(55 days)
No
The device description and performance studies focus on mechanical properties and usability, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
No
The device is a suture retention device used to facilitate soft tissue procedures and rotator cuff repair, acting as a mechanical aid rather than providing therapy itself.
No
The device is described as a "suture retention device to facilitate percutaneous and endoscopic soft tissue procedures" and is used for "rotator cuff repair procedures," which are treatment-oriented. It does not mention any function for diagnosing conditions.
No
The device description clearly outlines physical components like suture bundles, a needle delivery system, and a securing element (SuperBall), indicating it is a hardware-based medical device.
Based on the provided information, the SuperBall-RC™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate percutaneous and endoscopic soft tissue procedures and is indicated for use in rotator cuff repair procedures. This describes a surgical device used in vivo (within the body) to repair tissue.
- Device Description: The description details a physical implant and delivery system used to secure soft tissue. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SuperBall-RC™ System is a surgical implant and delivery system used for mechanical repair of tissue.
N/A
Intended Use / Indications for Use
The SuperBall-RC™ System is intended for use as a suture retention device to facilitate percutaneous and endoscopic soft tissue procedures.
The SuperBall-RC™ System is indicated for use in rotator cuff repair procedures.
Product codes
MBI, GAT
Device Description
The SuperBall-RC™ System is an all-inside, all-suture repair device.
Each device includes two non-absorbable, soft suture bundles that are attached to each other (USP 1 UHMWPE) and preloaded within a needle delivery system along with the SuperBall securing element made of a braided, coreless sack.
The adjustable depth delivery system insertion needle angles), enables the positioning and subsequent deployment of the two bundles under/within the soft tissue. Once placed, manipulation of the delivery system's the pulling suture (USP 3-0 Polyester Cottony II Green), thereby approximating the positioned bundles. The tightened implant is secured by the SuperBall is passed to nestle beside the deployed bundles. By pulling the SuperBall Actuating suture (USP 2-0 Polyester Tevdek II Green), a ball is formed, securing the implant in position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rotator cuff
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
Shear pullout testing was performed to verify that the SuperBall-RC possesses sufficient mechanical strength given: (1) change in indications and (2) change in implant length. When used in rotator cuff repair procedures, the SuperBall can be used either to (1) perform a primary repair of the tissue or (2) to anchor a repair patch in place. Accordingly, both of the repair configurations were subjected to testing.
Usability testing was performed and all physicians who evaluated the device for the proposed rotator cuff indication indicated that the device is easy for use as no damage was inflicted upon the models (cadaveric shoulder models) and no complications were noted throughout, indicating that the device poses no safety related implications for the additional indication.
Testing demonstrated the SuperBall-RC provides sufficient fixation strength for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 contains 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.
February 19, 2025
Arcuro Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K244015
Trade/Device Name: SuperBall-RCTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, GAT Dated: December 26, 2024 Received: December 26, 2024
Dear Mrs. Hogan:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
SuperBall-RC ™
Indications for Use (Describe)
The SuperBall-RC™ System is intended for use as a suture retention device to facilitate percutaneous and endoscopic soft tissue procedures.
The SuperBall-RC™ System is indicated for use in rotator cuff repair procedures.
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) #:
510(k) Summary
Prepared on: 2025-02-13
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Arcuro Medical Ltd. | ||||
|---|---|---|---|---|---|
| Applicant Address | 17 Tchelet Street Misgav Business Park Misgav 20174000 Israel | ||||
| Applicant Contact Telephone | +972-52-6511506 | ||||
| Applicant Contact | Ms. Lee Ranon | ||||
| Applicant Contact Email | lee.ranon@arcuromedical.com | ||||
| Correspondent Name | Hogan Lovells US LLP | ||||
| Correspondent Address | 1735 Market Street, Floor 23 Philadelphia PA 19103 United States | ||||
| Correspondent Contact Telephone | (267) 675-4611 | ||||
| Correspondent Contact | Mrs. Janice Hogan | ||||
| Correspondent Contact Email | janice.hogan@hoganlovells.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | SuperBall-RC™ 12 degree inserter (SBD-SB-RC-12D ); | ||||
| SuperBall-RC™ 18 degree inserter (SBD-SB-RC-18D) | |||||
| Common Name | Smooth or threaded metallic bone fixation fastener | ||||
| Classification Name | Fastener, Fixation, Nondegradable, Soft Tissue | ||||
| Regulation Number | 888.3040 | ||||
| Product Code(s) | MBI, GAT | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K221731 | FiberStitch™ Implant | MBI | |||
| K223500 | SuperBall™ Meniscal Repair System | GAT | |||
| K131637 (Reference) | RMST Staple | GDW | |||
| Device Description Summary | 21 CFR 807.92(a)(4) | ||||
| The SuperBall-RC™ System is an all-inside, all-suture repair device. |
Each device includes two non-absorbable, soft suture bundles that are attached to each other (USP 1 UHMWPE) and preloaded within a needle delivery system along with the SuperBall securing element made of a braided, coreless sack.
The adjustable depth delivery system insertion needle angles), enables the positioning and subsequent deployment of the two bundles under/within the soft tissue. Once placed, manipulation of the delivery system's the
5
pulling suture (USP 3-0 Polyester Cottony II Green), thereby approximating the positioned bundles. The tightened implant is secured by the SuperBall is passed to nestle beside the deployed bundles. By pulling the SuperBall Actuating suture (USP 2-0 Polyester Tevdek II Green), a ball is formed, securing the implant in position.
Intended Use/Indications for Use
The SuperBall-RC™ System is intended for use as a suture retention device to facilitate percutaneous and endoscopic soft tissue procedures.
The SuperBall-RC™ System is indicated for use in rotator cuff repair procedures.
Indications for Use Comparison
The subject and predicate (K221731) have the same indications except that the subject device is additionally indicated for percutaneous procedures and the predicate is additionally indicated for use in meniscal procedures. These differences do not alter the intended use of the device.
Technological Comparison
Comparing the key technological characteristics of the subject SuperBall-RC" System and the use, the use environment, target user, and patient population of all are identical. The devices are similar in terms of design, materials, and principles of operation in that both are all suture devices. While there are minor differences in design, bench testing has demonstrated equivalent performance.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Shear pullout testing was performed to verify that the SuperBall-RC possesses sufficient mechanical strength given: (1) change in indications and (2) change in implant length. When used in rotator cuff repair procedures, the SuperBall can be used either to (1) perform a primary repair of the tissue or (2) to anchor a repair patch in place. Accordingly, both of the repair configurations were subjected to testing.
Usability testing was performed and all physicians who evaluated the device for the proposed rotator cuff indication indicated that the device is easy for use as no damage was inflicted upon the models (cadaveric shoulder models) and no complications were noted throughout, indicating that the device poses no safety related implications for the additional indication.
Testing demonstrated the SuperBall-RC provides sufficient fixation strength for its intended use.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)