(39 days)
Not Found
No
The device description and the absence of any mention of AI, ML, image processing, training/test sets, or performance metrics related to algorithmic analysis strongly suggest this is a traditional mechanical surgical kit.
No
The device is described as an operating kit used for the reduction and fixation of fractures, which are procedures rather than a therapeutic device that would directly treat a condition. While it aids in the healing process, it is a surgical tool.
No
Explanation: The device is described as an operating kit used for the reduction and fixation of fractures, consisting of Kirschner wires, bone screws, and a drill bit. These are surgical tools and implants, not devices designed to diagnose a condition.
No
The device description explicitly lists physical components (Kirschner wires, bone screws, drill bit), indicating it is a hardware device, not software-only.
Based on the provided information, 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 listed (Kirschner wires, bone screws, drill bit) are all instruments and implants used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is used for direct surgical intervention.
N/A
Intended Use / Indications for Use
The STORM™ Operating Kit is used in conjunction with the STORM™ 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 STORM®® 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.
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
K06/607 pg 1 of 2
AUL 1 8 2006
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 or 510(k) Statement
Submitted by Peter OGrodnik Managing Director Intelligent Orthopaedics Limited Building 103 Campbell Road Stoke on Trent Staffordshire ST4 4DE United Kingdom
Date
26th May 2006
Contact person
Julio Gonzalez BSN medical Inc 5285 Carnegie Blvd Charlotte NC
| Proprietary Name | STORM® Operating Kit |
|---|---|
| Common Name | External Fixation Systems |
| Classification / Reference | Class II – 888.3040 Smooth or Threaded Bone Fixation fasteners |
| Product Code & Panel | HTY and HWC / Orthopedic |
Device Description
The STORM®® 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 reduction and fixation of fractures of the lower leg or distal femur
Technological characteristics
The STΦRM®® Operating Kit components are made from stainless and are presented non-sterile for sterilisation by autoclave.
1
K061607 pg 2 of 2
Substantial Equivalence
The components of the STΦRM™ Operating Kit are substantially equivalent to K960385 - Sterile Kirschner Wires and Steimann Pins, DePuy; K983121 - Non-Sterile Kirschner wires and Steinmann Pins, Syntec-Taichung Medical Instruments co Ltd and K043185- Synthes 3.5mm Cortex Screws, Synthes.
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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of four stylized human profiles facing to the right, with three lines above them that appear to represent movement or progress. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 18 2006
Intelligent Orthopaedics Limited % BSN medical Ltd. Mr. Neil McLachlan Global RA Manager Brierfield Mill Brierfield, Nelson Lanchashire BB9 5NJ
Re: K061607
Trade/Device Name: STΦRM™ Operating Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, HWC Dated: May 31, 2006 Received: June 9, 2006
Dear Mr. McLachlan:
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. Neil McLachlan
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. 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,
Karbarz Ruchur
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
Indications for Use:
The STORM™ Operating Kit is used in conjunction with the STORM™ 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)
Chabane Guellah
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page _1_of_l
D-2
510(k) Number K061667