(156 days)
No
The description focuses on mechanical components and the process of distraction osteogenesis, with no mention of AI or ML technologies.
Yes
The device is described as being used for "bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction," which directly addresses and treats a medical condition.
No
This device is designed for bone stabilization and elongation through distraction osteogenesis to correct defects, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical, implantable components (footplates, drive screw, activation arm, SonicPins) and a physical activation driver, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The RxG Distraction System is an implantable surgical device. It is used inside the body to physically manipulate and lengthen bone.
- Intended Use: The intended use is for "bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction." This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a device used for surgical intervention and bone manipulation, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.
Product codes
PBJ
Device Description
The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of cranial bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 40 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.
The purpose of this Traditional 510(k) is to expand the indications for use of the RxG Distraction System to include cranial use in the pediatric and adult populations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial
Indicated Patient Age Range
pediatric and adult populations.
Intended User / Care Setting
Health Care Facilities/ Hospitals
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)
Nonclinical Testing:
Performance Bench: Comparative mechanical testing was performed between the RxG distractor and LactoSorb distractor to measure deformation and distraction distance. Acceptance Criteria: The RxG distractor should exhibit less deformation than the LactoSorb distractor. Devices were affixed to sawbone blocks to simulate an osteotomy, and then placed in a waterbath of Ringer's solution for the duration of testing. After the 48 hour latency period, distraction and consolidation were simulated over a period of 52 days. Deformation measurements were taken at regular intervals.
Final deformation was determined by measuring the distance between the two footplates of each distractor. The RxG Distraction System exhibited less deformation and achieved greater distraction distance than the LactoSorb distractor. The results of the testing showed substantial equivalence to the primary predicate.
Biocompatibility: Biocompatibility requirements were assessed in accordance with FDA Blue Book Memorandum #G95-1 “Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by FDA. The battery of testing included the following tests: Toxicology Cytotoxicity Chemical Analysis.
The RxG Distraction System patient-contacting materials Resorb xG, Ti-6Al-4V, and Stainless Steel used for the components in the subject device are previously cleared in K133304, have the same chemical composition, undergo the same manufacturing processes, have the same body contact, and are subjected to the same sterilization methods as the reference device. The results of the testing showed that the biocompatibility requirements have been met. No claim of "pyrogen free" is made.
Sterility: Bioburden, dose verification, and tests of sterility for the gamma sterilization process were validated in accordance with ISO 11137-1, -2, as well as ISO 11737-1, -2 to achieve an SAL of 10-6.
The subject device undergoes the same sterilization methods as the reference devices in K121606 and K133304. The results of the testing showed that the sterilization doses achieve an SAL of 10-6 for the devices.
Packaging & Shelf-Life: Validation of package integrity was performed in accordance with ISO 11607-1, -2. Real-time stability testing was performed for the Resorb xG implants in K121606.
The packaging & shelf-life for the subject device is identical to the reference device in K133304. The results of the testing showed that the packaging is suitable for the intended sterilization process and can maintain sterility during the intended shelf life period of 5 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
KLS-Martin L.P. Mr. Gary Moore Ouality MGT and Regulatory Affairs Manager 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K150771
Trade/Device Name: RxG Distraction System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: July 21, 2015 Received: July 24, 2015
Dear Mr. Moore:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -SFD/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150771
Device Name RxG Distraction System
Indications for Use (Describe)
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediations.
| Type of Use (Select one or both, as applicable) | Registration Use (Part 21 CFR 201 Subpart D) OTC System Use (Part 21 CFR 201 Subpart G) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------- |
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/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are smaller than the other letters.
P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartinnorthamerica.com
| | 510(k) Summary
21 CFR 807.92 |
|--------------------|-------------------------------------------------------------------------------------------------------------|
| Submitter: | KLS-MARTIN L.P.
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 |
| Contact Person: | Jennifer Damato
Director of Quality MGT & Regulatory Affairs
Phone: 800-625-1557
Fax: 904-641-7378 |
| Date Prepared: | August 19, 2015 |
| Trade Name: | RxG Distraction System |
| Common Name: | Cranial Distraction System |
| Classification: | Preformed nonalterable cranioplasty plate
Class II, 21 CFR 882.5330, Product Code PBJ |
| Primary Predicate: | LactoSorb Distraction (K002083) |
| Reference Devices: | RxG Distraction System (K133304)
Resorb-X G (K121606) |
Device Description:
The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of cranial bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 40 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.
