(299 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical instruments, with no mention of AI/ML algorithms or data processing.
Yes
The device is used to treat cranial conditions like craniosynostosis by gradually distracting bone, which is a therapeutic intervention.
No
The device is described as an implantable spring system used for temporary stabilization and distraction of the bony cranial roof during and after surgery, specifically for treating conditions like craniosynostosis. Its function is to facilitate bone formation through distraction osteogenesis, not to diagnose a condition.
No
The device description explicitly states the system consists of "implantable spring distractors and supporting instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The KLS Martin CranioXpand Spring System is an implantable surgical device used to physically distract and stabilize bone in the skull. It is used in vivo (within the body) during and after surgery.
- Intended Use: The intended use clearly states it's for the treatment of cranial conditions through osteotomies and gradual bone distraction. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PBJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium
Indicated Patient Age Range
infant pediatric subpopulation (29 days to 30 days) 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) 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.
- Spring Testing: 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. Conclusion: Pass.
- Insertion Instruments Testing: 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 (
§ 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).
0
November 21, 2023
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 the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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).
1
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
510(k) Summary
| Submitter: | KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy S.
Jacksonville, FL 32246 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Daphne Vincent
Regulatory Affairs Project Manager
Phone: 800-625-1557
Email: daphne.vincent@klsmartin.com |
| Alternate Contact: | Melissa Bachorski
Director of RA/QMS North America
Phone: 800-625-1557
Email: 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
5
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.
| Model
| Number | 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:
| Model
| Number | Accessory Name | Intended Use |
|---|---|---|
| 25-025-52-07 | Spring Selection Instrument | Used to facilitate spring size selection |
| 25-025-42-07 | Forward Opening Insertion | |
| Instrument | Used to aid with implantation and | |
| positioning of anterior spring | ||
| 25-25-43-07 | Backward Opening Insertion | |
| Instrument | Used to aid with implantation and | |
| positioning 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 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.
7
| Specification/
Characterization | CranioXpand
[K230211] | OsteoMed SmartFlex Cranial
Spring Distraction System
[K123885] | Comment |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 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 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 |
|---|---|---|
| Spring | ||
| Testing | 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 |
9
| Test Name | Method | Conclusion |
|---|---|---|
| Insertion | ||
| Instruments | ||
| Testing | 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 (