(228 days)
The ChM 4.5mm Cortical screws are intended for fixation of various long bones, such as the humerus, femur and tibia. They are also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
This Traditional 510(k) submission is being supplied to the U.S. FDA to seek clearance to market the new ChM 4.5mm Cortical screws. The ChM 4.5mm Cortical screws are single-use, stand alone, open reduction and internal fixation devices. They have self-tapping features, hexdrive head recess, and are manufactured from titanium alloy in accordance with ISO 5832-11/ ASTM F1295-16. The ChM 4.5mm Cortical screws are offered non-sterile only and are available in various lengths. The device is meant to be used as a load sharing device, and it may be removed once the fracture is healed. Implantation with use of cortical screws should be performed in the operating room conditions.
The applicant, ChM sp. z o.o., submitted a 510(k) premarket notification for their ChM 4.5mm Cortical screws (K210490). This device is a bone fixation fastener intended for the fixation of various long bones and non-unions in adults and children (with fused growth plates or where screw fixation will not cross growth plates).
The provided text does not contain any information about an AI/ML powered medical device or a study involving such a device. The submission is for a traditional medical device (bone screws) and the premarket notification focuses on demonstrating substantial equivalence to a predicate device (Synthes Cortical Screws, K112583) based on material, design, indications for use, patient population, performance requirements, and operational principles.
Therefore, I cannot provide details on acceptance criteria and a study that proves an AI/ML device meets those criteria based on the given information. The concept of "acceptance criteria" in this context pertains to the demonstration of substantial equivalence for a physical medical device, primarily through non-clinical biomechanical and biocompatibility testing, rather than performance metrics for an AI algorithm.
Here's a breakdown of why this information is not present and what was presented instead:
- No AI/ML Device: The entire submission describes a physical medical device (bone screws), not a software or AI-driven diagnostic/therapeutic tool.
- No AI-specific Acceptance Criteria: Consequently, there are no acceptance criteria related to AI performance metrics like sensitivity, specificity, AUC, or the improvement of human readers with AI assistance.
- No AI-related Study: The study mentioned is non-clinical biomechanical testing (ASTM F543-17) and biocompatibility testing (ISO 10993-1). These are standard tests for bone implants, not AI/ML model validation studies.
- No Training/Test Sets for AI: There is no mention of training sets, test sets, ground truth establishment for AI, expert readers for AI adjudication, or MRMC studies, as these concepts are not applicable to the evaluation of a bone screw.
In summary, the provided text is for a traditional medical device (bone screws) and does not involve an AI/ML powered medical device or any associated performance acceptance criteria and studies typical for such AI technologies.
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ChM sp. z o.o. Boguslaw Krzywicki Certification and Registration Specialist Lewickie 3b Juchnowiec Koscielny, Podlaskie 16-061 Poland
Re: K210490
Trade/Device Name: ChM 4.5mm Cortical screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 1, 2020 Received: February 19, 2021
Dear Boguslaw Krzywicki:
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, 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
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Indications for Use
510(k) Number (if known) K210490
Device Name ChM 4.5mm Cortical screws
Indications for Use (Describe)
The ChM 4.5mm Cortical screws are intended for fixation of various long bones, such as the humerus, femur and tibia. They are also for use in fixation of non-unions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
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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Image /page/3/Picture/0 description: The image shows a logo with the text "lat ChM". The "lat" is written in a cursive font and is black. The "ChM" is written in a sans-serif font and is red. There is a faded gray number "40" in the background. The logo appears to be for an organization or event celebrating 40 years.
| Company | ChM sp. z o.o.Lewickie 3b,16-061 Juchnowiec KościelnyTel: + 48 85 86 86 100;Fax: + 48 85 86 86 101 |
|---|---|
| Contact | Bogusław KrzywickiCertification and Registration SpecialistChM sp. z o.o.Tel: + 48 85 86 86 306;Fax: + 48 85 86 86 101Email: boguslaw.krzywicki@chm.eu |
| Date Prepared | September 29, 2021 |
NIP 966-11-76-019 REGON 050561656 BDO: 000002928 Sąd Rejonowy w Białymstoku XII Wydział Gospodarczy: KRS 0000187570 Wysokość kapitału zakładowego 9 050 000 zł
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Image /page/4/Picture/0 description: The image shows the logo for CHM sp. z o.o. The logo consists of the letters "CHM" in a stylized red font, with the letters connected to each other. Below the letters, the text "sp. z o.o." and "Lewickie 3b" are written in a smaller, black font. A registered trademark symbol is located in the upper right corner of the logo.
