(228 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical screw, with no mention of AI/ML or related concepts.
No
The device, ChM 4.5mm Cortical screws, is intended for fixation of bones and non-unions/malunions, acting as an internal fixation device to aid in healing rather than directly treating a disease or condition. While it assists in the healing process of injuries/conditions, its primary role is structural support and fixation, which aligns with a medical device for treatment but not specifically a therapeutic device in the context of actively administering therapy or monitoring/diagnosing.
No
The device, ChM 4.5mm Cortical screws, is described as an open reduction and internal fixation device intended for the fixation of bones. Its purpose is mechanical support and stabilization, not to diagnose a condition or disease.
No
The device description clearly states it is a physical implant (cortical screws) made of titanium alloy, intended for surgical fixation of bones. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The ChM 4.5mm Cortical screws are described as "single-use, stand alone, open reduction and internal fixation devices." They are implants used to fix bones.
- Intended Use: The intended use is for "fixation of various long bones" and "fixation of non-unions or malunions." This is a surgical procedure, not a diagnostic test performed on a specimen.
- Anatomical Site: The device is used directly on "various long bones."
- Care Setting: The device is used in "operating room conditions."
All of these points indicate that the device is a surgical implant used for treatment, not a diagnostic tool used on a sample outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various long bones, such as the humerus, femur and tibia
Indicated Patient Age Range
adults and in both children (2-12 years) and adolescents (12-21 years)
Intended User / Care Setting
operating room conditions.
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)
Non-clinical Testing
Non-clinical, biomechanical testing as specified in the ASTM F543 – 17 was performed on the ChM 4.5mm Cortical screws to determine substantial equivalence. Testing demonstrated that the ChM 4.5mm Cortical screws are substantially equivalent to the predicate device currently cleared for marketing.
Safety in MRI Not Evaluated.
Biocompatibility Testing
The biocompatibility evaluation (ISO 10993-1 Fifth edition 2018-08) was performed to evaluate the biological safety of ChM 4.5mm Cortical screws according to FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". According to ISO 10993-1 Annex A, the implants belong to „Implant medical device" category, principally contacting tissue and bone, duration of contact exceeds 30 days (long term contact).
The material is titanium alloy as per ISO 5832-11/ ASTM F1295-16.
ChM 4.5mm Cortical screws are biocompatible.
Animal Testing
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission.
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
§ 888.3040 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
Image /page/0/Picture/0 description: The image shows the date October 5, 2021. The text is written in a clear, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is black against a white background.
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.
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
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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 Kościelny
Tel: + 48 85 86 86 100;
Fax: + 48 85 86 86 101 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bogusław Krzywicki
Certification and Registration Specialist
ChM sp. z o.o.
Tel: + 48 85 86 86 306;
Fax: + 48 85 86 86 101
Email: 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
Page 1
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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
ﮨﮯ
| 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 (21 |
| C.F.R. 888.3040) | |
| Product Code | HWC |
| Predicate Device(s) | ChM 4.5mm Cortical screws were shown to be |
| substantially equivalent to the: |
K112583 – Synthes Cortical Screws
Substantial equivalence for ChM 4.5mm Cortical screws
is based on its similarities in: material, design features,
indications for use, patient population, performance
requirements, and operational principles when compared
to the predicate devices cleared under the above-
mentioned submission. |
| Device Description | 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. |
| Intended use and
Indications for Use | 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. |
| Comparison of
Technological
characteristics with the
Predicate Device | The ChM 4.5mm Cortical screws have similar
technological characteristics to the identified predicate.
The material, design features, indications for use, patient
population, performance requirements, and operational
principles are equivalent to the predicate device. |
| | A review of the test data for the subject devices indicates
that they are capable of withstanding expected in vivo
loading without failure. |
| Performance Data | Non-clinical Testing
Non-clinical, biomechanical testing as specified in the
ASTM F543 – 17 was performed on the ChM 4.5mm
Cortical screws to determine substantial equivalence.
Testing demonstrated that the ChM 4.5mm Cortical
screws are substantially equivalent to the predicate
device currently cleared for marketing.
Safety in MRI Not Evaluated.
Biocompatibility Testing
The biocompatibility evaluation (ISO 10993-1 Fifth edition
2018-08) was performed to evaluate the biological safety
of ChM 4.5mm Cortical screws according to FDA
Guidance: Use of International Standard ISO 10993-1,
"Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management
process". According to ISO 10993-1 Annex A, the
implants belong to „Implant medical device" category,
principally contacting tissue and bone, duration of contact
exceeds 30 days (long term contact).
The material is titanium alloy as per ISO 5832-11/ ASTM
F1295-16. |
| | ChM 4.5mm Cortical screws are biocompatible.
Animal Testing
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission. |
| Substantial
Equivalence
Conclusion | Based upon a comparison of the material, design
features, indications for use, patient population,
performance requirements, and operational principles, the
subject ChM 4.5mm Cortical screws are substantially
equivalent to the predicate device identified in this
premarket notification.
ChM 4.5mm Cortical screws manufactured by ChM sp. z
o.o. proved to perform at least as well as the predicate
device. |
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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