(29 days)
The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
The ASCENSION Silicone MCP and PIP implants are anatomically designed, single-use, one-piece, flexible hinge prostheses designed to be implanted without bone cement across the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joint. They are made from medical grade silicone elastomer. The proximal and distal stems of the prostheses are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. The MCP and PIP implants provide 90 degrees of flexion from full extension.
The provided text is an FDA 510(k) clearance letter for the Ascension Silicone MCP and Ascension Silicone PIP devices. This document focuses on the regulatory clearance of a physical medical device (finger joint prostheses) based on a special 510(k) for adding "MR Safe" labeling.
The information you've requested (acceptance criteria and study details for an AI/software device) is not present in this document. The document explicitly states:
- "Non-clinical performance data is not required to support the addition of MR Safe labeling to the subject devices."
- The determination of "MR Safe" was established through a "scientific rationale that addressed information about the electrical conductivity and magnetic properties of the device material per the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'"
Therefore, I cannot provide the requested details because the device in question is not an AI/software medical device that underwent the type of performance study you're asking about.
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December 14, 2023
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Ascension Orthopedics, Inc. Omunique Luke Regulatory Affairs Specialist II 11101 Metric Blvd Austin, Texas 78758
Re: K233670
Trade/Device Name: Ascension Silicone MCP; Ascension Silicone PIP Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KYJ Dated: November 15, 2023 Received: November 15, 2023
Dear Omunique Luke:
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.
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).
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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.
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-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,
Joseph P. Russell Digitally signed by Joseph P. Russell -S -2 Date: 2023.12.14 10:56:54 -05'00'
for: Farzana Sharmin, PhD 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
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Indications for Use
Submission Number (if known)
Device Name
Ascension Silicone MCP: Ascension Silicone PIP
Indications for Use (Describe)
The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
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) Summary
Silicone Implant MR Safe Labeling Special 510(K)
| Sponsor | Ascension Orthopedics, Inc.11101 Metric Blvd.Austin, TX 78758 |
|---|---|
| EstablishmentNumber | 3014207283 |
| Point of Contact | Omunique (Nikki) LukeRegulatory Affairs Specialist512-964-2309 |
| Date | November 15, 2023 |
| Trade Name(s) | Ascension Silicone MCPAscension Silicone PIP |
| Common Name | Finger Prosthesis |
| Product Code | KYJ |
| Regulation | 888.3230 - Finger joint polymer constrained prosthesis |
| Classification | Class II |
| Primary PredicateDevice | Ascension Silicone MCP: K022892 |
| Additional PredicateDevice | Ascension Silicone PIP: K082231 |
| Review Branch | Orthopedic |
| Device Description | The ASCENSION Silicone MCP and PIP implants are anatomicallydesigned, single-use, one-piece, flexible hinge prostheses designed to beimplanted without bone cement across the metacarpophalangeal (MCP)joint and proximal interphalangeal (PIP) joint. They are made from medicalgrade silicone elastomer. The proximal and distal stems of the prosthesesare pre-flexed to match the approximate natural flexion position of the jointwhen the hand is relaxed. The MCP and PIP implants provide 90 degrees offlexion from full extension. |
| IntendedUse/Indications forUse | The ASCENSION Silicone PIP implant is intended for cementlessreplacement of the proximal interphalangeal joint in patients withadvanced osteoarthritis, post-traumatic arthritis and rheumatoidarthritis.The ASCENSION Silicone MCP implant is intended for cementlessreplacement of the metacarpophalangeal (MCP) joint of the fingerwhere disabled by rheumatoid, degenerative or traumatic arthritis. |
| TechnologicalCharacteristics | The purpose of this submission is the addition of MR Safe Labeling to thesubject devices. There are no other changes proposed in this submission.The following aspects of the devices are not impacted by the additionallabeling and remain equivalent to the predicate devices as cleared in theirrespective 510(k)s.● Intended Use / Indications for Use● Contraindications● Warnings and Precautions● Design● Performance Specifications● Materials● Biocompatibility● Sterilization and Shelf life |
| NonclinicalPerformance Data | Safety and compatibility in the magnetic resonance (MR) environment wereestablished through a scientific rationale that addressed information aboutthe electrical conductivity and magnetic properties of the device material perthe FDA guidance document "Testing and Labeling Medical Devices forSafety in the Magnetic Resonance (MR) Environment."In accordance with the terminology in ASTM F2503-20, the AscensionSilicone MCP and Ascension Silicone PIP implant systems are consideredMR Safe.Non-clinical performance data is not required to support the addition of MRSafe labeling to the subject devices. |
| Conclusion | The Ascension Silicone MCP and Ascension Silicone PIP system implantsare comprised of medical-grade silicone, a non-magnetic and non-electrically conductive material. Based on the analysis of silicone, thesilicone material (and, therefore, devices comprised solely of silicone) is notexpected to exhibit any significant or unsafe interactions with the MRenvironment. |
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§ 888.3230 Finger joint polymer constrained prosthesis.
(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.