(449 days)
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No
The 510(k) summary describes a mechanical implant system for bone fixation and reconstruction. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or performance studies.
No
The device is described as an implant system for fracture fixation and reconstruction procedures of bones, which is a structural support device rather than a therapeutic one that delivers treatment to patients.
No
Explanation: The device is a system for fracture fixation and reconstruction, specifically for surgical procedures in the foot and ankle. It is an implantable device and instruments used during surgery, not a device that diagnoses conditions.
No
The device description explicitly states that the BESPA Charcot System consists of implants and system-specific instruments, which are physical hardware components made of titanium alloy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- BESPA Charcot System Function: The BESPA Charcot System is a surgical implant system used for fracture fixation, reconstruction, arthrodesis, and osteotomies of bones in the foot and ankle. It is a physical device implanted into the body to provide structural support and stability.
- Lack of Specimen Analysis: The device description and intended use clearly indicate that it does not involve the analysis of any biological specimens.
Therefore, based on the provided information, the BESPA Charcot System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BESPA Charcot System is indicated for fracture fixation, reconstruction procedures, arthrodesis, and osteotomies of various bones and bone fragments in the foot and ankle, including metatarsals and tarsals. For example, medial and/or lateral column fusion as a result of neuropathic osteoarthropathy (Charcot). The BEPSA Charcot System is intended for use in adult populations. The device is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The BESPA Charcot System is offered non-sterile and consists of implants and system-specific instruments.
The Segmental Column is composed of various modular cylindrical components which screw together to create an implant assembly of the surgeon's desired features. The system contains transverse screws of various lengths. The implant construct has a compression capability.
All implants are made of titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
foot and ankle, including metatarsals and tarsals.
Indicated Patient Age Range
adult populations
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
There are no clinical data generated and held by the manufacturer, i.e., no premarketing or post-market clinical studies or animal studies have been performed.
Biocompatibility: The biological evaluation was assessed for potential effects according to ISO 10993-1. Implants are made of Ti-6AI-4V ELI conforming to ASTM standard F136. Evaluation was based on raw material data, biocompatibility testing according to ISO 10993 standards, and published literature. Results show high demonstrable biological safety.
Mechanical Testing: Testing was performed to demonstrate equivalence to other cleared fixation devices and bone screws, or to meet physiologically relevant acceptance criteria, according to ASTM F1264, ASTM F543, and ASTM F384.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
November 9, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font. The logo is simple and professional, and it is easily recognizable.
Bespa Global, LLC % Katelyn Jessup Regulatory & Quality Specialist Kapstone Medical, LLC 520 Elliot St. Charlotte, North Carolina 28202
Re: K202326
Trade/Device Name: BESPA Charcot System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 7, 2021 Received: October 8, 2021
Dear Katelyn Jessup:
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.
1
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, 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
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Indications for Use
510(k) Number (if known) K202326
Device Name BESPA Charcot System
Indications for Use (Describe)
The The BESPA Charcot System is indicated for fracture fixation, reconstruction procedures, and osteotomies of various bones and bone fragments in the foot and ankle, including metatarsals and tarsals. For example, medial and/or lateral column fusion as a result of neuropathy (Charcot). The BEPSA Charcot System is intended for use in adult populations.
| 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 - K202326
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR 807.92, the following summary of information is provided.
1. Date of Preparation
November 9, 2021
2. Applicant
BESPA Global, LLC 9 Rand Road Cape Elizabeth, Maine 04107
3. Submitter/Contact Person
Katelyn Jessup Regulatory and Quality Specialist Kapstone Medical LLC 520 Elliot St. Charlotte, NC 28202 Phone: 704-843-7852
4. Device Name
Trade Name: BESPA Charcot System Common Device Name: BESPA Charcot System Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener Requlation Number: 888,3040 Product Code: HWC Common Name: Screw, Fixation, Bone Classification: Class II Panel: Orthopedic
5. Predicate Devices
Wright Medical Salvation Beams and Bolts System (K140741) - Primary Smith & Nephew Cannulated Screws and Washers (K111994)
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Image /page/4/Picture/0 description: The image shows the logo for BESPA GLOBAL. The logo consists of a gray globe on the left and the words "BESPA GLOBAL" on the right. The word "BESPA" is in large, dark blue letters, and the word "GLOBAL" is in smaller, gray letters below it.
6. Intended Use (Intended Purpose and Conditions of Use)
The BESPA Charcot System is intended to treat Charcot deformity in the foot. It consists of the Medial & Lateral Segmental Columns. The system is used to align and secure various bones in the foot. The BESPA Charcot System is for prescription use only.
7. Indications for Use
The BESPA Charcot System is indicated for fracture fixation, reconstruction procedures, arthrodesis, and osteotomies of various bones and bone fragments in the foot and ankle, including metatarsals and tarsals. For example, medial and/or lateral column fusion as a result of neuropathic osteoarthropathy (Charcot). The BEPSA Charcot System is intended for use in adult populations. The device is for prescription use only.
8. Device Description
The BESPA Charcot System is offered non-sterile and consists of implants and systemspecific instruments.
The Segmental Column is composed of various modular cylindrical components which screw together to create an implant assembly of the surgeon's desired features. The system contains transverse screws of various lengths. The implant construct has a compression capability.
All implants are made of titanium alloy.
9. Comparison of Technological Characteristics with the Predicate Devices
As was established in this submission, the subject device BESPA Charcot System is substantially equivalent to the predicate device, cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, function, and sterility.
10. Performance Data
There are no clinical data generated and held by the manufacturer, i.e., no premarketing or post-market clinical studies or animal studies have been performed. The following information is provided in support of substantial equivalence.
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Image /page/5/Picture/0 description: The image shows the logo for BESPA GLOBAL. The logo consists of a gray globe on the left and the text "BESPA" in large, dark blue letters on the right. Below "BESPA" is the word "GLOBAL" in smaller, gray letters. The globe depicts the continents of North and South America.
10.1 Biocompatibility
The subject device BESPA Charcot System is classified as an implant device with tissue/bone contact and permanent contact. Therefore, according to ISO 10993-1 the biological evaluation was assessed for potential effects. The BESPA Charcot System devices are manufactured from Ti-6AI-4V ELI conforming to ASTM standard F136. The evaluation was based on raw material data, biocompatibility testing according to the applicable ISO 10993 standards, and published literature.
The results show that implants made of Ti-6AI-4V ELI have a high demonstrable biological safety. No concerns arose that would preclude clinical use of the BESPA Charcot System. The accessories are classified as externally communicating medical devices with tissue/bone contact and less than 24 hours contact. All used materials have a medical grade. The requirements of the ISO 10993 standard are fulfilled.
Mechanical Testing 10.2
Testing was performed to demonstrate equivalence to other cleared fixation devices and bone screws, or to meet physiologically relevant acceptance criteria, according to the standards below.
- . ASTM F1264 "Standard Specification and Test Methods for Intramedullary Fixation Devices"
- . ASTM F543 "Standard Specification and Test Methods for Metallic Medical Bone Screws"
- ASTM F384 "Standard Specifications and Test Methods for Metallic Angled ● Orthopedic Fracture Fixation Devices"
11. Conclusion
The BESPA Charcot System and the predicate device Wright Medical Salvation Beams and Bolts System (K140741) have the same "Indications for Use," are available by prescription only, and are provided non-sterile. Any technical differences, which were identified, do not result in new questions of safety or effectiveness.
Through assessment of technological characteristics, indications for use and performance data, it can be concluded that BESPA Charcot System is both a safe and effective device and is substantially equivalent to the Salvation Beams and Bolts Svstem.