(194 days)
The Peekplus® Interbody Fusion Device ("Peekplus Device") is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Peekplus® devices are to be used with autogenous bone graft material and supplemental fixation.
The Peekplus® Interbody Fusion Device is manufactured for Vallum Corporation by Binder Biomedical. Inc. and is identical to the Intervertebral Body Fusion Device cleared in K093015. The Peekplus® is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Peekplus® also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Peekplus® is provided non-sterile.
This document is a 510(k) premarket notification for the "Peekplus® Interbody Fusion Device." The device is being cleared based on substantial equivalence to a predicate device, not on new performance studies. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria is not present in this document in the typical sense of a de novo performance study.
Here's a breakdown based on the provided text:
Summary of Device Acceptance:
The Peekplus® Interbody Fusion Device demonstrates substantial equivalence to the legally marketed predicate device (Binder Biomedical Inc. Intervertebral Body Fusion Device, K093015) by having:
- Identical intended use and indications for use.
- Identical technological characteristics and principles of operation.
- Identical materials and manufacturer (Binder Biomedical Inc. manufactures for Vallum Corporation).
- Same specifications, drawings, and labeling.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence determination based on an already cleared predicate device, there are no new performance criteria or reported performance results in the traditional sense that would come from a dedicated clinical or non-clinical study for the Peekplus® device itself. Instead, the "acceptance criteria" are demonstrating equivalence to the predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate K093015) | Reported Device Performance (Peekplus®) |
|---|---|
| Intended Use: For intervertebral body fusion. | Identical |
| Indications for Use: | Identical |
| - Patients with DDD at 1 or 2 contiguous levels (L2-S1) | - Same |
| - DDD confirmed by history and radiographic studies | - Same |
| - Skeletally mature | - Same |
| - At least 6 months non-operative treatment | - Same |
| - May have previous non-fusion spinal surgery at involved level(s) | - Same |
| - May have up to Grade 1 spondylolisthesis or retrolisthesis | - Same |
| - To be used with autogenous bone graft material and supplemental fixation | - Same |
| Technological Characteristics: | Identical (same design, materials, manufacturer) |
| Material: PEEK-OPTIMA® spacers | Identical |
| Design: Shaped to accommodate autogenous bone graft and anatomical variation; series of ridges for fixation/prevent migration. | Identical |
| Manufacturing Process: (Minor additional processing step for surface smoothing, noted as not impacting substantial equivalence). | One minor additional manufacturing process step (surface smoothing at nanometer depths) was noted, which was determined not to impact substantial equivalence. |
| Sterility: Provided non-sterile | Non-sterile |
| Performance Data: No new worst-case created from manufacturing change. | Confirmed by Finite Element Analysis (FEA) that no new worst-case was created. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No separate test set for the Peekplus® device's performance was used in this submission beyond the finite element analysis (FEA) to confirm no new worst-case was created due to a minor manufacturing change. The core of the submission relies on the established performance and safety of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No experts were used in this submission to establish ground truth for a new test set, as the device's clearance is based on substantial equivalence to an existing device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical or performance test set requiring adjudication was performed for this submission.
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:
Not applicable. This is not an AI/software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical interbody fusion device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the Peekplus® device, in the context of this submission, is effectively the established safety and effectiveness of the legally marketed predicate device (Binder Biomedical Inc. Intervertebral Body Fusion Device, K093015). The submission argues that the Peekplus® device is so similar that its "truth" aligns with the predicate's.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of a physical medical device submission for substantial equivalence.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" for this type of submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vallum Corporation % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, Massachusetts 01864
Re: K173864
Trade/Device Name: Peekplus® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 4, 2018 Received: June 5, 2018
Dear Ms. O'Connell:
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 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);
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
July 2, 2018
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173864
Device Name Peekplus® Interbody Fusion Device
Indications for Use (Describe)
The Peekplus® Interbody Fusion Device ("Peekplus Device") is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Peekplus® devices are to be used with autogenous bone graft material and supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Vallum Corporation's Peekplus® Interbody Fusion Device
Submitted by
Vallum Corporation 61 Spit Brook Road Nashua, NH 03060 Phone: 603-577-1989 Contact Person: Maureen O'Connell
Device Name and Address of Sponsor
Vallum Corporation 61 Spit Brook Road Nashua, NH 03060 Phone: 603-577-1989 Contact Person: Stephen Blinn
Preparation Date June 1, 2018
Device Name Peekplus® Interbody Fusion Device
Common Name
Intervertebral Body Fusion Device
Classification
Orthosis, Spinal Intervertebral Fusion
Purpose of Submission New device
Primary Predicate Device Binder Biomedical Inc. Intervertebral Body Fusion Device (K093015)
Intended Use / Indications for Use
The Peekplus® Interbody Fusion Device ("Peekplus Device") is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have had a previous nonfusion spinal surgery at the involved level(s) and may have had up to a Grade 1
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K173864 Page 1 of 2
spondylolisthesis or retrolisthesis at the involved level(s). The Peekplus® devices are to be used with autogenous bone graft material and supplemental fixation.
Technological Characteristics
The Peekplus® Interbody Fusion Device is manufactured for Vallum Corporation by Binder Biomedical. Inc. and is identical to the Intervertebral Body Fusion Device cleared in K093015. The Peekplus® is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Peekplus® also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Peekplus® is provided non-sterile.
Performance Data
Additional performance testing was not conducted in this submission, however, finite element analysis (FEA) was conducted to confirm a new worst-case was not created.
Basis of Substantial Equivalence
Both the Peekplus® Interbody Fusion Device and the Binder Biomedical Inc.'s Intervertebral Body Fusion Device cleared in K093015 are intended for use in intervertebral body fusion. The Peekplus® Interbody Fusion Device and the predicate device are indicated for use with autogenous bone graft in patients with degenerative disc disease ("DDD") at one or two spinal levels from L2-S1. The Peekplus® and its predicate are indicated for use in skeletally mature patients who have had at least six (6) months of non-operative treatment, and in patients who may have up to Grade 1 spondylolisthesis, retrolisthesis or previous non-fusion at the involved level(s). Thus, the indications for use for the Peekplus® are the same as those of the predicate and may be found substantially equivalent.
The Peekplus® Interbody Fusion Device and the predicate device share kev technological characteristics. The PeekPlus® is manufactured for Vallum Corporation by Binder Biomedical, Inc. the holder of the 510(k) for the predicate device. All devices are made to the same specification, with the same drawings and have the same labeling. One minor additional manufacturing processing step is performed which does not impact the substantial equivalence of the devices as the process smooths the surface layer of the implants at depths measured in nanometers.
Therefore. the Peekplus® and the Binder devices both have the same intended use, the same indications for use, the same technological characteristics and principles of operation. In addition, the Peekplus® has the identical materials as the Binder device manufactured by the same manufacturer as the Binder devices. Thus, the Peekplus® is substantially equivalent to the predicate.
§ 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.