AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intra- articular and extra-articular fractures, and for osteotomies of the distal radius in adults.

The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

Device Description

The AFFINITY - Variable Angle Distal Radius System is contains a set of titanium plates and screws that are intended to be end-user sterilized. The AFFINITY - Variable Angle Distal Radius System plates are provided in different configurations and are intended to be used in combination with the variable angle drilling guide and the Styloid hole variable angle drill guide to provide the necessary angulation for optimal screw positioning. The system includes Extra-articular plates (intermediate, wide, and narrow), Distal dorso-ulnar and dorso-radial L-plates, Distal ulnar T-plates, and straight Radius styloid plates.

AI/ML Overview

This is a medical device 510(k) summary, not a study of an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not applicable.

The document describes the AFFINITY - Variable Angle Distal Radius System, which is a set of titanium plates and screws for fixing fractures and osteotomies of the distal radius. This is a traditional medical device, not an AI/ML product.

Instead of clinical performance, the summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the non-clinical testing performed, presented in a table format, though it's important to note this does not align with the AI/ML-specific request for acceptance criteria and device performance:

Acceptance Criteria (Non-Clinical Test Method)	Reported Device Performance (Test Conclusion)
Mechanical Testing of Plates: ASTM F384-17 (Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices) - Annex 1 Static Bend Testing - Annex 2 Fatigue Bend Testing	Substantial equivalence to predicate device
Mechanical Testing of Screws: ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) - Annex 1 Torsional Properties - Annex 2 Driving Torque - Annex 3 Axial Pullout	Substantial equivalence to predicate device
Biocompatibility Testing: - ISO 10993-5: Tests for in-vitro cytotoxicity - ISO 10993-18: Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials. - XPS investigation for film-forming contaminations - Detection and Quantification of Bacterial Endotoxins	- no cytotoxic effect - chemical characterization as per the report - appropriate surface cleanliness - no risk of bacterial pyrogenicity
Sterilization Testing: Validating steam sterilization method according to ISO 11737-2:2009, ISO 17665-1:2006, ISO 14161:2009.	The results of the validating steam sterilization method show that the implants, accessories, and models can be sterilized to a SAL of 10-6 using the recommended steam sterilization instructions

Regarding the specific points requested for an AI/ML device:

A table of acceptance criteria and the reported device performance: Provided above for non-clinical testing, but not for AI/ML performance.
Sample size used for the test set and the data provenance: Not applicable as there is no test set for an AI/ML algorithm. The "test set" for this device refers to physical samples used in mechanical and biocompatibility testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
The type of ground truth used: Not applicable. The "ground truth" for this device is established by international standards for material properties, mechanical strength, and biocompatibility.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this document describes a traditional mechanical medical device, not an AI/ML product. The evaluation criteria are based on established engineering and biological standards for such devices, demonstrating substantial equivalence to a predicate device rather than AI/ML performance metrics.

Summary

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September 16, 2019

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Industrias Medicas Sampedro S.A.S Liliana Zuluaga-Idarraga Technical Director Carrera 47 No. 100 Sur 40 La Estrella, 055468 CO

Re: K191641

Trade/Device Name: AFFINITY - Variable Angle Distal Radius System, AFFINITY - Variable Angle Distal Radius Plates, AFFINITY - Variable Angle Distal Radius Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 14, 2019 Received: June 19, 2019

Dear Liliana Zuluaga-Idarraga:

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

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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 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) K191641

Device Name

AFFINITY - Variable Angle Distal Radius System

Indications for Use (Describe)

AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intra- articular and extra-articular fractures, and for osteotomies of the distal radius in adults.

The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

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

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.

Submission date

Date of the Traditional 510(k) submission is 28th August 2019.

Submitter information

Company name	Industrias Médicas Sampedro S.A.S
Establishment registration number	N/A
Street Address	Carrera 47 No. 100 Sur 40
City	La Estrella
Zip code	055468
Country	Colombia
Phone number	+5743223375
Fax number	+574 338 3013
Principal contact person	Liliana Zuluaga-Idárraga
Contact title	Technical Director
Contact e-mail address	liliana.zuluaga@imsampedro.com
Additional contact person	Daniela Villa-Moreno
Contact title	Regulatory Affairs Coordinator
Contact e-mail address	daniela.villa@imsampedro.com

