(299 days)
The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congental deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.
The KLS Martin CranioXpand Spring System consists of implantable spring distractors and supporting instruments intended for temporary stabilization and distraction of the bony cranial roof during and after surgery through distraction osteogenesis. The CranioXpand Springs are offered in various sizes. The spring features include rounded atraumatic contours to ensure optimal embedding in soft tissue with curved ends to ensure the devices can securely anchor in the bone. Two springs are provided as part of the CranioXpand system for anterior and posterior placement on the osteotomies. The springs are removed after adequate bone formation or after the bone consolidation phase is complete. These devices are typically left in the implanted location for 3 - 6 months before explantation. The CranioXpand Instruments are accessories used to facilitate spring size selection, and spring insertion and positioning.
The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the KLS-Martin L.P. CranioXpand device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets clinical performance acceptance criteria through the types of studies you've queried (e.g., MRMC studies, standalone AI performance, expert ground truth adjudication).
The CranioXpand device is a physical implant (spring system) used for cranial conditions in pediatric patients, not an AI or software-based diagnostic tool. Therefore, the types of studies and acceptance criteria you've asked about, which are common for AI-driven image analysis or diagnostic devices, are not applicable to the information contained within this 510(k) submission.
The "studies" conducted for this device are non-clinical performance bench testing and biocompatibility testing, designed to show that the CranioXpand is as safe and effective as its predicate device.
However, I can extract the information relevant to their acceptance criteria and performance studies for this type of medical device:
Here's a breakdown based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CranioXpand device, as reported in this 510(k), are focused on bench testing to demonstrate performance equivalence to the predicate device and biocompatibility.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2018 for long-term implants in contact with tissue/bone for the springs, and external communicating devices with limited contact for the instruments, covering endpoints such as cytotoxicity, sensitization, irritation, pyrogenicity, carcinogenicity, implantation, acute/subacute/subchronic/chronic toxicity. | The CranioXpand device and accessories were evaluated per FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Process" and found to comply with the requirements of ISO 10993-1:2018 thus are considered biocompatible. |
| Spring Testing (Performance Bench Test) | Force measurements during cyclical testing (compressing to 10mm, holding 5s, decompressing, repeated 6 times) must show performance comparable to the predicate device. The exact quantitative criteria for "comparable" are not explicitly stated, but the conclusion is a "Pass." | "A comparison of the performance of the subject and predicate springs via force measurements during cyclical testing was conducted... The acceptance criteria of the test were met, thus demonstrating that the performance of the subject device is substantially equivalent to that of the predicate device." Concluded: Pass |
| Insertion Instruments Testing | Instrument must appropriately open, close, and pick up the spring. Measurements to verify the instrument could compress spring legs sufficiently (<17mm). | "A visual and holding inspection was performed of whether the instrument could appropriately open, close, and pick up the spring. Measurements were conducted to verify that the instrument could compress the spring legs sufficiently (<17mm)." Concluded: Pass |
| Selection Instrument Testing (Static) | Force output via static testing (load applied until 15mm distance between legs, held 5s, unloaded). The specific values of the force output for acceptance are not provided, but the test passed. | "The force output of the selection instrument via static testing was determined by recording the force while first applying a load on the instrument (1.0mm/s until distance between legs is 15mm), holding the position (5 seconds), then unloading the instrument (same speed)." Concluded: Pass |
| Selection Instrument Testing (Dynamic) | Withstand 1000 load cycles at continuous load (load applied at 0.5mm/s to 45mm, held 1s, unloaded, repeated 1000 times). | "Verification of whether the selection instrument could withstand 1000 load cycles at continuous load via dynamic testing was determined by recording the force while repeating the following steps until 1000 cycles are reached: first applying a load on the instrument (45mm at test speed of 0.5mm/s), holding the position, (1 second) then unloading the instrument (same speed)." Concluded: Pass |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for the bench testing beyond implying "samples" of the subject and predicate springs and instruments were tested. For such physical device testing, sample sizes are typically determined by engineering standards and statistical confidence levels relevant to manufacturing variability, rather than patient-based data.
