(30 days)
Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
The Peridot-TD 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, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD 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-TD 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-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
The Peridot-TD 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-TD 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.
The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cages holders are made of titanium alloy as per ASTM F136.
The Peridot-TD Cages 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), 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 screw and rod system, anterior plate and screw system, or lateral plate and screw 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.
The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation.
The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.
The provided document is a 510(k) premarket notification for a medical device called the "Peridot-TD Spacer system" and "Anterior cervical interbody fusion - ACIF". This submission is for additional models with added sterilization methods to a previously cleared 510(k) (K230708).
The document does not contain information about software performance, AI assistance, or human reader studies. It focuses on the mechanical performance and substantial equivalence of an intervertebral body fusion device. Therefore, many of the requested criteria cannot be extracted from this document.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests conducted according to ASTM standards for mechanical properties. The "acceptance criteria" are implied by the successful completion of these tests, demonstrating substantial equivalence to the predicate device. Specific numerical "reported device performance" values or explicit criteria are not provided in this summary, only that the "worst-case devices were tested".
| Acceptance Criteria Category | Reported Device Performance (Summary from this document) |
|---|---|
| Mechanical Performance (Cervical - ACIF) | |
| Static Compression (ASTM F2077) | Tested (Worst-case devices) |
| Static Torsion (ASTM F2077) | Tested (Worst-case devices) |
| Fatigue Compression (ASTM F2077) | Tested (Worst-case devices) |
| Fatigue Torsion (ASTM F2077) | Tested (Worst-case devices) |
| Subsidence (ASTM F2267) | Tested (Worst-case devices) |
| Static Tensile (ASTM F1147) | Tested (Worst-case devices) |
| Static Shear (ASTM F1044) | Tested (Worst-case devices) |
| Fatigue Shear (ASTM F1160) | Tested (Worst-case devices) |
| Wear (ASTM F1978) | Tested (Worst-case devices) |
| Mechanical Performance (Lumbar - Spacer System) | |
| Static Compression (ASTM F2077) | Tested (Worst-case devices) |
| Static Compression-shear (ASTM F2077) | Tested (Worst-case devices) |
| Fatigue Compression (ASTM F2077) | Tested (Worst-case devices) |
| Fatigue Compression-shear (ASTM F2077) | Tested (Worst-case devices) |
| Subsidence (ASTM F2267) | Tested (Worst-case devices) |
| Static Tensile (ASTM F1147) | Tested (Worst-case devices) |
| Static Shear (ASTM F1044) | Tested (Worst-case devices) |
| Fatigue Shear (ASTM F1160) | Tested (Worst-case devices) |
| Wear (ASTM F1978) | Tested (Worst-case devices) |
2. Sample size used for the test set and the data provenance
This document discusses in vitro mechanical testing, not a clinical test set with patient data. Therefore, the concept of data provenance (country of origin, retrospective/prospective) is not applicable in the way it would be for a diagnostic AI device. The sample size for the mechanical tests is not explicitly stated, although it mentions "worst-case devices were tested," implying a representative selection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes mechanical testing of a physical medical device, not a diagnostic device requiring expert review for ground truth.
4. Adjudication method for the test set
Not applicable. This document describes mechanical testing of a physical medical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document is for a physical intervertebral body fusion device and does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical intervertebral body fusion device and does not involve an algorithm.
7. The type of ground truth used
For mechanical testing, the "ground truth" is typically defined by the specified ASTM standards and the expected mechanical properties of the materials and design. Failure criteria for these tests would serve as the ground truth.
For the clinical indications for use, the document states that cervical disc degeneration and/or spinal instability are "confirmed by imaging studies (radiographs, CT, MRI)" and degenerative disc disease by "patient history and radiographic studies." This implies a combination of imaging and clinical assessment as the basis for patient selection for the device.
8. The sample size for the training set
Not applicable. This document is for a physical medical device and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This document is for a physical medical device and does not involve a training set for an algorithm.