Submission information

Trade name	AFFINITY - Variable Angle Distal Radius System
Common or Usual name	Plate, Fixation, BoneScrew, Fixation, Bone
Classification name	21 CFR 888.3030; Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040; Smooth or threaded metallic bone fixationfastener
Product code (classification regulation)	HRSHWC
Classification Panel	Orthopedic
Device class	Class II

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Predicate device

The predicate device to which substantial equivalence is claimed to:

Trade or proprietary or model name	VariAx Distal Radius Plating System, VariAx 2 System
510(k) number	K162841
Decision date	02/21/2017
Product code	HRS
	HWC
Manufacturer	Stryker GmbH
Review Panel	Orthopedic

Reference device

Trade or proprietary or model name 510(k) number Decision date Product code Manufacturer Review Panel

Distal Volar Radius Anatomical plate system K050932 04/26/2005 LXT Hand Innovations, Inc Orthopedic

Device Description

Indications for Use

AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intraarticular and extra-articular fractures, and for osteotomies of the distal radius in adults.

The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

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Characteristic	Subject device:	Predicate device:	Reference device: Distal Vola
	AFFINITY - Variable AngleDistal Radius System (Platesand Screws)	VariAx Distal Radius PlatingSystem, VariAx 2 System(K162841)	Radius Anatomical platesystem (K050932)
Product code	HRS, HWC	HRS, HWC	LXT
Classification	Class II. 21 CFR 888.3030;Single/multiplecomponent metallic bonefixation appliances andaccessories21 CFR 888.3040; Smoothor threaded metallic bonefixation fastener	Class II. 21 CFR 888.3030;Single/multiple componentmetallic bone fixationappliances and accessories21 CFR 888.3040; Smooth orthreaded metallic bonefixation fastener	Class II. 21 CFR 888.3030;Single/multiplecomponent metallic bonefixation appliances andaccessories
Intended Use	Fixation of simple and complexintra-articular and extra-articular fractures, and forosteotomies of the distalradius in adults. Fractures AOtypes A2, A3, B1, B3, C1, C2,C3.	VariAx Distal Radius PlatingSystem is intended for internalfixation of small bone fracture,primarily including distalradius fractures. The VariAx 2System is intended for internalfixation.	Distal Volar Radius Anatomicalplate system is intended forthe fixation of fractures andosteotomies involving thedistal radius.
Fixation method	Screw	Screw	Screw
Material(s)	Plates: biocompatiblecommercially puretitanium grade 4 (ASTM F67)Screws: biocompatibletitanium alloy (Ti6Al4V) (ASTMF136)	Plates: commercially puretitanium grade 2 (ASTM F67)Screws: titanium alloy (ASTMF136)	Plates and Screws:titanium alloy (ASTM F136)
Manufacturing	Industrias Médicas Sampedro	Stryker Trauma GmbH	HAND INNOVATIONS, INC
Sterilization	Steam Sterilization	Steam Sterilization	Steam Sterilization
Patient-specific	NO	NO	NO
Patient-specificaccessories?	NO	NO	NO

Comparison to the predicate and reference devices

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Non-clinical Testing

The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:

Name	Test method	Conclusion
Mechanical testing of the plates	ASTM F384-17 (Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices)Annex 1 Static Bend TestingAnnex 2 Fatigue Bend Testing	Substantial equivalence
Mechanical testing of the screws	ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws)Annex 1 Torsional PropertiesAnnex 2 Driving TorqueAnnex 3 Axial Pullout	Substantial equivalence
Biocompatibility test overview
Test / assessment description	Test report conclusion
Cytotoxicity:ISO 10993-5: Tests for in-vitro cytotoxicity	no cytotoxic effect
Chemical characterization:ISO 10993-18: Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials.	chemical characterization as per the report
Film-forming contaminations: XPS investigation	appropriate surface cleanliness
Detection and Quantification of Bacterial Endotoxins	no risk of bacterial pyrogenicity
Sterilization test overview
Test / assessment description	Test report conclusion
Validating steam sterilization method according to ISO 11737-2:2009, ISO 17665-1:2006, ISO 14161:2009.	The results of the validating steam sterilization method show that the implants, accessories, and models can be sterilized to a SAL of 10-6 using the recommended steam sterilization instructions

Conclusion

The non-clinical tests and technological comparisons demonstrate that the subject device is substantially equivalent to the predicate.

Regulation Number and Section

§ 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.