(36 days)
Not Found
No
The summary describes a kit of surgical tools (wires, screws, drill bit) and makes no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is used for surgical procedures (reduction and fixation of fractures) and includes surgical tools, making it a surgical device rather than a therapeutic device in this context.
No
The device description indicates it is an operating kit used for the reduction and fixation of fractures, which are treatment procedures, not diagnostic ones.
No
The device description explicitly lists physical components (Kirschner wires, bone screws, drill bit), indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reduction and fixation of fractures of the lower leg or distal femur." This is a surgical procedure performed directly on the patient's body.
- Device Description: The components (Kirschner wires, bone screws, drill bit) are all instruments used in a surgical setting for manipulating and fixing bone.
- Definition of IVD: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
This device is a surgical instrument kit used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The STORM(TM) Operating Kit is used in conjunction with the STORM(TM) in the reduction and fixation of fractures of the lower leg or distal femur.
Product codes (comma separated list FDA assigned to the subject device)
HTY, HWC
Device Description
The STΦRM™ Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower leg or distal 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061607 STORMTM Operating Kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 111001 (1/2)
MAY 17 2011
FDA CDRH DMC
APR 11 2011
Received
PO Box 2681 Stoke on Trent ST4 9BE
T: +44 (0) 17 82 84 78 40 F: +44 (0) 17 82 84 60 46 www.intelligent-orthopaedics.co.uk
E) 510(k) Summary
Submitted by
Peter Ogrodnik Managing Director Intelligent Orthopaedics Limited Building 103 Campbell Road Stoke on Trent Staffordshire ST4 4DE United Kingdom
Date
25th March 2011
Contact person: Peter Ogrodnik
Sterile STORM®® Operating Kit
Proprietary Name Common Name Classification / Reference
External Fixation Systems Class II - 888.3040 Smooth or Threaded Bone Fixation fasteners HTY and HWC / Orthopedic
Product Code & Panel
Device Description
The STΦRM™ Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.
Intended Use
The STORM™ Operating Kit is used in conjunction with the STΦRM™ in the reductic and fixation of fractures of the lower leg or distal femur
Technological characteristics
The STΦRM™ Operating Kit components are made from stainless steel and are presented sterile.
Substantial Equivalence
The components of the Sterile STORM™ Operating Kit are substantially equivalent to K061607 STORM™ Operating Kit
1
Equivalency is based on similarities in intended use, materials and design to the predicate devices and the mechanical performance demonstrating substantial equivalence to the predicate devices.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, rendered in a simple, abstract design. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Room -WO66-G609 Silver Spring, MD 20993-0002
Intelligent Orthopaedics Limited % Staffordshire University Mr. Peter Ogrodnik Managing Director Business Village, Leek Road Stoke On Trent, Staffordshire United Kingdom ST4 2AR
MAY 17 2011
Re: K111001
Trade/Device Name: STORMTM Operating Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: March 25, 2011 Received: April 22, 2011
Dear Mr. Ogrodnik:
We have reviewed your Section 51.0(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 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); medical device reporting (reporting of medical
3
Page 2 - Mr. Peter Ogrodnik
device-related adverse events) (21 CFR 803); 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.
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Aig B. R. h
for
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): {{{| | 0 0
Device Name:
Indications for Use:
The STΦRM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign-Off) (Division of Surgical, Orthopedic,
Division of Surgical, Orthopedic, Division Restorative Devices
Page 1 of 1
510(k) Number K111001