(87 days)
No
The description focuses on the mechanical design and intended use of a bone screw, with no mention of AI or ML capabilities.
Yes
The device, a cannulated compression screw, is used for the fixation of bone fractures and for bone reconstruction, which are therapeutic interventions.
No
This device is a surgical screw used for fixation and reconstruction of bones; it does not diagnose medical conditions.
No
The device description clearly describes a physical screw, a hardware component, used for bone fixation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone fractures or for bone reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "cannulated compression screw" used for bone fixation. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The "new" I.CO.S Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures. .
- Fractures management in the foot or hand .
- Arthrodesis in hand, foot or ankle surgery ●
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones .
- Treatment of inferior tibio fibular diastasis .
The size of the chosen screw should be adapted to the specific indication.
Product codes (comma separated list FDA assigned to the subject device)
87HWC
Device Description
The "new" I.CO.S" Screw is a cannulated compression screw with non-theaded shaft, allowing optimal compression. The head of this screw can be driven forward and translated along the body in order to increase the compression controled by the surgeon. It also has a self-tapping screw tip. It comes in diameters from 4.0 mm to 6.5 mm and in length from 26 to 90. It is identical in design to the I.CO.S® Screw (K993762)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, long bones, small bones, foot, hand, ankle, tibio fibular
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)
Rupture torque of the "new" I.CO.S" Screw is the same as for the device of the cleared, since the design has not changed. It was compared with requirements of the French Standard NºNF-S -90414 and found to have a resistance torsion in compliance with the selected standard.
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
SEP = 6 2001
( ଠାରୁଥୀ
SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION: A.
NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE Tél. : (33) 4 74 78 15 15 FRANCE Fax : (33) 4 74 78 15 16
ESTABLISHMENT REGISTRATION NUMBER: 9615741 B.
OFFICIAL CONTACT PERSON C.
Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 Tel. : (301) 519-1098 Fax : (301) 519-1389 estrin@yourFDAconsultant.com
DATE OF PREPARATION OF THIS SUMMARY: June 7, 2001 D.
I.CO.S® Screw PROPRIETARY (TRADE) NAME: E.
- Bone fixation screw, Cannulated compression screw F. COMMON NAME:
- CLASSIFICATION NAME AND REFERENCE G. Smooth or threaded metallic bone fixation fastener (21 CFR, Section 888.3040)
- PROPOSED REGULATORY CLASS: Class II H.
- DEVICE PRODUCT CODE: 87HWC I.
- PANEL CODE: 87 OR Orthopedic J.
DESCRIPTION OF DEVICE: K.
The "new" I.CO.S" Screw is a cannulated compression screw with non-theaded shaft, allowing optimal compression. The head of this screw can be driven forward and translated along the body in order to increase the compression controled by the surgeon. It also has a self-tapping screw tip. It comes in diameters from 4.0 mm to 6.5 mm and in length from 26 to 90. It is identical in design to the I.CO.S® Screw (K993762)
1
INDICATIONS FOR USE: L.
The "new" I.CO.S $crew is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures. .
- Fractures management in the foot or hand .
- Arthrodesis in hand, foot or ankle surgery ●
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones .
- Treatment of inferior tibio fibular diastasis .
The size of the chosen screw should be adapted to the specific indication.
M.
PREDICATE DEVICE:
The "new" I.CO.S." Screw is substantially equivalent in design, composition and cleared for market:
| Orthopeadic Biosystem Ltd.: | K963420 |
|---|---|
| AAP Implants Inc.: | K990776 |
| Synthes: | K962823 |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: N.
The "new" I.CO.S screw is technically equivalent to the device currently approves They have the same intended use, and the design has not changed Both the 1.CO.S Screw, the Self-drilling Facet Screw from Orthopaedic Biosystems Ltd, Synthes Serile 3.0mm-4.5mm-7.0/7.3mm Cannulated screws, and the cannulated screw from A A implants Inc. have the same intended use and all are indicated for fixing fractures or osteotomies. All are available in Titanium alloys. All of them are selftapping screws, and most of them are cannulated. All of them have a non threaded part, allowing compression between the two bone fragments.
The I.CO.S Screw meets the ASTM standards (ASTM F136) for the material and design for medical application. The bone screws are of the same thread configuration and length as offered by Orthopeadic Biosystem Ltd, AAP Implants Inc, Synthes and many other orthopaedic companies. The minor and major tive, Synances well as the head size are comparable. cannulated and are topped with a hexagonal socket.
SUMMARY OF STUDIES: 0.
SUMMARY OF STUDIES:
Rupture torque of the "new" I.CO.S" Screw is the same as for the device of the cleared, since the design has not changed. It was compared with requirements of the French Standard NºNF-S -90414 and found to have a resistance torsion in compliance with the selected standard.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 6 2001
NewDeal SA c/o Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K011821
Trade/Device Name: I.CO.S. Screws Regulatory Number: 888.3040 Regulatory Class: II Product Code: HWC Dated: June 7, 2001 Received: June 11, 2001
Dear Mr. Estrin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Norman F. Estrin, Ph.D., RAC
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and will of you ding of substantial equivalence of your device to a legally marketed nouticate 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 and 11 you desire specific ac in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, (301) 594-1639 - 1837 - 1831) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sus. W.R., M.S.
Image /page/3/Picture/4 description: The image contains a signature that appears to say "Ron" in cursive. The signature is written in black ink on a white background. The "R" is capitalized and the "o" and "n" are lowercase and connected.
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
4
510(k) Number (if known): K011821
I.CO.S. ® Device Name: SCREW
Indications for Use:
The "new" I.CO.S Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of bone fragments, in long bones or small bones fractures.
- · Fractures management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
The size of the chosen screw should be adapted to the specific indication.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
SR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011824