(113 days)
No
The document describes a physical intervertebral body fusion device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for degenerative disc disease to alleviate discogenic back pain, which is a medical treatment.
No
The device, MIDLINE II™ / MIDLINE II -Ti™, is an intervertebral body fusion device used for treating degenerative disc disease, not for diagnosing it. Its purpose is to provide structural support and facilitate fusion, not to detect or analyze medical conditions.
No
The device description clearly states it is a physical intervertebral body fusion device made from PEEK and Tantalum, secured with titanium bone screws. It is a hardware implant, not software.
Based on the provided text, the MIDLINE II™ / MIDLINE II -Ti™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to fuse vertebrae in the spine (L2 to S1) for patients with degenerative disc disease. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The device description details the materials and construction of a physical implant designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the living body) to analyze samples and provide diagnostic information. The MIDLINE II™ / MIDLINE II -Ti™ is a surgical implant used in vivo for treatment.
N/A
Intended Use / Indications for Use
The MIDLINE II™ / MIDLINE II -Ti™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The MIDLINE II™ / MIDLINE II -Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE IIIM / MIDLINE II-Ti™ system must be used with bone grafting material (autograft only).
Product codes
OVD
Device Description
The MIDLINE III™ / MIDLINE II-Ti™ is a radiolucent intervertebral body fusion device manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with three metallic X-ray markers manufactured from unalloyed Tantalum (ASTM F560) and plasma sprayed with optional commercially pure titanium (CPT) per ASTM F1580. The device is secured with titanium (Ti-6A1-4V per ASTM F136) unicortical cancellous bone screws provided and is intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the MIDLINE™ (K133286) to include a titanium coating (ASTM F1580-12) and an additional lordotic option.
The MIDLINE II™ / MIDLINE II-Ti™ is provided in 11-21mm heights, 30-42mm widths, 24-30.2mm lengths, and lordotic angles ranging from 8°-20°. The devices are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (Spinal)
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)
Testing performed indicate that the MIDLINE II™ / MIDLINE II-Ti™ is as mechanically sound as predicate devices. Testing included static compression, static compressionshear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-11 and F2267-04. In addition, coating validation testing was performed, including static tensile bonding, shear bonding, and Taber abrasion testing. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133286, K101301, K111122, K102090, K123045, K101310
Reference Device(s)
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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2014
Centinel Spine, Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H. Street Northwest, 12th Washington, District of Columbia 20005
Re: K141942
Trade/Device Name: MIDLINE IITM / MIDLINE II-TiTM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: October 8, 2014 Received: October 9, 2014
Dear Mr. Eggleton:
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
1
Page 2 - Mr. Justin Eggleton
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 Industry and Consumer Education 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. 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/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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141942
Device Name MIDLINE IITM / MIDLINE II-TiTM
Indications for Use (Describe)
The MIDLINE II™ / MIDLINE II -Ti™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The MIDLINE II™ / MIDLINE II -Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE II™ / MIDLINE II -Ti™ system must be used with bone grafting material (autograft only).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary
| Device Trade Name: | MIDLINE IITM / MIDLINE II-TiTM |
|---|---|
| Manufacturer: | Centinel Spine, Inc. |
| 900 Airport Road, Suite 3B | |
| West Chester, PA 19380 | |
| Contact: | Mr. John Parry |
| Development Manager | |
| Phone: (484) 887.8813 | |
| J.Parry@centinelspine.com | |
| Prepared by: | Justin Eggleton |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | October 8, 2014 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | OVD |
| Primary Predicate: | K133286 (MIDLINETM) |
| Additional Predicates: | STALIF MIDLINE™ (K101301), Aesculap SIBD XP Spinal |
| System (K111122), SpineSmith Cynch Spinal System (K102090), | |
| NuVasive Brigade Hyperlodotic System (K123045), Theken Spine | |
| VuaPOD (K101310) | |
| Reference Device: | K133200 (STALIF C® Ti) |
Indications For Use:
The MIDLINE III™ / MIDLINE II-Ti™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the
4
treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The MIDLINE II™ / MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE IIIM / MIDLINE II-Ti™ system must be used with bone grafting material (autograft only).
Device Description:
The MIDLINE III™ / MIDLINE II-Ti™ is a radiolucent intervertebral body fusion device manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with three metallic X-ray markers manufactured from unalloyed Tantalum (ASTM F560) and plasma sprayed with optional commercially pure titanium (CPT) per ASTM F1580. The device is secured with titanium (Ti-6A1-4V per ASTM F136) unicortical cancellous bone screws provided and is intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the MIDLINE™ (K133286) to include a titanium coating (ASTM F1580-12) and an additional lordotic option.
The MIDLINE II™ / MIDLINE II-Ti™ is provided in 11-21mm heights, 30-42mm widths, 24-30.2mm lengths, and lordotic angles ranging from 8°-20°. The devices are provided sterile.
Predicate Device:
The subject MIDLINE IIIM / MIDLINE II-Ti™ device is substantially equivalent to predicate MIDLINE™ and STALIF MIDLINE™ devices (K133286, K101301) with respect to indications, design, function, and performance.
Substantial Equivalence:
Testing performed indicate that the MIDLINE II™ / MIDLINE II-Ti™ is as mechanically sound as predicate devices. Testing included static compression, static compressionshear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-11 and F2267-04. In addition, coating validation testing was performed, including static tensile bonding, shear bonding, and Taber abrasion testing. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Conclusion:
Centinel Spine provided sufficient information to demonstrate the MIDLINE III™ / MIDLINE II-Ti™ is substantially equivalent to predicate MIDLINE™ and STALIF MIDLINE™ devices (K133286, K101301).