(71 days)
The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use 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 1 spondylolisthesis or retrolisthesis at the involved level(s). 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.
Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
The Paramount™ Intervertebral Body Fusion Device is made of PEEK-OPTIMA®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The devices are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The provided 510(k) summary for the Paramount™ Intervertebral Body Fusion Device describes performance data primarily related to mechanical testing and biocompatibility, not an AI/algorithm-based device. Therefore, many of the requested criteria (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as they relate to AI/algorithm performance rather than a traditional medical device's physical and biological properties.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Mechanical Testing | The device passed mechanical tests based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02, demonstrating substantial equivalence to predicate devices. |
| Biocompatibility Testing | Biocompatibility was demonstrated via testing per ISO10993. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a physical implant, not an AI/algorithm. The "test set" in this context would refer to material samples or device prototypes subjected to mechanical and biological tests, not a dataset of patient information. The document does not specify the number of samples used for these tests.
- Country of origin of the data: Not specified.
- Retrospective or prospective: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for mechanical testing is defined by the standards themselves (e.g., passing a certain load or fatigue cycle). For biocompatibility, it's defined by biological assays. No human experts in the sense of adjudicating medical images or clinical outcomes were involved in establishing "ground truth" for these performance tests.
4. Adjudication Method for the Test Set
Not applicable. This concept pertains to resolving discrepancies in expert labeling of data, which is not relevant for the described performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretative devices to assess the impact of AI on human reader performance. The Paramount™ Intervertebral Body Fusion Device is a therapeutic implant.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Testing: Ground truth is established by the pass/fail criteria defined in industry standards (ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02) which relate to structural integrity, strength, and fatigue resistance.
- Biocompatibility Testing: Ground truth is established by the pass/fail criteria defined in international standard ISO10993, which assesses the biological response to the device material (PEEK-OPTIMA®).
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary regarding AI/Algorithm Context:
The provided 510(k) document is for a physical medical device (an intervertebral body fusion device) and does not describe an AI or algorithm. Therefore, requests relating to AI/algorithm validation methodologies (like training/test sets, ground truth establishment by experts, MRMC studies, standalone performance) are not applicable to the information contained within this specific regulatory submission. The performance data focuses on mechanical and biocompatibility testing to demonstrate substantial equivalence to predicate devices, which is standard for orthopedic implants.
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K072120
Page 1 of 1
510(k) SUMMARY
DATE:
October 1, 2007
SUBMITTER:
Innovative Spinal Technologies, Inc. 111 Forbes Boulevard Mansfield, MA 02048 Telephone: 508/452-3520 Fax:
OCT 】 1 2007
CONTACT PERSON: Gina Yeh
TRADE NAME: Paramount™ Intervertebral Body Fusion Device
FDA CLASSIFICATION / CODE: 888.3080 / MAX
DEVICE DESCRIPTION: The Paramount™ Intervertebral Body Fusion Device is made of PEEK-OPTIMA®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The devices are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.
INTENDED USE: The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use 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 1 spondylolisthesis or retrolisthesis at the involved level(s). 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.
Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
PREDICATE DEVICES: The predicate devices include: Innovative Spinal Technologies. Inc. Paramount™ VBR System (K062759) and Centerpulse/ Zimmer Spine, Inc. BAK™ Interbody Fusion System (P950002).
PERFORMANCE DATA: The mechanical test results based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02 demonstrate that the Paramount™ Intervertebral Body Fusion Device can be expected to perform in a manner substantially equivalent to the predicate devices. In addition, biocompatibility of the device was demonstrated via testing per ISO10993.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2007
Innovative Spinal Technologies, Incorporated % Ms. Gina Yeh Manager, Regulatory Affairs 111 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K072120
Trade/Device Name: Paramount Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 31, 2007 Received: August 1, 2007
Dear Ms. Yeh:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Gina Yeh
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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K072120
Page lot 1
Appendix 1
Indication for Use Statement
510(k) Number: K072120
Device Name: Paramount TM Intervertebral Body Fusion Device
Indications:
The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use 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 1 spondylolisthesis or retrolisthesis at the involved level(s). 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.
Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.
Prescription Use × or (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seubare BuchMD
. Restorative. and Neurological Devices
510(k) Number K072120
§ 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.