(124 days)
Not Found
No
The summary describes a passive implant (spinal cage) and its material properties and mechanical testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is a non-powered surgical implant designed to restore intervertebral space height and is indicated for use in patients with degenerative disc disease. Its purpose is to physically treat and alleviate symptoms associated with this condition, which aligns with the definition of a therapeutic device.
No.
The device is a permanent implant (cage system) used for intervertebral body fusion to treat degenerative disc disease, not to diagnose the condition.
No
The device description explicitly states the system consists of "various cages for intervertebral body fusion" manufactured from "3D printed Titanium Alloy." This indicates a physical implant, not a software-only device.
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 for spinal fusion. It involves placing a cage with bone graft into the intervertebral space. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant made of titanium, designed to restore disc height and facilitate fusion. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies described are biomechanical tests evaluating the structural integrity and performance of the implant, which is typical for a surgical device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PYXIS 3D Titanium Cage System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s).
The PYXIS 3D Titanium Cage System is to be combined with supplemental fixation cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The GS Medical PYXIS 3D Titanium Cage System devices are designed for restoring the height of the intervertebral space after resection of he disc. They system consists of various cages for intervertebral body fusion ranging in height from 5mm-21mm with multiple lordotic options depending on the approach.
The components are manufactured from 3D printed Titanium Alloy (Ti-6Al-4V ELI) meeting the specifications of ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion.
The PYXIS 3D Titanium Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal levels from L2-S1 (lumbar spine)
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, shear static and dynamic compression, 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 26, 2023
GS Medical Co. Ltd. Barry E. Sands President and Founder RQMIS, Inc. 110 Haverhill Rd., Suite 524 Amesbury, Massachusetts 01913
Re: K223868
Trade/Device Name: PYXIS 3D Titanium Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 28, 2023 Received: March 1, 2023
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 (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
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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 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
Enclosure
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Indications for Use
510(k) Number (if known) K223868
Device Name PYXIS 3D Titanium Cage System
Indications for Use (Describe)
The PYXIS 3D Titanium Cage System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s).
The PYXIS 3D Titanium Cage System is to be combined with supplemental fixation cleared for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
X 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 Co. Ltd.
PYXIS 3D Titanium Cage System
SUBMITTER'S ADDRESS, TELEPHONE NUMBER, CONTACT PERSON l.
GS Medical Co. Ltd. Sam Camp 90, Osongsaengmyeong 4-ro Osong-eup, Cheongwon-gun Chungcheongbuk-do 363-951 Korea Phone: 352-327-4641 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
Date Prepared: April 25, 2023
ll. SUBJECT DEVICE
| Trade/proprietary name of device: | PYXIS 3D Titanium Cage System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device with Bone |
| Graft, Lumbar | |
| Regulation Number: | 21 CFR 888.3080 |
| Classification: | Class II |
| Product Code(s) | MAX |
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PREDICATE DEVICES III.
Primary Predicate:
- EIT Cellular Titanium Cervical Cages, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, EIT Cellular Titanium ALIF Cages K172888 MAX, ODP 21 CFR 888.3080 Class II
Additional Predicates:
- EIT Cellular Titanium Lumbar cage LLIF K181644 MAX 21 CFR 888.3080 Class II
- . AnyPlus PEEK Cage K100516 MAX 21 CFR 888.3080 Class II
IV. INTENDED USE/INDICATIONS FOR USE:
The PYXIS 3D Titanium Cage System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The PYXIS 3D Titanium Cage System is to be combined with supplemental fixation cleared for use in the lumbar spine.
V. DEVICE DESCRIPTION/TECHNOLOGICAL CHARACTERISTICS
The GS Medical PYXIS 3D Titanium Cage System devices are designed for restoring the height of the intervertebral space after resection of he disc. They system consists of various cages for intervertebral body fusion ranging in height from 5mm-21mm with multiple lordotic options depending on the approach.
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The components are manufactured from 3D printed Titanium Alloy (Ti-6Al-4V ELI) meeting the specifications of ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion.
The PYXIS 3D Titanium Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions.
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, shear static and dynamic compression, 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.
VII. CONCLUSION
The PYXIS 3D Titanium Cage has been found to be substantially equivalent to the primary predicate with respect to technical characteristics, design, materials, and intended use. And to the additional predicate with respect to performance. The minor technological differences between the subject device and the predicate do not raise new questions of safety and effectiveness.