The purpose of this Traditional 510(k) is to expand the indications for use of the RxG Distraction System to include cranial use in the pediatric and adult populations.
Indications for Use:
The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.
4
KLS martın LP.
P.O. Box 16369 • Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartinnorthamerica.com
Technological Characteristics / Substantial Equivalence:
| | RxG Distraction System
(Subject Device) | LactoSorb Distraction
(Primary Predicate – K002083) | RxG Distraction System
(Reference Device – K133304) | Resorb-X G
(Reference Device – K121606) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The RxG Distraction System includes
devices intended for use in bone
stabilization and elongation
(lengthening) in the correction of
congenital or developmental defects in
cranial reconstruction for the pediatric
and adult populations. | The Lorenz Resorbable Distraction System
includes devices intended for use in bone
stabilization and elongation (lengthening)
when correction of oral (alveolar ridge),
cranial, maxillofacial deficiencies or
post-traumatic defects require gradual bone
distraction. The Lorenz Resorbable Distraction
System also includes devices intended for use
in bone stabilization and elongation
(lengthening) when correction of mandibular
deficiencies or post-traumatic defects require
gradual bone distraction patients two (2) years
old or younger. The mid-face distractor is
intended primarily for LeFort III osteotomies. | The RxG Distraction System includes
devices intended for use in bone
stabilization and elongation
(lengthening) in the correction of
congenital or developmental defects of
the midface and alveolar ridge.
The RxG Distraction System also
includes devices intended for use in
bone stabilization and elongation
(lengthening) in the correction of
congenital or developmental defects of
the mandible in patients 2 years old or
younger.
The RxG Distraction System is not
intended for load-bearing applications
in adult or adolescent populations. | Resorb-X G is intended for use in
non-load bearing fracture repair and
reconstructive procedures in
adolescent and adult populations. In
addition, resorbable meshes, plates
and pins may be used in non-loading
bearing applications for maintaining
the relative position of, and/or
containing, bony fragments, bone
grafts (autograft or allograft), or bone
graft substitutes in cranial
reconstruction. |
| Contraindications | 1. Active infection
2. Foreign body sensitivity. Where
material sensitivity is suspected,
testing is to be completed prior to
implantation.
3. Patients with limited blood supply,
insufficient quantity or quality of
bone, or latent infection.
4. Patients or parents/guardians of
patients are unwilling or incapable
of following postoperative care
instructions.
5. Patients with bleeding disorders or
poor wound healing.
6. Patients with metabolic disorders. | 1. Active infection
2. Foreign body sensitivity. Where material
sensitivity is suspected, testing is to be
completed prior to implantation.
3. Patients with limited blood supply,
insufficient quantity or quality of bone,
or latent infection.
4. Patients, or parents/guardians of patients
are unwilling or incapable of following
postoperative care instructions.
5. Patients with bleeding disorders or poor
wound healing.
6. Patients with metabolic disorders. | 1. Active infection
2. Foreign body sensitivity | 1. High-load regions in the absence
of traditional rigid fixation
2. Active or latent infections
3. Patients in a bad general state of
health or suffering from
metabolic disorders |
| Target Population | Pediatrics and Adults | Pediatrics and Adults | Pediatrics and Adults | Pediatrics and Adults |
| Anatomical Sites | Cranial | Cranial, Oral, Mandibular, and Maxillofacial | Oral, Mandibular, and Maxillofacial | Cranial |
| | RxG Distraction System
(Subject Device) | LactoSorb Distraction
(Primary Predicate – K002083) | RxG Distraction System
(Reference Device- K133304) | Resorb-X G
(Reference Device – K121606) |
| Materials | | | | |
| Bone Plates | 85:15 PLLA-PGA | 82:18 PLLA-PGA | 85:15 PLLA-PGA | 85:15 PLLA-PGA |
| Bone
Pins/Screws | 85:15 PLLA-PGA | 82:18 PLLA-PGA | 85:15 PLLA-PGA | 85:15 PLLA-PGA |
| Drive Screw | TI-6AL-4V or Stainless Steel | Stainless Steel | TI-6AL-4V or Stainless Steel | N/A |
| Activation Arm | TI-6AL-4V or Stainless Steel | TI-6AL-4V , Stainless Steel | TI-6AL-4V or Stainless Steel | N/A |
| Sterility | Provided Sterile (Gamma
Radiation) | Provided Sterile (ETO) | Provided Sterile (Gamma
Radiation) | Provided Sterile (Gamma
Radiation) |
| Standards Met | See Section 9.0 | ASTM F136, ASTM F138 | Same as current submission | ISO 10993-1, -5, -12, -18
