(85 days)
No
The device description focuses on the physical characteristics of the interbody fusion system (materials, sizes, teeth, markers) and its intended use in spinal fusion procedures. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies rely on equivalence to predicate devices, not on validation of algorithmic performance.
Yes
The device is described as an "intervertebral body fusion device" used for the treatment of cervical disc degeneration, instability, and degenerative disc disease, facilitating fusion and aiding in spinal fixation. These applications align with the definition of a therapeutic device designed to treat a medical condition.
No
This device is an intervertebral body fusion device used for spinal fusion procedures, not for diagnosing conditions. While it mentions imaging studies (radiographs, CT, MRI) in relation to confirming conditions for which the device is indicated, the device itself does not perform diagnostic functions. It is a surgical implant.
No
The device description clearly states it is an intervertebral body fixation device made from physical materials (PEEK, Tantalum, Titanium alloy) and includes instruments for placement. This indicates a hardware-based medical device, not software only.
Based on the provided information, 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.
- Device Description and Intended Use: The Peridot Spinal Interbody System is a physical implant designed to be surgically placed within the spine to aid in fusion. Its intended use is to treat conditions like disc degeneration and instability by providing structural support and facilitating bone growth.
- Lack of Specimen Analysis: The device itself does not analyze any biological specimens. While imaging studies (radiographs, CT, MRI) are used to diagnose the patient's condition and guide the use of the device, the device itself is not performing the diagnostic analysis.
Therefore, the Peridot Spinal Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Peridot Spinal Interbody System - Cervical
The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment.
The Peridot Cervical Spinal Interbody system are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to faciliate fusion with supplemental fixation indicated for cervical fusion procedures.
Peridot Spinal Interbody System - Lumbar
The Peridot Lumbar Spinal Interbody system are 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 Lumbar Spinal Interbody system are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes
ODP, MAX
Device Description
This product is intervertebral body fixation devices intended for use as an aid in spinal fusion. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560.
X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.
The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile.
The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instrument supplied.
Peridot Spinal Interbody System
This product is intervertebral body fixation devices intended for use as an aid in spinal fixation. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. And some cage holders are made of titanium alloy as per ASTM F136.
X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.
The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile.
The devices consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages.
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
C2-T1, 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 Peridot Spinal Interbody System is the same as the legally marketed devices 'K192026' and 'K202872'. So, the performance test was proved by the previous legally marketed devices performance test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows 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.
March 15, 2022
GBS Commonwealth Co., Ltd. Mr. Jimmy Kim C-309. Woolim Lion's Valley, 168. Gasan Digital 1-ro Geumcheon-gu, Seoul 08507 South Korea
Re: K213980
Trade/Device Name: Peridot Spinal Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: December 16, 2021 Received: December 20, 2021
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 (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
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/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 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, 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) K213980
Device Name Peridot Spinal Interbody System
Indications for Use (Describe)
Peridot Spinal Interbody System - Cervical
The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment.
The Peridot Cervical Spinal Interbody system are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to faciliate fusion with supplemental fixation indicated for cervical fusion procedures.
Peridot Spinal Interbody System - Lumbar
The Peridot Lumbar Spinal Interbody system are 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 Lumbar Spinal Interbody system are 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) | |
|---|---|
| ☑ 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/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, blue font, stacked on top of the word "COMMONWEALTH", which is also in blue. The logo is set against a light gray, oval-shaped background. The logo appears to be for a company or organization called GBS Commonwealth.
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: | Jimmy Kim |
| Date prepared | December, 16, 2021 |
| Trade Name | Peridot Spinal Interbody System |
|---|---|
| Regulatory Class | Class II |
| Classification Name | Intervertebral body fusion device |
| (21 CFR 888.3080) | |
| Panel | Orthopedic |
| Product Code | ODP, MAX |
2. Purpose of 510(k)
The GBS Commonwealth Co. Ltd., here by submits this submission: for Initial product Introduction of the Peridot Spinal Interbody System.
The Purpose of this 510(k) submission is to combine the existing 510(k) clearance system (K192026 and K202872). The Peridot Spinal Interbody System has the same intended use and fundamental scientific technology as the previously cleared system (K192026 and K202872).
3. Predicate or legally marketed devices which are substantially equivalent
- Primary Predicate Device : K192026 Peridot Intervertebral body fusion system
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Image /page/4/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, blue font. Below the letters is the word "COMMONWEALTH" in a smaller, bold, blue font. The logo has a white background.
- Additional Predicate Device : K202872 Prase PEEK Anterior Cervical Interbody Spacer K163491 NuVasive CoRoent Small Interbody System
4. Description of the Device
Peridot Spinal Interbody System
This product is intervertebral body fixation devices intended for use as an aid in spinal fusion. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560.
X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.
The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile.
The device is supplied with their specific instrument. The specific instrument is supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instrument supplied.
Peridot Spinal Interbody System
This product is intervertebral body fixation devices intended for use as an aid in spinal fixation. This product is made from PEEK as per ASTM F2026 and Tantalum marker as per ASTM F560. And some cage holders are made of titanium alloy as per ASTM F136.
X-ray markers system on the cages permits the identification of cage position and allows post-operative assessment.
The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The devices are supplied non-sterile.
The devices consist of cages differentiated by their approach, with varying dimensions and ancillary products for placement of the cages.
The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.
5
Image /page/5/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, blue font. Below the letters, the word "COMMONWEALTH" is written in a smaller, bold, blue font. The background of the logo is a light gray color.
The device must be used in combination with the dedicated instrument supplied.
5. Indication for Use
Peridot Spinal Interbody System
The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. The Peridot Cervical Spinal Interbody system are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to faciliate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.
Peridot Spinal Interbody System
The Peridot Lumbar Spinal Interbody system are 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 Lumbar Spinal Interbody system are 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.
Comparison of the technological characteristics of the subject and predicate devices 6.
The Peridot Spinal Interbody System are the same as the legally marketed devices 'Peridot Intervertebral body fusion System (K192026)' and 'Prase PEEK Anterior Cervical Interbody spacer (K202872)'. It has the same design, material, scientific technologies and indications for use.
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Image /page/6/Picture/1 description: The image shows the logo for GBS Commonwealth. The letters "GBS" are in large, bold, blue font. Below the letters, the word "COMMONWEALTH" is written in a smaller, bold, blue font. The background of the logo is a light gray color.
Performance Testing 7.
The Peridot Spinal Interbody System is the same as the legally marketed devices 'K192026' and 'K202872'. So, the performance test was proved by the previous legally marketed devices performance test.
Conclusion 8.
The Peridot Spinal Interbody System has been demonstrated to be same to the predicate device with respect to technical characteristics, performance, and intended use.
The information provided within this premarket notification supports same as the subject device to the predicate devices.