(28 days)
Not Found
No
The summary describes a physical interbody fusion device and its design modifications, materials, and intended use. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant for spinal fusion to treat degenerative disc disease, which is a therapeutic intervention.
No
The device description and indications for use clearly describe an implantable device used for interbody fusion in patients with degenerative disc disease, not a device used to diagnose a medical condition.
No
The device description explicitly states the device is made of physical materials (PEEK-OPTIMA LT1, Tantalum, Titanium) and is an implant, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for spinal fusion, specifically for treating degenerative disc disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics, materials, and design modifications of a spinal implant. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a medical device intended for surgical implantation to treat a specific condition.
N/A
Intended Use / Indications for Use
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiquous spinal levels from L2 -- S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
MectaLIF Extension is a design modification to MectaLIF Posterior and Oblique (K110927) and MectaLIF Transforaminal (K120024). The bullet nose modification to the implant tip geometry creates a self-distracting feature which facilitates insertion of the implant into the disc space. MectaLIF Extension also includes intermediate sizes of MectaLIF Posterior and Oblique as well as new sizes of MectaLIF Oblique. The materials and indications for use are identical to the predicate devices. The materials are PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026) and Tantalum (ISO 13782 / ASTM F 560). MectaLIF Transforaminal also has a Gear made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The devices are intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 -- 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The modification to the device system to include the addition of MectaLIF Extension was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The testing was conducted on the worst case component size and option/design based on engineering analysis. The MectaLIF Extension was compared to the worst case of the predicate devices and it was determined that the MectaLIF Extension are not worst case.
MectaLIF Extension has similar performance testing as the predicates in terms of: Static Axial Compression - ASTM F2077 Dynamic Axial Compression - ASTM F2077 Static Compression/Shear - ASTM F2077 Dynamic Compression/Shear - ASTM F2077 Subsidence Resistance - ASTM F2267
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.
K110927, K120024, K072791, K040536, K073291, K081917, P960025
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
§ 888.3080 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.
0
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two triangles, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is a dashed line, and below that is the word "International" in a smaller font. To the right of the word "Medacta" is a small square with a plus sign inside.
JUL 0 5 2013
510(k) Summary
Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
- Contact Person: Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805) 322-3289 Fax: (805) 437-7553 Email: AGross@medacta.us.com
Date Prepared: June 7, 2013
DEVICE INFORMATION
Trade/Proprietary Name: MectaLIF Extension Common Name: Intervertebral Body Fusion Device Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar
21 CFR 888.3080 Class II Device Product Codes: MAX
Predicate Devices:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K110927 | MectaLIF Posterior and Oblique | Medacta International | 6/13/2011 |
| K120024 | MectaLIF Transforaminal | Medacta International | 2/28/2012 |
| K072791 | OPAL Spacer | Synthes | 12/26/2007 |
| K040536 | Boomerang | Medtronic | 5/5/2004 |
| K073291 | Capstone | Medtronic | 04/24/2008 |
| K081917 | Devex/Leopard | Depuy Spine | 5/22/2009 |
| P960025 | Lumbar IF Cage | Depuy Acromed | 2/2/1999 |
MectaLIF Extension 510(k)
Section 5 - Page 2 of 4
1
Product Description
MectaLIF Extension is a design modification to MectaLIF Posterior and Oblique (K110927) and MectaLIF Transforaminal (K120024). The bullet nose modification to the implant tip geometry creates a self-distracting feature which facilitates insertion of the implant into the disc space. MectaLIF Extension also includes intermediate sizes of MectaLIF Posterior and Oblique as well as new sizes of MectaLIF Oblique. The materials and indications for use are identical to the predicate devices. The materials are PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026) and Tantalum (ISO 13782 / ASTM F 560). MectaLIF Transforaminal also has a Gear made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The devices are intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft.
Indications for Use
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiquous spinal levels from L2 -- S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
Comparison to Predicate Devices
The indications for use and materials of the MectaLIF Extension are identical to the previously cleared predicate devices. The design features, geometries, and sizes of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the MectaLIF Extension are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Performance Testing
The modification to the device system to include the addition of MectaLIF Extension was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The testing was conducted on the worst case component size and
2
option/design based on engineering analysis. The MectaLIF Extension was compared to the worst case of the predicate devices and it was determined that the MectaLIF Extension are not worst case.
MectaLIF Extension has similar performance testing as the predicates in terms of: Static Axial Compression - ASTM F2077 Dynamic Axial Compression - ASTM F2077 Static Compression/Shear - ASTM F2077 Dynamic Compression/Shear - ASTM F2077 Subsidence Resistance - ASTM F2267
Conclusion:
Based on the above information, the MectaLIF Extension can be considered as substantially equivalent to its predicate devices.
Section 5 - Page 4 of 4
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medacta International SA % Mr. Adam Gross Director of Regulatory, Quality and Compliance 4725 Calle Quetzal, Unit B Camarillo, California 93012
Re: K131671
Trade/Device Name: MectaLIF Extension Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 7, 2013 Received: June 7, 2013
Dear Mr. Gross:
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,
July 5, 2013
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
4
Page 2 - Mr. Adam Gross
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 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" (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/dcfault.htm for the CDRH3'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,
Mark N. Melkerson -S
- Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131671
Device Name: MectaLIF Extension
Indications for Use:
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Palients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
Prescription Use × (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
MectaLIF Extension 510(k) June 6, 2013
Section 4 - Page 2 of 2