(205 days)
No
The description focuses on the physical characteristics and mechanical testing of a silicone prosthesis, with no mention of AI or ML.
Yes
The device is intended to treat several medical conditions, including hallux limitus/rigidus and painful rheumatoid arthritis, by replacing a joint with a prosthesis, which aligns with the definition of a therapeutic device.
No
The device description clearly states it is an implantable prosthesis intended to replace osteo-cartilaginous heads, functioning as a joint spacer. Its use cases are related to treating conditions, not diagnosing them.
No
The device description clearly states it is a "double-stemmed, constrained, silicone prosthesis, intended to be implanted". This describes a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing a joint in the foot. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The device is a physical prosthesis designed to be implanted in the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status based on such analysis.
The device is clearly a surgical implant intended for the treatment of specific conditions affecting the first metatarsophalangeal joint.
N/A
Intended Use / Indications for Use
The BRM Extremities NewPrim device is intended for use in:
- Hallux rigidus or hallux limitus;
- Painful rheumatoid arthritis;
- Hallux abducto valgus associated with arthritis;
- Unstable or painful joint from previous surgery
Product codes (comma separated list FDA assigned to the subject device)
KWH
Device Description
The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
First metatarsophalangeal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 tensile testing demonstrated that the static strength of the subject device is substantially equivalent to that of the reference predicate (K023562). Results of fatigue testing demonstrated that the NewPrim spacer performs as intended in fatigue displacements more extreme than expected with physiologic implant displacement. Additionally, the NewPrim System 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.
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
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.
0
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February 13, 2020
BRM Extremities % Margeaux Rogers Associate Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K191966
Trade/Device Name: NewPrim System Regulation Number: 21 CFR 888.3720 Regulation Name: Toe Joint Polymer Constrained Prosthesis Regulatory Class: Class II Product Code: KWH Dated: January 16, 2020 Received: January 16, 2020
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
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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 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 (QS) 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 medical devices and radiation-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,
For Ting Song, Ph.D. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Device Name BRM Extremities NewPrim System
Indications for Use (Describe)
The BRM Extremities NewPrim device is intended for use in:
- Hallux rigidus or hallux limitus;
- Painful rheumatoid arthritis;
- Hallux abducto valgus associated with arthritis;
- Unstable or painful joint from previous surgery
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| Manufacturer: | BRM Extremities |
|---|---|
| Via Ciro Menotti 10 | |
| 20129 Milano, Italy | |
| Contact: | Ing. Andrea De Maglio |
| Regulatory Affairs Manager | |
| BRM Extremities Srl | |
| Tel. 02.36735123 | |
| Cell. 389.1938034 | |
| Email. A.demaglio@brm-extremities.com | |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1050 K Street, NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5800 | |
| Date Prepared: | February 12, 2020 |
| Device Trade Name: | BRM Extremities NewPrim System |
| Device Common Name: | Toe joint polymer constrained prosthesis |
| Classification: | 21 CFR 888.3720 – Prosthesis, Toe, Constrained Polymer |
| Class II | |
| Product Codes: | KWH |
Indications for Use:
The BRM Extremities NewPrim device is intended for use in:
- Hallux rigidus or hallux limitus; -
- Painful rheumatoid arthritis; -
- Hallux abducto valgus associated with arthritis; -
- Unstable or painful joint from previous surgery -
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Device Description:
The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
Predicate Devices:
The NewPrim system is substantially equivalent to the primary predicate RTS Flexible 1st MPJ Implant w/ Grommets (K153609) and reference predicate Integra Classic Great Toe Implant (K023562).
Substantial Equivalence:
The NewPrim System 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 first metatarsal joint. The devices are constrained and made of silicone elastomer. The devices also have proximal and distal grommets that may be used with the silicone implant.
Static tensile testing demonstrated that the static strength of the subject device is substantially equivalent to that of the reference predicate (K023562). Results of fatigue testing demonstrated that the NewPrim spacer performs as intended in fatigue displacements more extreme than expected with physiologic implant displacement. Additionally, the NewPrim System is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing.