99/29/98
ESCULAP INC
019
System® Evolution: Additional Components
Amendment to #K982914
2 1998 OCT
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
AESCULAP SPINE SYSTEM® EVOLUTION ADDITIONAL COMPONENTS
September 29, 1998
Company
Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact Lia S. Jones, Regulatory Associate Phone: 650-876-7000 x 350 650-589-3007 FAX:
Trade Name
Aesculap Spine System® Evolution
Common Name
Spinal Fixation System
Product Code and Regulatory Classification
| MNI: | 888.3070 | Pedicle Screw Spinal Fixation Orthosis |
|---|---|---|
| MNH: | 888.3070 | Spondylolisthesis Spinal Fixation Device System |
| KWP: | 888.3050 | Spinal Interlaminal Fixation Orthosis |
Product Classification
Class II
Intended Use
When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.
When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T1 through S1.
1
Amendment to #K982914
15:10
Page 2 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
AESCULAP SPINE SYSTEM® EVOLUTION ADDITIONAL COMPONENTS
Device Description
Spine System® Evolution is a multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion. The additional components presented in this submission are pedicle, laminar, thoracic and counter hooks. The spinal implants are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III. The specialized instrumentation used to implant and explant the Spine System® Evolution implants are made from surgical grade stainless steel in accordance to ISO 7153/1.
Performance Data
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the components that comprise Spine System® Evolution were subjected to mechanical testing according to the ASTM Standard F 1717-96 (Static and Fatigue Test Methods for Spinal Implant Constructs in a Corpectorny Model).
Substantial Equivalence
Aescular believes that the Spine System® Evolution additional components presented in this submission are substantially equivalent in design, material composition, function and intended use to currently marketed spinal implant systems, such as:
-
CD Horizon™ Spinal System . by Sofamor Danek (K964159, K962708, K961633)
-
Mirage™ Spinal System g by Alphatec (K951846)
-
Moss® Miami Titanium Spinal System . by Depuy Motech™ (K980447, K955348)
-
Synergy™ Posterior Spinal System . by Cross® Medical Products, Inc. (K973836, K950099, K940631)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1898
Ms. Lia S. Jones Regulatory Associate Aesculap®, Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7030
Re: K982914
Spine System® Evolution - additional components Regulatory Class: II Product Codes: MNI, KWP, and MNH Dated: August 17, 1998 Received: August 19, 1998
Dear Ms. Jones:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Lia S. Jones
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
- ~ Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Amendment to #K982914
Assculap Spine System® Evolution: Additional Components
Page 1 of 1
INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Aesculap Spine System® Evolution Additional Components
Indication for Use:-
When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is intended to provide immobilization and stabilization of spinal seqments 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; degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).
It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autoqenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.
When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine turnors and fractures. It is intended for posterior fixation from levels T1 through S1.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number |
or Over-the-Counter Use
K982914
(Optional Format 1-2-96)