(90 days)
Not Found
No
The description focuses on patient-specific guides designed from CT scans and surgeon prescriptions, manufactured using a validated process. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "surgical instrument" and "bone resection guides" intended to assist in pre-operative planning and guide surgical instruments for osteotomies, which are surgical procedures, not therapeutic actions.
No
The device is described as a "surgical instrument" and "bone resection guides" intended to assist in pre-operative planning and guiding surgical procedures, not to diagnose a medical condition.
No
The device description explicitly states the system includes single-use, patient-specific bone resection guides which are additively manufactured with titanium alloy, indicating a significant hardware component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's a "surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments." This describes a device used during a surgical procedure, not a device used to examine specimens outside the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on patient-specific bone resection guides and surgical instruments used to facilitate surgery. It describes a physical tool used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are typically used in a laboratory setting or at the point of care to analyze samples and provide information about a patient's health status. This device is a surgical tool used to guide procedures based on pre-operative imaging.
N/A
Intended Use / Indications for Use
The Better Bunion System is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only.
Product codes
PBF
Device Description
The RedPoint Medical Better Bunion system includes single use, patient specific bone resection guides designed from DICOM files from a patients' CT scans and a surgeon's prescription. The Better Bunion system includes single use and reusable instruments to facilitate surgery. The Better Bunion patient specific bone resection guides assist the surgeon in cutting bone in the foot and ankle according to the pre-surgical plan. The quides are individually manufactured for each patient using a validated design and manufacturing process with strict procedures for transfer and conversion of patient images from DICOM files to digital models (STL files), and in turn to patient specific bone resection guides that are additively manufactured with titanium alloy conforming to ASTM F3001. The bone cutting guides are single use devices and provided clean, not sterile to the end user.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM files from a patients' CT scans
Anatomical Site
foot and ankle
Indicated Patient Age Range
adult and pediatric patients 12 years of age and older.
Intended User / Care Setting
Not Found
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)
- Verification of fit and usability of the Better Bunion patient specific cutting guides for the Lapidus procedure, and Akin, Calcaneal, and Met-Traverse Metadductus osteotomies.
- Simulated surgeries for correction of hallux valqus deformities demonstrated the Better Bunion guides to provide a final average intermetatarsal (IM) angle of +/-2 degrees relative to plan, an IM angle of
§ 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
June 9, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Redpoint Medical, LLC % Robert Poggie President BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'lle-Perrot, QC J7V7P2 Canada
Re: K220717
Trade/Device Name: RedPoint Medical's Better Bunion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF Dated: March 9, 2022 Received: March 11, 2022
Dear Robert Poggie:
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.
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
1
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 (OS) 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 mediation-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: Shumaya Ali, M.P.H. Assistant Director DHT6C: 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
2
Indications for Use
510(k) Number (if known) K220717
Device Name
Better Bunion System
Indications for Use (Describe)
The Better Bunion System is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only.
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) |
|---|---|
| ------------------------------------------------ | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY - K220717, The Better Bunion System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the Better Bunion System.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, |
| Notre-Dame-De-L'Ile-Perrot, QC, J7V 7P2, CANADA | |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (514) 901-0796 |
| Fax Number: | (514) 901-0796 |
| Date of Submission: | March 9, 2022 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | RedPoint Medical, LLC |
|---|---|
| Manufacturer Address: | 13326 West Road, Carmel, Indiana, 46074, USA |
| Registration Number: | 10084570 |
| Contact Name: | James Spitler |
| Title: | Chief Technology Officer |
| Device Trade Name: | Better Bunion System |
| Common Name: | Patient specific orthopedic guides |
| Classification Name: | Orthopaedic surgical planning and instruments guide |
| Classification Code: | PBF |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR 888.3030. |
C1. PRIMARY PREDICATE DEVICE
Materialise Surgicase Guides
C2. PREDICATE DEVICE
K211244 3D System's VSP Orthopedics System
4
D. DEVICE DESCRIPTION
The RedPoint Medical Better Bunion system includes single use, patient specific bone resection guides designed from DICOM files from a patients' CT scans and a surgeon's prescription. The Better Bunion system includes single use and reusable instruments to facilitate surgery. The Better Bunion patient specific bone resection guides assist the surgeon in cutting bone in the foot and ankle according to the pre-surgical plan. The quides are individually manufactured for each patient using a validated design and manufacturing process with strict procedures for transfer and conversion of patient images from DICOM files to digital models (STL files), and in turn to patient specific bone resection guides that are additively manufactured with titanium alloy conforming to ASTM F3001. The bone cutting guides are single use devices and provided clean, not sterile to the end user.
E. INTENDED USE
The Better Bunion System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Better Bunion System patient specific bone resection guides have similar intended use and technological characteristics as the predicate devices, with focus on foot and ankle procedures including osteotomies of the first metatarsal for correction of hallux valgus deformities. The following points compare the similarities and differences of technological features of the subject and predicate devices.
- The indications for use for the subject device and predicate devices are similar in aiding surgeons in planning and executing patient specific, non-acute, non-joint replacing bone resections of the lower extremities. The primary differences in indications for use are the subject device is intended for osteotomy procedures in the foot and ankle while the predicate devices are generally indicated in upper and lower extremities, and for planning and performing osteotomies about the knee.
- The designs of the patient specific guides for the subject and predicate devices are based on a patient´s images and surgeon´s prescription. The design of the subject bone resection guides is limited to DICOM images from the patients CT scans.
- The subject and predicate devices use validated software for conversion of imaging data to digital models of the bones that can be used to design and manufacture patient specific instruments for guiding the resection of bone.
- The subject and predicate devices include patient specific cutting guides to aid in surgical procedures. The cutting guides of the predicate devices are made from
5
additively manufactured Nylon-12, while the subject device is made from additively manufactured titanium alloy conforming to ASTM F3001.
- · The accuracy of the predicate and subject cutting quides were validated in simulated surgical studies.
- · The subject and predicate device cutting quides are provided clean, not sterile to the end-user.
- The subject and primary predicate devices include pediatric use. The subject device is indicated for pediatric patients greater than 12 years of age that may not be fully grown; the primary predicate devices is indicated for patients 7 years of age and older. For both the subject and primary predicate devices, the physician must consider the patient pathology evolution between CT scan date and the surgery date to validate the imaging data prior to surgery. If the patient's anatomy changed since the date of imaging, the patient specific cutting guides should not be used.
G. PERFORMANCE DATA
The following summarizes performance testing and verification activities for the Better Bunion system.
- Verification of fit and usability of the Better Bunion patient specific cutting guides for the Lapidus procedure, and Akin, Calcaneal, and Met-Traverse Metadductus osteotomies.
- Simulated surgeries for correction of hallux valqus deformities demonstrated the Better Bunion guides to provide a final average intermetatarsal (IM) angle of ±2º relative to plan, an IM angle of