(49 days)
No
The device description focuses on the material, design, and mechanical function of a fracture fixation system, with no mention of AI or ML capabilities.
Yes
The device is a titanium implant system designed for fracture fixation, which is a therapeutic intervention to stabilize and heal bone fractures.
No
This device is a titanium implant system designed for fracture fixation of the proximal ulna, not for diagnosing medical conditions.
No
The device description clearly states it is a titanium implant fracture fixation system consisting of plates and screws, which are physical 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 to stabilize fractures of the proximal ulna (olecranon) in the elbow. This is a surgical implant used directly on the patient's bone.
- Device Description: The device is a titanium plate and screw system designed for internal fixation of bone fractures.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Indications for Use include fixation of complex intra- and extra- articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of the proximal ulna (olecranon). The I.T.S. Olecranonplate with Angular Stability is used to stabilize fracture(s) of the proximal ulna (olecranon) in the elbow.
Product codes
HRS
Device Description
The I.T.S. Olecranonplate with Angular Stability is a low-profile universal left and right titanium 8, 10, and 12 hole plate with various length 4.2mm Cancellous self-tapping and head locking stabilization screws. Additional 3.5mm Cortical screws of various lengths are self-tapping and are interchangeable in use to lock the plate to the dorsal shaft of the ulna. The Olecranonplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal ulna (olecranon) in the elbow
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
001 17 2005
Section XII: 510(k) Summary of Safety and Effectiveness SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH
Autal 28
Lassnitzhoehe A - 8301
AUSTRIA |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372 |
| TRADE NAME: | Olecranonplate with Angular Stability |
| COMMON NAME: | Bone Plate System |
| CLASSIFICATION: | Plate, Fixation, Bone (see 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: | HRS |
| SUBSTANTIALLY
EQUIVALENT DEVICES | Acumed Olecranon Plate (K012655)
Synthes Curved Reconstruction Plate (K011334)
Zimmer (1974) Zuelzer Hook Plate for fracture of the Olecranon |
| DEVICE DESCRIPTION: | The I.T.S. Olecranonplate with Angular Stability is a low-profile
universal left and right titanium 8, 10, and 12 hole plate with various
length 4.2mm Cancellous self-tapping and head locking stabilization
screws. Additional 3.5mm Cortical screws of various lengths are self-
tapping and are interchangeable in use to lock the plate to the dorsal shaft
of the ulna. The Olecranonplate is made from CP titanium according to
ASTM F 67-00 and the screws are made from 6-4 alloyed titanium
according to ASTM F 136-02. The plate and screws are surface
conditioned with a TIODIZE, Type II preparation. |
| INTENDED USE: | Indications for Use include fixation of complex intra- and extra- articular
fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, & 4 simple
fractures, and Type 5a, 5b, 5c, & 6 complex fractures (comminuted) of
the proximal ulna (olecranon). The I.T.S. Olecranonplate with Angular
Stability is used to stabilize fracture(s) of the proximal ulna (olecranon) in
the elbow. |
| BASIS OF SUBSTANTIAL
EQUIVALENCE: | The I. T.S. Olecranonplate with Angular Stability is substantially
equivalent to the Acumed, Synthes, and Zimmer Olecranon plate systems. |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The I.T.S. Olecranonplate with Angular Stability is shown to be safe and
effective for use in fracture fixation of the proximal ulna (olecranon) in
the elbow. |
KOS 2368
0 / )
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with three branches instead of the usual two.
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
I.T.S. Implantat-Technologie-Systeme GmbH c/o Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200" Street Prior Lake, Minnesota 55372
Re: K052368 Trade/Device Name: Olecranonplate with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 26, 2005 Received: August 29, 2005
Dear Mr. Lippincott:
We have reviewed your Scction 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 cither 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 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 - Al Lippincott
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.hunl
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Sar Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows four black squares with white letters and symbols inside. The first square contains the letter 'i', the second square contains the letter 't', the third square contains the letter 's', and the fourth square contains a right-pointing triangle. Each square has a black circle below it, which appears to be a dot. The image is simple and graphic, with a clear contrast between the black squares and the white letters and symbols.
plant-Technology-Systems GmbH
Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter
Autal 28, 8301 Lassnitzhone / Graz AUSTRIA ·
Tel ++43 (0)316 211 21 0 Fax ++43 (0)316 211 21 20 ffice@its-implant.com
Indications for Use
510(k) NUMBER:
DEVICE NAME: OLECRANONPLATE WITH
ANGULAR STABILITY
INDICATIONS FOR USE:
The I.T.S. Olecranonplate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal ulna (olecranon) in the elbow.
Indications for Use include fixation of complex intra- and extra-
articular fractures, osteotomies, nonunions, malunions, Type 1, 2, 3, &
4 simple fractures, and Type 5a, 5b, 5c, & 6 complex fractures
(comminuted) of the proximal ulna (olecranon).
Prescription Use
AND/OR Over-The-Counter-Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_10052368
Concurrence of CDRH, Office of Device Evaluation (ODE)