(263 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is a medical screw used for the fixation of bone fractures in the general management of fractures and reconstructive surgery. This falls under the definition of a therapeutic device as it is intended to treat a pathological condition.
No
Explanation: The device description states its use is for "fixation of bone fractures" and the intended use is for "general management of fractures and reconstructive surgery," which are therapeutic applications, not diagnostic.
No
The device description explicitly states that the POGO Screws are comprised of physical components manufactured from 316 surgical stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the general management of fractures and reconstructive surgery." This describes a surgical implant used directly on the patient's bone, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a "cannulated screw for the fixation of bone fractures," made of surgical stainless steel. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The POGO Screw is a surgical implant used in vivo (within the living body) for mechanical support.
N/A
Intended Use / Indications for Use
The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
Product codes
HWC
Device Description
The POGO Screws are comprised of various size cannulated screws for the fixation of bone fractures. The components are manufactured from 316 surgical stainless steel. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing was conducted to support equivalency. The test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
10/9/2008
510K Summary of Safety and Effectiveness Fx Devices POGO Screw Oct 10. 2008
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- Sponsor Name FxDevices One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
NOV 2 5 2008
- Sponsor Name FxDevices One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
| 2. | Device Name: | POGO Screw |
|---|---|---|
| Panel | Orthopaedic | |
| Classification Name | Smooth or Threaded Metallic Bone Fixation Fastener | |
| CFR Number | Class II (per 21 CFR 888.3040) | |
| Product Code | HWC |
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- Device Description
The POGO Screws are comprised of various size cannulated screws for the fixation of bone fractures. The components are manufactured from 316 surgical stainless steel. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.
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- Intended Use The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
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- Comparison of Technological Characteristics The POGO Screw and the predicate device accomplish the same function of providing compression fixation between a base bone and a bone fragment. Both devices accommodate a range of total lengths within each product design.
- 7 Performance Testing Bench testing was conducted to support equivalency
- 8 Statement of Equivalency The POGO Screw is substantially equivalent in design, materials, construction and intended use as those of the predicate. Since the POGO Screw is the same in intended use and technological characteristics as the predicate devices, the POGO Screw does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.
1
FxDevices Premarket Notification -- POGO Screw 10/9/2008
The test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text appears to be part of a document or sign.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FxDevices, Inc. % Mr. Rich Lipschutz Operations Manager One South Ocean Blvd., Suite 324 Boca Raton, Florida 33432
NOV 2 5 2008
Re: K080649
Trade/Device Name: POGO Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 10, 2008 Received: October 16, 2008
Dear Mr. Lipschutz:
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.
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle symbol on the right and text arranged in a circle on the left. The text reads "DEPARTMENT OF HEALTH * HUMAN SERVICES * USA" around the circle.
3
Page 2 - Mr. Rich Lipschutz
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
FxDevices Premarket Notification - POGO Screw
Indications for Use
510(k) Number (if known): Ko80649
Device Name:
Indications For Use:
The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. McKerss
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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