(76 days)
Not Found
No
The document describes a mechanical expandable cage system for spinal fusion and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes.
The device is used for a medical procedure (intervertebral body fusion) to treat a medical condition (degenerative disc disease), which fits the definition of a therapeutic device.
No
This device is an intervertebral body fusion device (an implantable cage) used for spinal fixation, not a diagnostic tool. Its purpose is treatment through fusion, not diagnosis of a condition.
No
The device description clearly states the device is an implant made of Titanium 6AL-4V Alloy, which is a 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 AccelFix Lumbar Expandable Cage System is a physical implant made of Titanium alloy, designed to be surgically inserted into the spine for fusion procedures.
- Intended Use: The intended use is for intervertebral body fusion in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a medical device used for treatment (fusion), not for diagnosing a condition by analyzing a biological sample.
N/A
Intended Use / Indications for Use
AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
The AccelFix Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.
- AccelFix-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
- AccelFix-XTP Expandable Cage is to be implanted via Anterior to Psoas approach and lateral Approach.
- AccelFix-XL Expandable Cage is to be implanted via lateral approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-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)
Bench testing to evaluate the mechanical properties of the AccelFix Lumbar Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices.
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.
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August 24, 2023
L&K BioMed Co., Ltd. Katherine Kim RA #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si, Gyeonggi-do 17015 Korea, South
Re: K231680
Trade/Device Name: AccelFix Lumbar Expandable Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 31, 2023 Received: August 2, 2023
Dear Katherine Kim:
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.
1
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) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231680
Device Name
AccelFix Lumbar Expandable Cage System
Indications for Use (Describe)
AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
| 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) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. SUBMITTER
| Submitter's Name: | L&K BIOMED Co., Ltd. |
|---|---|
| Submitter's Address: | #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil |
| Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea | |
| Submitter's Telephone: | +82-2-6717-1983 |
| Submission date: | July 6, 2023 |
| Contact Person: | Katherine Kim |
| khkim@lnkbiomed.com/khkim3747@gmail.com |
2. DEVICE NAME
| Trade or Proprietary Name | AccelFix Lumbar Expandable Cage System |
|---|---|
| Common or Usual Name | Intervertebral Body Fusion Device, Intervertebral cage, Spacer |
| Regulation class / Number | ClassII, CFR 888.3080 |
| Regulation Name | Intervertebral Body Fusion Device |
| Product Code | MAX |
| Classification Panel | Orthopedics |
3. PREDICATE DEVICE
The changes to this product, the additional approach, do not affect the product's design, dimensional sizes, indication for use, material, scientific technology and manufacturing process.
The design feature and indications for use and manufacturing process for the subject device 'AccelFix Lumbar Expandable Cage System' is substantially equivalent to the predicate device.
Primary Predicate Device: AccelFix Lumbar Expandable Cage System (K190708)
4. DESCRIPTION OF THE DEVICE
The AccelFix Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.
- · AccelFix-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
- . AccelFix-XTP Expandable Cage is to be implanted via Anterior to Psoas approach and lateral Approach.
- AccelFix-XL Expandable Cage is to be implanted via lateral approach.
5. INDICATION FOR USE
AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation systems. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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6. PERFORMANCE DATA
Changes made by this submission are not subject to additional mechanical testing.
The predicate AccelFix Lumbar Expandable Cage System was tested according to the ASTM F 2077. ASTM F 2267 and ASTM draft as described below.
Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the AccelFix Lumbar Expandable Cage System to the predicate devices.
- Static Axial Compression Test ASTM F 2077 -17
- Static Compression-Shear Test ASTM F 2077 -17
- Static Torsion Test ASTM F 2077 -17
- · Static Expulsion Test
- Static Subsidence Test ASTM F 2267 04 (Reapproved 2018)/F 2077-17
- Dynamic Axial Compression Test- ASTM F 2077 -17
- Dynamic Compression-Shear Test ASTM F 2077 -17
Bench testing to evaluate the mechanical properties of the AccelFix Lumbar Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices.
7. MATERIAL
The AccelFix Lumbar Expandable Cage is manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices. And additional instruments and changed instrument pieces that are patient anatomy contacting are manufactured of medical grade materials (medical-grade stainless steel, medical grade silicone) and are tissue contacting in limitedexposure duration of less than 24 hours. Only the materials that contact with tissue are considered in this regard. The additional instruments that contact tissue area during surgery are made of Stainless-Steel ASTM F 899-20(STS455, STS630, STS 304). These materials have been widely recognized to be safe materials and known to be biocompatible.
