(106 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical properties and sterilization of a surgical screw, with no mention of AI or ML.
Yes
The device is intended for fixation of fractures and non-unions, arthrodesis, bunionectomies, and osteotomies, which are all therapeutic interventions designed to treat medical conditions.
No
The device is a surgical implant (screw) used for fixation of bones, not for diagnosing conditions.
No
The device description clearly states it is a stainless steel, cannulated, partially threaded, headless screw, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- SECURE Screw Function: The SECURE Screw is a surgical implant intended for the fixation of bones and joints within the body. It is a physical device used in a surgical procedure, not a test performed on a sample.
The provided information clearly describes a surgical implant for orthopedic use, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The SECURE Screw is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Product codes
HWC
Device Description
The A.M. Surgical SECURE Screw is a stainless steel, cannulated, partially threaded, headless screw intended to be used for fracture fixation of small, long bones of the hands and feet. Screw threads provide compression to promote reunion of fracture fragments. The device is offered in five different lengths; 40mm, 45mm, 50mm, 55mm, and 60mm. All dimensions, excluding length, are the same among the different sizes. These varying lengths allow for personalized medical treatment of fractures geared toward each individual patient and different types of fractures. The device is manufactured out of a single piece of 316L VM (UNS-S31673) stainless steel, is provided sterile (via gamma radiation), and is not reusable or re-sterilizable. This device is intended for permanent implantation, but can also be removed. To install and remove the device from a patient, the F543 compliant T8 hexalobe drive connection on the screw head is used in conjunction with a commercially available guide wire, drill bit, and driver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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
To verify the design meets it functional and performance requirements, representative samples of the device meet biocompatibility, sterility and performance testing in accordance with the following industry standards.
- ISO 10993-1: Biological evaluation of medical devices
- ANSI/AAMI/ISO -11137-2: Sterilization of health care products -● Radiation - Part 2: Establishing the sterilization dose
- ASTM F543-17: Standard Specification and Test Methods for Metallic . Medical Bone Screws (Appendices 1, 2 and 3)
No clinical data were required or submitted in support of this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
October 16, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.
A.M. Surgical, Inc. Vincent Pascale Chief Operations Officer 285 Middle Country Road, Suite 206 Smithtown, New York 11787
Re: K191771
Trade/Device Name: SECURE Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: July 2, 2019 Received: July 2, 2019
Dear Vincent Pascale:
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,
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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II. Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K191771 |
| Device Name | SECURE Screw |
| Indications for Use (Describe) | The SECURE Screw is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. |
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (7/17) | Page 1 of 1 |
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III. 510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for A.M. Surgical, Inc. The logo features a stylized "A" shape formed by three angled bars, with the leftmost bar in blue and the other two in shades of gray. Below the shape, the text "A.M. SURGICAL, INC." is displayed in a bold, sans-serif font, with the "TM" symbol indicating a trademark.
K191771 SECURE Screw
SUBMITTER/OWNER I.
A.M. Surgical, Inc. 285 Middle Country Road, Suite 206 Smithtown, NY 11787
Establishment Registration: 2437731
Phone: 631-979-9777
Fax: 631-980-4369
Contact Person: Vin Pascale
Date Prepared: July 1, 2019
II. DEVICE
Tradename of Device: SECURE Screw Common or Usual Name: Bone screw, fastener, fixation device Classification Regulation: 21 CFR 888.3040 Screw, Fixation, Bone Regulatory Class: II Product Code: HWC Special Controls or Device Specific Standards: N/A
III. PREDICATE DEVICE
The subject device is equivalent to the predicate K050636 Synthes 3.0mm headless compression screws.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The A.M. Surgical SECURE Screw is a stainless steel, cannulated, partially threaded, headless screw intended to be used for fracture fixation of small, long bones of the hands and feet. Screw threads provide compression to promote reunion of fracture fragments. The device is offered in five different lengths; 40mm, 45mm, 50mm, 55mm, and 60mm. All dimensions, excluding length, are the same among the different sizes. These varying lengths allow for personalized medical treatment of fractures geared toward each individual patient and different types of fractures. The device is manufactured out of a single piece of 316L VM (UNS-S31673) stainless steel, is provided sterile (via gamma radiation), and is not reusable or re-sterilizable. This device is intended for permanent implantation, but
4
can also be removed. To install and remove the device from a patient, the F543 compliant T8 hexalobe drive connection on the screw head is used in conjunction with a commercially available guide wire, drill bit, and driver.
INDICATIONS FOR USE V.
The SECURE Screw Fixation Device is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
There are no differences between the SECURE System and the predicate with respect to indications and intended use.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The general device description, intended use, indications for use, material, sterility, and single use configuration are the same between the SECURE Screw and the predicate device. The minor differences in the screw diameter and lengths offered do not affect the safety and efficacy of the device.
VII. PERFORMANCE DATA
To verify the design meets it functional and performance requirements, representative samples of the device meet biocompatibility, sterility and performance testing in accordance with the following industry standards.
- ISO 10993-1: Biological evaluation of medical devices
- ANSI/AAMI/ISO -11137-2: Sterilization of health care products -● Radiation - Part 2: Establishing the sterilization dose
- ASTM F543-17: Standard Specification and Test Methods for Metallic . Medical Bone Screws (Appendices 1, 2 and 3)
No clinical data were required or submitted in support of this submission.
VIII. CONCLUSIONS
The SECURE Screw has the same indications for use and nearly identical technological characteristics to the predicate device (K050636) previously cleared by the FDA. A.M. Surgical has concluded the SECURE Screw does not raise any new safety or effectiveness issues and is substantially equivalent to legally marketed bone screws that are in commercial distribution, and have been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976. This conclusion is based upon the devices' common indications for use, principles of operation, technology, materials and testing standards employed.