(76 days)
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.
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.
I am sorry, but the provided text does not contain information about the acceptance criteria for a medical device or a study proving that the device meets those criteria. The document appears to be an FDA 510(k) summary for the "AccelFix Lumbar Expandable Cage System," primarily discussing its substantial equivalence to a predicate device based on design, materials, manufacturing processes, and mechanical testing.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract image of a human figure, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size than the rest of the text. The logo is clean and professional, and it is easily recognizable as the symbol of the FDA.
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
{2}------------------------------------------------
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)
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 Druq 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
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-gilGiheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea |
| Submitter's Telephone: | +82-2-6717-1983 |
| Submission date: | July 6, 2023 |
| Contact Person: | Katherine Kimkhkim@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.
{4}------------------------------------------------
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 DevicesK190708 | Indication for use are same |
{5}------------------------------------------------
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 IndicatorModule and handle areseparated and excludedfrom the expandable cageinserter. | The indicator module, cageinserter body and handleare integrated | Difference |
| Material | STS 630, STS 304-tissuecontact | STS 630(ASTM F 899-20)STS 304(ASTM F 899-20)STS 455(ASTM F 899-20)Ti6AL4V (ASTM F 136) Silicone | Difference |
| Manufacturingprocess | The handle and indicator module are separated andremoved from the cage insert of the subject device.Therefore, the manufacturing process of the handle andindicator module and the process of integrating (assembly)the cage insert body are excluded, and the rest of theprocesses are the same as the predicate devicemanufacturing process. | Difference |
ADDITIONAL INSTRUMENTS (CLASS II)
| Characteristics | Material | Similarities/Differences |
|---|---|---|
| Subject Devicestissue contactmaterial | ASTM F 899-20 (STS 630, STS 304, STS455)Tissue contacts materials | Similar |
| Predicate DevicesK190708 | ASTM F 899-20 (STS 630, STS 304, STS455)Tissue contacts materials |
APPROACH
| Characteristics | Subject Devices | Predicate Devices K190708 | Similarities/Differences |
|---|---|---|---|
| ApproachAccelFix-XTPCage | Anterior to Psoas ApproachLateral Approach. | Lateral Approach. | Differenceadded Lateral Approach |
STERILIZATION
| Subject Devices | Predicate DevicesK190708 | Similarities/Differences |
|---|---|---|
| Sterile device: Gamma radiation Non-sterile device: recommendedsteam sterilization (autoclavesterilization) | Sterile device: Gamma radiation Non-sterile device: recommendedsteam sterilization (autoclavesterilization) | Similar |
| Subject Devices | Predicate Devices K190708 | Similarities/Differences |
| (1) Soak the instrument in the tap waterfor 1 minute.(2) Prepare cleaning solution at the(0.8%~1.6concentration%)by thesuggesteddetergentmanufacturer and soak the instrumentin the prepared cleaning solution for 5minutes, and then remove thecontamination from the instrumentsurface with a soft brush. However,the operating part should be operatedto clean the contamination.(3) Rinse the instrument for at least 3minutes with tap water. However, thesmall diameter hole is rinsed using asyringe or the like.(4) Rinse the instrument by shaking withpurified water for at least 5 minutes.(5) Wipe off water in the instruments witha clean cloth. However, compressedair can be used for the device withcomplex structures.(6) Prepare for storage and sterilization. | - Use the neutral pH enzyme soakingsolution that has been prepared.- Completely submerge the instrument inenzyme solution and allow it to soak for20 minutes (water temperature: followthe manufacturer's instruction). Scrubinstrument using a soft-bristled brush togently clean the device (particularattention shall be given to crevices,lumens, mated surfaces, and other hard-to-clean areas) until all visible soil hasbeen removed. Lumens should becleaned with a long, narrow, soft-bristled brush (i.e., pipe cleaner brush).Note: Any assembled instruments, pleasedisassemble the parts before submerging.Note: The enzyme solution should bechanged on a regular basis in order toensure its effectiveness.- Remove the device from the enzymesolution and rinse in purified water(from one or any combination of thefollowing processes: ultra-filter, RO,DI and/or distilled) for a minimum of 3minutes. Thoroughly flush lumens,holes and other difficult to reach areas.Prepare the neutral pH cleaning(detergent) solution according to themanufacturer's instructions, dilutionrecommendations, and temperaturesand place in a sonication unit.- Completely submerge deviceincleaning solution and sonicate for 10minutes, preferably at 45-50 kHz.- Rinse instrument in purified water(from one or any combination of thefollowing processes: ultra-filter, RO,DI and/or distilled) thoroughly for atleast 3 minutes.- Repeat Steps 5 and 6 with freshlyprepared cleaning solution.- Dry the instrument with a clean,disposable, absorbent, non-sheddingwipe.- Visually inspect the devices undernormal room lighting condition toverify all foreign debris has beenremoved thoroughly clean.- Verify that the devices are visuallyclean. | 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 theconcentration (0.8% | None | Added |
{6}------------------------------------------------
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.
{8}------------------------------------------------
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).
§ 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.