(123 days)
The IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Warning: IFS Bone Fixation Devices are not indicated for spinal fixation.
The IFS Bone Fixation Devices consist of cancellous, malleolar, or cortical screws ranging from 6 to 160mm in length and 1.5mm to 7.3mm in diameter. Threaded, spaded or blunt guide wires range from 0.028 to 0.188 of an inch in diameter and 4 to 12 inches in length. All IFS Bone Fixation Devices are manufactured using 316L stainless steel.
The provided text is a 510(k) summary for a medical device (IFS Bone Fixation Devices) seeking clearance from the FDA. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials to prove safety and effectiveness through specific acceptance criteria and performance studies.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way a de novo or PMA submission would.
Here's why and what information is available:
- No specific acceptance criteria or performance study results: The core of a 510(k) is to show that the new device is "substantially equivalent" to an already legally marketed predicate device. This means the new device has "similar design attributes, material, and intended use" and the same technological characteristics as the predicate. It does not typically involve setting specific performance metrics (like sensitivity, specificity, accuracy) and then conducting a new study to meet those targets.
- Focus on substantial equivalence: The provided text explicitly states: "There are no significant differences between bone fixation devices and the other devices as listed in the Substantially Equivalent Devices. The IFS Bone Fixation Devices and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, experts, or ground truth, as this information is not part of a 510(k) summary focused on substantial equivalence.
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Image /page/0/Picture/0 description: The image shows the logo for Internal Fixation Systems (IFS). The logo consists of a circular graphic to the left of the letters "IFS". The words "Internal Fixation Systems" are printed below the graphic and letters.
KO71035 pg 1/2
Internal Fixation Systems, Inc. 510(k) Summary
AUG 1 3 2007
| Company Name: | Internal Fixation Systems, Inc.10100 N.W. 116th WayMiami, Florida 33178 |
|---|---|
| Contact Name: | Steve Hernandez10100 N.W. 116th WayMiami, Florida 33178(305) 216-4766 |
| Trade Name: | IFS Bone Fixation Devices |
| Common Name: | Bone Fixation Fasteners |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| RegulationNumber: | 21 CFR 888.3040 |
| Regulatory Class: | II |
| Device ProductCode: | HWC |
| SubstantiallyEquivalent Devices: | Depuy Kirschner Wires and Steinmann Pins (K960385)Plus Cancellous Bone Screws (K011719)Biodynamic Technologies, Inc. (K972403)GSO Bone Fixation Fasteners (K063589)Nexa Bone Screw System (K053394)Synthes 3.5 Cortex Screws (K043185)Synthes 7.0/7.3 Cannulated Screws (K962011)OsteoMed 1.2mm Auto-Drive Screw System (K023260) |
| Device Description: | The IFS Bone Fixation Devices consist of cancellous,malleolar, or cortical screws ranging from 6 to 160mm inlength and 1.5mm to 7.3mm in diameter. Threaded, spaded orblunt guide wires range from 0.028 to 0.188 of an inch indiameter and 4 to 12 inches in length. All IFS Bone Fixation |
May 27, 2007
Page 1 of 2
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Image /page/1/Picture/1 description: The image shows the logo for Internal Fixation Systems (IFS). The logo consists of a circular graphic to the left of the letters IFS. The graphic contains three arrows pointing in a circular direction. The text "Internal Fixation Systems" is located below the graphic and letters.
Devices are manufactured using 316L stainless steel.
Intended Use: The IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Technological The IFS Bone Fixation Devices are substantially equivalent to Characteristics the predicate devices with respect to design and material. Comparison:
Sterilization IFS Bone Fixation Devices will be distributed non-sterile. The Information: devices are sterilized by the end user per the AAMI Guidelines "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve the Sterility Assurance Level (SAL) of 10-6.
Conclusion: There are no significant differences between bone fixation devices and the other devices as listed in the Substantially Equivalent Devices. The IFS Bone Fixation Devices and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
AUG 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Internal Fixation Systems, Inc. % Mr. Steve Hernandez President 10100 NW 116th Way, Ste. 18 Miami, Florida 33178
Re: K071035
Trade/Device Name: IFS Bone Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 19, 2007 Received: June 21, 2007
Dear Mr. Hernandez:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Steve Hernandez
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Brelup
Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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40710
Indications for Use
510(k) Number (if known):
Device Name: IFS Bone Fixation Devices
Indications for Use: The IFS Bone Fixation Devices are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Warning: IFS Bone Fixation Devices are not indicated for spinal fixation.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number____<
§ 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.