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October 13, 2023
GBS Commonwealth Co., Ltd. Mr. Jimmy Kim #C-309, 168 Gasan Digital 1-ro Geumcheon-Gu, Seoul 08507 South Korea
Re: K232822
Trade/Device Name: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical 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: 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).
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Your device is also subject to, among other requirements, the Quality System (QS) 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 OS 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,
Brent Showalter -S
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
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Indications for Use
510(k) Number (if known) K232822
Device Name
Anterior cervical interbody fusion - ACIF (The Peridot-TD Antervertebral body fusion system), Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
Indications for Use (Describe)
Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
The Peridot-TD 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-TD Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. These patients should have had at least six weeks of nonoperative treatment.
These patients should have had at least six weeks of onoperative treatment.
Danida TD
11.
The Peridot-TD Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneve bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
The Peridot-TD 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-TD 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.
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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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 KoreaPhone. 82-2-6925-4469e-mail: Jimmy.kim@gbscommonwealth.com |
|---|---|
| Contact Person: | Jimmy Kim |
| Date prepared | September, 7, 2023 |
| Trade Name | Peridot-TD Spacer system (The Peridot-TD Intervertebralbody fusion system) and Anterior cervical interbody fusion -ACIF (The Peridot-TD Anterior Cervical Intervertebral bodyfusion 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:
Additional models with sterilization methods added to the previously cleared 510(k), K230708. (Add user sterilization (Steam sterilization) from existing gamma sterilization)
Predicate or legally marketed devices which are substantially equivalent 3.
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- Primary Predicate Device : K230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) and Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) / GBS Commonwealth
4. Description of the Device
The Peridot-TD Cages are intervertebral fusion device manufactured from poly-ether-ether-ketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The Peridot-TD Cages have a 0.5 ~ 1.0micron thick surface coat of commercially pure (CP) titanium per ASTM F67. And some cages holders are made of titanium alloy as per ASTM F136.
The Peridot-TD Cages 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), 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 screw and rod system, anterior plate and screw system, or lateral plate and screw 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.
The hyperlordotic lumbar cages (>20 degree) should be an anterior plate system as the form of supplement fixation.
The device is supplied with its specific instruments. The device must be used in combination with the dedicated instruments supplied. The specific instruments are supplied dedicated tray and non-sterile.
5. Indication for Use
Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical
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Intervertebral body fusion system)
The Peridot-TD 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, myelopathy, and/or pain at one or multiple contiguous levels from C2-T1. The Peridot-TD 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-TD 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-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
The Peridot-TD 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-TD 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.
Comparison of the technological characteristics of the subject and predicate 6. devices
The subject device has the same design, material, scientific technologies and indications for use as previously cleared 510(k). K230708. Only models have been added according to the addition of sterilization method.
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7. Performance Testing
The worst-case devices were tested.
-
- Anterior cervical interbody fusion ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
- Static Compression (ASTM F2077)
- Static Torsion (ASTM F2077)
- Fatigue Compression (ASTM F2077)
- Fatique Torsion (ASTM F2077)
- Subsidence (ASTM F2267)
- Static Tensile (ASTM F1147)
- Static Shear (ASTM F1044)
- Fatigue Shear (ASTM F1160)
- Wear (ASTM F1978)
-
- Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
- Static Compression (ASTM F2077)
- Static Compression-shear (ASTM F2077)
- Fatigue Compression (ASTM F2077)
- Fatigue Compression-shear (ASTM F2077)
- Subsidence (ASTM F2267)
- Static Tensile (ASTM F1147)
- Static Shear (ASTM F1044)
- Fatigue Shear (ASTM F1160)
- Wear (ASTM F1978)
8. Conclusion
Based on the information provided in this premarket notification of GBS Commonwealth Co., Ltd. concludes that Anterior cervical interbody fusion - ACIF and Peridot-TD Spacer are substantially equivalent to predicate devices.
§ 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.