(72 days)
The LimaCorporate Kirschner wires are indicated as guide pins for insertion of other implants.
The LimaCorporate Kirschner wire is a metallic smooth wire, intended as non-implantable medical device.
This instrument is needed to guide the surgeon during orthopedic surgeries for the bone preparation in partial or total primary or revision shoulder joint replacement.
The LimaCorporate Kirschner wire is available in single diameter (2.5mm) and various lengths (150mm, 200mm and 240mm).
The LimaCorporate Kirschner wire is made from stainless steel 316L (AISI 316L), according to ISO 5832-1 and it does not have any coating.
The LimaCorporate Kirschner wire is designed for single use. It is supplied sterile and it is sterilized by means of radiation.
This document (K203475) describes a 510(k) premarket notification for a medical device called the "LimaCorporate Kirschner Wire." The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as typically done for new, higher-risk devices.
Therefore, the information provided does not contain the typical acceptance criteria and rigorous study design associated with demonstrating performance for an AI/ML medical device. Instead, it focuses on comparing the new device's characteristics to a predicate device.
Here's an analysis based on the provided document, addressing your points where applicable, and noting where the information is absent due to the nature of a 510(k) for a physical, non-AI device:
Device Name: LimaCorporate Kirschner Wire
Device Type: Smooth or threaded metallic bone fixation fastener (Specifically, a smooth metallic wire for guiding other implants).
Regulatory Class: Class II
Product Code: HTY
This document is a 510(k) submission for a physical, non-AI medical device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of attributes, not a clinical performance study with defined performance metrics like sensitivity, specificity, or AI model accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device and submission, the "acceptance criteria" are not performance metrics of an AI model, but rather successful demonstration that the device's technical characteristics are substantially equivalent to the predicate device.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance / Evidence |
|---|---|
| Identical Design - Kirschner wire design (smooth version). | The LimaCorporate Kirschner wire has "identical design compared to the predicate device (K153204. in smooth version)." |
| Similar Size Range - Comparison of available diameters and lengths. | The LimaCorporate Kirschner wire has "similar size range when compared to the predicate device (K153204)." (Specifically, 2.5mm diameter; 150mm, 200mm, 240mm lengths are mentioned). |
| Same Raw Material - Material composition meeting appropriate ISO standard. | The LimaCorporate Kirschner wire has the "same raw material, when compared to the predicate device (K153204) and both of them meet appropriate ISO standard." (Specifically, Stainless Steel 316L (AISI 316L) according to ISO 5832-1). |
| Included Indications for Use - New device's indications fall within predicate's. | The "LimaCorporate Kirschner wire indication for use is included in those of the predicate device (K153204)." (Indication: "as guide pins for insertion of other implants.") |
| Sterilization Validation - Proof of sterility for single-use, radiation-sterilized device. | "Sterilization validation" was performed. (Details of the validation study, e.g., sterility assurance level (SAL), methods, or results are not provided in this summary, but would be part of the full submission). |
| Biocompatibility Evaluation - Proof that material is safe for contact with tissue. | "Biocompatibility evaluation" was performed. (Details, e.g., specific ISO 10993 tests performed or results, are not provided in this summary, but would be part of the full submission). |
| Conformity to International Standards - Device meets relevant material standards. | The LimaCorporate Kirschner wire "conforms to the international standard ISO 5838-1 (2013)." |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable to this 510(k) submission, as it is for a physical medical device (Kirschner wire), not an AI/ML software. There is no "test set" of data in the sense of medical images or patient records used to evaluate an algorithm's performance. The "testing" refers to non-clinical bench testing (sterilization validation, biocompatibility) and direct comparison of physical attributes to the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. There is no AI/ML algorithm or "test set" requiring expert-established ground truth in this submission.
4. Adjudication Method for the Test Set
Not applicable, as there is no AI/ML algorithm or "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is involved. This submission is for a Kirschner wire (a surgical instrument).
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No. This pertains to AI/ML devices.
7. The Type of Ground Truth Used
Not applicable in the context of AI/ML. For this device, "ground truth" generally refers to verified physical properties, material composition, and functional characteristics validated through engineering testing and adherence to standards.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML model to train for this physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML model or training set.
