(125 days)
The KG2 implant is indicated for transforaminal and posterior interbody fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The KG2 implant is used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The interbody fusion devices are intended to be used with FDA-cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
The Kleiner KG2 is a cage intended for lumbar intervertebral fusion (PLIF/TLIF approach). The design contains both solid and porous structures formed as a diamond mesh, and it contains a bone grafting hole. The cage is additively manufactured from titanium alloy. The KG2 cage may be used with coverplate.
The sterile Kleiner KG2 implant comes pre-assembled on the inserter and includes pre-packaged sterile, single-use instrumentation for primary insertion, graft passing, and cover plate insertion. A reusable set of instruments are included for disc preparation, trial sizing, and repositioning/removal.
This document, an FDA 510(k) clearance letter for the Kleiner KG2 System, does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The provided text is a summary of the device's substantial equivalence to predicate devices, focusing on regulatory compliance rather than a comprehensive performance study report.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, ground truth establishment, or expert details for any such test set.
- Information about multi-reader multi-case (MRMC) studies, standalone algorithm performance, or training set details.
The document primarily focuses on substantiating equivalence through general performance characteristics and adherence to industry standards, rather than detailing a specific clinical or AI-driven performance study.
However, based on Section 7, "Summary of Performance Data," some aspects related to device performance evaluation can be inferred.
Inferred Information from the Document:
While a formal "acceptance criteria" table is not present, the Summary of Performance Data implicitly states that the Kleiner KG2 System underwent various tests to demonstrate its performance and safety, thereby meeting the necessary regulatory requirements for substantial equivalence. The document indicates that by demonstrating equivalence in these tests to predicate devices, the Kleiner KG2 System meets the implied acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. Instead, it lists the types of tests conducted and generally states that the device demonstrated equivalent or stronger performance compared to predicate devices.
| Acceptance Criteria (Inferred from Standards & Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance (ASTM F2077 & ASTM F2267): | Confirmed equivalent performance to cited predicate device; implants are stronger compared to previously cleared devices. |
| - Static compression | Demonstrated satisfactory performance (implied by equivalence). |
| - Static compression-shear | Demonstrated satisfactory performance (implied by equivalence). |
| - Dynamic compression | Demonstrated satisfactory performance (implied by equivalence). |
| - Dynamic compression-shear | Demonstrated satisfactory performance (implied by equivalence). |
| - Subsidence | Demonstrated satisfactory performance (implied by equivalence). |
| Packaging Integrity (ISO 11607, parts 1 & 2): | Satisfactory packaging integrity for terminally sterilized medical devices. |
| Biocompatibility (ISO 10993-1): | Biocompatibility evaluated in accordance with FDA Guidance. (Implied |
to be satisfactory). |
| Sterilization (ISO 11137-1 & ISO 11137-2): | Sterilization testing conducted; reusable instruments conform to SAL 10-6 steam sterilization. (Implied to be satisfactory). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for mechanical testing or other non-clinical tests. It refers to established ASTM and ISO standards (e.g., ASTM F2077, ASTM F2267, ISO 11607, ISO 10993-1, ISO 11137) which typically detail the number of samples required for such tests.
Data provenance is implicitly from laboratory testing (e.g., mechanical, packaging, biocompatibility labs), likely conducted by or for the manufacturer. The document does not specify countries of origin, but the manufacturer is based in the Netherlands. These are prospective tests performed for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable in this context. The "ground truth" for mechanical and material performance is established by the specifications and methodologies within the cited ASTM and ISO standards, evaluated by qualified engineers and technicians performing the tests.
4. Adjudication Method for the Test Set:
Not applicable. This concept typically applies to clinical studies or assessments requiring human interpretation of data (e.g., image-based diagnosis). Performance under engineering standards is typically objective and measured directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This device is an intervertebral body fusion device (an implant), not a diagnostic device requiring human interpretation of medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the performance data mentioned:
- Mechanical Testing: Ground truth is defined by the objective physical measurements and failure modes specified in standards like ASTM F2077 and F2267, compared against predefined thresholds or performance of predicate devices.
- Biocompatibility: Ground truth is established by the cellular and tissue responses observed in standardized tests, evaluated against criteria from ISO 10993-1.
- Sterilization & Packaging: Ground truth is defined by the sterility assurance level (SAL) and packaging integrity requirements outlined in ISO 11607 and ISO 11137.
