(96 days)
Not Found
No
The device description and performance studies focus on mechanical properties and usability of a physical implant and suture system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "Interfacing Anchor" and "Bone Tunnel Construct" intended for "soft tissue to bone fixation" in "Shoulder Rotator Cuff Repair," which is a therapeutic intervention.
No
The device description clearly states its purpose is for "soft tissue to bone fixation for the following indications: Shoulder Rotator Cuff Repair," which indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is comprised of physical components like a pre-deployed all-suture anchor, repair sutures, 302 stainless steel needles, and UHMWPE suture. It also mentions sterilization and physical testing. There is no mention of software as a component or the primary function of the device.
No, 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 and Intended Use: The description clearly states that the OsseoFit Interfacing Anchor and Bone Tunnel Construct are intended for soft tissue to bone fixation during surgical procedures (specifically Rotator Cuff Repair). This is a surgical implant used directly within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, chemical reactions, or diagnostic testing.
Therefore, based on the provided information, the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct are surgical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct are intended for use in soft tissue to bone fixation for the following indications: Shoulder Rotator Cuff Repair
Product codes
MBI, GAT
Device Description
The Riverpoint Medical Interfacing Anchor is comprised of a pre-deployed all-suture anchor with attached repair sutures and 302 stainless steel needles. The Interfacing Anchor is inserted into either the humerus or into passing slots available in devices intended for total shoulder arthroplasty. The Riverpoint Medical Bone Tunnel Construct is comprised of a double armed Ultra-High Molecular Weight Polyethylene (UHMWPE) suture with a preassembled polypropylene passing loop and 302 stainless steel needles.
Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA authorized. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Interfacing Anchor and Bone Tunnel Construct are available in common sizes and lengths with preattached 302 stainless steel needles and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone, Shoulder Rotator Cuff
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital/clinic/surgical setting.
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 performance testing for the Soft Anchor and Bone Tunnel Construct included a usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015- Medical devices - Application of usability engineering to medical devices. Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP , USP and USP . Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance "Pryogens and Endotoxins Testing: Questions and Answers." Non-clinical mechanical testing was performed to verify the fixation strength of the Soft Anchor and Bone Tunnel Construct and is compared to the predicate device.
In all instances of the testing referenced above, the acceptance criteria were met, and the proposed OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct performed as intended. Results of performance testing for the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct concluded that the device performed comparably to the predicate device in cyclic and pullout testing and the validations performed demonstrated that the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct met all requirements for its intended use.
A usability engineering study was performed to evaluate the performance of the proposed OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct device. In addition, bench testing was performed under simulated clinical conditions in order to evaluate the intended use listed in the IFU. Results of the usability study and performance testing of the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct support the use of the device and applicable IFU.
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
November 26, 2024
Image /page/0/Picture/1 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.
Riverpoint Medical LLC Paul Vagts Regulatory Affairs Manager 825 NE 25th Ave. Portland, Oregon 97232
Re: K242494
Trade/Device Name: OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, GAT Dated: October 28, 2024 Received: October 28, 2024
Dear Paul Vagts:
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.
1
2
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 (QS) 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 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-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)
K242494
Device Name
OsseoFit Interfacing Anchor;
OsseoFit Bone Tunnel Construct
Indications for Use (Describe)
The OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct are intended for use in soft tissue to bone fixation for the following indications: Shoulder Rotator Cuff Repair
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the logo for Riverpoint. The logo consists of the letters "RP" in a green rounded square, followed by the word "RIVERPOINT" in green, sans-serif font. The logo is simple and modern, and the green color suggests a connection to nature or the environment.
