(64 days)
Not Found
No
The summary describes a physical implant (cervical cage) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to facilitate intervertebral body fusion in patients with degenerative disc disease, which is a condition that causes pain and degeneration of the disc. The device is designed to treat this condition and restore the height of the intervertebral space, which classifies it as therapeutic.
No
The device is a cervical cage designed for facilitating intervertebral body fusion, not for diagnosing medical conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states the device is made of 3D printed titanium alloy and describes various physical dimensions and testing of the hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The GS Medical PYXIS 3D Titanium Cervical Cages are physical implants designed to be surgically placed in the cervical spine to facilitate fusion. They are made of titanium and are used to restore disc height.
- Intended Use: The intended use clearly states the device is for facilitating intervertebral body fusion in the cervical spine. This is a surgical procedure, not a diagnostic test performed on a sample.
The description focuses on the physical characteristics of the implant and its surgical application, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The GS Medical PYXIS 3D Titanium Cervical Cages 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. GS Medical PYXIS 3D Titanium Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical PYXIS 3D Titanium Cervical Cages are 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.
Product codes
ODP
Device Description
The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.
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 of the PYXIS 3D Titanium Cage System underwent testing according to ASTM 2077, specifically static and dynamic axial compression testing, static and dynamic compression shear testing, static and dynamic Torsion testing; expulsion testing, and subsidence testing according to ASTM F2267.
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
August 20, 2024
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
GS Medical Co. Ltd. % Barry E. Sands President and Founder ROMIS, Inc 110 Haverhill Rd. Suite 524 Amesbury, Massachusetts 01913
Re: K241738
Trade/Device Name: PYXIS 3D Titanium Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: June 11, 2024 Received: June 17, 2024
Dear Mr. 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 (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).
1
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 QS 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, 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
PYXIS 3D Titanium Cervical Cage system
Indications for Use (Describe)
The GS Medical PYXIS 3D Titanium Cervical Cages 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. GS Medical PYXIS 3D Titanium Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograff bone. GS Medical PYXIS 3D Titanium Cervical Cages are 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 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
GS Medical Co. Ltd.
PYXIS 3D Titanium Cervical Cage System
l. SUBMITTER'S ADDRESS, TELEPHONE NUMBER, CONTACT PERSON
- GS Medical Co. Ltd. Seon Yeon Kim 90, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk, Korea, South - 28161 Phone: +82-43-237-7397 Email: sykim@gsmedi.com
Author:
Arunkumar Prabhakaran US Regulatory Submissions Manager Phone: 978-358-7307 Email: regulatorysubmissions@rqmis.com
Primary Contact:
Barry E. Sands RQMIS Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 Phone: (978) 358-7307 Email: regulatorysubmissions@rqmis.com
Date Prepared: June 10, 2024
II. SUBJECT DEVICE
| Trade/proprietary name of device: | PYXIS 3D Titanium Cervical Cage System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Bone |
| Graft, Cervical | |
| Regulation Number: | 21 CFR 888.3080 |
| Classification: | Class II |
| Product Code: | ODP |
4
III. PREDICATE DEVICES
Primary Predicate:
- · EIT Cellular Titanium® Cervical Cage K172888 ODP 21 CFR 888.3080 Class II
Additional Predicate:
- AnyPlus Cervical PEEK Cage K153517 ODP 21 CFR 888.3080 Class II
- · PYXIS 3D Titanium cage System K223868 MAX 21 CFR 888.3080 Class II
IV. INTENDED USE/INDICATIONS FOR USE
The GS Medical PYXIS 3D Titanium Cervical Cages 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. GS Medical PYXIS 3D Titanium Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical PYXIS 3D Titanium Cervical Cages are 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.
V. DEVICE DESCRIPTION/TECHNOLOGICAL CHARACTERISTICS
The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc.
The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868).
5
The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.
VI. PERFORMANCE DATA
The worst-case cage of the PYXIS 3D Titanium Cage System underwent testing according to ASTM 2077, specifically static and dynamic axial compression testing, static and dynamic compression shear testing, static and dynamic Torsion testing; expulsion testing, and subsidence testing according to ASTM F2267.
CONCLUSION VII.
The technological differences between the subject device and the predicates (K172888 and K153517) do not raise new questions of safety and effectiveness. Any differences in technological characteristics have been tested and documented. The subject device and predicates (K172888 and K153517) have been determined to be equivalent in terms of indications for use, materials, performance, sterility, and biocompatibility.