(442 days)
No
The description focuses on patient-specific design based on CT scans and additive manufacturing, without mentioning AI or ML algorithms for image analysis, planning, or guide generation.
No.
The device is a surgical instrument intended to assist in preoperative planning and guiding surgical procedures, not directly treat a disease or condition.
No
Explanation: The device is a surgical marking guide used for pre-operative planning and guiding surgical instruments, not for diagnosing medical conditions.
No
The device description explicitly states the device is "additively manufactured from biocompatible nylon" and is a physical guide used in surgery, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Paragon 28 Patient Specific Marking Guide is a surgical instrument used during surgery to assist in planning and guiding the marking of bone or surgical instruments. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's a surgical instrument for assisting in preoperative planning and guiding surgical actions, not for analyzing samples for diagnostic purposes.
The device is a patient-specific surgical guide, which falls under the category of medical devices used in surgical procedures.
N/A
Intended Use / Indications for Use
The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot and ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.
Product codes
PBF
Device Description
The Paragon 28 Patient Specific Marking Guides are designed and additively manufactured based on an individual patient's CT scan(s). In surgery, these guides, templates, or anatomical models are used to assist a surgeon in guiding the marking of a bone and/or guiding a surgical instrument for placement (i.e., placing a k-wire). The guides are not used for cutting bone. All guides are patient specific and utilize a CT scanning protocol previously cleared in K180239 (Paragon 28 formerly Additive Orthopaedics). The anatomical landmarks necessary for the design and creation of the Patient Specific Marking Guides must be present and identifiable on computed tomography scan.
The Paragon 28 Patient Specific Marking Guides are additively manufactured from biocompatible nylon (PA 2200 - polyamide 12 white) and produced by laser sintering. The Patient Specific Marking Guides are optional for surgeons to help visualize and plan osteotomies in the foot and ankle and are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan(s)
Anatomical Site
foot and ankle
Indicated Patient Age Range
adult patients
Intended User / Care Setting
surgical instrument
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 testing outlined below was intended to show that the output of the design and development process demonstrated compliance with the device specifications. Biocompatibility testing was conducted to prove the device is not toxic and safe for limited (
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
June 28, 2022
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Additive Orthopaedics, LLC % Jan Triani Director QA/RA Paragon 28, Inc. 44 Riverdale Ave Monmouth Beach, New Jersey 07750
Re: K211076
Trade/Device Name: Patient Specific Marking Guides Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF Dated: April 8, 2021 Received: April 12, 2021
Dear Jan Triani:
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: 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) K211076
Device Name Patient Specific Marking Guide
Indications for Use (Describe)
The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.
| 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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Paragon 28, Inc. Patient Specific Marking Guides
5. 510K Summary - K211076
1. INRODUCTION
This document contains the 510(k) summary for the Paragon 28, Inc. Patient Specific Marking Guides. The content of this summary is based on Per 21 CFR 807.92
2. SUBMITTER
| Name: | Paragon 28, Inc. |
|---|---|
| Address: | 44 Riverdale Ave |
| Monmouth Beach, NJ 07750 | |
| Phone: (855)786-2828 | |
| Official Contact | Jan Triani |
| Regulatory Consultant | |
| Patient Specific Paragon 28, Inc. | |
| Date Prepared: | May 31, 2022 |
| 3. DEVICE INFORMATION: | |
| Trade Name: | Patient Specific Marking Guides |
| Common Name: | Patient specific orthopedic anatomical models, |
| templates, and guides | |
| Classification Name: | Orthopaedic Surgical Planning and Instrument |
| Guides | |
| Classification: | 21 CFR 888.3030 |
| Product Code: | PBF |
4. PREDICATE DEVICES
Predicate Device:
-
VSP® Orthopedics System, 3D Systems, Inc. (K190044) .
Reference Device: -
Patient Specific 3D Printed Bone Segments Additive Orthopaedics, LLC (K180239) ●
-
Vantage PSI System, 3D Systems, Inc. (K193432) .
4
Paragon 28, Inc. Patient Specific Marking Guides
The predicate devices have not been the subject of any design related recall.
5. DEVICE DESCRIPTION
The Paragon 28 Patient Specific Marking Guides are designed and additively manufactured based on an individual patient's CT scan(s). In surgery, these guides, templates, or anatomical models are used to assist a surgeon in guiding the marking of a bone and/or guiding a surgical instrument for placement (i.e., placing a k-wire). The guides are not used for cutting bone. All guides are patient specific and utilize a CT scanning protocol previously cleared in K180239 (Paragon 28 formerly Additive Orthopaedics). The anatomical landmarks necessary for the design and creation of the Patient Specific Marking Guides must be present and identifiable on computed tomography scan.
The Paragon 28 Patient Specific Marking Guides are additively manufactured from biocompatible nylon (PA 2200 - polyamide 12 white) and produced by laser sintering. The Patient Specific Marking Guides are optional for surgeons to help visualize and plan osteotomies in the foot and ankle and are for single use only.
6. INDICATIONS FOR USE
The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot and ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTI S WITH THE PREDICATE DEVICE
Technological Characteristics Comparison
The Patient Specific Marking Guides and the legally marketed predicate devices have similar indications, and manufacturing process. The dimensions and geometry of the Patient Specific Marking Guides are patient specific, utilizing a previously cleared CT scanning protocol. Both the subject and predicate devices' dimensions and geometry are made based on the patient's anatomy.
Substantial Equivalence Non-Clinical Evidence
The intended use and technological characteristics of the subject device are substantially equivalent to the predicate device. The potential impact of a technological difference, for instance polymeric material grade, was addressed by the biocompatibility testing per ISO 10993-1.
8. SUMMARY OF PERFORMANCE TESTING
The testing outlined below was intended to show that the output of the design and development process demonstrated compliance with the device specifications. Biocompatibility testing was conducted to prove the device is not toxic and safe for limited (