(29 days)
Not Found
No
The document describes a physical implant made of silicone and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable prosthesis intended for the replacement of joints damaged by various forms of arthritis, which is a therapeutic intervention.
No
The device is an implant for joint replacement, not a tool used to identify or analyze a medical condition.
No
The device description clearly states it is a physical implant made of silicone elastomer, intended for surgical replacement of joints. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ASCENSION Silicone PIP and MCP implants are physical implants designed to replace joints in the finger. They are surgically implanted into the body.
- Intended Use: The intended use is for the cementless replacement of joints in patients with arthritis. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The provided information clearly describes a surgically implanted medical device, not a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
KYJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal joint, metacarpophalangeal (MCP) joint of the finger
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
Safety and compatibility in the magnetic resonance (MR) environment were 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." In accordance with the terminology in ASTM F2503-20, the Ascension Silicone MCP and Ascension Silicone PIP implant systems are considered MR Safe. Non-clinical performance data is not required to support the addition of MR Safe labeling to the subject devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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December 14, 2023
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.
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 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Number | 3014207283 |
| Point of Contact | Omunique (Nikki) Luke
Regulatory Affairs Specialist
512-964-2309 |
| Date | November 15, 2023 |
| Trade Name(s) | Ascension Silicone MCP
Ascension Silicone PIP |
| Common Name | Finger Prosthesis |
| Product Code | KYJ |
| Regulation | 888.3230 - Finger joint polymer constrained prosthesis |
| Classification | Class II |
| Primary Predicate
Device | Ascension Silicone MCP: K022892 |
| Additional Predicate
Device | Ascension Silicone PIP: K082231 |
| Review Branch | Orthopedic |
| Device Description | 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. |
| Intended
Use/Indications for
Use | 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. |
| Technological
Characteristics | The purpose of this submission is the addition of MR Safe Labeling to the
subject devices. There are no other changes proposed in this submission.
The following aspects of the devices are not impacted by the additional
labeling and remain equivalent to the predicate devices as cleared in their
respective 510(k)s.
● Intended Use / Indications for Use
● Contraindications
● Warnings and Precautions
● Design
● Performance Specifications
● Materials
● Biocompatibility
● Sterilization and Shelf life |
| Nonclinical
Performance Data | Safety and compatibility in the magnetic resonance (MR) environment were
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."
In accordance with the terminology in ASTM F2503-20, the Ascension
Silicone MCP and Ascension Silicone PIP implant systems are considered
MR Safe.
Non-clinical performance data is not required to support the addition of MR
Safe labeling to the subject devices. |
| Conclusion | The Ascension Silicone MCP and Ascension Silicone PIP system implants
are comprised of medical-grade silicone, a non-magnetic and non-
electrically conductive material. Based on the analysis of silicone, the
silicone material (and, therefore, devices comprised solely of silicone) is not
expected to exhibit any significant or unsafe interactions with the MR
environment. |
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