(194 days)
Not Found
No
The device description and intended use are purely mechanical, describing a physical implant for spinal fusion. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used to treat degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
Explanation: The device description states that the Peekplus® Interbody Fusion Device is comprised of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomic variation, which are then used for fusion. It does not mention any function for diagnosing conditions.
No
The device description clearly states it is a physical implant made of PEEK-OPTIMA® material, designed to be surgically inserted into the spine. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Peekplus Device Function: The Peekplus® Interbody Fusion Device is a physical implant designed to be surgically placed in the spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by promoting fusion, not for analyzing biological samples.
- Device Description: The description details the physical materials and design of the implant, not components for analyzing biological specimens.
Therefore, based on the provided information, the Peekplus® Interbody Fusion Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (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)
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.
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.
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/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
1
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
2
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.