(364 days)
Not Found
No
The summary describes a physical interbody fusion cage and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The NEST Interbody System is an implant designed for intervertebral body fusion, providing support during surgery rather than treating or preventing a disease.
No
The NEST Interbody System is an implantable medical device designed for surgical intervention in spinal fusion, not for diagnosing medical conditions.
No
The device description clearly states it is an "intervertebral body fusion cage" which is a physical implant made of Ti6Al4V alloy. The performance studies also describe mechanical testing of this physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- NEST Interbody System Function: The NEST Interbody System is a surgical implant designed to be placed between vertebrae during spinal fusion surgery. It provides structural support and promotes bone growth.
- Lack of Specimen Analysis: The description of the NEST Interbody System does not involve the analysis of any specimens taken from the human body. Its function is purely mechanical and biological (promoting fusion) within the body.
The device description clearly indicates it is a surgical implant used in the body, not a device used to test samples from the body.
N/A
Intended Use / Indications for Use
The NEST Interbody System is indicated for interbody fusion with autograf and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should be skeletally mature and have six months of non-operative treatment. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The NEST Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Product codes
MAX
Device Description
The NEST Interbody System is an intervertebral body fusion cage which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow, rectangular implant consists of both solid and porous structures and serrations on the superior and inferior porous surfaces are for enhanced fixation. The implant is designed to be used with supplemental fixation with cleared for use in the lumbosacral spine. The implant is offered in a variety of sizes to accommodate a variety of patients' anatomy. NEST is additively manufactured from Ti6Al4V alloy (ASTM F3001) and is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbosacral spine, L2 to 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)
Testing in compliance with: FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the NEST Cage and demonstrated substantially equivalent performance to the identified predicate devices.
The following mechanical tests were performed:
Static Compression (per ASTM F2077)
Dynamic Compression (per ASTM F2077)
Static Compression Shear (per ASTM F2077)
Static Torsion (per ASTM F2077)
Subsidence (per ASTM F2267)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K152304, K153621, K150481, P960025
Reference Device(s)
Not Found
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.
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Paonan Biotech Co., Ltd. Tony Lin R&D Engineer 3F, No. 50, Lane 258, Rueiguang Rd. Neihu District, Taipei City 11491 Taiwan
Re: K180230
Trade/Device Name: NEST Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 21, 2018 Received: December 26, 2018
Dear Mr. Lin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
January 25, 2019
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 mediation-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,
Katherine D. Kavlock -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) K180230
Device Name NEST Interbody System
Indications for Use (Describe)
The NEST Interbody System is indicated for interbody fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should be skeletally mature and have six months of non-operative treatment. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).
The NEST Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Type of Use (Select one or both, as applicable)
| ☑ Reproduction (Part 21 CFR 301 Subpart B) | ☐ Over-The-Counter Use (OTC) |
|---|---|
| -------------------------------------------------------------------------------------------- | ------------------------------ |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Biomech. The text "BIOMECH" is in a sans-serif font and is colored gray. Below the word "BIOMECH" is the text "Paonan Biotech Co.,Ltd" in a smaller font size. To the right of the text is a graphic of two curved shapes, one blue and one green.
Paonan Biotech Co., Ltd. NEST Interbody System
Traditional 510(k)
K180230 510(k) Summary
| Submitted by | Paonan Biotech Co., Ltd.
3F., No. 50, Lane 258, Rueiguang Road, Neihu District 11491, Taipei City, Taiwan |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tony Lin
R & D Engineer
Phone: +886-2-26274366 #603
Email: linzw@paonan.com.tw |
| Date Prepared | January 19th, 2018 |
| Common Name | Intervertebral body fusion device |
| Trade Name | NEST Interbody System |
| Proposed Class | Class II |
| Classification Name and Number | Intervertebral body fusion device, 21 CFR §888.3080 |
| Product Code | MAX |
| Predicate Devices | Legally marketed predicate devices to which substantial equivalence is claimed:
Primary predicate:
●
Stryker Spine Tritanium® PL Cage (K152304)
Additional predicate:
●
Spineart JULIET® Ti (K153621)
K2M Cascadia Interbody System (K150481)
DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spinal System(P960025) |
| Device Description | The NEST Interbody System is an intervertebral body fusion cage which can
be inserted between two lumbar or lumbosacral vertebral bodies to give support
and correction during lumbar interbody fusion surgeries. The hollow,
rectangular implant consists of both solid and porous structures and serrations on
the superior and inferior porous surfaces are for enhanced fixation. |
| The implant is designed to be used with supplemental fixation with cleared for use
in the lumbosacral spine. The implant is offered in a variety of sizes
to accommodate a variety of patients' anatomy. NEST is additively
manufactured from Ti6Al4V alloy (ASTM F3001) and is provided sterile. | |
| Intended Use and Indications for Use | The NEST Interbody System is indicated for interbody fusion with autograf
and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone
graft in patients with degenerative disc disease (DDD) at one or two
contiguous levels from L2 to S1. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by patient history and radiographic studies.
Patients should be skeletally mature and have six months of non-operative
treatment. The DDD patients may also have up to Grade 1 spondylolisthesis at the
involved level(s). The NEST Interbody System is intended to be used with
supplemental spinal fixation systems that have been cleared for use in the
lumbosacral spine |
| Summary of the Technological
Characteristics | The subject NEST Cage and the predicates are identical in indications for use,
surgical technique, manufacturing method and raw material. The subject NEST
Cage and the predicates share similar design features:
Graft windows for packing autogenous bone Serrations on the superior and inferior surfaces Comparable heights, widths, depths, and lordotic angles, material |
| Summary of
Non-Clinical Testing | Testing in compliance with: FDA's "Class II Special Controls Guidance
Document: Intervertebral Body Fusion Device" was performed for the NEST Cage
and demonstrated substantially equivalent performance to the identified predicate
devices.
The following mechanical tests were performed:
Static Compression (per ASTM F2077) |
| | Dynamic Compression (per ASTM F2077)
Static Compression Shear (per ASTM F2077)
Static Torsion (per ASTM F2077)
Subsidence (per ASTM F2267) |
| Conclusion | Based on the design features, the use of established well known materials, featur
comparisons, indications for use, and results of the mechanical testing, the
NEST Cage has demonstrated substantial equivalence to the identified predicate
devices. |
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Image /page/4/Picture/0 description: The image shows the logo for BIOMECH Paonan Biotech Co.,Ltd. The word "BIOMECH" is in large, gray, sans-serif font. Below it, the words "Paonan Biotech Co.,Ltd" are in a smaller, gray, sans-serif font. To the right of the word "BIOMECH" is a graphic of two curved shapes, one blue and one green.
Paonan Biotech Co., Ltd. NEST Interbody System
Traditional 510(k)
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Image /page/5/Picture/0 description: The image contains the word "BIOMECH" in large, gray, sans-serif font. Below that, in a smaller font, is the text "Paonan Biotech Co.,Ltd". To the right of the word "BIOMECH" is a graphic consisting of two curved shapes, one in blue and one in green. The blue shape is on top of the green shape.
Paonan Biotech Co., Ltd. NEST Interbody System Traditional 510(k)