- Data Provenance: The data provenance is from non-clinical laboratory bench testing of the physical devices (springs and instruments). This is not patient data, nor is there any mention of country of origin for such data, as it's likely conducted internally or by contract labs. It is inherently prospective in the sense that the tests are designed and performed to demonstrate specific performance characteristics.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This FDA submission is for a physical medical device (implant) and its instruments, not an AI or diagnostic software. Therefore, there is no "ground truth" derived from expert image interpretation or clinical diagnosis in the context of the requested AI-related study types. The "ground truth" for these tests is the physical measurement of force, distance, and visual inspection by testing personnel, adhering to established engineering and quality control standards.
4. Adjudication Method for the Test Set
- Not applicable. As there are no human expert interpretations of data (like images) that require adjudication for ground truth establishment.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not conducted as this is a physical implant, not a diagnostic or image-reading AI device. The comparison here is between the subject device's physical performance and the physical performance of a predicate device, as demonstrated through bench testing.
6. Standalone (Algorithm Only) Performance
- Not applicable. There is no algorithm or software for "standalone" performance to be evaluated.
7. Type of Ground Truth Used
- Physical Measurement and Engineering Specifications: The "ground truth" in this context refers to the expected physical properties and performance characteristics of the device (e.g., force specifications, dimensions, functional operation). This is established through engineering design, material specifications, and the performance characteristics of the legally marketed predicate device.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning algorithms. Design and manufacturing processes are iteratively refined, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI model.
In summary: The provided 510(k) document is for a physical medical implant (CranioXpand) and demonstrates substantial equivalence through biocompatibility testing and engineering bench tests comparing its physical performance to a predicate device. It does not involve AI, image analysis, or clinical studies characteristic of AI-driven diagnostic devices where concepts like MRMC studies, expert ground truth, and training/test sets are relevant.
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November 21, 2023
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KLS-Martin L.P. Daphne Vincent Regulatory Affairs Project Manager 11201 Saint Johns Industrial Parkway S Jacksonville. Florida 32246
Re: K230211
Trade/Device Name: CranioXpand Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: October 24, 2023 Received: October 24, 2023
Dear Daphne Vincent:
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" (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).
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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.
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 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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2023.11.21, and the time is 14:31:43 -05'00'.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices
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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) K230211
Device Name CranioXpand
Indications for Use (Describe)
The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congental deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.
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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510(k) Summary
| Submitter: | KLS-Martin L.P.11201 Saint Johns Industrial Pkwy S.Jacksonville, FL 32246 |
|---|---|
| Primary Contact: | Daphne VincentRegulatory Affairs Project ManagerPhone: 800-625-1557Email: daphne.vincent@klsmartin.com |
| Alternate Contact: | Melissa BachorskiDirector of RA/QMS North AmericaPhone: 800-625-1557Email: RA_ProjectMgr@klsmartin.com |
| Date Prepared: | November 21, 2023 |
| Trade Name: | CranioXpand |
| Classification Name: | Cranial Distraction System |
| Regulation Description: | Preformed non-alterable cranioplasty plate |
| Regulation Numbers: | 882.5330 |
| Product Code: | PBJ |
| Predicate Device: | OsteoMed SmartFlex Cranial Spring Distraction System[K123885] |
| Classification Name: | Cranial Distraction System |
| Regulation Description: | Preformed non-alterable cranioplasty plate |
| Regulation Numbers: | 882.5330 |
| Product Code: | PBJ |
Device Description Summary:
The KLS Martin CranioXpand Spring System consists of implantable spring distractors and supporting instruments intended for temporary stabilization and distraction of the bony cranial roof during and after surgery through distraction osteogenesis. The CranioXpand Springs are offered in various sizes. The spring features include rounded atraumatic contours to ensure optimal embedding in soft tissue with curved ends to ensure the devices can
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securely anchor in the bone. Two springs are provided as part of the CranioXpand system for anterior and posterior placement on the osteotomies. The springs are removed after adequate bone formation or after the bone consolidation phase is complete. These devices are typically left in the implanted location for 3 - 6 months before explantation.
