(98 days)
Not Found
No
The summary describes a mechanical implant and its associated instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes.
The device is indicated for intervertebral body fusion procedures to treat degenerative disc disease, which explicitly states its therapeutic purpose.
No
This device is an intervertebral body fusion system, intended for surgical implantation to provide support and correction during spinal fusion procedures, not to diagnose a condition.
No
The device description clearly states it is a physical implant made of titanium alloy and 3D printed titanium power, intended for surgical implantation. It also mentions associated instruments and sterilization procedures, all indicative of a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Peridot-EX Expandable Intervertebral body fusion system is a physical implant made of titanium alloy. It is surgically inserted into the spine to provide support and correction during fusion procedures.
- Intended Use: The intended use is for intervertebral body fusion in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
The device is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Peridot-EX Expandable 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 radios. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems and anterior screw and anterior screw and rod systems). The Peridot-EX Expandable Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment with an intervertebral cage. Hyperlordotic interbody devices (> 20° lordosis) must be used with at least anterior supplemental fixation.
Product codes
MAX
Device Description
The Peridot-EX Expandable Intervertebral body fusion system is various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. It is manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and 3D Printing manufactured from titanium power (Ti-6AI-4V ELI) as described by ASTM F3001.
The Peridot-EX Expandable Intervertebral body fusion system expands for adjustable lordosis and height to match patient anatomy. The hollow geometry of the implants allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
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 devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.
All implants are intended for SINGLE USE ONLY and should not be reused under any circumstances.
The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and 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 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.
-
- Peridot-EX Expandable Intervertebral body fusion system
- Static Compression (ASTM F2077)
- Static Compression-shear (ASTM F2077)
- Static Torsion (ASTM F2077)
- Fatigue Compression (ASTM F2077)
- Fatigue Compression-shear (ASTM F2077)
- Subsidence (ASTM F2267)
- Expulsion (ASTM F-04.25.02.02)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K193258, K210800, K142498, K222554, K161379, K213755, K190762
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.
0
November 7, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue box, followed by the words "U.S. FOOD & DRUG" in large blue letters, and the word "ADMINISTRATION" in smaller blue letters below.
GBS Commonwealth Co., Ltd. Jimmy Kim RA C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro Geumcheon-gu, Seoul 08507 Korea. South
Re: K232292
Trade/Device Name: Peridot-EX Expandable Intervertebral body fusion system Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 7, 2023 Received: September 13, 2023
Dear Mr. 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232292
Device Name
Peridot-EX Expandable Intervertebral body fusion system
Indications for Use (Describe)
The Peridot-EX Expandable 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 radios. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems and anterior screw and anterior screw and rod systems). The Peridot-EX Expandable Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment with an intervertebral cage. Hyperlordotic interbody devices (> 20° lordosis) must be used with at least anterior 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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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 is the word "COMMONWEALTH" in a smaller, purple font. The background of the logo is a light gray color.
K232292 510(k) SUMMARY
The following summary is being submitted as required by 21 CFR 807.92(a):
Device Identification 1.
| 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:
Date prepared | Jimmy Kim
July, 28, 2023 |
| Trade Name | Peridot-EX Expandable Intervertebral body fusion system |
|---|---|
| Regulatory Class | Class II |
| Classification Name | Intervertebral body fusion device |
| (21 CFR 888.3080) | |
| Panel | Orthopedic |
| Product Code | MAX |
2. Purpose of 510(k)
The GBS Commonwealth Co. Ltd., here by submits this submission: for Initial product Introduction of Peridot-EX Expandable Intervertebral body fusion system
Predicate or legally marketed devices which are substantially equivalent 3.
- Primary Predicate Device : K193258 ProLift Expandable System, Life Spine, Inc.
- Additional Predicate Device : 1) K210800 IO Expandable Lumbar Interbody Fusion system, MiRus,LLC
4
Image /page/4/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 background of the logo is a light gray color.
4. Description of the Device
The Peridot-EX Expandable Intervertebral body fusion system is various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. It is manufactured from titanium alloy (Ti-6AI-4V ELI) as described by ASTM F136 and 3D Printing manufactured from titanium power (Ti-6AI-4V ELI) as described by ASTM F3001.
The Peridot-EX Expandable Intervertebral body fusion system expands for adjustable lordosis and height to match patient anatomy. The hollow geometry of the implants allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
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 devices are to be sterilized by gamma radiation per ISO 11137 or provided non-sterile. The non-sterile devices are to be sterilized by steam sterilization per ISO 17665.
All implants are intended for SINGLE USE ONLY and should not be reused under any circumstances.
The device is supplied with their specific instrument. The device must be used in combination with the dedicated instrument supplied. The specific instrument is supplied dedicated tray and non-sterile.
5. Indication for Use
The Peridot-EX Expandable Intervertebral body fusion system
The Peridot-EX Expandable 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.
5
Image /page/5/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 background of the logo is a light gray color.
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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems and anterior screw and rod systems).
The Peridot-EX Expandable Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Hyperlordotic interbody devices (> 20° lordosis) must be used with at least anterior supplemental fixation.
6. Comparison of the technological characteristics of the subject and predicate devices
The Peridot-EX Expandable Intervertebral body fusion system is considered substantially equivalent to the primary predicate device ProLift Expandable System K193258 and additional predicated devices K210800, K142498, K222554, K161379, K213755 and K190762.
They are similar in design, material, scientific technologies and indications for use.
Performance Testing 7.
The worst-case devices were tested.
-
- Peridot-EX Expandable Intervertebral body fusion system
- Static Compression (ASTM F2077)
- Static Compression-shear (ASTM F2077)
- Static Torsion (ASTM F2077)
- Fatigue Compression (ASTM F2077)
- Fatigue Compression-shear (ASTM F2077)
6
Image /page/6/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, bold, purple font. The background of the logo is a light gray globe.
- Subsidence (ASTM F2267)
- Expulsion (ASTM F-04.25.02.02)
8. Conclusion
Based on the information provided in this premarket notification of GBS Commonwealth Co., Ltd. concludes that Peridot-EX Expandable Intervertebral body fusion system is substantially equivalent to predicate device.