(41 days)
Not Found
No
The device description focuses on the material and mechanical properties of a titanium implant for fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an implant for stabilizing fractures, indicating a direct therapeutic purpose.
No
The device is described as an implant for fracture fixation, not for diagnosing conditions.
No
The device description clearly states it is a titanium implant fracture fixation system, which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is a "titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder." This describes a surgical implant used to treat a physical condition (fractures).
- Device Description: The description details a physical implant (plate and screws) made of titanium, designed to be surgically placed within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests 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.
Therefore, based on the provided information, the I.T.S. Humeral Head Plate with Angular Stability is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The I.T.S. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder.
Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The I.T.S. Humeral Head Plate with Angular Stability is a low-profile universal left and right titanium 4, 6, and 8 hole plate with various length cancellous self-tapping stabilization screws. The humeral head plate 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 humerus in the shoulder
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.
K041860, K011815, K042059, K041965, K983853, K955472
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
§ 888.3030 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
K05/4/2
JUL 1 1 2005
510(k) Summary of Safety and Effectiveness Section XII:
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| NAME OF FIRM: | I.T.S. Impiantat-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: | Humeral Head Plate 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 | Synthes LCP Proximal Humerus Plates (K041860 & K011815)
Hand Innovations Shoulder Fixation System (K042059)
Arthrex Humeral Fracture Plates and Screws (K041965)
DePuy ACE TIMAX® Meta Plate (K983853)
ACE Humerus & Radius Plates (K955472) |
| DEVICE DESCRIPTION: | The I.T.S. Humeral Head Plate with Angular Stability is a low-
profile universal left and right titanium 4, 6, and 8 hole plate with
various length cancellous self-tapping stabilization screws. The
humeral head plate 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: | The I.T.S. Humeral Head Plate with Angular Stability is used to
stabilize fracture(s) of the proximal humerus bone in the shoulder. |
| BASIS OF SUBSTANTIAL
EQUIVALENCE: | The I.T.S. Humeral Head Plate with Angular Stability is
substantially equivalent to the Synthes, Hand Innovations, Arthrex,
and DePuy ACE proximal humerus bone plate systems. |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The I.T.S. Claviculplate with Angular Stability is shown to be safe
and effective for use in fracture fixation of the proximal humerus
in the shoulder. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile or a wave-like design. The image is in black and white.
JUL 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
I.T.S. Implantat-Technologie-Systeme GmbH C/o Mr. Al Lippincott U.S. Agent and Official Correspondent. Engineering Consulting Services Incorporated 3150 E. 200th Street Prior Lake, Minnesota 55372
Re: K051412
K031412
Trade/Device Name: Humeral Head Plate with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and appliance Regulatory Class: II Product Code: HRS Dated: May 25, 2005 Received: May 31, 2005
Dear Mr. Lippincott:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 910(tr) prematice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manated to fithe Medical Device Amendments, or to commerce prior to May 28, 1776, the enaounce with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval and Cosment Act (Act) that to not require approval controls provisions of the Act. The Act. The You may, therefore, market the device, salgoer to the general registration, listing of
general controls provisions of the Act include requirements for annual registration an general controls of the rice list. Increases of the start of the adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into .. Existing major regulations affecting your device. EDA if may be subject to such additional controls: Extreman, Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Feasta. Rogerming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies of the May must that FDA has made a decemination and regulations administered by other Federal and light or any Federal statures and regulations daminities to: registration and listing (21 little comply with all the Act STEquilements, moradian and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000) 11 CFR 1000 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
2
Page 2 – Mr. Al Lippincott
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin manieans your antial equivalence of your device to a legally premarket notification. "The PDT Inturing of booses on the spermits 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 If you desire specific advice for your act (240) 276-0120 . Also, please note the regulation entitled, Comaci the Office of Compuner an (21 transmit (21CFR Part 807.97). You may obtain Misoraliung by relevelee to promanson ibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-204, or Manufacturers, international and Oolisanhttp://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
A
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Implant-Technology-Systems GmbH
Geschäftsführende Gesellschafterin: Dr. Eva Ruprechter
Tel ++43 (0)316 211 21 0 Fax ++43 (0)316 211 21 20 office@its-implant.com
Indications for Use
| 510(k) NUMBER: | ____________________________ |
|---|---|
| DEVICE NAME: | HUMERAL HEAD PLATE |
| WITH ANGULAR STABILITY | |
| INDICATIONS FOR USE: |
The I.T.S. Humeral Head Plate with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the proximal humerus in the shoulder.
Indications for Use include fracture and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
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)
Stupt Churde
Divisions of Comerals Restitute Profitistion (ODE) and Neurological Devices
510(k) Numb