Conclusion from the document:
The provided document (K203475) details a 510(k) clearance for the LimaCorporate Kirschner Wire. The basis for clearance is demonstrating substantial equivalence to an existing predicate device (In2Bones® Kirschner Wire, K153204) rather than proving de novo safety and effectiveness through extensive clinical trials or performance studies as would be required for a novel device or AI/ML product. The manufacturer states that "Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires," implying that the comparison of design, materials, size, and indications, alongside standard non-clinical tests (sterilization, biocompatibility), are sufficient evidence for this type of device.
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February 5, 2021
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Limacorporate S.p.A. Lacey Harbour U.S. Contact Via Nazionale, 52 Villanova di San Daniele, Udine 33038 Italy
Re: K203475
Trade/Device Name: LimaCorporate Kirschner Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: November 18, 2020 Received: November 25, 2020
Dear Lacey Harbour:
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 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
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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 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 Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203475
Device Name LimaCorporate Kirschner wire
Indications for Use (Describe)
The LimaCorporate Kirschner wires are indicated as guide pins for insertion of other implants.
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)
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510(k) Summary
Date: January 27, 2021 Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Lacey Harbour, MB(ASCP)CM US Regulatory Manager, Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA Office Phone: 817.385.0777 ext.200 Cell Phone: 432.638.6615 FAX: 817.385.0377
| Product | ProductCode | Regulation and Classification Name |
|---|---|---|
| LimaCorporateKirschner wire | HTY | Smooth or threaded metallic bone fixation fastenerper 21 CFR 888.3040 |
Description
The LimaCorporate Kirschner wire is a metallic smooth wire, intended as non-implantable medical device.
This instrument is needed to guide the surgeon during orthopedic surgeries for the bone preparation in partial or total primary or revision shoulder joint replacement.
The LimaCorporate Kirschner wire is available in single diameter (2.5mm) and various lengths (150mm, 200mm and 240mm).
The LimaCorporate Kirschner wire is made from stainless steel 316L (AISI 316L), according to ISO 5832-1 and it does not have any coating.
The LimaCorporate Kirschner wire is designed for single use. It is supplied sterile and it is sterilized by means of radiation.
Intended Use/Indications:
The LimaCorporate Kirschner wires are indicated as guide pins for insertion of other implants.
Predicate Devices:
In2Bones® Kirschner Wire (K153204).
Summary of technology comparison:
The LimaCorporate Kirschner wire is substantially equivalent to the predicate device (K153204) regarding design, size, range, and materials:
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The LimaCorporate Kirschner wire has identical design compared to the predicate device (K153204. in smooth version).
-
The LimaCorporate Kirschner wire has similar size range when compared to the predicate device (K153204).
-
The LimaCorporate Kirschner wire has the same raw material, when compared to the predicate device (K153204) and both of them meet appropriate ISO standard.
Substantial equivalence summary:
The LimaCorporate Kirschner wire indication for use is included in those of the predicate device (K153204).
The LimaCorporate Kirschner wire has similar technological characteristics when compared to the predicate device (K153204).
Summary of performance data:
The LimaCorporate Kirschner wires are single use instruments, sterilized by means of radiation; they are sterile stainless steel wires with diameter and lengths comparable to those of the predicate device (K153204). The design is substantial equivalent to the one of the predicate device; the indication for use is included in those of the predicate device: the material of the LimaCorporate Kirschner wire is the same as that of the predicate device. Moreover, LimaCorporate Kirschner wire conforms to the international standard ISO 5838-1 (2013). Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires.
Non-Clinical Testing:
The following activities were performed:
- Sterilization validation;
- Biocompatibility evaluation. ●
Clinical Testing:
Clinical testing is not necessary to demonstrate substantial equivalence of the LimaCorporate Kirschner wire to the predicate device.
Conclusion
Based on a comparison of intended use, materials, summary of technological characteristics and preclinical testing, the LimaCorporate Kirschner wires are substantially equivalent to the predicate device identified in this premarket notification.
§ 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.