(213 days)
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 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).
The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification summary for a medical device (CYGNUS-C Standalone ACIF system), which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical or performance study with detailed acceptance criteria.
Therefore, I cannot provide the requested information. The document primarily discusses:
- Device Description and Intended Use: For cervical spinal fusion.
- Predicate Devices: Used for comparison to establish substantial equivalence.
- Technological Characteristics: Materials and design.
- Performance Data (Mechanical Testing): States that the device underwent testing according to ASTM standards (ASTM 2077, ASTM F2267) and "the results met all acceptance criteria." However, it does not specify what those acceptance criteria were nor the detailed results of the tests.
- Biocompatibility: Based on predicate devices.
- Conclusion: Substantial equivalence.
There is no mention of a human-in-the-loop study, MRMC study, expert ground truth establishment, or training/test set details related to AI/algorithm performance, as the device described is a physical implant, not an AI-powered diagnostic tool.
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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 integratedfixation, 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.
§ 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.