(105 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a spinal implant, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes
The device is an intervertebral body fusion device intended for spinal fusion procedures to treat degenerative disc disease and spondylolisthesis, which are medical conditions that cause pain and require treatment.
No
The device is an implantable spinal system used for spinal fusion procedures. It is a treatment device, not one used for diagnosis.
No
The device description clearly states it is an implantable spinal device manufactured from physical materials (PEEK-OPTIMA® LT, titanium, Tantalum) and secured with physical screws. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implantable spinal device for spinal fusion procedures. This is a surgical intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the materials and construction of a physical implant designed to be placed within the body.
- Performance Studies: The performance studies focus on the mechanical and structural integrity of the implant (static and dynamic testing, wear, expulsion, etc.), which are relevant to an implantable device, not a diagnostic assay.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the AIS SIBD XP Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AIS SIBD XP Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplemental fixation is used.
As an intervertebral body fusion device designed for use with autograft, the SIBD XP Spinal System is intended for spinal fusion procedures at one or two contiquous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).
Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aescular® Implant Systems device.
Product codes
OVD
Device Description
The AIS SIBD XP Spinal System is an implantable spinal device manufactured from PEEK-OPTIMA® LT (Polyetheretherketone) per ASTM F2026, with a titanium laver and a vacuum plasma spray coating (Plasmapore®). The device will have Tantalum markers per ASTM F-560.The implant is secured to vertebral bodies by four titanium screws inserted through the anterior screw holes. The implants are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to S1
Indicated Patient Age Range
skeletally mature
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
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the AIS SIBD XP Spinal System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic torsion per ASTM F2077 .
- Static and dynamic axial compression per ASTM F2077 .
- Static and dynamic shear compression testing per ASTM F2077 .
- Subsidence per ASTM F2267 .
- . Wear Debris per ASTM F2077 & ASTM F1877
- . Expulsion per ASTM Draft Standard F-04.25.02.02
In addition to FDA's Spine Guidance, Aesculap has also completed non-clinical testing recommended in the "Guidance for Industry on the Testing of Metallic Plasma Spraved Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The following tests were performed:
- Microstructure of the coating per ASTM F1854 .
- Static Tensile Strength per ASTM F1147 .
- · Static Shear Strength per ASTM F1044
- Shear Fatigue Test per ASTM F1160
- · Abrasion Resistance per ASTM F1978
The results of these tests showed that the AIS SIBD XP Spinal System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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510(k) SUMMARY (as required by 21 CFR 807.92) B.
AUG - 4 2011
Aescular® Implant Systems(AIS) - SIBD XP Spinal System August 1, 2011
| COMPANY: | Aesculap®Implant Systems, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
| ---------- | -------------------------------------------------------------------------------------------------------------------------------------- |
|---|
CONTACT: Lisa M. Boyle 610-984-9274 (phone) 610-791-6882 (fax)
TRADE NAME: AIS SIBD XP Spinal System
COMMON NAME. Intervertebral Body Fusion Device
CLASSIFICATION NAME: Intervertebral Fusion Device with Integrated Fixation, Lumbar
REGULATION NUMBER: 888.3080
PRODUCT CODE: OVD
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the AIS SIBD XP Spinal System.
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems, Inc. believes that the AIS SIBD XP Spinal System is substantially equivalent to the design of the AIS SIBD Spinal System (K100802). The Plasmapore® coating used for the subject device is similar to the the Plasmapore® coating of the AIS Hydrolift VBR System (K083186). Furthermore, the coating has been used and cleared in a number of legally marketed systems in the US and Europe for many years.
DEVICE DESCRIPTION
The AIS SIBD XP Spinal System is an implantable spinal device manufactured from PEEK-OPTIMA® LT (Polyetheretherketone) per ASTM F2026, with a titanium laver and a vacuum plasma spray coating (Plasmapore®). The device will have Tantalum markers per ASTM F-560.The implant is secured to vertebral bodies by four titanium screws inserted through the anterior screw holes. The implants are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy.
page 1 of 3
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Image /page/1/Picture/0 description: The image contains the word "killing" written in a handwritten style. The letters are connected, and the word appears to be written with a dark ink or marker on a white background. The handwriting is somewhat stylized, with variations in the thickness of the strokes.
INDICATIONS FOR USE
The AIS SIBD XP Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplemental fixation is used.
As an intervertebral body fusion device designed for use with autograft, the SIBD XP Spinal System is intended for spinal fusion procedures at one or two contiquous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondvlolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).
Patients should be skeletally mature and must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Aescular® Implant Systems device.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the SIBD XP Spinal System are offered in the same range of shapes and sizes as the predicate device. The material used for the Aescular® Implant Systems device is the same as that used to manufacture the predicate devices. The only difference between the predicate device and the subject device is the titanium laver and a vacuum plasma spray coating (Plasmapore®).
PERFORMANCE DATA
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the AIS SIBD XP Spinal System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic torsion per ASTM F2077 .
- Static and dynamic axial compression per ASTM F2077 .
- Static and dynamic shear compression testing per ASTM F2077 .
- Subsidence per ASTM F2267 .
- . Wear Debris per ASTM F2077 & ASTM F1877
- . Expulsion per ASTM Draft Standard F-04.25.02.02
In addition to FDA's Spine Guidance, Aesculap has also completed non-clinical testing recommended in the "Guidance for Industry on the Testing of Metallic Plasma Spraved Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The following tests were performed:
- Microstructure of the coating per ASTM F1854 .
- Static Tensile Strength per ASTM F1147 .
- · Static Shear Strength per ASTM F1044
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- Shear Fatigue Test per ASTM F1160
- · Abrasion Resistance per ASTM F1978
The results of these tests showed that the AIS SIBD XP Spinal System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
- 4 2011 പ്രിട്ര
Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K111122
Trade/Device Name: Aesculap® Implant Systems (AIS) - SIBD XP Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: July 08, 2011 Received: July 11, 2011
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. 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
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Page 2 - Ms. Lisa M. Boyle
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 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/About/DA/CentersOffices/CDRH/CDRHOffices/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/ReportalProblem/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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Mulhern
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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Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number: k11/22
Device Name: Aesculap® Implant Systems (AIS) - SIBD XP Spinal System
Indications for Use:
The AIS SIBD XP Spinal System is a stand-alone device intended to be used with the four supplied bone screws if no supplemental fixation is used.
As an intervertebral body fusion device designed for use with autograft, the SIBD XP Spinal System is intended for spinal fusion procedures at one or two contiguous levels in the Uyotar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s).
Patients should be skeletally mature and must have undergone a regimen of at least six ({) months of non-operative treatment prior to being treated with the Aesculap® Implant Systems device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Auckth for MXM 8/3/11
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K111222