The CranioXpand Instruments are accessories used to facilitate spring size selection, and spring insertion and positioning.
| ModelNumber | Device Size | Device Information |
|---|---|---|
| 25-025-10-71 | CranioXpand Spring (1.0 mm) | 1.0 mm Wire Thickness;No Marking on Spring |
| 25-025-12-71 | CranioXpand Spring (1.2 mm) | 1.2 mm wire thickness;Two rings laser marked on spring |
| 25-025-16-71 | CranioXpand Spring (1.6mm) | 1.6 mm wire thickness;Six rings laser marked on spring |
The CranioXpand device is offered in the following models:
The different models of the CranioXpand device are the same except for difference in wire thickness and the marking on the spring indicating wire thickness.
This submission includes the following accessories:
| ModelNumber | Accessory Name | Intended Use |
|---|---|---|
| 25-025-52-07 | Spring Selection Instrument | Used to facilitate spring size selection |
| 25-025-42-07 | Forward Opening InsertionInstrument | Used to aid with implantation andpositioning of anterior spring |
| 25-25-43-07 | Backward Opening InsertionInstrument | Used to aid with implantation andpositioning of posterior spring |
Indications for Use:
The KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days to < 2 years of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization and distraction of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.
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Indications for Use Comparison:
The intended use and indications of use of the subject device and the predicate device are the same. Both devices are indicated for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. Both devices are intended to provide temporary stabilization and gradual lengthening in the cranium and are intended to be removed after consolidation.
The only minute difference is that the predicate device is meant for use in cranial bones, whereas the subject device is meant for use in the bony cranial roof. This is not a cause for concern as the area indicated by the subject device is a subset of the area indicated by the predicate device.
Technological Comparison
The subject and the predicate devices share similar technological characteristics. The similarities and differences are detailed below. Any differences in technological features between the subject and predicate devices do not raise new or different questions of safety and effectiveness.
● Similarities to Predicate Device:
The technological characteristics and operational principle for the subject device and predicate device are the same. In both, the technological characteristics of a spring distractor is utilized to achieve the operational principle of distraction osteogenesis. The design of both devices is similar. Both devices have a design utilizing a spring mechanism anchored by feet and are accompanied by instruments aiding with spring implantation and spring removal. The material, the target population, and sterilization method for both devices are the same. Both are manufactured using implant grade stainless steel (316 LVM (1.4441) according to ASTM F138). The target population for both is the infant pediatric subpopulation. The sterilization method for both springs is gamma sterilization whereas the instruments are offered non-sterile.
- Differences from Predicate Device:
Although both devices have similar designs, there are slight differences. The subject device consists of a V shaped springs with a center helix whereas the predicate device consists of a U shaped design with no center helix. The predicate device variants are distinguished by force, while the subject device variants are distinguished by diameter. The differences in the springs of the subject and predicate devices are addressed with performance data.