8. The Sample Size for the Training Set:
Not applicable, as this is an implantable medical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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September 14, 2021
Baat Medical Products BV Martjin Heikens Regulatory Affairs Manager F. Hazemeijerstraat 800, Building A04 Hengelo, Overijssel 7555RJ Netherlands
Re: K211474
Trade/Device Name: Kleiner KG2 System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 23, 2021 Received: August 26, 2021
Dear Martjin Heikens:
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.
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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 medical devices and radiation-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.
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
510(k) Number (if known) K211474
Device Name Kleiner KG2 System
Indications for Use (Describe)
The KG2 implant is indicated for transforaminal and posterior interbody fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The KG2 implant is used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The interbody fusion devices are intended to be used with FDA-cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for BAAT Medical. The logo features a stylized human figure inside a blue circle on the left. To the right of the figure is the text "BAAT" in a larger font size, with a line underneath it. Below "BAAT" is the word "MEDICAL" in a smaller font size.
5. Traditional 510(k) Summary
-
- Applicant/Submitter
| Submitter Name: | BAAT Medical Products BV |
|---|---|
| Submitter Address: | F. Hazemeijerstraat 800 - Building A047555 RJ HengeloThe Netherlands |
| Phone Number: | +31-(0)88-5656600 |
| Contact person: | Kelsey van Abbema |
| Date Prepared: | 08-SEPT-2021 |
| Device | |
| Device Trade name: | Kleiner KG2 System |
| Classification: | Intervertebral body fusion device (21 CFR 888.3080) |
Product Code: MAX
Review Panel: Orthopedic
4. Device Description
The Kleiner KG2 is a cage intended for lumbar intervertebral fusion (PLIF/TLIF approach). The design contains both solid and porous structures formed as a diamond mesh, and it contains a bone grafting hole. The cage is additively manufactured from titanium alloy. The KG2 cage may be used with coverplate.
The sterile Kleiner KG2 implant comes pre-assembled on the inserter and includes pre-packaged sterile, single-use instrumentation for primary insertion, graft passing, and cover plate insertion. A reusable set of instruments are included for disc preparation, trial sizing, and repositioning/removal.
5. Intended Use/Indication for Use Statement
The KG2 implant is indicated for transforaminal and posterior interbody fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1
BAAT MEDICAL Products BV F. Hazemeijerstraat 800 7555 RJ Hengelo The Netherlands
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Image /page/4/Picture/1 description: The image contains the logo for BAAT Medical. The logo consists of two parts: a circular graphic on the left and the text "BAAT MEDICAL" on the right. The circular graphic features a stylized human figure in white against a gradient blue background. The text "BAAT" is positioned above the word "MEDICAL", with a horizontal line separating the two.
spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The KG2 implant is used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The interbody fusion devices are intended to be used with FDA-cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.
6. Summary of Technological Characteristics of Device Compared to Predicate devices
- Intended Use: The Kleiner KG2 System and all the predicates have similar intended uses.
- Materials: The Kleiner KG2 System is fabricated from the same material as the predicate device
- . Design Features/Functions: The Kleiner KG2 System and cited predicate devices share similar basic design features and functions.
- . Dimensions: The Kleiner KG2 System is dimensionally similar to cited predicate devices.
- . Performance Specification: Mechanical testing confirmed the Kleiner KG2 System demonstrated equivalent performance to the cited predicate device.
7. Summary of Performance Data
- Mechanical testing was carried out as per ASTM F2077 and ASTM F2267: Static compression, ● static compression-shear, dynamic compression, dynamic compression-shear and subsidence.
- Packaging testing was carried out as per ISO 11607, parts 1 and 2 for terminallysterilized medical devices.
- Biocompatibility evaluation was conducted in accordance with FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
- Sterilization testing was conducted as per ISO 11137-1 and ISO11137-2.
- The reusable instruments are supplied non-sterile and are to be steam sterilized (to achieve SAL 10-6) by the end user according to a validated process.
8. Conclusion of Substantial Equivalence
The subject Kleiner KG2 System has the same intended use/indications for use, the same or similar technology, comparable principles of operation, same range of size parameters, and same materials as the identified predicate systems: Ossous Aries-TC and Aries-TS (K181347), Stryker (K2M) Mojave (K193203), and NuVasive MLX (K173025). The Kleiner KG2 System does not present any new issues of safety or effectiveness as compared to the predicate systems. Performance testing demonstrates the subject implants are as stronger compared to previously cleared devices with similar indications. Therefore, the Kleiner KG2 System is substantially equivalent to the identified predicate systems.
§ 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.