510(k) SUMMARY OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct K242494
| Submitter Information | ||
|---|---|---|
| Submitter's Name: | Riverpoint Medical | |
| Address: | 825 NE 25th Ave. | |
| Portland, OR 97232 | ||
| Phone Number: | (503) 517-8001 or (971) 288-1083 (503) 517-8002 | |
| Fax Number: | 3006981798 | |
| Registration Number: | Paul Vagts | |
| Contact Person: | (503) 517-8001 | |
| Date of Preparation: | October 27th, 2024 | |
| Device Name | ||
| Trade Name: | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | |
| Common or Usual Names: | Fastener, Fixation, Nondegradable, Soft Tissue | |
| Primary Device Classification | ||
| Product Code: | MBI | |
| FDA Class: | 2 | |
| Regulation Number: | 888.3040: Smooth or threaded metallic bone | |
| fixation fastener | ||
| Secondary Device Classification | ||
| Product Code: | GAT | |
| FDA Class: | 2 | |
| Regulation Number: | 878.5000: Suture, Non-absorbable, Synthetic, | |
| Polyethylene |
Predicate Device
K203740 - Riverpoint Medical JuggerKnot Soft Anchor
Device Description
The Riverpoint Medical Interfacing Anchor is comprised of a pre-deployed all-suture anchor with attached repair sutures and 302 stainless steel needles. The Interfacing Anchor is inserted into either the humerus or into passing slots available in devices intended for total shoulder arthroplasty. The Riverpoint Medical Bone Tunnel Construct is comprised of a double armed Ultra-High Molecular Weight Polyethylene (UHMWPE) suture with a preassembled polypropylene passing loop and 302 stainless steel
5
RP RIVERPOINT
needles. The Bone Tunnel Construct is passed through the passing slots available in devices intended for total shoulder arthroplasty.
Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA authorized. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Interfacing Anchor and Bone Tunnel Construct are available in common sizes and lengths with preattached 302 stainless steel needles and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
Intended Use / Indications for Use
The OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct are intended for use in soft tissue to bone fixation for the following indications:
Shoulder Rotator Cuff Repair
Performance Data
The sutures used to construct the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE sutures are tested per USP performance requirements for needle attachment and tensile strength. FDA Guidance "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff" and FDA Guidance "Class II Special Controls Guidance Document: Surqical Sutures; Guidance for Industry and FDA" were followed during the preparation of this submission. Non-clinical performance testing for the Soft Anchor and Bone Tunnel Construct included a usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015- Medical devices - Application of usability engineering to medical devices. Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP , USP and USP . Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance "Pryogens and Endotoxins Testing: Questions and Answers." Non-clinical mechanical testing was performed to verify the fixation strength of the Soft Anchor and Bone Tunnel Construct and is compared to the predicate device.
In all instances of the testing referenced above, the acceptance criteria were met, and the proposed OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct performed as intended. Results of performance testing for the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct concluded that the device performed comparably to the predicate device in cyclic and pullout testing and the validations performed demonstrated that the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct met all requirements for its intended use.
Comparison of Technical Characteristics
The main difference in technical characteristics of the existing JuggerKnot Soft Anchor is that the proposed OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct is anchor configuration, instructions for use including fixation through passing slots available in devices intended for total shoulder arthroplasty, and principles of operation.
6
RP RIVERPOINT
The JuggerKnot Soft Anchor predicate device is sterilized using the same processes, packaged using the same packaging materials, composed of the same materials, and tested to comparable performance requirements. The minor differences in technical characteristics are limited to 1) Anchor geometry, 2) Principles of Operation, and 3) Instructions for Use.
However, Riverpoint Medical believes these minor differences do not raise any new questions of safety or effectiveness. A usability enqineering study was performed to evaluate the performance of the proposed OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct device. In addition, bench testing was performed under simulated clinical conditions in order to evaluate the intended use listed in the IFU. Results of the usability study and performance testing of the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct support the use of the device and applicable IFU.
Substantial Equivalence
The OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct has similar intended use and indications for use and similar technical characteristics as the predicate device. The information provided in this Traditional 510(k) demonstrates the (1) any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed device is at least as safe and effective as the predicate devices. Therefore, the Riverpoint Medical OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct is substantially equivalent to the predicate device.