(209 days)
No
The summary describes a physical implant (a spinal cage) and its mechanical properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for intervertebral body fusion of the lumbar spine to treat degenerative disc disease, which is a therapeutic purpose. It is implanted to facilitate fusion and stabilize the spine.
No
Explanation: The device is an implant for intervertebral body fusion of the lumbar spine, specifically a cage. Its function is to facilitate fusion and provide stabilization, not to diagnose medical conditions. Its use in radiographic evaluation is for position and orientation, not diagnosis.
No
The device description clearly states it is an implantable cage made of PEEK and titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states the INNESIS PEEK TL Cage is an implant for the posterior stabilization of the lumbar spinal column. It is a physical device inserted into the body, not a test performed on a sample taken from the body.
- The intended use is for surgical implantation. The indications for use describe a surgical procedure (intervertebral body fusion) and the device's role in that procedure.
- The performance studies are mechanical tests. The summary of performance studies details tests related to the physical strength and stability of the implant, not diagnostic performance metrics like sensitivity or specificity.
The device is a medical implant used in a surgical procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The INNESIS PEEK TL Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally 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 or retrolisthesis at the involved level. 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The INNESIS PEEK TL Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The INNESIS PEEK TL Cages are offered in a variety of heights, footprints and curved shapes. The device has ridges on both its inferior and superior surfaces, and two large graft windows which help facilitate bony integration. The device includes marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage. The INNESIS PEEK TL Cage components are manufactured from Polyetheretherketone (VESTAKEEP® 14 R, ASTM F2026). They contain marker made of medical grade titanium alloy (Ti6Al4V-ELI, ASTM F136). The INNESIS PEEK TL Cage and instrumentation set is sold non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
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)
- Static and dynamic axial compression test, conducted in accordance with ASTM F2077-11
- Static compression shear test, conducted in accordance with ASTM F2077-11
- Static and dynamic torsion test, conducted in accordance with ASTM F2077-11
- Static subsidence test, conducted in accordance with ASTM F2267-04
- Expulsion test, conducted in accordance with ASTM Draft Standard F04.25.02.02.
The material of the INNESIS PEEK TL Cage (permanent implant- long term) is PEEK (Polyetheretherketone, ASTM F2026) and Titanium Alloy (Ti6Al4V-ELI, ASTM F136) are known biocompatible materials. These materials are recognized as suitable biomaterials, have been evaluated to ISO 10993 requirements, and predicate devices have previously been cleared by FDA for this same intended use. The cleaning process to remove manufacturing materials and solution residues has been validated.
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.
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2014
BK Meditech Company, Limited % Elaine Duncan, M.S.M.E., RAC Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082
Re: K140577
Trade/Device Name: INNESIS PEEK TL CAGE Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 28, 2014 Received: August 29, 2014
Dear Ms. Duncan:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Elaine Duncan, M.S.M.E., RAC
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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.
Ronald PAJean -S for
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) K140577
Device Name INNESIS PEEK TL CAGE
Indications for Use (Describe)
The INNESIS PEEK TL Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally 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 or retrolisthesis at the involved level. 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) |
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3
510(k) {
Submitted on behalf of:
| Company Name: | BK Meditech Co, Ltd |
|---|---|
| Address: | 58, Eunhaengnamu-ro |
| Hwasung-Si, Kyunggi-Do | |
| Republic of Korea 445-931 | |
| Telephone: | 82-31-352-9135 |
| Fax: | 82-31-352-9134 |
| by: | Elaine Duncan, M.S.M.E., RAC |
| President, Paladin Medical, Inc. | |
| PO Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | July 21, 2014 |
| TRADE NAME: | INNESIS PEEK TL CAGE |
| COMMON NAME: | Intervertebral body fusion device |
| DEVICE CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Orthosis, Intervertebral body fusion device, lumbar |
| REGULATION: | 888.3080 |
| PRODUCT CODE: | MAX |
INDICATIONS FOR USE:
The INNESIS PEEK TL Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative 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 or retrolisthesis at the involved level. 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.
DESCRIPTION of the DEVICE:
The INNESIS PEEK TL Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The INNESIS PEEK TL Cages are offered in a variety of heights, footprints and curved shapes. The device has ridges on both its inferior and superior surfaces, and two large graft windows which help facilitate bony integration. The device includes marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage. The INNESIS PEEK TL Cage components are manufactured from
Polyetheretherketone (VESTAKEEP® 14 R, ASTM F2026). They contain marker made of
4
medical grade titanium alloy (Ti6Al4V-ELI, ASTM F136). The INNESIS PEEK TL Cage and instrumentation set is sold non-sterile.
SUBSTANTIALLY EQUIVALENT TO:
The subject and predicate devices are substantially equivalent in the areas of materials, design, indications for use and operational principles. Based on the comparison between the subject and predicate devices and testing to standard requirements, BK MEDITECH Co., Ltd. believes that the INNESIS PEEK TL Cages are substantially equivalent to the predicate devices listed below:
| 510(k) | Tradename | Manufacturer |
|---|---|---|
| K120464-PRIMARY PREDICATE | INNESIS PEEK CAGE | BK MEDITECH Co, Ltd. |
| K100089-Reference predicate | ||
| various physical features | SYNTHES T-PAL SPACER | SYNTHES SPINE |
| K123388-Reference predicate- | ||
| material | "K7c" | K7, LLC |
| K100042-Reference predicate- | ||
| mechanical data | Kyphos Interbody Fusion System | Difusion Technologies |
SUMMARY of TESTING per GUIDANCE:
Testing results are for the following:
- Static and dynamic axial compression test, conducted in accordance with ASTM F2077-11
- Static compression shear test, conducted in accordance with ASTM F2077-11
- Static and dynamic torsion test, conducted in accordance with ASTM F2077-11
- Static subsidence test, conducted in accordance with ASTM F2267-04
- Expulsion test, conducted in accordance with ASTM Draft Standard F04.25.02.02.
The material of the INNESIS PEEK TL Cage (permanent implant- long term) is PEEK (Polyetheretherketone, ASTM F2026) and Titanium Alloy (Ti6Al4V-ELI, ASTM F136) are known biocompatible materials. These materials are recognized as suitable biomaterials, have been evaluated to ISO 10993 requirements, and predicate devices have previously been cleared by FDA for this same intended use. The cleaning process to remove manufacturing materials and solution residues has been validated.
Conclusions:
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. Tests performed according to ASTM F2077/ F2267 indicate that The INNESIS PEEK TL Cage meet required mechanical strengths. Some of the predicate devices have a different geometry than The INNESIS PEEK TL Cage. But the non-clinical mechanical test results demonstrate that any minor differences do not impact performance as compared to the predicates and demonstrate that The INNESIS PEEK TL Cage is substantially equivalent to the predicate device.