(301 days)
MAX, K192115
No
The summary describes a mechanical implant and its manufacturing process, with no mention of AI or ML capabilities.
Yes
The device is indicated for the treatment of degenerative disc disease and designed to facilitate fusion and provide mechanical stability in the lumbar spine, which are therapeutic actions.
No
The device is an implantable lumbar intervertebral fusion cage designed to facilitate fusion and provide mechanical stability, not to diagnose a condition.
No
The device description clearly states it is a physical implantable cage system manufactured from metal, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to provide structural support and facilitate bone growth.
- Device Description: The description details a physical implantable device made of titanium alloy, designed to be placed in the disc space.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is an implantable medical device used inside the body.
N/A
Intended Use / Indications for Use
The KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). 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 KLIMT Expandable LIF Cage System is a lumbar intervertebral fusion cage that is implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The subject cage is vertically expandable i.e., it has a height adjustable feature for ease of implantation and final secure fit to a patient's anatomy. The cage's components are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method) and assembled into a final cage unit. The cages are manufactured from titanium alloy powder per ASTM F3001 and titanium alloy per ASTM F136 and are provided both sterile and nonsterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.
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)
Non-Clinical Tests:
- Static Compression Bending (per ASTM F2077)
- Dynamic Compression Bending (per ASTM F2077)
- Static Compression Shear Bending (per ASTM F2077)
- Dynamic Compression Shear Bending (per ASTM F2077)
- Static Torsion (per ASTM F2077)
- Subsidence (per ASTM F2267)
- Expulsion
Clinical Tests:
- N/A
Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.
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
October 10, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CTL Medical Corporation % Dhaval Saraiya Regulatory Affairs and Quality Assurance Consultant Omnee Strategic Solutions, Inc. 7 Desrosiers Landing South Grafton, Massachusetts 01560
Re: K233947
Trade/Device Name: KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 4, 2024 Received: October 4, 2024
Dear Dhaval Saraiya:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Katherine D. Kavlock -S
for
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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Indications for Use
Submission Number (if known)
Device Name
KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System
Indications for Use (Describe)
The KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System is 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for CTL Amedica. The logo features a stylized graphic of two curved shapes in yellow and gray, followed by the text "CTL AMEDICA" in black. The "CTL" portion of the text is in a lighter shade of yellow, while the "AMEDICA" portion is in black.
510(k) Summary
In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System 510(k) premarket notification.
| Sponsor: | CTL Medical Corporation
Sean Suh
2052 McKenzie Drive
Building 1
Carrollton, TX 75006 | | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------|----------------|
| Contact Person: | Dhaval S. | Omnee Strategic Solutions, Inc.
Regulatory/Quality Consultant
Email: omneestrategicsol@gmail.com | | |
| Date: | Apr 26, 2024 | | | |
| Subject Device: | Trade Name: KLIMT™ Expandable Lumbar Interbody Fusion
(LIF) Cage System
Common Name: Intervertebral Body Fusion Devices
Classification Name: MAX – Intervertebral Fusion Device with
Bone Graft, Lumbar (21 CFR 888.3080) | | | |
| Predicate Device(s): | | | | |
| | Primary
Predicate: | K192115 | SABLE Expandable
Spacer | Globus Medical |
| | Reference
Device: | K131981 | CEZANNE II Interbody
Fusion System | CTL Medical |
Purpose and Device Description:
The purpose of this submission is to request clearance for the new KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System. The KLIMT Expandable LIF Cage System is a lumbar intervertebral fusion cage that is implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The subject cage is vertically expandable i.e., it has a height adjustable feature for ease of implantation and final secure fit to a patient's anatomy. The cage's components are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method) and assembled into a final cage unit. The cages are manufactured from titanium alloy powder per ASTM F3001 and titanium alloy per ASTM F136 and are provided both sterile and nonsterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per
5
Image /page/5/Picture/0 description: The image shows the logo for CTL Amedica. The logo features three curved shapes on the left side, with the first shape being gray and the other two being yellow. To the right of the shapes is the text "CTL AMEDICA", with "CTL" in yellow and "AMEDICA" in black.
ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.
Intended Use and Indications for Use:
The KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). 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.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The intended use is similar to the intended use cleared in K192115 and K131981. ●
- Indications for Use: The indications for use are similar to the indications for use cleared in K192115 and K131981.
- Materials: The KLIMT Expandable LIF Cage System implants are manufactured from titanium alloy powder per ASTM F3001 and titanium alloy per ASTM F136 and instruments are manufactured from Stainless Steel per ASTM F899 which are commonly used materials in orthopedic implants and instruments and similar to materials used in the identified predicate devices.
- Design Features: The design features for the KLIMT Expandable LIF Cage System implants and instruments are identical to those in currently marketed devices cleared in K192115 and K131981.
- Sterilization: The KLIMT Expandable LIF Cage System implants are offered to the user in both sterile and non-sterile configurations and instruments are offered to the user in the non-sterile configuration. The non-sterile implants and instruments will be required to be steam sterilized by the user prior to use, similar to the devices cleared in the identified predicate devices.
Summary of Performance Data (Nonclinical and/or Clinical):
Non-Clinical Tests: ●
- o Static Compression Bending (per ASTM F2077)
- o Dynamic Compression Bending (per ASTM F2077)
- · Static Compression Shear Bending (per ASTM F2077)
- O Dynamic Compression Shear Bending (per ASTM F2077)
- o Static Torsion (per ASTM F2077)
- o Subsidence (per ASTM F2267)
- o Expulsiom
Clinical Tests: ●
- O N/A
Substantial Equivalence
The KLIMT Expandable LIF Cage System has been shown to be substantially equivalent to the predicate device. Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.