(435 days)
Not Found
No
The 510(k) summary describes a purely mechanical implantable device for surgical fixation. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies focus on mechanical properties and biocompatibility.
Yes
The device is used for fixation of soft tissue grafts during surgical procedures, specifically ACL reconstruction of the knee, which is a medical intervention intended to treat a condition.
No
The WasherCap™ Fixation System is a surgical implant used for fixing soft tissue grafts during ACL reconstruction, not for diagnosis.
No
The device description explicitly states it is an implantable device consisting of physical components (Cap, Screw, Washer) made of PEEK and titanium alloy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the WasherCap™ Fixation System is for the "fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee." This describes a surgical implant used in vivo (within the body) to physically support and fix tissue.
- Device Description: The description reinforces this by stating it's an "implantable device indicated for soft tissue graft fastening during Anterior Cruciate Ligament repair surgery." It's made of materials like PEEK and titanium, which are common for surgical implants.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The provided text contains no mention of analyzing specimens, diagnostic purposes, or any of the typical components or functions of an IVD.
The WasherCap™ Fixation System is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
Product codes
MBI
Device Description
WasherCap™ Fixation System is an implantable device indicated for soft tissue graft fastening during Anterior Cruciate Ligament repair surgery.
WasherCap™ Fixation System consists of three components: a Cap, a Screw and a Washer. The Cap and the Washer are manufactured from polyetheretherketone (PEEK) as per ASTM F-2026. The Screw is made of titanium alloy as per ASTM F136.
The WasherCap™ Fixation System is provided sterile and individually packaged and, it is available in a variety of sizes and should be implanted following the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-Clinical Studies:
- DESIGN VALIDATION
- Design Validation Protocol and Report of WasherCap™ Fixation System.
- PERFORMANCE TESTING
- Cyclic and load-to-failure properties of WasherCap™ Fixation System.
- PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- The subject device is not labeled as non-pyrogenic or pyrogen free.
Clinical Studies:
- No clinical studies were conducted.
Key Metrics
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
September 22, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that 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.
Abanza Tecnomed S.L. Aitor Olaso Quality And Regulatory Affairs Manager Calle Nueva 8-11 Mutilva, Navarra 31192 Spain
Re: K212197
Trade/Device Name: WasherCap™ Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: August 15, 2022 Received: August 16, 2022
Dear Aitor Olaso:
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
1
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 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,
Laura C. Rose, Ph.D. 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
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
WasherCap™ Fixation System
Indications for Use (Describe)
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
| 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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3
510(k) Number: K212197 Dated: July 13, 2021
5. 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
5.1 Submitter Information
| Company: | ABANZA TECNOMED, S.L.
Calle Nueva 8 - 11
Mutilva, Navarra 31192 Spain
Telephone: +34 948 04 46 43
Fax: N/A
regulatory@abanzamed.com |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Aitor Olaso
Quality And Regulatory Affairs Manager
ABANZA TECNOMED, S.L.
Calle Nueva 8 - 11
Mutilva, Navarra 31192 Spain
Telephone: +34 948 04 46 43
Fax: N/A
regulatory@abanzamed.com |
| Date Summary Prepared: | July 13, 2021 |
| 5.2 Name of the Device | |
| Trade Name: | WasherCap™ Fixation System |
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue. |
| Classification Name: | Orthopedic Regulation name: 888.3040 Class II |
| Review Panel: | Orthopedic (OR) |
| Regulation: | 888.3040 |
| Class: | Class II |
| Product Code: | MBI |
5.3 Equivalence Claimed to Predicate Device
The WasherCap™ Fixation System is equivalent to the OrthoPediatrics ACL Reconstruction System (K130217), manufactured by OrthoPediatrics, Corp..
5.4 Device Description
4
Page 2 of 3 WasherCap™ Fixation System is an implantable device indicated for soft tissue graft fastening during Anterior Cruciate Ligament repair surgery.
WasherCap™ Fixation System consists of three components: a Cap, a Screw and a Washer. The Cap and the Washer are manufactured from polyetheretherketone (PEEK) as per ASTM F-2026. The Screw is made of titanium alloy as per ASTM F136.
The WasherCap™ Fixation System is provided sterile and individually packaged and, it is available in a variety of sizes and should be implanted following the surgical procedure.
5.5 Indications for Use
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
5.6 Substantial Equivalence
The WasherCap™ Fixation System is intended for fixation of soft tissue grafts during ACL repair surgeries. Compared to the predicate device, the subject device is a single three-piece device achieving the same intended effect by fastening the soft tissue grafts inside the device which is implanted to the indication of the subject device is within the indication of the predicate device.
In addition, the WasherCap™ Fixation System and the predicate device share the same technological characteristics, including performance, basic design, materials, device usage, sterility and sizes.
Therefore, the WasherCap™ Fixation System is substantially equivalent to the predicate device.
5.7 Performance Data
Based on the Risk analysis, design validation and performance testing, the substantial equivalence determination is supported with:
Non-Clinical Studies
- · DESIGN VALIDATION
- o Design Validation Protocol and Report of WasherCap™ Fixation System.
- · PERFORMANCE TESTING
- o Cyclic and load-to-failure properties of WasherCap™ Fixation System.
- · PYROGENICITY
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- o Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject device is not labeled as non-pyrogenic or pyrogen free.
Clinical Studies:
5
- No clinical studies were conducted.
5.8 Conclusion
Based on the information provided by ABANZA TECNOMED, S.L. within this submission, the WasherCap™ Fixation System possesses the same intended use, basic design, materials and technological characteristics as the legally marketed predicate device. Therefore, the WasherCap™ Fixation System is substantially equivalent and it will perform as safety and effectively within the same intended use.