8. COMPARISON OF TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject and predicate devices are identical technological characteristics and there is not any new issues of safety and effectiveness. The characteristics are similar or identical between the subject and the predicate, but the data for the characteristics are as compared to the data below.
- . Instruction for use (added lateral approach to AccelFix-XTP Cage)
- · Design and sizes
- Expanding Mechanism
- · Material (material change due to design change of Expandable Cage Inserter)
- " Approach (added lateral approach to AccelFix-XTP Cage)
- Sterilization & Method
- Manufacturing process (for the subject device of Expandable Cage Inserter, the handle manufacturing process and the integrating process(assembling) of indicator module, cage inserter body and handle are excluded from the predicate device manufacturing process).
| INDICATION FOR USE | |
|---|---|
| Similarities | |
| Subject Devices | |
| Predicate Devices | |
| K190708 | Indication for use are same |
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DESIGN AND SIZES OF IMPLANTS
| Characteristics | Subject Devices | Predicate Devices K190708 | Similarities/Differences |
|---|---|---|---|
| Design | Subject implant has the same design as predicate implant | Similar | |
| Sizes | Subject implant has the same sizes as predicate implant | Similar | |
| Material | Ti-6Al-4V ELI titanium alloy (ASTM F136) | Ti-6Al-4V ELI titanium alloy (ASTM F136) | Similar |
| Manufacturing Process | Subject implant's manufacturing process is the same as predicate implant's | Similar |
INSTRUMENTS (EXPANDABLE CAGE INSERTER XTP01-0001)
| Characteristics | Subject Devices | Predicate Devices K190708 | Similarities/Differences |
|---|---|---|---|
| Design(changed) | The Height Indicator | ||
| Module and handle are | |||
| separated and excluded | |||
| from the expandable cage | |||
| inserter. | The indicator module, cage | ||
| inserter body and handle | |||
| are integrated | Difference | ||
| Material | STS 630, STS 304-tissue | ||
| contact | STS 630(ASTM F 899-20) | ||
| STS 304(ASTM F 899-20) | |||
| STS 455(ASTM F 899-20) | |||
| Ti6AL4V (ASTM F 136) Silicone | Difference | ||
| Manufacturing | |||
| process | The handle and indicator module are separated and | ||
| removed from the cage insert of the subject device. | |||
| Therefore, the manufacturing process of the handle and | |||
| indicator module and the process of integrating (assembly) | |||
| the cage insert body are excluded, and the rest of the | |||
| processes are the same as the predicate device | |||
| manufacturing process. | Difference |
ADDITIONAL INSTRUMENTS (CLASS II)
| Characteristics | Material | Similarities/Differences |
|---|---|---|
| Subject Devices | ||
| tissue contact | ||
| material | ASTM F 899-20 (STS 630, STS 304, STS455) | |
| Tissue contacts materials | Similar | |
| Predicate Devices | ||
| K190708 | ASTM F 899-20 (STS 630, STS 304, STS455) | |
| Tissue contacts materials |
APPROACH
| Characteristics | Subject Devices | Predicate Devices K190708 | Similarities/Differences |
|---|---|---|---|
| Approach | |||
| AccelFix-XTP | |||
| Cage | Anterior to Psoas Approach | ||
| Lateral Approach. | Lateral Approach. | Difference | |
| added Lateral Approach |
STERILIZATION
| Subject Devices | Predicate Devices
K190708 | Similarities/Differences |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Sterile device: Gamma radiation Non-sterile device: recommended
steam sterilization (autoclave
sterilization) | Sterile device: Gamma radiation Non-sterile device: recommended
steam sterilization (autoclave
sterilization) | Similar |
| Subject Devices | Predicate Devices K190708 | Similarities
/Differences |
| (1) Soak the instrument in the tap water
for 1 minute.
(2) Prepare cleaning solution at the
(0.8%~1.6
concentration
%)
by the
suggested
detergent
manufacturer and soak the instrument
in the prepared cleaning solution for 5
minutes, and then remove the
contamination from the instrument
surface with a soft brush. However,
the operating part should be operated
to clean the contamination.
