(137 days)
The STALIF MIDLINE™ 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 STALIF MIDLINE™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIF MIDLINE™ system must be used with bone grafting material (autograft only).
The STALIF MIDLINE™ is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the STALIFTM TT (K073109) to include a modified anti-back out feature and additional sizes.
The provided text describes the STALIF MIDLINE™ intervertebral body fusion device and its substantial equivalence to a predicate device (STALIF™ TT, K073109). The information primarily focuses on the device's indications for use, description, and mechanical performance testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Equivalence | Static Compression (ASTM F2077) | "mechanically equivalent to predicate devices" |
| Dynamic Compression (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Static Torsion (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Dynamic Torsion (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Static Compression-Shear (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Dynamic Compression-Shear (ASTM F2077) | "mechanically equivalent to predicate devices" | |
| Static Subsidence (ASTM F2267) | "mechanically equivalent to predicate devices" | |
| Functional Equivalence | Same indications for use as predicate (K073109) | Met |
| Similar design to predicate (K073109) | Met (modified anti-back out feature and additional sizes) | |
| Similar function to predicate (K073109) | Met | |
| Similar materials to predicate (K073109) | Met | |
| Safety and Effectiveness | Substantial equivalence to predicate device (K073109) | Determined by FDA |
The study that proves the device meets the acceptance criteria is the mechanical testing performed in accordance with ASTM F2077 and ASTM F2267. This testing indicated that the STALIF MIDLINE™ is "mechanically equivalent to predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for the mechanical tests, the type of data (human or animal), or its provenance. It only states that "Testing performed in accordance with ASTM F2077... and ASTM F2267... indicates the STALIF MIDLINE™ is mechanically equivalent to predicate devices." These ASTM standards refer to in-vitro mechanical testing of intervertebral body fusion devices, not clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the study involves mechanical testing of a medical device, not a performance study that requires expert review of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no human interpretation of data described in the mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The provided document concerns the regulatory clearance of a physical medical implant (intervertebral body fusion device) based on mechanical equivalence, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance of the STALIF MIDLINE™ device is established by the specifications and performance characteristics defined in the ASTM F2077 and ASTM F2267 standards, and by comparison to the established mechanical performance of the predicate device (STALIF™ TT, K073109).
8. The sample size for the training set
This is not applicable. The device is a physical implant assessed through mechanical testing; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an algorithm. The "ground truth" for the mechanical testing is based on established engineering standards for medical devices and the predicate device's performance.
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510(k) Summary
SEP 2 4 2010
| Contact: | Mr. Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800 |
|---|---|
| Date Prepared: | July 1, 2010 |
| Device Trade Name: | STALIF MIDLINE™ |
| Manufacturer: | Centinel Spine, Inc505 Park Ave. 14th FloorNew York, NY 10022 |
| Classification: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Code: | MAX |
Indications For Use:
The STALIF MIDLINE™ 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 STALIF MIDLINE™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIF MIDLINE™ system must be used with bone grafting material (autograft only).
Device Description:
The STALIF MIDLINE™ is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the STALIFTM TT (K073109) to include a modified anti-back out feature and additional sizes.
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Predicate Device(s):
STALIF MIDLINE™ was shown to be substantially equivalent to the previously cleared STALIF™ device (K073109) and has the same indications for use, design, function, and materials used.
Performance:
Testing performed in accordance with ASTM F2077 (static/dynamic compression, static/dynamic torsion, static/dynamic compression-shear) and ASTM F2267 (static subsidence) indicates the STALIF MIDLINE™ is mechanically equivalent to predicate devices.
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the emblem of the U.S. Department of Health and Human Services, which is a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle, following its curvature. The text is in uppercase letters and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Centinel Spine, Inc. % Musculoskeletal Clinical and Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street NW, 12th Floor Washington, District of Columbia 20005
SEP 2 4 2010
Re: K101301
Trade Name: STALIF MIDLINE™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 2, 2010 Received: September 3, 2010 ·
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.
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Page 2 - Mr. Justin Eggleton
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 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/AboutFDA/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/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,
Mark A. Milliken
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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(40130)
Indications for Use
SEP 2 4 2010
SEF 2 4 2010
510(k) Number (if known):
Device Name: STALIF MIDLINETM
The STALIF MIDLINE™ 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 STALIF MIDLINE™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIF MIDLINE™ system must be used with bone grafting material (autograft only).
Prescription Use v -(Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K101301 510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.