(29 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, instrumentation) and materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies section also indicates no nonclinical testing was used for substantial equivalence, which would be expected for an AI/ML device.
Yes.
The device is used to facilitate healing of bone fractures, which is a therapeutic purpose.
No
Explanation: The device description states its purpose is to "draw two or more aligned bone fragments together to facilitate healing" in fracture fixation. It consists of plates and screws for mechanical support, not for diagnosis.
No
The device description clearly states it consists of physical implant components (plates and screws) made of titanium, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "draw two or more aligned bone fragments together to facilitate healing in an adult patient." This is a mechanical function performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and associated instrumentation used for bone fixation. These are physical implants and tools used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used within the body for structural support and healing.
N/A
Intended Use / Indications for Use
The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient.
The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of:
- the phalanges,
- the metacarpal bones.
- the carpal bones,
- for arthrodesis,
- for corrective osteotomies, and
- for subcapital radial head fractures.
The I.T.S. Hand Locking Plates System is not for spinal use.
Product codes
HRS, KTT, HWC
Device Description
The I.T.S. Hand Locking Plates System -- HLS consists of small bone trauma implant components commonly found with large companies with orthopedic markets in the United States. The I.T.S. HLS System consists of 1.0 and 1.5mm thick plates in Straight, T-Shape, Y-Shape, L-Shape (Left & Right), Extended and Square Plate configurations (with multiple hole sizing) that utilize both Locking and Non-Locking self-tapping Screws in 1.5mm, 1.8mm and 2.3mm sizes in various lengths. A 2.0mm Headless Compression Screw in various lengths is also available.
All small plate components are manufactured from Commercialy Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/contouring by the surgeon to fit the small bone anatomy. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. small plates and screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured small plate design minimizes soft-tissue irritation for the patient. Associated instrumentation such as Plate Holder, Drills, Drill Guides, Depth Guage, Countersink Reamers, Guide Wire and ancillary instrumentation is available. All small plates and screws are provided Non-Sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalanges, metacarpal bones, carpal bones, radial head (hand)
Indicated Patient Age Range
adult patient
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)
No nonclinical testing was used in the determination of Substantial Equivalence (SE).
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.
Stryker - Hand Plating System (K961497 & K060613), Synthes - LCP Compact Hand 1.5 (K092247), Biomet/DePuy - ALPS Small Bone Locked Plating System (K101240, K061748 & K041081), I.T.S. GmbH - Extremity Fixation Systems (K131722)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2014
I.T.S. GmbH % Mr. Al Lippincott Engineering Consulting Services, Inc. 3150 East 200th Street Prior Lake, Minnesota 55372
Re: K142418 Trade/Device Name: I.T.S. Hand Locking Plates System- HLS Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, KTT, HWC Dated: August 20, 2014 Received: August 28, 2014
Dear Mr. Lippincott:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Al Lippincott
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
K142418 page 1 of 1
K142418 510(k) NUMBER:
DEVICE NAME: I.T.S. Hand Locking Plates System - HLS
The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient .
The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of:
- the phalanges, 트
- the metacarpal bones. ■
- 트 the carpal bones,
- . for arthrodesis,
- . for corrective osteotomies, and
- . for subcapital radial head fractures.
The I.T.S. Hand Locking Plates System is not for spinal use.
XXXXX AND/OR Over-The-Counter-Use Prescription Use
(21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 | Page
3
510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
| NAME OF FIRM: | I.T.S. GmbH
Autal 28
Lassnitzhöehe A-8301
AUSTRIA
www.its-implant.com |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372
Tel. No. 952-492-5858
e-mail: allippincott@msn.com |
| DATE: | August 20, 2014 |
| TRADE NAME: | I.T.S. Hand Locking Plates System - HLS |
| COMMON NAME: | Small Bone Plating System, Compression Screw |
| CLASSIFICATION: | Plate, Fixation, Bone & Screw, Fixation, Bone |
| | Smooth or threaded metallic bone fixation appliances and
accessories (per 21 CRF, Sec. 888.3040). |
| | Single/Multiple Component Metallic Bone Fixation Appliances
and Accessories (per 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: | HRS |
| SUBSEQUENT PRODUCT CODE: | KTT, HWC |
| SUBSTANTIALLY
EQUIVALENT DEVICES | Stryker - Hand Plating System (K961497 & K060613)
Synthes - LCP Compact Hand 1.5 (K092247)
Biomet/DePuy - ALPS Small Bone Locked Plating System
(K101240, K061748 & K041081)
I.T.S. GmbH - Extremity Fixation Systems (K131722) |
| DEVICE DESCRIPTION: | The I.T.S. Hand Locking Plates System -- HLS consists of Predicate
small bone trauma implant components commonly found with
large companies with orthopedic markets in the United States.
The I.T.S. HLS System consists of 1.0 and 1.5mm thick plates in
Straight, T-Shape, Y-Shape, L-Shape (Left & Right), Extended and
Square Plate configurations (with multiple hole sizing) that utilize
both Locking and Non-Locking self-tapping Screws in 1.5mm,
1.8mm and 2.3mm sizes in various lengths. A 2.0mm Headless
Compression Screw in various lengths is also available. |
| | All small plate components are manufactured from Commercialy
Pure (CP) Titanium material to ASTM F67 and allow for minor
intra-operative forming/contouring by the surgeon to fit the small
bone anatomy. All screws consist of a 6-4 Alloyed Titanium
material to ASTM F136. All I.T.S. small plates and screws are
processed with an anodize DOTIZE surface treatment. The low-
profile and contoured small plate design minimizes soft-tissue
irritation for the patient.
Associated instrumentation such as Plate Holder, Drills, Drill
Guides, Depth Guage, Countersink Reamers, Guide Wire and
ancillary instrumentation is available. All small plates and screws
are provided Non-Sterile. |
| INTENDED USE: | The intended use of the I.T.S. Hand Locking Plates System - HLS
is to draw two or more aligned bone fragments together to
facilitate healing in an adult patient. |
| | The I.T.S. Hand Locking Plates System - HLS is indicated for
use in fracture fixation of: |
| | the phalanges, the metacarpal bones, the carpal bones, for arthrodesis, for corrective osteotomies, and for subcapital radial head fractures. |
| | The I.T.S. Hand Locking Plates System is not for spinal use. |
| EQUIVALENCE: | The I.T.S. GmbH Hand Locking Plates System - HLS is
Substantially Equivalent (SE) to the Stryker, Synthes,
Biomet/DePuy and I.T.S. GmbH bone plate/screw systems. No
nonclinical testing was used in the determination of Substantial
Equivalence (SE). |
| SUMMARY OF TECH-
NOLOGICAL CHAR-
ACTERISTICS | The I.T.S. GmbH Hand Locking Plates System - HLS is Similar in
Material, Geometry Design/Markings, and Indications to Stryker,
Synthes and Biomet/DePuy predicate system(s) currently sold in
the U.S. market. |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The I.T.S. GmbH Hand Locking Plates System - HLS is shown to
be safe and effective for use in fracture fixation of small bones in
the hand. |
Page 1 of 2
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Section XII
் பட்டி போட்டிகள் விட
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Section XII
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .