(56 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is surgically implanted to fix osteotomies and reconstruct lesser toes, providing stability and maintaining alignment during healing. This describes a direct therapeutic intervention to treat a medical condition.
No
Explanation: The device description clearly states its purpose is for the "fixation of osteotomies and reconstruction of the lesser toes" and to provide "stability and maintain the alignment of bone during the healing process." This indicates a therapeutic or reconstructive function, not a diagnostic one. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly states it is a "surgically implanted device" and describes physical components like a "solid, non-threaded implant" and a "dorsal fin." This indicates a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The VeriFixx™ Small Bone Implant is a surgically implanted device used to fix bones in the toe. It is a physical implant that provides structural support and stability within the body.
- Intended Use: The intended use is for the fixation of osteotomies and reconstruction of lesser toes, which is a surgical procedure performed directly on the patient's body.
The description clearly indicates a device that is implanted in vivo (within the living body) for structural support, not a device that analyzes samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The VeriFixx™ Small Bone Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The VeriFixx™ SBI is single use, gamma sterilized device that is surgically implanted into the intramedullary canal of the bones in the toe to create a fusion and provides stability and maintain the alignment of bone during the healing process. The device is a solid, non-threaded implant that has a superior surface protrusion known as the dorsal fin, which is intended to maintain alignment of the joint during the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones in the toe
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)
The following bench tests were used to demonstrate equivalent performance of VeriFixx™ SBI to the predicate: insertion and pullout force testing, static and dynamic four-point bend testing, coating thickness characterization (ASTM F1854), surface roughness characterization, taber abrasion testing (ASTM F1978), and wear particle characterizations (ASTM F1877).
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.
HammerFix™ (Extremity Medical, LLC) (K133636)
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
November 17, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & 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.
Armis Biopharma, Inc. % Lynn C. Hansen Director of Clinical and Regulatory Affairs Pharmatech Associates, Inc. 22320 Foothill Blvd. Suite 330 Hayward, California 94541
Re: K202777
Trade/Device Name: VeriFixx™ Small Bone Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: September 21, 2020 Received: September 22, 2020
Dear Lynn C. Hansen:
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.
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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 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 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.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K202777
Device Name VeriFixx™ Small Bone Implant
Indications for Use (Describe)
The VeriFixx™ Small Bone Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
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
| Date: | November 12, 2020 |
|---|---|
| Sponsor: | Armis Biopharma, Inc. |
| 2950 East Harmony Road, Suite 252 | |
| Ft. Collins, CO 80528 | |
| Tel: 1-800-970-1779 | |
| Fax: 1-970-797-2721 | |
| Sponsor Contact: | Lynn C. Hansen, RAC |
| Director of Clinical and Regulatory Affairs | |
| Pharmatech Associates | |
| E-mail: lhansen@pai-qbd.com | |
| Tel: 650-303-6003 | |
| Trade Names: | VeriFixx™ Small Bone Implant |
| Common Name: | Pin, Fixation, Smooth Implant |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Regulation / Product Code: | 21 CFR 880.3040 / HTY |
| Regulatory Class: | Class II |
| Device Description: | The VeriFixx™ SBI is single use, gamma sterilized device that is |
| surgically implanted into the intramedullary canal of the bones in the toe | |
| to create a fusion and provides stability and maintain the alignment of | |
| bone during the healing process. The device is a solid, non-threaded | |
| implant that has a superior surface protrusion known as the dorsal fin, | |
| which is intended to maintain alignment of the joint during the healing | |
| process. | |
| Indications for Use: | The VeriFixx™ Small Bone Implant is indicated for the fixation of |
| osteotomies and reconstruction of the lesser toes following correction | |
| procedures for hammertoe, claw toe, and mallet toe. | |
| Materials: | The VeriFixx™ SBI is comprised of polyether-ether-ketone (PEEK) |
| which conforms to ASTM F2026 and coated with commercially pure | |
| (CP) titanium (ASTM F67). | |
| Primary Predicate: | HammerFix™ (Extremity Medical, LLC) (K133636) |
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510(k) Summary
| Performance
Data: | The following bench tests were used to demonstrate equivalent
performance of VeriFixx™ SBI to the predicate: insertion and
pullout force testing, static and dynamic four-point bend testing,
coating thickness characterization (ASTM F1854), surface
roughness characterization, taber abrasion testing (ASTM F1978),
and wear particle characterizations (ASTM F1877). |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The VeriFixx™ SBI possesses the same technological characteristics as
the predicate device. These include:
performance, basic design, and material. Differences between the VeriFixx™ SBI (non-threaded device, different
sizes, CP Ti coating technology and presence of alignment fin) were
shown not to raise new questions of safety or effectiveness. Therefore,
the fundamental scientific technology of the VeriFixx™ SBI is similar to
the predicate. |
| Conclusion: | The VeriFixx™ SBI possesses indications for use and technological
characteristics similar to the predicate device. Therefore, the VeriFixx™
SBI is substantially equivalent to the predicate. |