(86 days)
No
The device description and performance studies focus on a laser-based visual alignment guide and its electrical and mechanical properties, with no mention of AI or ML algorithms for image processing, data analysis, or decision support.
No
The device, a Laser Alignment Guide, is described as an instrument to aid in the alignment of another system (APEX 3D Total Ankle Replacement System) during surgery, rather than directly treating a condition or restoring a function.
No
The device is a surgical alignment guide, providing "a visual guide to verify alignment of the instrumentation associated with the APEX 3D Total Ankle Replacement System." It is used during surgery, not for diagnosing a condition.
No
The device description explicitly states it is a "single-use electrical device" and describes a laser projecting a line, indicating it is a hardware component.
Based on the provided information, the Paragon 28 Laser Alignment Guide is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the Laser Alignment Guide is a tool used during surgery to provide a visual guide for aligning surgical instrumentation. It projects a line onto the patient's body.
- No Sample Analysis: The device does not analyze any samples taken from the patient's body. It is a surgical aid used externally.
Therefore, the Paragon 28 Laser Alignment Guide falls under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended use only.
Product codes
HSN
Device Description
The Paragon 28 Laser Alignment Guide is a line extension to the APEX 3D Total Ankle Replacement System instrumentation (K192994). The Paragon 28® APEX 3D™ Total Ankle Replacement System Laser Alignment Guide is designed to provide a visual guide to verify alignment of the instrumentation associated with the APEX 3D™ Total Ankle Replacement System. Once inserted into the proper instrumentation, the Laser projects a line onto the patient to be used by surgeons as a visual reference for alignment. The Laser Alignment Guide is a singleuse electrical device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Non-clinical testing performed included a cadaveric design evaluation of the Laser line, a stability assessment, and electrical safety testing. The results of this testing demonstrate that the subject system performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
November 13, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line.
Paragon 28, Inc. % Dave McGurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001
Re: K202373
Trade/Device Name: APEX 3D Total Ankle Replacement System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: September 18, 2020 Received: September 18, 2020
Dear Dave McGurl:
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
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,
for Ting Song, Ph.D., R.A.C. 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
2
Indications for Use
510(k) Number (if known) K202373
Device Name APEX 3D Total Ankle Replacement System
Indications for Use (Describe)
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended use only.
| 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) |
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510(k) Summary
| 510(k) Number: | K202373 |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr., | |
| Englewood, CO 80112 | |
| Contact: | Ms. Haylie Hertz |
| Regulatory Affairs Specialist | |
| Phone: 855-786-2828 | |
| hhertz@paragon28.com | |
| Correspondent: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1050 K Street, NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5800 | |
| Date Prepared: | August 21, 2020 |
| Device Trade Name: | APEX 3D Total Ankle Replacement System |
| Device Common Name: | Total Ankle Prosthesis |
| Classification: | 21 CFR 888.3110 |
| Class II | |
| Product Codes: | HSN |
Indications for Use:
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.
Device Description:
The Paragon 28 Laser Alignment Guide is a line extension to the APEX 3D Total Ankle Replacement System instrumentation (K192994). The Paragon 28® APEX 3D™ Total Ankle
4
Replacement System Laser Alignment Guide is designed to provide a visual guide to verify alignment of the instrumentation associated with the APEX 3D™ Total Ankle Replacement System. Once inserted into the proper instrumentation, the Laser projects a line onto the patient to be used by surgeons as a visual reference for alignment. The Laser Alignment Guide is a singleuse electrical device.
Predicate Devices:
The Paragon 28 Laser Alignment Guide is substantially equivalent to the APEX 3D Total Ankle Replacement System Instrumentation (K192994) and the Corin Optimized Positioning System (K152893). The OEC Elite (K192819) is considered a reference device.
Substantial Equivalence:
The subject Laser Alignment Guide is substantially equivalent to the predicate systems with respect to intended use, indications, and design. The subject Laser Alignment Guide possesses similar technological characteristics as the predicate devices, including design, material, chemical composition, and energy source. Non-clinical testing performed included a cadaveric design evaluation of the Laser line, a stability assessment, and electrical safety testing. The results of this testing demonstrate that the subject system performs as intended.
Conclusion:
The APEX 3D Total Ankle Replacement System Laser Alignment Guide possesses the same intended use and technological characteristics as the predicate devices. Therefore, the Laser Alignment Guide is substantially equivalent for its intended use.