(444 days)
Not Found
No
The description focuses on the material, manufacturing process (3D printing), and mechanical properties of the interbody fusion cages. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to treat cervical and lumbar degenerative disc disease and related symptoms by facilitating spinal fusion and stabilization, which aligns with the definition of a therapeutic device.
No
The device is an intervertebral body fusion system intended to stabilize the spinal segment and facilitate fusion, not to diagnose a condition. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the Peridot-PT Cages are physical implants made from Ti-6Al-4V ELI using an additive manufacturing process. It describes their physical characteristics, materials, and intended use as interbody fusion devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to facilitate spinal fusion. It is used in the body to provide structural support and promote bone growth.
- Device Description: The device description details a physical implant made of titanium, designed to be placed between vertebrae.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body, or provide information about a patient's health status through in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Peridot-PT system is a therapeutic device used in a surgical procedure.
N/A
Intended Use / Indications for Use
Peridot-PT Anterior Cervical Intervertebral body fusion System
The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and or pain at one or multiple contiguous levels from C2-T1. The Peridot-PT Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Peridot-PT Intervertebral body fusion system
The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The Peridot-PT Cages are a comprehensive portfolio of 3D-pri interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).
Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles.
The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).
The implant cages are supplied sterilized.
The Peridot-PT Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft.
The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
cervical (C2-T1) and lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature patients
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)
The worst-case devices were tested in static compression, static compression-shear, static torsion, fatigue compression, fatigue compression-shear, fatigue torsion (ASTM F2077) and subsidence test (ASTM F2267).
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 17, 2023
GBS Commonwealth Co., Ltd. Jimmy Kim C-309. Woolim Lion's Valley, 168. Gasan Digital 1-ro Geumcheon-gu, Seoul 08507 South Korea
Re: K213755
Trade/Device Name: Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: January 13, 2023 Received: January 17, 2023
Dear Jimmy Kim:
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213755
Device Name
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
Indications for Use (Describe)
Peridot-PT Anterior Cervical Intervertebral body fusion System
The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and or pain at one or multiple contiguous levels from C2-T1. The Peridot-PT Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Peridot-PT Intervertebral body fusion system
The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, purple font. Below the letters, the word "COMMONWEALTH" is written in a smaller, purple font. The logo is set against a background of a globe.
SUMMARY
The following summary is being submitted as required by 21 CFR 807.92(a):
1. Device Identification
| Submitter: | GBS Commonwealth Co., Ltd.
#C-309, 168 Gasan Digital 1-ro, Geumcheon-Gu Seoul,
South Korea
Phone. 82-2-6925-4469
e-mail: Jimmy.kim@gbscommonwealth.com |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jimmy Kim |
| Date prepared | November 26, 2021 |
| Trade Name | Peridot-PT Anterior Cervical Intervertebral body
fusion System, Peridot-PT Intervertebral body
fusion system |
|---------------------|--------------------------------------------------------------------------------------------------------------------|
| Regulatory Class | Class II |
| Classification Name | Intervertebral body fusion device
(21 CFR 888.3080) |
| Panel | Orthopedic |
| Product Code | ODP, MAX |
Purpose of 510(k) 2.
The GBS Commonwealth Co. Ltd., here by submits this submission: for Initial product Introduction of Peridot-PT Anterior Cervical Intervertebral body fusion system and Peridot-PT Intervertebral body fusion system
3. Predicate or legally marketed devices which are substantially equivalent
Primary Predicate Device : K201605 EIT Cellular Titanium ALIF,TLIF,T/PLIF Cage 1) Additional Predicate Device : K192026 Peridot Interverbral body fusion system K202872 Prase PEEK Anterior Cervical Interbody Spacer
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Description of the Device 4.
Image /page/4/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, purple font. The word "COMMONWEALTH" is in smaller, purple font below the letters. The background of the logo is a gray globe.
The Peridot-PT Cages are a comprehensive portfolio of 3D-pri interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).
Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles.
The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).
The implant cages are supplied sterilized.
The Peridot-PT Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft.
The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.
Indication for Use 5.
Peridot-PT Anterior Cervical Intervertebral body fusion System
The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-PT Anterior Cervical Intervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or
5
corticocancellous bone graft to facilitate fusion.
Image /page/5/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, purple font. Below the letters is the word "COMMONWEALTH" in a smaller, bold, purple font. Behind the letters is a faded gray image of a globe.
Peridot-PT Intervertebral body fusion system
Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
6. Comparison of the technological characteristics of the subject and predicate devices
Peridot-PT Anterior Cervical Intervertebral body fusion system and Peridot-PT Intervertebral body fusion system are considered substantially equivalent to the primary predicate EIT Cellular Titanium ALIF, TLIF, LLIF T/PLIF Cage K201605 and additional predicate devices. They are similar in design, material, scientific technologies and indications for use.
Performance Testing 7.
The worst-case devices were tested in static compression, static compression-shear, static torsion, fatigue compression, fatigue compression-shear, fatigue torsion (ASTM F2077) and subsidence test (ASTM F2267).
Conclusion 8.
Based on the information provided in this premarket notification of GBS Commonwealth Co., Ltd. concludes that Peridot-PT Anterior Cervical Intervertebral body fusion system and Peridot-PT Intervertebral body fusion system are substantially equivalent to predicate devices.