(129 days)
Not Found
No
The device description focuses on the material (PEEK, Tantalum), mechanical design (teeth, sizes), and intended use for spinal fusion. There is no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as an "intervertebral body fixation device" used "as an aid in spinal fusion" for degenerative disc disease, which is a therapeutic intervention.
No
Explanation: This device is an intervertebral body fixation device designed to facilitate spinal fusion, not to diagnose a medical condition. Its function is therapeutic, not diagnostic.
No
The device description clearly states the device is an intervertebral body fixation device made from PEEK and Tantalum, which are physical materials, and is supplied with specific instruments. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate intervertebral body fusion in the cervical spine using autograft bone. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable intervertebral body fixation device made of PEEK and Tantalum. It is designed to be surgically placed within the spine.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (like blood, urine, tissue) to provide diagnostic information about a patient's health status. Its function is structural support and fusion facilitation.
- Mechanical Testing: The performance studies described are mechanical tests of the device's structural integrity, not diagnostic performance metrics.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Prase PEEK Anterior Cervical Interbody Spacer is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Prase PEEK Anterior Cervical Interbody Spacer is used to facilitate intervertebral body fusion in the cervical spine from the C3 to C7 disc levels using autograft bone. Prase PEEK Anterior Cervical Interbody Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Product codes
ODP
Device Description
The Prase PEEK Anterior Cervical Interbody Spacer is intervertebral body fixation devices intended for use as an aid in spinal fusion. The Prase PEEK Anterior Cervical Interbody Spacer 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 instruments. The specific instruments are supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instruments supplied.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine from the C3 to C7 disc levels
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
Mechanical testing includes static compression, static torsion, fatigue compression, fatigue torsion test were performed according to ASTM F2077-18, subsidence testing performed according to ASTM F2267-04.
Key Metrics
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.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 4, 2021
GBS Commonwealth Co., Ltd. Mr. Jimmy Kim #C-309, 168 Gasan Digital 1-ro Geumcheon-Gu Seoul South Korea
Re: K202872
Trade/Device Name: Prase PEEK Anterior Cervical Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 4, 2020 Received: December 11, 2020
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
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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, 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
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Indications for Use
510(k) Number (if known) K202872
Device Name Prase PEEK Anterior Cervical Interbody Spacer
Indications for Use (Describe)
Prase PEEK Anterior Cervical Interbody Spacer is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Prase PEEK Anterior Cervical Interbody Spacer is used to facilitate intervertebral body fusion in the cervical spine from the C3 to C7 disc levels using autograft bone. Prase PEEK Anterior Cervical Interbody Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CER 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the text "K202872 Page 1 of 3" at the top, indicating a document identifier and page number. Below the text is a logo with the letters "GBS" in large, bold, blue font. Underneath the letters, the word "COMMONWEALTH" is written in a smaller font, also in blue. The logo appears to represent an organization or company named 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 | September, 25, 2020 |
| Trade Name | Prase PEEK Anterior Cervical Interbody Spacer |
|---|---|
| Regulatory Class | Class II |
| Regulation | |
| Name/Common Name | Intervertebral fusion device with bone graft, |
| Cervical | |
| Classification Name | Intervertebral body fusion device |
| (21 CFR 888.3080) | |
| Panel | Orthopedic |
| Product Code | ODP |
Purpose of 510(k) 2.
The GBS Commonwealth Co. Ltd., submits this submission for Initial product Introduction of Prase PEEK Anterior Cervical Interbody Spacer
3. Predicate or legally marketed devices which are substantially equivalent
-
Primary Predicate Device : K151677 LnK Cervical Interbody Fusion Cage System
-
Additional Predicate Device : K192026 Peridot Interverbral body fusion system K200592 The GS Medical Anyplus PEEK Cage system
Description of the Device 4.
The Prase PEEK Anterior Cervical Interbody Spacer is intervertebral body
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Image /page/4/Picture/0 description: The image shows the text 'K202872 Page 2 of 3' at the top. Below the text is a logo with the letters 'GBS' in large, bold, blue font. Underneath the letters, the word 'COMMONWEALTH' is written in a smaller, bold, blue font. The logo appears to be for a company or organization called GBS Commonwealth.
fixation devices intended for use as an aid in spinal fusion. The Prase PEEK Anterior Cervical Interbody Spacer 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 instruments. The specific instruments are supplied dedicated tray and non-sterile. The device must be used in combination with the dedicated instruments supplied.
5. Indication for Use
Prase PEEK Anterior Cervical Interbody Spacer is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Prase PEEK Anterior Cervical Interbody Spacer is used to facilitate intervertebral body fusion in the cervical spine from the C3 to C7 disc levels using autograft bone. Prase PEEK Anterior Cervical Interbody Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
6. Comparison of the technological characteristics of the subject and predicate devices
Prase PEEK Anterior Cervical Interbody Spacer is considered substantially equivalent to the primary predicate LnK Cervical Interbody Fusion Cage System K151677and additional predicate device. They are similar in design, material, scientific technologies and indications for use.
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Image /page/5/Picture/0 description: The image shows the text "K202872 Page 3 of 3" at the top. Below the text is a logo for GBS Commonwealth. The GBS is in large, bold, blue letters, and the word "COMMONWEALTH" is in smaller, bold, blue letters below the GBS.
7. Performance Testing
Mechanical testing includes static compression, static torsion, fatigue compression, fatigue torsion test were performed according to ASTM F2077-18, subsidence testing performed according to ASTM F2267-04.
Conclusion 8.
Prase PEEK Anterior Cervical Interbody Spacer is substantially equivalent to legally marketed predicates.