Date: 2021-09-29 Rev .: 02
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| Device Trade Name | ChM 4.5mm Cortical screws |
|---|---|
| 510k number | K210490 |
| Device Common Name | Bone screws |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21C.F.R. 888.3040) |
| Product Code | HWC |
| Predicate Device(s) | ChM 4.5mm Cortical screws were shown to besubstantially equivalent to the:K112583 – Synthes Cortical ScrewsSubstantial equivalence for ChM 4.5mm Cortical screwsis based on its similarities in: material, design features,indications for use, patient population, performancerequirements, and operational principles when comparedto the predicate devices cleared under the above-mentioned submission. |
| Device Description | This Traditional 510(k) submission is being supplied tothe U.S. FDA to seek clearance to market the new ChM4.5mm Cortical screws.The ChM 4.5mm Cortical screws are single-use, standalone, open reduction and internal fixation devices. Theyhave self-tapping features, hexdrive head recess, and aremanufactured from titanium alloy in accordance with ISO5832-11/ ASTM F1295-16. The ChM 4.5mm Corticalscrews are offered non-sterile only and are available invarious lengths. The device is meant to be used as a loadsharing device, and it may be removed once the fractureis healed.Implantation with use of cortical screws should beperformed in the operating room conditions. |
| Intended use andIndications for Use | The ChM 4.5mm Cortical screws are intended for fixationof various long bones, such as the humerus, femur andtibia. They are also for use in fixation of non-unions ormalunions in adults and in both children (2-12 years) andadolescents (12-21 years) in which growth plates havefused or in which growth plates will not be crossed byscrew fixation. |
| Comparison ofTechnologicalcharacteristics with thePredicate Device | The ChM 4.5mm Cortical screws have similartechnological characteristics to the identified predicate.The material, design features, indications for use, patientpopulation, performance requirements, and operationalprinciples are equivalent to the predicate device. |
| A review of the test data for the subject devices indicatesthat they are capable of withstanding expected in vivoloading without failure. | |
| Performance Data | Non-clinical TestingNon-clinical, biomechanical testing as specified in theASTM F543 – 17 was performed on the ChM 4.5mmCortical screws to determine substantial equivalence.Testing demonstrated that the ChM 4.5mm Corticalscrews are substantially equivalent to the predicatedevice currently cleared for marketing.Safety in MRI Not Evaluated.Biocompatibility TestingThe biocompatibility evaluation (ISO 10993-1 Fifth edition2018-08) was performed to evaluate the biological safetyof ChM 4.5mm Cortical screws according to FDAGuidance: Use of International Standard ISO 10993-1,"Biological evaluation of medical devices – Part 1:Evaluation and testing within a risk managementprocess". According to ISO 10993-1 Annex A, theimplants belong to „Implant medical device" category,principally contacting tissue and bone, duration of contactexceeds 30 days (long term contact).The material is titanium alloy as per ISO 5832-11/ ASTMF1295-16. |
| ChM 4.5mm Cortical screws are biocompatible.Animal TestingAnimal testing was not required for this submission.Clinical TestingClinical testing was not required for this submission. | |
| SubstantialEquivalenceConclusion | Based upon a comparison of the material, designfeatures, indications for use, patient population,performance requirements, and operational principles, thesubject ChM 4.5mm Cortical screws are substantiallyequivalent to the predicate device identified in thispremarket notification.ChM 4.5mm Cortical screws manufactured by ChM sp. zo.o. proved to perform at least as well as the predicatedevice. |
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Image /page/5/Picture/0 description: The image shows a logo with the letters "CHM" in a stylized, red font. Below the letters, there is the text "sp. z o.o. Lewickie 3b" in black font. To the right of the letters, there is a circled "R" symbol, indicating a registered trademark.
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Image /page/6/Picture/0 description: The image shows a logo with the letters "CHM" in red, stylized to appear hand-drawn. Below the letters, there is the text "sp. z o.o." followed by "Lewickie 3b" in a smaller, sans-serif font. A circled "R" trademark symbol is located in the upper right corner of the logo.
Date: 2021-09-29 Rev .: 02
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