(32 days)
The IVA Cage (ACIF, Ti ACIF) are 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 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 with an intervertebral cage
The IVA Cage (PLF, TLIF, DLIF, Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 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.
The IVA Cage Ti (ACIF, PLIF, TLIF, DLIF and ALIF) is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine.
The provided text does not contain information about the acceptance criteria and performance of a device based on a study with AI in the loop. The document is a 510(k) premarket notification for an intervertebral body fusion device (IVA Cage Ti) and focuses on demonstrating substantial equivalence to a legally marketed predicate device.
The document discusses:
- Device Name: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
- Regulation Number: 21 CFR 888.3080
- Regulatory Class: Class II
- Product Code: MAX, ODP
- Indications for Use: Intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical and lumbar spine, with specific disc levels mentioned.
- Performance Data: States "The addition of components to the system did not introduce a new worst case construct as evaluated based on an engineering analysis. Dynamic axial compression test per ASTM F2077 was performed."
- Predicates: IVA (ACIF, PLIF, TLIF, DLIF, and ALIF) Cage (K162220) and SUSTAIN® & SUSTAIN® - R (K130478).
- Substantial Equivalence Determination: Based on technical characteristics, performance, and intended use to the predicate system(s).
There is no mention of:
- Acceptance criteria for an AI-powered device.
- A study evaluating AI performance (standalone or with human-in-the-loop).
- Sample sizes for test or training sets related to AI.
- Experts or ground truth establishment for AI.
- MRMC comparative effectiveness study or related effect sizes.
Therefore, I cannot provide the requested information based on the given input text.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Huvexel Co., Ltd % Mr. Milan George Senior Director Dio Medical Corporation 8770 W Bryn Mawr Avenue Ste. 1250 Chicago, Illinois 60631
October 31, 2017
Re: K173080
Trade/Device Name: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: September 28, 2016 Received: September 29, 2017
Dear Mr. George:
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name IVA CAGE Ti (ACIF, PLIF, TLIF, DLIF and ALIF)
Indications for Use (Describe)
The IVA Cage (ACIF, Ti ACIF) are 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 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 with an intervertebral cage
The IVA Cage (PLF, TLIF, DLIF, Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 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.
| 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) |
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
HUVEXEL Co., Ltd's IVA CAGE Ti (ACIF, PLIF, TLIF, DLIF and ALIF)
| Sponsor: | Manufacturer | HUVEXEL Co., Ltd.101-105 Megacenter, SK Technopark124 Sagimakgol-ro, Jungwon-gu Seongnam-siGyeonggi-do, South Korea |
|---|---|---|
| Official ContactPhone:Fax: | Milan George267-737-9496 x102847-795-1079 | |
| September 28, 2017 | ||
| Device Name: | IVA CAGE TI (ACIF, PLIF, TLIF, DLIF and ALIF) | |
| Common Name: | Intervertebral Body Fusion Device | |
| Classification Name: | Intervertebral Body Fusion Device, CervicalIntervertebral Body Fusion Device, Lumbar | |
| ClassificationNumber: | 21 CFR 888.3080 | |
| ProductCode/Classification: | ODP, MAX class II | |
| Description: | The IVA Cage Ti (ACIF, PLIF, TLIF, DLIF and ALIF) is intended forintervertebral body fusion in skeletally mature patients. The intendedoperation of these devices are concentrated around disc levels from theC2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbarspine. | |
| Device Modification& TechnologicalCharacteristics: | The purpose of this 510(k) submission is to introduce additionalconfigurations of cages in Titanium. The modified system has the sameintended use and fundamental scientific technology as the previously-cleared system. |
{4}------------------------------------------------
Indications For Use: The IVA Cage (ACIF, TI ACIF) are 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 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 IVA Cage (PLIF, TLIF, DLIF, ALIF, Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 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.
-
Performance Data: The addition of components to the system did not introduce a new worst case construct as evaluated based on an engineering analysis. Dynamic axial compression test per ASTM F2077 was performed.
Primary predicate: IVA (ACIF, PLIF, TLIF, DLIF, and ALIF) Cage (K162220) -Predicate Device: HUVEXEL Co., Ltd Additional predicate: SUSTAIN® & SUSTAIN® - R (K130478) - Globus Medical Inc. -
Reference Device: K121862 - Rex Anterior Cervical Plate System
Performance and SE The IVA CAGE Ti (ACIF, PLIF, TLIF, DLIF and ALIF) have been demonstrated Determination: to be substantially equivalent to the predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s).
§ 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.