(162 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a spinal fusion cage, with no mention of AI or ML technology.
Yes.
The device is used to treat degenerative disc disease and facilitate fusion in the cervical and lumbar spine, which fits the definition of a therapeutic device.
No
Explanation: The device is an intervertebral body fusion cage, which is an implant designed to facilitate fusion in the spine, not to diagnose a condition. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is an implantable cage made of PEEK and Titanium, which are hardware components. It also mentions surgical instruments made of stainless steel.
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 description clearly states that the Galaxy Peek Cage is an implantable device made of PEEK and titanium, designed for intervertebral body fusion in the spine.
- Intended Use: The intended use is to facilitate fusion in patients with degenerative disc disease by being surgically implanted into the spine.
The device is a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Galaxy (ACIF) Peek Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Galaxy (PLIF, TLIF, and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine from L2-S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. And consist of:
-
Cervical interbody fusion Device (Galaxy ACIF cage), which may be implanted as a single device via an anterior approach.
-
Lumbar Interbody Fusion Device (Galaxy PLIF, TLIF and ALIF), which may be implanted.
- o Bilaterally via a posterior(PL1F) approach;
- As a single device via a transforaminal(TLIF) approach; 0
- As a Single device via Anterior (ALIF) approach. o
The implants are made of polyether-ether-ketone (PEEK-OPTIMA LTI) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V).
The Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C3 disc to the C7-T1 disc), Lumbar spine (L2-S1)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
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 Galaxy (ACIF, PLIF, TLIF and ALJF) Peek Cage devices were tested according to the ASTM 2077. specifically, Static and Dynamic Axial CompressionTesting, Static and Dynamic Torsion Testing and Static Subsidence testing under Axial Compression, per ASTM 2267.
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.
0
510(k) Summary
Submitter:
DIO Medical Co., Ltd. Sung-Hee Lee 103~105 Megacenter, SK Technopark 190-1 Sangdaewon-dong, Jungwon-guSungnam-si Kyunggi-do, South Korea Phone: 82-31-776-3690 Fax: 82-31-776-3691
Official Correspondent: Kodent Inc.
April Lee 325 N. Puente St. Unit B Brea CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116
Device Information
Trade Name: Common Name: Classification Name:
Product Code: Regulation Number: Date prepared:
Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage Intervertebral Body Fusion Device, IBF Device Intervertebral Body fusion Device, Cervical Intervertebral Body fusion Device, Lumbar ODP, MAX 888.3080 12/17/2012
General Description
The Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. And consist of:
-
Cervical interbody fusion Device (Galaxy ACIF cage), which may be implanted as a single device via an anterior approach.
-
Lumbar Interbody Fusion Device (Galaxy PLIF, TLIF and ALIF), which may be implanted.
- o Bilaterally via a posterior(PL1F) approach;
- As a single device via a transforaminal(TLIF) approach; 0
- As a Single device via Anterior (ALIF) approach. o
The implants are made of polyether-ether-ketone (PEEK-OPTIMA LTI) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V).
The Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
FEB 2 8 2013
1
Indication for Use
The Galaxy (ACIF) Peek Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Galaxy (PLIF, TLIF, and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine from L2-S1 in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Materials:
The implants are made of polyether-ether-ketone (PEEK-OPTIMA LT1) body with the x-ray markers made of Titanium alloy (Ti-6A1-4V). The intended use, technological characteristics, mode of action and materials of construction are the same as those of the referenced predicate devices.
Performance Data:
The Galaxy (ACIF, PLIF, TLIF and ALJF) Peek Cage devices were tested according to the ASTM 2077. specifically, Static and Dynamic Axial CompressionTesting, Static and Dynamic Torsion Testing and Static Subsidence testing under Axial Compression, per ASTM 2267.
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
*BM KOREA Co. Ltd., SYNSTER Cage (K111820)
Comparison to Predicate Devices:
The Substantial equivalence of this device is based on equivalence in intended use, material, designs, and operational principles to the predicate device, BM KOREACo.Ltd, SYNSTER cage (K111820)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
DIO Medical Co., LTD. % Kodent Incorporated Ms. April Lee Consultant 325 North Puente Street, Unit B Brea, California 92821
Re: K122872
Trade/Device Name: Galaxy (ACIF, PLIF, TLIF, and ALIF) Peek Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: February 15, 2013 Received: February 25, 2013
Dear Ms. Lee:
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, 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 vour 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 (reporting of medical
3
Page 2 - Ms. April Lee
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(K) Number (if known): K122872
Device Name: Galaxy (ACIF, PLIF, TLIF and ALIF) Peek Cage
Indication for Use:
The Galaxy (ACIF) Peek Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Galaxy (PLIF, TLIF, and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine from L2-S1 in skeletally mature patients who have had six months of non-overative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Prescription Use
Over-The-Counter AND/OR
(Part 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Anton E. Dmitriev, PhD Division of Orthopedic Devices