(170 days)
No
The document describes a physical spinal implant and its material properties and mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an intervertebral body fusion device that is implanted to improve stability of the spine and support fusion in patients with degenerative disc disease, which is a medical condition. This directly indicates a therapeutic intent.
No
Explanation: The device is an intervertebral body fusion device used for spinal fusion procedures. Its purpose is to improve spinal stability and support fusion, not to diagnose a condition.
No
The device description clearly states it is an intervertebral body fusion device manufactured from PEEK with a titanium layer and coating, indicating it is a physical implant, 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 a surgical implant for spinal fusion. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as an intervertebral body fusion device made of PEEK and titanium, designed to be implanted into the vertebral space. This is a physical implant, not a reagent or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or treatment. The device itself is the treatment.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Plasmapore® XP Spinal Implant System is indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Plasmapore® XP Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Plasmapore® oyetems, antenor place of can be used individually or in pairs. The Plasmapore® XP Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
Product codes
MAX
Device Description
The Plasmapore® XP Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK – Optima (per ASTM F2026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have titanium alloy (TiAl6V4) radiographic markers per ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, L2-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed to demonstrate that the AIS ProSpace XP implant is substantially equivalent to other predicate devices. The following testing was performed:
- Static torsion per ASTM F2077 .
- Static and dynamic axial compression per ASTM F2077 ●
- Shear resistance evaluation per ASTM F2267 .
- Subsidence per ASTM F2267. .
- Wear Debris Analysis per ASTM F1877 ●
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 Sprayed 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 Fatique Test per ASTM F1160 .
- Abrasion Resistance per ASTM F1978 .
The results of these tests showed that the Plasmapore® XP Spinal Implant System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3080 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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Page 1 of 3
510(k) Premarket Notification System
Plasmapore® XP (Prospace) Spinal Implant (Plasmapore® Coated)
510(k) SUMMARY (as required by 21 CFR 807.92) B.
JAN 2 2 2014
Aesculap® Implant Systems(AIS) – Plasmapore® XP Spinal Implant System
December 18, 2013
| COMPANY: | Aesculap®Implant Systems (AIS), LLC.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle, Sr. Regulatory Affairs Specialist
610-984-9274 (phone)
610-791-6882 (fax)
lisa.boyle@aesculap.com |
| TRADE NAME: | AIS Plasmapore® XP Spinal Implant System |
| COMMON NAME: | Intervertebral Fusion Device Device |
| CLASSIFICATION NAME: | Orthosis, Spinal Intervertebral Fusion |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | MAX |
Orthopedics
PURPOSE FOR PREMARKET SUBMISSION
The AIS Plasmapore® XP Spinal Implant System described in this submission is for modifications made to the PEEK Prospace implant and for the addition of a Plasmapore® coating to the existing ProSpace PEEK Intervertebral Body Fusion implants cleared under K071983.
INDICATIONS FOR USE
REVIEW PANEL:
When used as an Intervertebral Body Fusion System:
The Plasmapore® XP Spinal Implant System is indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Plasmapore® XP Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Plasmapore® oyetems, antenor place of can be used individually or in pairs. The Plasmapore® XP Spinal Implant System is also intended for use with autogenous bone graft.
1
510(k) Premarket Notification System
Plasmapore® XP (Prospace) Spinal Implant (Plasmapore® Coated
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
DEVICE DESCRIPTION
The Plasmapore® XP Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK – Optima (per ASTM F2026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have titanium alloy (TiAl6V4) radiographic markers per ISO 5832-3.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the Plasmapore® XP Spinal Implant System are offered in the same range of shapes and sizes as the predicate device. The material used for the Aesculap® 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 layer 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 ProSpace XP implant is substantially equivalent to other predicate devices. The following testing was performed:
- Static torsion per ASTM F2077 .
- Static and dynamic axial compression per ASTM F2077 ●
- Shear resistance evaluation per ASTM F2267 .
- Subsidence per ASTM F2267. .
- Wear Debris Analysis per ASTM F1877 ●
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 Sprayed 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 Fatique Test per ASTM F1160 .
- Abrasion Resistance per ASTM F1978 .
2
510(k) Premarket Notification System
Plasmapore® XP (Prospace) Spinal Implant (Plasmapore® Coated)
The results of these tests showed that the Plasmapore® XP Spinal Implant System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
SUBSTANTIAL EQUIVALENCE
AIS believes that the Plasmapore® XP Spinal Implant System is substantially equivalent to the design of the AIS PEEK VBR and Intervertebral Body Fusion Systems (K071983). The Plasmapore® coating has been used and cleared in a number of legally marketed product lines manufactured by Aesculap (hip, knee, and spinal implants) for many years. The most recent Spinal Implant to be cleared with the Plasmapore® coating is the CeSpace XP Intervertebral Body Fusion Device (K123909).
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Aesculap Implant Systems, Incorporated Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K132421
Trade/Device Name: AIS Plasmapore XP Spinal Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 19, 2013 Received: December 20, 2013
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 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
4
Page 2 - Ms. Lisa M. Boyle
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K 132421
Device Name
Plasmapore® XP Spinal Implant System
Indications for Use (Describe)
The Plasmapore® XP Spinal Implant System are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion surgery at the involved spinal level(s). The Plasmapore® XP Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The Plasmapore® XP Spinal Implants can be used individually or in pairs. The Plasmapore® XP Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regiment of non-operative treatment prior to being treated with the device.
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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A CONTRACTION OF THE WARDED A FOR FOR FOR FOR FOR FOR FOR FOR FOR THE OFFICE
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
PSC Publishing Services (10)) 443-6740
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