(59 days)
Not Found
No
The device description and performance studies focus on mechanical properties and material compatibility, with no mention of AI or ML.
Yes.
The device is intended to provide fixation and stabilization as an adjunct in the healing process of hematoma distraction arthroplasty, which is a therapeutic purpose.
No
The device description clearly states its purpose as providing fixation during the healing process, acting as a fixation post, distribution bridge, or for distributing suture tension. It's a physical implant for stabilization, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components (buttons and suture strand) made of titanium alloy and UHMWPE, which are hardware materials.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for fixation of bone-to-bone or soft-tissue to bone during surgical procedures, specifically for CMC joint arthroplasty. This is a surgical implant/device, not a test performed on biological samples in vitro.
- Device Description: The description details physical components (buttons, suture) made of materials like titanium and UHMWPE, designed for surgical implantation. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: An IVD would typically involve analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. This device does not perform any such analysis.
- Performance Studies: The performance studies focus on mechanical properties (fatigue testing, MR compatibility) and sterility, which are relevant to surgical implants, not IVDs.
The Acu-Sinch Knotless Mini is a surgical implant used to provide structural support and fixation during a specific surgical procedure.
N/A
Intended Use / Indications for Use
Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Acu-Sinch Knotless Mini is intended to provide fixation during the healing process of a trapeziectomy. Acu-Sinch Knotless Mini consists of two buttons, a suture strand, and instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM FI 36 (Ti-6AL-4V ELI). The suture is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The devices are sterile and for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Carpal Metacarpal (CMC) joint, base of the first and second metacarpal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and Dynamic fatigue testing was conducted to demonstrate that the proposed Acu-Sinch Knotless Mini performs statistically equivalent to the Predicate Device; Arthrex CMC Mini Tightrope cleared under K140328. Acu-Sinch Knotless Mini performed as well as, or better than the predicate device.
MR force, torque, and image artifact testing were conducted in accordance with ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of In Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Maging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Endotoxin testing (LAL and MMP) was conducted and met the requirement of
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 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.
January 23, 2025
Acumed LLC Marina Bull Regulatory Affairs Specialist 5885 NE Cornelious Pass Hillsboro, Oregon 97124
Re: K243624
Trade/Device Name: Acu-Sinch Knotless Mini Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: November 22, 2024 Received: November 25, 2024
Dear Marina Bull:
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 (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,
RYAN TROMBETTA -S
For: Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Acu-Sinch Knotless Mini
Indications for Use (Describe)
Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Type of Use (Select one or both, as applicable)
IX.Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K243624 | Prepared on: 2024-11-23 | |||
|---|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||||
| Applicant Name | Acumed LLC | ||||
| Applicant Address | 5885 NE Cornelious Pass Hillsboro OR 97124 United States | ||||
| Applicant Contact Telephone | 970-846-6282 | ||||
| Applicant Contact | Ms. Marina Bull | ||||
| Applicant Contact Email | marina.bull@acumed.net | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | Acu-Sinch Knotless Mini | ||||
| Common Name | Washer, Bolt, Nut | ||||
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories | ||||
| Regulation Number | 888.3030 | ||||
| Product Code(s) | HTN | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate# | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K140328 | Arthrex CMC Min Tightrope | HTN | |||
| Device Description Summary | 21 CFR 807.92(a)(4) | ||||
| The Acu-Sinch Knotless Mini is intended to provide fixation during the healing process of a trapeziectomy. Acu-Sinch Knotless Mini consists of two buttons, a suture strand, and instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM FI 36 (Ti-6AL-4V ELI). The suture is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The devices are sterile and for single use. | |||||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | ||||
| Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis. | |||||
| Indications for Use Comparison | 21 CFR 807.92(a)(5) |
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The Acu-Sinch Knotless Minj, has been compared to the predicate device, The Arthrex OMC Mini Tightrope within the 51 0(k) submission. The basis of substantial equivalence for the subject device is their similarities in intended use, material technology, operating principles, anatomical site, for implantation, performance and design. The analysis of difference between the subject device and predicate device supports substantial equivalence as the differences do not constitute a new intended use/indications for use, and the information the submission demonstrated that the subject device is comparable to the predicate device and does not raise different questions of safety or effectiveness.
The Acu-Sinch Knotless Mini has the same intended use/indications for use as the Arthrex CMC Mini Tightrope. Both have two buttons and a suture when used for bone or soft-tisue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Technological Comparison
The Subject Device has the same technological characteristics as the Predicate Device and Predicate Devices make use of a suture to provide fixation between the buttons, located on the thumb metacarpal and index metacarpal.
The button and suture system is used for distributing suture tension over areas of ligament or tendon repair or in the suspensory fration of the thumb metacarpal at the base of the second metacarpal when the trapezium is removed.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Static and Dynamic fatigue testing was conducted to demonstrate that the proposed Acu-Sinch Knotless Mini performs statistically equivalent to the Predicate Device; Arthrex CMC Mini Tightrope cleared under KI 40328. Acu-Sinch Knotless Mini performed as well as, or better than the predicate device. " 1 1 1 8
WN force, torque, and image artifact testing were conducted in accordance with ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of In Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Maging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Endotoxin testing (LAL and MMP) was conducted and met the requirement of