(441 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a silicone joint spacer, with no mention of AI/ML algorithms or data processing.
Yes.
The device is intended for replacement of damaged joints due to various arthritis types and provides a physical replacement for the damaged joint, indicating a therapeutic purpose.
No
The device is a joint replacement implant, not a tool for diagnosing conditions. Its intended use is to replace damaged joints, not to identify or assess damage.
No
The device description clearly states it is a "double-stemmed, constrained, silicone prosthesis with a hinge joint," indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant for replacing damaged joints in the hand (metacarpophalangeal and proximal interphalangeal joints). This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant made of silicone with a hinge joint, designed to be surgically placed within the body. This is consistent with a medical device for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgical implant intended to treat a medical condition by replacing a damaged joint. This falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by:
- Osteoarthrosis;
- Rheumatoid arthritis;
- Post traumatic arthritis. ●
The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by:
- Rheumatoid arthritis; •
- Osteoarthritis;
- Ankylosed joints or those with limited range of motion which have not responded to conservative treatment;
- . Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone;
- Destroved articular surface(s). .
Product codes (comma separated list FDA assigned to the subject device)
KYJ
Device Description
The Digitalis Spacer is a double-stemmed, constrained, silicone prosthesis with a hinge joint. The subject device is available in two options, one intended for use in the metacarpophalangeal (MCP) and the other for use in the proximal interphalangeal joints (PIP). The implant MCP option is intended to be implanted to replace the osteo-cartilaginous heads of the metacarpophalangeal joint an act as a joint spacer between the resected head of the metacarpal at the distal head and the base of the proximal phalanx. The implant PIP option is intended to be implanted to replace the osteo-cartilaginous heads of the proximal interphalangeal joint and act as a joint spacer between the head of proximal phalanx and base of the medial phalanx.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metacarpophalangeal joint of the hand, proximal interphalangeal joint of the hand
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)
Mechanical testing included evaluation of static strength of the silicone material as well as fatigue strength testing of the worst-case construct.
The BRM Digitalis Spacer is identical to the reference device in terms of material. Based on similarities in material and intended use, static strength testing performed on sections of the reference device components is applicable to the subject device; the static tensile strength of the BRM Digitalis Spacer is expected to exceed anticipated physiologic loading.
Fatigue testing performed on the subject device which incorporated both high and low cycle activities representative of intended physiologic use was performed according to ASTM F1781 (2021). Additionally, crack propagation was specifically analyzed as well as wear particle analysis. Additionally, the Digitalis Spacer is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K022892, K082231, K870200, K931588
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
BRM Extremities Srl % Margeaux Rogers Director, Regulatory Affairs Mcra, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K220142
Trade/Device Name: BRM Digitalis Spacer Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KYJ Dated: March 9, 2023 Received: March 9, 2023
Dear Margeaux Rogers:
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 (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 located 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.
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
April 4, 2023
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2023.04.04
Farzana Sharmin, PhD Acting 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
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Indications for Use
510(k) Number (if known) K220142
Device Name BRM Digitalis Spacer
Indications for Use (Describe)
The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by:
- · Osteoarthrosis;
- · Rheumatoid arthritis;
- Post traumatic arthritis.
The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by:
- · Rheumatoid arthritis;
- · Osteoarthritis:
- · Ankylosed joints or those with limited range of motion which have not responded to conservative treatment;
- · Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone;
- · Destroyed articular surface(s).
| 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 – K220142
| Manufacturer: | BRM Extremities | |
|---|---|---|
| Registered Office: | Via Lorenzo Mascheroni 29 | |
| 20145 Milano (MI) - Italy | ||
| Headquarter: | Via Papa Giovanni XXIII, 9 | |
| 23862 Civate (LC) - Italy | ||
| Contact: | Margeaux Rogers | |
| Senior Director, Regulatory Affairs | ||
| MCRA, LLC | ||
| Phone: 202.552.5805 | ||
| Email: mrogers@mcra.com | ||
| Prepared By: | MCRA, LLC | |
| 803 7th Street NW | ||
| Washington, DC 20001 | ||
| Phone: 202.552.5800 | ||
| Date Prepared: | March 21, 2023 | |
| Device Trade Name: | BRM Digitalis Spacer | |
| Device Common Name: | Prosthesis, Finger, Constrained Polymer | |
| Classification: | 21 CFR 888.3230 – Finger joint polymer constrained prosthesi | |
| Class II | ||
| Product Codes: | KYJ |
Indications for Use:
The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by:
- Osteoarthrosis;
- Rheumatoid arthritis;
- Post traumatic arthritis. ●
The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by:
- Rheumatoid arthritis; •
- Osteoarthritis;
4
- Ankylosed joints or those with limited range of motion which have not responded to conservative treatment;
- . Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone;
- Destroved articular surface(s). .
Device Description:
The Digitalis Spacer is a double-stemmed, constrained, silicone prosthesis with a hinge joint. The subject device is available in two options, one intended for use in the metacarpophalangeal (MCP) and the other for use in the proximal interphalangeal joints (PIP). The implant MCP option is intended to be implanted to replace the osteo-cartilaginous heads of the metacarpophalangeal joint an act as a joint spacer between the resected head of the metacarpal at the distal head and the base of the proximal phalanx. The implant PIP option is intended to be implanted to replace the osteo-cartilaginous heads of the proximal interphalangeal joint and act as a joint spacer between the head of proximal phalanx and base of the medial phalanx.
Primary Predicate Device:
The Digitalis Spacer is substantially equivalent to the primary predicate device Ascension Silicone MCP Spacers (K022892) with respect to intended use and indications for use, similar dimensions, and geometry.
Additional Predicate Devices:
The Digitalis Spacer is substantially equivalent to the additional predicate devices Ascension PIP Spacers (K082231) and Stryker Silicone PIP & MCP (K870200 & K931588) with respect to intended use and indications for use, similar dimensions, and geometry.
Reference Device:
The Digitalis Spacer is similar to the reference device NewPrim System (K191966) with respect to material.
Discussion of Non-Clinical Testing/Performance Data:
Mechanical testing included evaluation of static strength of the silicone material as well as fatigue strength testing of the worst-case construct.
The BRM Digitalis Spacer is identical to the reference device in terms of material. Based on similarities in material and intended use, static strength testing performed on sections of the reference device components is applicable to the subject device; the static tensile strength of the BRM Digitalis Spacer is expected to exceed anticipated physiologic loading.
5
Fatigue testing performed on the subject device which incorporated both high and low cycle activities representative of intended physiologic use was performed according to ASTM F1781 (2021). Additionally, crack propagation was specifically analyzed as well as wear particle analysis. Additionally, the Digitalis Spacer is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing.
Substantial Equivalence Conclusions:
The Digitalis Spacer and the legally marketed predicate device have the same intended use and indications for use, similar dimensions, geometry and materials. The stems of the devices are fit into the intramedullary canals of the metacarpophalangeal and proximal interphalangeal joints. The devices are constrained and made of silicone elastomer.
Conclusions drawn from the nonclinical testing demonstrate that the BRM Digitalis Spacer is as safe, as effective, and performs as well as the legally marketed predicate device.