(3) Rinse the instrument for at least 3
minutes with tap water. However, the
small diameter hole is rinsed using a
syringe or the like.
(4) Rinse the instrument by shaking with
purified water for at least 5 minutes.
(5) Wipe off water in the instruments with
a clean cloth. However, compressed
air can be used for the device with
complex structures.
(6) Prepare for storage and sterilization. | - Use the neutral pH enzyme soaking
solution that has been prepared.
- Completely submerge the instrument in
enzyme solution and allow it to soak for
20 minutes (water temperature: follow
the manufacturer's instruction). Scrub
instrument using a soft-bristled brush to
gently clean the device (particular
attention shall be given to crevices,
lumens, mated surfaces, and other hard-
to-clean areas) until all visible soil has
been removed. Lumens should be
cleaned with a long, narrow, soft-
bristled brush (i.e., pipe cleaner brush).
Note: Any assembled instruments, please
disassemble the parts before submerging.
Note: The enzyme solution should be
changed on a regular basis in order to
ensure its effectiveness. - Remove the device from the enzyme
solution and rinse in purified water
(from one or any combination of the
following processes: ultra-filter, RO,
DI and/or distilled) for a minimum of 3
minutes. Thoroughly flush lumens,
holes and other difficult to reach areas.
Prepare the neutral pH cleaning
(detergent) solution according to the
manufacturer's instructions, dilution
recommendations, and temperatures
and place in a sonication unit. - Completely submerge device
in
cleaning solution and sonicate for 10
minutes, preferably at 45-50 kHz. - Rinse instrument in purified water
(from one or any combination of the
following processes: ultra-filter, RO,
DI and/or distilled) thoroughly for at
least 3 minutes. - Repeat Steps 5 and 6 with freshly
prepared cleaning solution. - Dry the instrument with a clean,
disposable, absorbent, non-shedding
wipe. - Visually inspect the devices under
normal room lighting condition to
verify all foreign debris has been
removed thoroughly clean. - Verify that the devices are visually
clean. | changed |
| Semi-auto Cleaning Procedure: Added Semi-auto cleaning procedure on subject devices | | Similarities
/Differences |
| Subject Devices | Predicate Devices K190708 | |
| (1) Prepare cleaning solution at the
concentration (0.8%1.6 %) suggested30) to dry it.
by the detergent manufacturer and soak
the instrument in the prepared cleaning
solution for 20 minutes. Clean the
instrument with a soft brush. (Especially,
carefully wipe the gaps, interiors, and
surfaces that are difficult to clean.) The
inside of the instrument should be
cleaned with a long, narrow, and soft
brush.
(2) Rinse with purified water for 3 minutes
to remove the cleaning solution. Use
rinsing water temperature between 35°C
and 45°C for part and holes that are
difficult to clean.
(3) Immerse the product in the cleaning
solution and clean using ultrasonic
cleaner at 45 kHz to 50 kHz for 10
minutes.
(4) Rinse with purified water for at least 3
minutes until there is no blood or
contaminants. If contaminants remain,
ultrasonic cleaning (step 3) and rinsing
(step 4) are performed once more.
(5) Wipe the instrument cleaned with a
clean, absorbent disposable wipe to dry
instrument. If additional drying is
needed after drying step, use medical
compressed air (psi 20
Check that the instrument is visually
cleaned. | None | Added |
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CLEANING METHOD
Manual Cleaning Procedure: The manual cleaning procedure for subject devices changed the cleaning time from the manual cleaning procedure for predicate devices and deleted the sonicate part.
7
- removed thoroughly clean. removed thoroughly clean. Verify that the instruments are in Verify that the instruments are in " visually clean. visually clean.
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Image /page/8/Picture/0 description: The image shows the text 'K231680' and 'Page 6 of 6' at the top. Below that is the logo for L&K BIOMED, which includes the company's name in bold letters and a graphic of blue circles to the right. The text and logo are positioned against a white background.
9. SUBSTANTIAL EQUIVALENCE AND CONCLUSION
The subject AccelFix Lumbar Expandable Cage System have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, material, intended use and manufacturing process. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate devices. The overall data lead to the conclusion that the AccelFix Lumbar Expandable Cage System is substantially equivalent to the predicate devices (K190708).