(59 days)
No
The summary describes a standard orthopedic screw with no mention of software, algorithms, or any technology that would suggest AI/ML.
No.
Explanation: The POGO Screw is a device used for the fixation of bone fractures in surgical settings, which is a structural and mechanical intervention rather than a therapeutic/treatment modality.
No
The device is described as cannulated screws for fracture fixation, which is a therapeutic rather than diagnostic function. Its intended use is in the "general management of fractures and reconstructive surgery," further indicating a non-diagnostic purpose.
No
The device description explicitly states it is comprised of physical screws made of stainless steel, which are hardware components.
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 device used directly on the body for structural support and repair.
- Device Description: The description details "cannulated screws for the fixation of bone fractures" made of stainless steel. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used to fix bones.
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
Dovice Bels.ipness are comprised of various size cannulated screws for the fixation of bone fractures. POGO screws are made of 316LVM Stainless Steel conforming to ASTM F138. 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
bone
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
Bench testing was conducted to support equivalency
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to support equivalency. The risk analysis and test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and effectively performing the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Modification to the POGO Screw
FxDEVICES
SEP 1 8 2009
Special Premarket Notification
K092489p.10亿2
510(k) Summary of Safety and Effectiveness FxDEVICES POGO Screw July 20, 2009
-
- Sponsor Name FxDevices One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
- Device Name POGO Screw Orthopaedic Panel Smooth or Threaded Metallic Bone Fixation Classification Name Fastener Class II (per 21 CFR 888.3040) CFR Number HWC Product Code
- Identification of Predicate or Legally Marketed Device 3. The POGO Screw is substantially equivalent to the POGO Screw cleared under K080649.
Device Description 4.
Dovice Bels.ipness are comprised of various size cannulated screws for the fixation of bone fractures. POGO screws are made of 316LVM Stainless Steel conforming to ASTM F138. 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.
- Intended Use 5. The ROGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
- Comparison of Technological Characteristics 6. 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.
1
FxDEVICES
Modification to the POGO Screw
K092189 p. Z of 2
Performance Testing
Bench testing was conducted to support equivalency
Statement of Equivalency 8.
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.
The risk analysis and test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and effectively performing the stated intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings, symbolizing health and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 1 8 2009
FxDEVICES c/o Mr. Rich Lipschutz President, FxDEVICES One South Ocean Boulevard, Suite 324 Boca Raton, Florida 33432
K092189 Re:
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: August 19, 2009 Received: August 21, 2009
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
3
Page 2 - Mr. Rich Lipschutz
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR-Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Barbara Buchner
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K092189
POGO Screw Device Name:
Indications For Use:
The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Somitu fer mym
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K092189