(122 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of a surgical implant, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the treatment of Pectus Excavatum and other sternal deformities, which are medical conditions, and it aims to reposition bony structures to correct these deformities, thereby achieving a therapeutic effect.
No
The device description clearly states it is a surgical implant intended to aid in the treatment of Pectus Excavatum by applying internal force to reposition bony structures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the Pectus Blu Support Bar and Stabilizers are surgical implants made of titanium alloy, which are hardware components.
Based on the provided information, the Pectus Blu system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of Pectus Excavatum and other sternal deformities by surgically implanting a support bar and stabilizers to reposition bony structures. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a surgical implant made of titanium alloy. It is used in vivo (inside the body) to physically correct a structural deformity. IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
Therefore, the Pectus Blu system falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
Product codes
HRS
Device Description
The Biomet Microfixation Pectus Blu Support Bar and Stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years, but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.
The Pectus Blu Support Bar and Stabilizers are made of titanium alloy (ASTM F136) and provided nonsterile for sterilization by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rib cage across the sternum, sternum, breastbone
Indicated Patient Age Range
pediatric (children and adolescents) and adult populations
Intended User / Care Setting
professional healthcare facilities
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)
Mechanical testing was performed according to ASTM F382-17 and all tests confirmed that the product met the predetermined acceptance criteria. MR compatibility testing was performed in compliance with the following standards: ASTM F2052-15, ASTM F2213-17, ASTM F2182-19, and ASTM F2119-07. The results of the testing showed the devices are MR Conditional, which is reflected in the product labeling. Biological safety risk assessments in compliance with ISO 10993-1:2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use. Clinical data was not required for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
January 7, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
Biomet Micofixation % Danielle Besal Principal Consultant MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, Colorado 80112
Re: K212841
Trade/Device Name: Pectus Blu Support Bar System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: December 1, 2021 Received: December 2, 2021
Dear Danielle Besal:
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.
Shumaya Ali, MPH Assistant Director DHT6B: Division of Restorative, Repair and Trauma 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) K212841
Device Name Pectus Blu Support Bar System
Indications for Use (Describe)
The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Pectus Blu Support Bar System December 1, 2021
| Company: | Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 |
|--------------------|-------------------------------------------------------------------------------------------------|
| Primary Contact: | Danielle Besal
Danielle.Besal@askmrcglobal.com
Phone: (901) 827-8670 |
| Company Contact: | Mark Wladkowski
mark.wladkowski@zimmerbiomet.com
Phone: (904) 362-3940 |
| Trade Name: | Pectus Blu Support Bar System |
| Common Name: | Plate, Fixation, Bone |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3030: Single/multiple component metallic bone fixation
appliances and accessories |
| Panel: | 87- Orthopedic |
| Product Code: | HRS: Plate, Fixation, Bone |
Device Description:
The Biomet Microfixation Pectus Blu Support Bar and Stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years, but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.
The Pectus Blu Support Bar and Stabilizers are made of titanium alloy (ASTM F136) and provided nonsterile for sterilization by the end user.
Indications for Use:
The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
Predicate Device:
K061384: Biomet Microfixation Lorenz Pectus Support Bar System
The similarities of the subject devices to the predicate devices are as follows:
- Intended use
- Support bar geometry and sizing .
- Materials of construction
- Sterilization method ●
The differences of the subject devices compared to the predicate devices are as follows:
- o Modified design of stabilizer that eliminates the need for wiring
4
- MR conditional labeling ●
Performance Testing:
Mechanical testing was performed according to ASTM F382-17 and all tests confirmed that the product met the predetermined acceptance criteria. MR compatibility testing was performed in compliance with the following standards: ASTM F2052-15, ASTM F2213-17, ASTM F2182-19, and ASTM F2119-07. The results of the testing showed the devices are MR Conditional, which is reflected in the product labeling. Biological safety risk assessments in compliance with ISO 10993-1:2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use. Clinical data was not required for the determination of substantial equivalence.
Substantial Equivalence:
The subject devices are substantially equivalent to the predicate Lorenz Pectus Support Bar System (K061384). The subject components are similar in indications, sizing and geometry, technological characteristics, and materials to the predicates as described in this premarket notification. Any differences in technological characteristics between the subject and predicate devices do not raise any new questions of safety and effectiveness and the subject device is at least as safe and effective as the predicate. It is concluded that the information in this 510(k) supports substantial equivalence of the devices.