(70 days)
The Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that care common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft, distal and proximal humerus, distal and proximal radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatassi, fibular shaft, malleolus fractures where indicated, The DRG Medium Screw™ System is indicated for:
Humeral Shaft Distal and proximal humerus Distal and proximal radius and ulna Radial and ulna shaft
Distal tibia and ankle Talus-calcaneus-matatarsal Fibular shaft and Malleolus fractures Intermediate Bone Fractures
The Dolphin Medical Technologies DRG Medium Screw™ System will be offered in Ti-6A1-V ELI. It will be available in common styles and assorted lengths for bone fixation and stabilization. A range of twenty six screw lengths will be made available in 4.5 mm diameter (16-72 mm) with four different distal thread length dimension (6.5mm, 16mm, 26mm). The screws are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated, on center axis.
The provided document is a 510(k) premarket notification for a medical device (DRG Medium Screw™ System), which focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the requested information elements (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size) are not applicable in the context of this document.
Explanation:
- 510(k) Premarket Notification: This regulatory pathway is used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and technological characteristics, and showing that the new device raises no new questions of safety or effectiveness. It does not inherently require a clinical study with predefined acceptance criteria for device performance in the same way a PMA (Premarket Approval) or De Novo application might.
- Performance Standards: The document explicitly states: "No performance standards applicable to the Bone Screw have been established by the FDA." Instead, it relies on meeting voluntary material standards (ASTM F136-84) and demonstrating equivalence to existing devices.
- Substantial Equivalence: The primary "proof" in this document is the comparison to a list of existing, approved bone screws (e.g., Ace Medical Company K903810, Osteomed K924018). The study that "proves" the device meets acceptance criteria is implicitly the comparison against these predicate devices based on their known design, materials, and clinical history.
In summary, the document addresses substantial equivalence, not performance acceptance criteria through a dedicated study.
{0}------------------------------------------------
3/15/99
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K990019". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with rounded shapes.
FDA Notification of:
Summary of Safety and Effectiveness Information Product: DRG Medium Screw™ System
Summary of Safety and Effectiveness Information
For Release upon Request Only
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name / Contact:
Company:
DMT (Dolphin Medical Technologies, Inc.) 5959 Cattlemen Lane Sarasota, FL 34232
Regulatory Affairs Department Contact: DMT 5959 Cattlemen Lane Sarasota, FL 34232 (941) 342-0414
Establishment Registration Number: 1063119
Classification Name:
Smooth or Threaded Bone Fixation Fastener
Common Used Name:
Bone Screw
DRG Medium Screw™ System Trade Proprietary Name:
The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-304. The product code generally refereed to is HWC ( Product Code: HWC ) , and DMT submits this application under this designation.
{1}------------------------------------------------
FDA Notification of:
Summary of Safety and Effectiveness Information Product: DRG Medium Screw™ System
Performance Standards:
No performance standards applicable to the Bone Screw have been established by the FDA. However, the titanium alloy 6AL-4V ELI alloy used to manufacture the DMT screws meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84).
Package and Labeling:
Package labeling has been developed to industry standards. Packaging is also standard commercially available type quality and is stored in a fashion, which prevents damage to the container or package the device is in.
System Description:
The Dolphin Medical Technologies DRG Medium Screw™ System will be offered in Ti-6A1-V ELI. It will be available in common styles and assorted lengths for bone fixation and stabilization. A range of twenty six screw lengths will be made available in 4.5 mm diameter (16-72 mm) with four different distal thread length dimension (6.5mm, 16mm, 26mm). The screws are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated, on center axis.
Indications for Use:
The Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that are common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft. distal and proximal humerus, distal and proximal radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatarsal, fibular shaft, malleolus fractures where indicated; The DRG Medium Screw™ System is indicated for:
Humeral Shaft
- Distal and proximal humerus
- Distal and proximal radius and ulna
Radial and ulna shaft
Distal tibia and ankle
Talus-calcaneus-matatarsal
Fibular shaft and Malleolus fractures
- Intermediate Bone Fractures
Fixation of these indications has been achieved in literally hundreds of thousands of cases with similar predicate devices.
