(86 days)
Not Found
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an implantable system designed to immobilize and stabilize spinal segments, promote fusion, and treat various acute and chronic instabilities or deformities of the spine. These are therapeutic actions.
No
Explanation: The "Spine System Evolution" is described as a "pedicle screw system" and an "implant" designed to provide "immobilization and stabilization of spinal segments" and "promote fusion." These functions are therapeutic and supportive, not diagnostic.
No
The device description explicitly states it is a "multiple component system comprised of a variety of single-use, non-sterile implants" made of Ti6Al4V, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to stabilize and promote fusion in the spine. It is a physical device implanted in the body.
- Device Description: The device description details the components of a surgical implant system (screws, rods, plates, etc.) made of a specific material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Spine System Evolution is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition. 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, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a posterior, non-cervical, non-pedicle screw fixation system, Spine System Evolution is intended for hook fixation from T1 to the ilium / sacrum. The non-pedicle screw indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH, MNI
Device Description
Spine System Evolution is a multiple component system comprised of a variety of single-use, non-sterile implants (Ti6Al4V acc. to ISO 5832/3) that allow the surgeon to build a spinal construct in order to stabilize and promote fusion in the thoracic, lumbar and sacral spine. It is a low-profile, top-loading system that utilizes one connection (conical nut) for all implants, such as standard and polyaxial pedicle screws, sacral plates and screws, rods and rod connectors, linking plates, lateral connectors, and various hook styles and configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine, L5-S1 vertebra, L3 to sacrum, T1 to the ilium / sacrum
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. The implants presented in this 510(k), however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy.
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.
K980484, K982914, K992738, K990118, K990721, K984350, K951846, K992792, K984251
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
Spine System® Evolution
JUN 2 9 2000
Koo1080
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
SPINE SYSTEM® EVOLUTION
April 3, 2000
- Aesculap®, Inc. COMPANY: 1000 Gateway Blvd. So. San Francisco, CA 94080
- Lia S. Jones, Regulatory Associate CONTACT: 650-624-5073 (phone) 650-589-3007 (fax) lia.jones@aesculap.com (email)
- Spine System® Evolution TRADE NAME:
- COMMON NAME: Posterior Spinal Fixation System
- DEVICE CLASS: Class II
- PRODUCT CODE(S): KWP, MNH, MNI
- CLASSIFICATION(S): 888.3050 Spinal Interlaminal Fixation Orthosis 888.3070 - Spondylolisthesis Spinal Fixation Device System 888.3070 - Pedicle Screw Spinal System
- Orthopedic Devices Branch REVIEW PANEL: Division of General and Restorative Devices
DEVICE DESCRIPTION
Spine System Evolution is a multiple component system comprised of a variety of single-use, non-sterile implants (Ti6Al4V acc. to ISO 5832/3) that allow the surgeon to build a spinal construct in order to stabilize and promote fusion in the thoracic, lumbar and sacral spine. It is a low-profile, top-loading system that utilizes one connection (conical nut) for all implants, such as standard and polyaxial pedicle screws, sacral plates and screws, rods and rod connectors, linking plates, lateral connectors, and various hook styles and configurations.
PURPOSE OF PREMARKET NOTIFICATION
This submission seeks to expand the current product line for Aesculap's Spine System Evolution (K980484, K982914) with new and modified components. There are no changes to the intended use, material composition or fundamental scientific technology.
1
Spine System® Evolution
Page 2 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
SPINE SYSTEM® EVOLUTION
April 3, 2000
INDICATIONS FOR USE
Spine System Evolution is a pedicle screw system indicated for the treatment of severe spondvlolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition. 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, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a posterior, non-cervical, non-pedicle screw fixation system, Spine System Evolution is intended for hook fixation from T1 to the ilium / sacrum. The non-pedicle screw indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. The implants presented in this 510(k), however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy.
SUBSTANTIAL EQUIVALENCE
The new and modified components described in this premarket notification are substantially equivalent in their intended use, material composition, labeling, design and basic operating principles to those in Aesculap's current Spine System Evolution (K980484, K982914), as well as the following competitor spinal systems:
- ISOBAR®, ISOLOCK® Spinal System (K992738, K990118, K990721) .
- ISOLA / VSP System (K984350) .
- Mirage™ Spinal System (K951846) .
- Xia™ Spinal System (K992792, K984251) .
2
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, represented by three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2000
Ms. Lia S. Jones Regulatory Associate Aesculap, Incorporated 1000 Gateway Boulevard South San Francisco, California 94080-7028
Re: K001080
Trade Name: Spinal System® Evolution Regulatory Class: II Product Code: KWP, MNH and MNI Dated: April 3, 2000 Received: April 4, 2000
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 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 requirement, 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- Ms. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Rene M. Jujan
Say Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Spine System® Evolution
Indication for Use:
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When used as a posterior, non-cervical, non-pedicle screw fixation system, Spine When used as a postenor, non och fixation from T1 to the illium / sacrum. The System Evolution is Inchart for need maalth in the disease (defined as back pain non-peatcle screw indication of the disc confirmed by first confirmed by first and of useogenic studies), spondylolisthesis, trauma (fracture or dislocation), spinal radiographic studies), Spondylolistics, kyphosis and lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Ninel Vang
(Division Sign-Off)
or Over-the-Counter Use
Division of Seral Restorative Devices 510(k) Numb:: 100 1080
(per 21 CFR 801.109)
(Optional Format 3-10-98)