(71 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for "fractured bone stabilization, fixation, and management" of fractures, which are therapeutic actions.
No.
The device is described as an intramedullary nail intended for fractured bone stabilization and fixation, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is an "intramedullary nail," which is a physical implantable hardware device.
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, tissue) to provide information about a person's health.
- Device Description: The Gotfried PH Nail is an implantable medical device used to stabilize and fix bone fractures. It is surgically inserted into the body.
- Intended Use: The intended use is for the mechanical stabilization and fixation of bone fractures, not for testing biological samples.
The information provided clearly describes a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, and base of neck fractures of the proximal femur.
Product codes
HSB
Device Description
The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and two distal locking bolts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
K04}}} page 141
FEB = 1 2015
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
- Efratgo Ltd. Hi Tech Bio-Surgical Submitter 1. 10 Ben Gurion Street Address: Kyriat Bialik, Israel 27000 972-4-870-6628 Phone: Contact Yechiel Gotfried, MD Person: November 15, 2004 Date: Gotfried PH (Physiological Hip) Nail Device & 2. Device: Fixation, Proximal, Femoral Implant Classification Name: Gotfried Percutaneous Compression Plating System K983814 3. Predicate Synthes PFN Proximal Femoral Nail K970097 Devices: Howmedica (Stryker) Gamma Locking Nail K034002 The Gotfried PH (Physiological Hip) Nail is an intramedullary Description: ব nail which utilizes two proximal dynamic femoral neck screws and two distal locking bolts. The Gotfried PH (Physiological Hip) Nail is intended for 5. Intended Use: fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, and base of neck fractures of the proximal femur. In terms of technology, the Gotfried PH (Physiological Hip) Nail 6. Comparison of is substantially equivalent to its predicate devices. It is Technological constructed of stainless steel and incorporates the same Characteristics: orthopedic design principles and components as its predicate devices. Its dimensions and the majority of tolerances are within the range that has been previously determined to be substantially equivalent by the FDA.
Image /page/0/Picture/5 description: The image shows the number 10 in bold font, followed by what appears to be the letters "C.M." and some illegible text. The text is in black and the background is white. The image is slightly blurry.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
FEB - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Efratgo, Ltd. C/o Mr. George J. Hattub, RAC & CQE Senior Staff Consultant MedicSense, Clinical and Regulatory Affairs 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K043233
Trade/Device Name: The Gotfried PH (Physiological Hip) Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 15, 2004 Received: November 22, 2004
Dear Mr. Hattub:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four been of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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 If your device to such additional controls. Existing major regulations affecting your device can mar be subject to observe a 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 I lease be devised alle i Brinination that your device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must or any I casual batates and regirements, 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.
2
Page 2 - Mr. George J. Hattub, RAC & CQE
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'ls ought maing of substantial equivalence of your device to a legally premarket notificated wice 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 It you acon office of Compliance at (301) 594-4639. 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 may be obtained from the Other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
043233 510(k) Number (if known):_
Device Name: The Gotfried PH (Physiological Hip) Nail
Indications For Use: The Gotfried PH (Physiological Hip) Nail is intended for fractured management of Coch Thion, and management of trochanteric (intertrochanteric and borte stabliled.com, matteric, and base of neck fractures of the proximal femur.
Prescription Use In (Part 21 CFR 801 Subgart 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
2- 510(k) Number K043233