{2}------------------------------------------------
FDA Notification of:
. . . . .
.
Summary of Safety and Effectiveness Information Product: DRG Medium Screw™ System
Substantial Equivalent Devices:
This product is substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market.
| Ace Medical Company: | K903810 |
|---|---|
| Osteomed: | K924018 |
| Zimmer: | K792022 |
| A.O. Synthes | K792291 |
| Aesculap: | K940207 |
| Howmedica: | K931524 |
| Alphatec Medical: | K921622 |
The DMT DRG Medium Screw™ System meet the ASTM standards (ASTM B348-83, F136-84, F67-88) for material and design for medical application. The bone screws are of the same thread configuration and length as offered by Synthes, Zimmer, Howmedica, Ace, Alphatec and many other orthopaedic companies. The minor and major diameters as well as the head size are comparable.
{3}------------------------------------------------
FDA Notification of:
Summary of Safety and Effectiveness Information Product: DRG Medium Screw™ System
Instrumentation:
DMT DRG Medium Screw™ System instrumentation used for the preparation and insertion of the DRG Medium Screws is considered to be general orthopaedic instrumentation. The system includes standard manual orthopaedic surgical instruments of the appropriate size and type. All DRG Medium Screw™M System instruments are manufactured from stainless steel meeting ASTM F899-84 standards.
Product Sterilization:
DMT will supply all instruments and implants Non-Sterile. Non-Sterile implants are packaged in "clean only" condition. The labeling of the implants and instruments clearly indicates their sterility status. The package insert contains a sterilization/re-sterilization guideline.
Summary:
Substantial Equivalence for the DRG Medium Screw™ may be found in comparison with devices from a number of manufactures. Bone Screw systems in general have been used for many years, and the clinical performance is well known and documented.
Another measure of the Safety and Effectiveness of a medical device is how it performs in long term use. The basic design concept of bone screws for use in the fixation and stabilization of fractures has had over 75 years of clinical evaluation. Uses, Indications, limitations and surgical techniques are well understood. Standardized manufacturing methods, design practices, material selections and testing techniques are known and represented within the guidelines of this submittal.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized emblem consisting of three abstract human profiles or faces, arranged in a row and connected by flowing lines. The emblem is meant to symbolize the department's focus on people and their well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Mr. Mark G. Urbanski President and CEO Dolphin Medical Technologies, Inc. 5959 Cattleman Lane Sarasota, Florida 34232
Re: K990019 DRG Medium Screw™ System Trade Name: Requlatory Class: II Product Code: HWC December 30, 1998 Dated: January 4, 1999 Received:
Dear Mr. Urbanski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{5}------------------------------------------------
Page 2 - Mr. Mark G. Urbanski
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitton, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
December 30, 1998
··
. .
Food and Drug Administration Center for Devices and Radiological Health Office of Evaluation Document Mail Center (HFZ-401) 1390 Piccard Drive Rockville, Maryland 20850
510(k) Application Product: DRG Medium Screwnd System
510 (k) No.#: K990019
Device Name: DRG Medium Screw™ System
Indications for Use: As listed in the cover letter for this 510(k) application, are as follows:
The Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that care common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft, distal and proximal humerus, distal and proximal radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatassi, fibular shaft, malleolus fractures where indicated, The DRG Medium Screw™ System is indicated for:
Humeral Shaft Distal and proximal humerus Distal and proximal radius and ulna Radial and ulna shaft
Distal tibia and ankle Talus-calcaneus-matatarsal Fibular shaft and Malleolus fractures Intermediate Bone Fractures
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✗
(Per 21 CFR 801.109)
OR
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990019
over-the-counter Use
(Optional Format 1-2-96)
N/A