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| Specification/Characterization | CranioXpand[K230211] | OsteoMed SmartFlex CranialSpring Distraction System[K123885] | Comment |
|---|---|---|---|
| Indications forUse | The KLS MartinCranioXpand Spring systemis indicated for use in thetreatment of cranialconditions such ascraniosynostosis andcongenital deficiencies inwhich osteotomies andgradual bone distraction areindicated for the infantpediatric subpopulation (29days to < 2 years of age).The CranioXpand implantsare implantable single-useproducts intended fortemporary stabilization anddistraction of the bonycranial roof during and aftersurgery. This device isintended to be removed afterbone consolidation. | The OsteoMed SmartFlex CranialSpring Distraction System isintended for use in the treatment ofcranial conditions such assyndromic craniosynostosis andcongenital deficiencies in whichosteotomies and gradual bonedistraction are indicated. Thisdevice is intended to providetemporary stabilization and graduallengthening of the cranial bones.This device is intended to beremoved after consolidation.The OsteoMed SmartFlex cranialspring distraction system isintended for single patient use only.Target population:pediatrics; sub-population - infantgreater than 1 month to 2 years ofage | Similar |
| IntendedPopulation | Infant | Infant | Same |
| Anatomical Site | Cranium | Cranium | Same |
| Function | Distraction of cranial bones | Distraction of cranial bones | Same |
| TechnologicalCharacteristics | Spring Distractor | Spring Distractor | Same |
| Design | Distraction via spring forcesand anchored by hooks offeet | Distraction via spring forces andanchored by hooks of feet | Same |
| Configuration | V shaped springs with acenter helix | U shaped design with no center helix | Different |
| Device Material | Stainless Steel (316 LVM(1.4441) according to ASTMF-138) | Stainless Steel (316 SS LVMaccording to ASTM F-138) | Similar |
| Sterility | Provided Sterile (GammaRadiation) | Provided Sterile (Gamma Radiation) | Same |
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Summary of Non-Clinical Performance Testing
Biocompatibility Testing:
The CranioXpand device is categorized as a long term implant in contact with tissue/bone (>30 days) in accordance with Attachment A of the FDA biocompatibility guidance and was evaluated for the following biocompatibility endpoints: cytotoxicity, sensitization, irritation or intracutaneous reactivity, material mediated pyrogenicity, carcinogenicity, implantation, acute systemic toxicity, and subacute, subchronic and chronic toxicity.
The Spring Selection Instrument, Insertion Instrument Forward Opening and Insertion Instrument Backward Opening accessories are categorized as external communicating devices with limited contact (≤ 24 h) in accordance with Attachment A of the FDA biocompatibility guidance and were evaluated for the following biocompatibility endpoints: cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity and materialmediated pyrogenicity.
The CranioXpand device and accessories were evaluated per FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Process" and found to comply with the requirements of ISO 10993-1:2018 thus are considered biocompatible.
Performance Bench Testing:
The performance of the subject and predicate springs was analyzed via bench testing measuring force elicited during cyclical testing. The acceptance criteria of the test were met, thus demonstrating that the performance of the subject device is substantially equivalent to that of the predicate device. Additionally, performance testing was conducted on the insertion instrument and selection instruments.
The following performance tests were completed for the CranioXpand device and accessories:
| Test Name | Method | Conclusion |
|---|---|---|
| SpringTesting | A comparison of the performance of the subject and predicate springs via force measurements during cyclical testing was conducted by recording the force while repeating the following cycle 6 times: first compressing the spring (until distance between arms was 10mm), holding the compression (5 seconds), then decompressing the spring. | Pass |
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| Test Name | Method | Conclusion |
|---|---|---|
| InsertionInstrumentsTesting | A visual and holding inspection was performed of whetherthe instrument could appropriately open, close, and pick upthe spring.Measurements were conducted to verify that the instrumentcould compress the spring legs sufficiently (<17mm). | Pass |
| SelectionInstrumentTesting | The force output of the selection instrument via static testingwas determined by recording the force while first applying aload on the instrument (1.0mm/s until distance between legsis 15mm), holding the position (5 seconds), then unloadingthe instrument (same speed).Verification of whether the selection instrument couldwithstand 1000 load cycles at continuous load via dynamictesting was determined by recording the force whilerepeating the following steps until 1000 cycles are reached:first applying a load on the instrument (45mm at test speed of0.5mm/s), holding the position, (1 second) then unloading the instrument (same speed). | Pass |
Conclusion
CranioXpand has the same intended use and similar technological characteristics to the predicate device. The differences in technological features between the subject and predicate devices do not raise new or different questions of safety and effectiveness as supported by the performance testing. Therefore, the CranioXpand is substantially equivalent to the predicate device.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).