(213 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in treating degenerative disc disease of the cervical spine with accompanying radicular symptoms, specifically to facilitate intervertebral body fusion, which is a therapeutic intervention.
No
Explanation: The device is an intervertebral body fusion system designed to facilitate fusion in the cervical spine. Its function is to restore intervertebral space height and provide stability, not to diagnose medical conditions or interpret patient data.
No
The device description explicitly details physical implants made of HA PEEK, titanium alloy, and tantalum, along with supplementary screws. This indicates a hardware-based medical device, not a software-only one.
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 used to facilitate intervertebral body fusion in the cervical spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the implant (cage, plate, screws) and the materials used. This aligns with a medical device intended for implantation, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro testing.
- Performance Studies: The performance studies described are biomechanical tests (compression, shear, torsion, expulsion, subsidence), which are relevant to the structural integrity and function of a surgical implant, not the analytical performance of a diagnostic test.
In summary, the GS Medical CYGNUS-C Standalone ACIF System is a surgical implant designed for spinal fusion, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GS Medical CYGNUS-C Standalone ACIF System 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. The GS Medical CYGNUS-C Standalone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. The GS Medical CYGNUS-C Standalone ACIF System is to be used with two titanium alloy screws which accompany the implant and does not require supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The CYGNUS-C Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Subject device also contains supplementary fixation screw. The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with a titanium alloy (Ti-6Al-4V) plate and X-ray (radioopaque) markers made of tantalum. The supplementary screws are made up of titanium alloy (Ti-6Al-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The worst-case cage construct of the CYGNUS-C ACIF Standalone System underwent testing according to ASTM 2077, specifically static and dynamic axial compression testing; shear static and dynamic compression; static and dynamic torsion testing; expulsion testing; and subsidence testing according to ASTM F2267. The results met all acceptance criteria, and the subject device cage is equivalent to additional predicate biomechanical performance.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 9, 2023
GS Medical Co. Ltd. % Barry Sands President and Founder RQMIS Inc. 110 Haverhill Road, Suite 524 Amesbury, Massachusetts 01913
Re: K222041
Trade/Device Name: CYGNUS-C Standalone ACIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: January 11, 2023 Received: January 11, 2023
Dear Barry Sands:
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.
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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 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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222041
Device Name CYGNUS-C Standalone ACIF system
Indications for Use (Describe)
The GS Medical CYGNUS-C Standalone ACIF System 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. The GS Medical CYGNUS-C Standalone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. The GS Medical CYGNUS-C Standalone ACIF System is to be used with two titanium alloy screws which accompany the implant and does not require supplemental fixation. Patients should have at least six (6) weeks of non-operative 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) | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
GS Medical's CYGNUS-C Standalone ACIF system
l. SUBMITTER'S ADDRESS, TELEPHONE NUMBER, CONTACT PERSON
Sam Camp Senior Engineer GS Medical Co. Ltd. 90 Osongsaengmyong 4-ro Osong-eup, Heungdeok-gu, Gheongju-si, Chungcheongbuk-do 28161 Korea Tel.: 405-535-2719 Email: scamp@gsmedicalusa.com
Contact Person:
Barry E. Sands RQMIS Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 Phone: (978) 358-7307 Email: regulatorysubmissions@rqmis.com Facsimile: (978) 477-0206
Date Prepared: February 3, 2023
II. SUBJECT DEVICE
| Trade/proprietary name of device: | CYGNUS-C Standalone ACIF system |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral fusion device with integrated |
| fixation, cervical | |
| Regulation Number: | 21 CFR 888.3080 |
| Classification: | Class II |
| Product Code(s) | OVE |
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III. PREDICATE DEVICES
Primary Predicate
| Name | Coalition Spacer |
|---|---|
| 510(k) number | K131449 |
| Product Code | OVE |
| CFR | 21 C.F.R. 888.3080 |
| Classification | Class II |
First Additional Predicate
| Name | AnyPlus Cervical PEEK Cage |
|---|---|
| 510(k) number | K153517 |
| Product Code | ODP |
| CFR | 21 C.F.R. 888.3080 |
| Classification | Class II |
Second Additional Predicate
| Name | CxHA PEEK Cervical IBF |
|---|---|
| 510(k) number | K181115 |
| Product Code | ODP |
| CFR | 21 C.F.R. 888.3080 |
| Classification | Class II |
IV. DEVICE DESCRIPTION
Intended Use/Indications for Use:
The GS Medical CYGNUS-C Standalone ACIF System 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. The GS Medical CYGNUS-C Standalone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. The GS Medical CYGNUS-C Standalone ACIF System is to be used with two titanium alloy screws which accompany the implant and does not require supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The intended use of the subject device and the predicates are identical.
TECHNOLOGICAL CHARACTERISTICS V.
The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical
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stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The CYGNUS-C Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Subject device also contains supplementary fixation screw. The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with a titanium alloy (Ti-6Al-4V) plate and X-ray (radioopaque) markers made of tantalum. The supplementary screws are made up of titanium alloy (Ti-6Al-4V).
VI. PERFORMANCE DATA
The worst-case cage construct of the CYGNUS-C ACIF Standalone System underwent testing according to ASTM 2077, specifically static and dynamic axial compression testing; shear static and dynamic compression; static and dynamic torsion testing; expulsion testing; and subsidence testing according to ASTM F2267. The results met all acceptance criteria, and the subject device cage is equivalent to additional predicate biomechanical performance.
BIOCOMPATIBILITY VII.
The biocompatibility of the subject implant body is based on the FDA's clearance of first additional predicate that contains bone contact materials made up of identical material (HA PEEK OPTIMA LT1) and same use as of subject device. And the biocompatibility of the plate and screw is based on the FDA's clearance of primary predicate that contains bone contact materials made up of identical material (Ti-6Al-4V) and same use as of subject device. The biocompatibility of the surgical instruments is based on the FDA's clearance of the first additional predicate that contains instruments made up of identical material and same use as of subject device.
VIII. CONCLUSION
The CYGNUS-C Standalone ACIF System has been found to be substantially equivalent to the primary predicate with respect to technical characteristics, design, materials, and intended use. And to the first additional predicate with respect to performance. The technological differences between the subject device and the predicate do not raise new questions of safety and effectiveness.