ISO 11137-1, -2, 11737-1, -2 |
| Where used (hospital, home,
ambulance, etc) | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals | Health Care Facilities/ Hospitals |
| Breakdown Products
(Plates, Pins/Screws) | H2O and CO2 | H2O and CO2 | H2O and CO2 | H2O and CO2 |
| Resorption Time | 12 - 14 months | 12 months | 12 - 14 months | 12 - 14 months |
| Max. Distraction Distance | | | | |
| Cranial
Distractor | 40 mm | 40 mm | N/A | N/A |
| Alveolar Ridge
Distractor | N/A | 25 mm | 25 mm | N/A |
| Midface
Distractor | N/A | 40 mm | 30 mm | N/A |
| Mandibular
Distractor | N/A | 25 mm | 30 mm | N/A |
| Plate Thickness | 2 - 5 mm | 2 - 5 mm | 2 - 5 mm | 0.3 - 1.0 mm |
| Cumulative Max. Plate
Volume | 7840 mm3 | Unknown | 7840 mm3 | 15876 mm3 |
| Pin/Screw Diameter | 1.6 mm or 2.1 mm | 1.5 – 2.5 mm | 2.1 mm | 1.6 mm or 2.1 mm |
| Pin/Screw Length | 3 - 9 mm | 6 - 9 mm | 3 - 7 mm | 3 - 7 mm |
5
kıs martın L.P.
P.O. Box 16369 • Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 ● Fax 904-641-7378 www.klsmartinnorthamerica.com
Technological Characteristics / Substantial Equivalence, Continued:
6
Image /page/6/Picture/0 description: The image shows the logo for KLS Martin L.P. The text "KLS" is in red, while the text "martin" is in gray. The text "L.P." is in black and is smaller than the other text. The logo is simple and modern.
Nonclinical Testing:
Nonclinical testing to support substantial equivalence of the RxG Distraction System is summarized in the following table:
| Test | Summary | Results |
|---|---|---|
| Performance Bench | Comparative mechanical testing was performed between the RxG distractor and LactoSorb distractor to measure deformation and distraction distance. Acceptance Criteria: The RxG distractor should exhibit less deformation than the LactoSorb distractor. Devices were affixed to sawbone blocks to simulate an osteotomy, and then placed in a waterbath of Ringer's solution for the duration of testing. After the 48 hour latency period, distraction and consolidation were simulated over a period of 52 days. Deformation measurements were taken at regular intervals. | Final deformation was determined by measuring the distance between the two footplates of each distractor. The RxG Distraction System exhibited less deformation and achieved greater distraction distance than the LactoSorb distractor. |
The results of the testing showed substantial equivalence to the primary predicate. |
| Biocompatibility | Biocompatibility requirements were assessed in accordance with FDA Blue Book Memorandum #G95-1 “Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by FDA. The battery of testing included the following tests:
Toxicology Cytotoxicity Chemical Analysis | The RxG Distraction System patient-contacting materials Resorb xG, Ti-6Al-4V, and Stainless Steel used for the components in the subject device are previously cleared in K133304, have the same chemical composition, undergo the same manufacturing processes, have the same body contact, and are subjected to the same sterilization methods as the reference device.
The results of the testing showed that the biocompatibility requirements have been met. No claim of "pyrogen free" is made. |
| Sterility | Bioburden, dose verification, and tests of sterility for the gamma sterilization process were validated in accordance with ISO 11137-1, -2, as well as ISO 11737-1, -2 to achieve an SAL of 10-6. | The subject device undergoes the same sterilization methods as the reference devices in K121606 and K133304.
The results of the testing showed that the sterilization doses achieve an SAL of 10-6 for the devices. |
| Packaging & Shelf-Life | Validation of package integrity was performed in accordance with ISO 11607-1, -2. Real-time stability testing was performed for the Resorb xG implants in K121606. | The packaging & shelf-life for the subject device is identical to the reference device in K133304.
The results of the testing showed that the packaging is suitable for the intended sterilization process and can maintain sterility during the intended shelf life period of 5 years. |
Clinical Testing:
Clinical testing was not necessary for the determination of substantial equivalence.
Conclusions:
The RxG Distraction System has the same intended use as the primary predicate, the LactoSorb Distractor (K002083). In addition, the subject device has the same technological characteristics as the RxG Distraction System (K133304) and Resorb-X G (K121606) reference devices. The nonclinical testing results and similarities in technological characteristics do not raise new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate devices.