(266 days)
Not Found
No
The summary describes a mechanical bone plate and screw system for fracture fixation. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing, not data analysis or image processing.
No
The device is a metallic implant used for internal fixation of bone fractures, which is a structural support device rather than one that delivers therapy.
No
The device is described as an "IRENE Locking Compression Plate System" indicated for the "fixation of fractures." Its description details bone plates and screws for internal fixation. This functionality is therapeutic, not diagnostic.
No
The device description explicitly states that the system includes "bone plates and screws" and describes mechanical testing of these physical components, indicating it is a hardware medical device.
Based on the provided text, the IRENE Locking Compression Plate System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "fixation of fractures" in bones (ulna, radius, humerus, femur, and tibia). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "bone plates and screws" designed for "internal fixation of bones." These are implants used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples. The IRENE system is used in vivo (in the body) for structural support.
N/A
Intended Use / Indications for Use
The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.
Product codes
HRS, HWC
Device Description
The IRENE Locking Compression Plate System is designed for internal fixation of bones that subject to fracture. The system includes bone plates and screws that can be used with the plate. Various sizes of plate are available for different fracture areas or clinical conditions. Bone screws are incorporated in the system and are intended to fix with plate with appropriate size. The plate has a limited-contact design. The plate system is provided unsterile. And the system is intended for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, radius, humerus, femur, and tibia
Indicated Patient Age Range
above 21
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)
Mechanical testing is conducted to demonstrate differences in technological characteristics of the proposed device to predicate device do not raise new question regarding safety and effectiveness, and Substantially Equivalent to the predicate device is thus concluded. The testing incorporates the following standards as test method to evaluate the performance of both proposed and predicate device:
- ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
- ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws.
Plate: static and dynamic testing conducted as per ASTM F382-13
Screw: torsional properties, driving torque and pull-out strength are conducted as per ASTM F543-13
Results of testing indicates no gap between the level of performance of proposed device and the predicate device, through which the differences are deemed not relevant to device performance and has been justified, and the conclusion of Substantial Equivalence is reached.
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.
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the human element of the department's work.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Tianjin Zhengtian Medical Instrument Co., Ltd Yifan Fu Regulatory Affairs Specialist No.318, Jingyi Road, Airport Economic Zone Tianjin, 300308 CHINA
February 25, 2016
Re: K151508 Trade/Device Name: IRENE Locking Compression Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 8, 2016 Received: January 13, 2016
Dear Yifan Fu:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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 yours,
Mark N. Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
IRENE Locking Compression Plate System
Indications for Use (Describe)
The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.
Type of Use (Select one or both, as applicable)
즈 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows the word "IRENE" in white text on a blue background. The text is in a sans-serif font and is horizontally centered. The blue background appears to be a solid color, providing a clean and simple backdrop for the text.
Section 10 510(k) Summary
This document is prepared to provide sufficient information for an understanding of the basis for the determination of substantial equivalence, as required by 21 CFR section 807.92(c).
-
- 510(k) Submitter and Owner
Tianjin ZhengTian Medical Instrument Co., Ltd Address: No.318, Jingyi Road, Airport Economic Zone, Tianjin, P.R. China Official Correspondent: Xiang, Zhaojun Position: Regulatory Affairs Supervisor Tel: +86 10 82292929 Fax: +86 10 82290740 E-mail: xiangzhaojun@naton.cn Date of Preparation of the Summary: Feb 25th, 2016
- 510(k) Submitter and Owner
-
- Submission Contact Fu, Yifan Position: Regulatory Affairs Specialist Tel: +86 10 82292929 E-mail: fuyifan@naton.cn
-
- Proposed Device
Trade name - IRENE Locking Compression Plate System Common name - Locking compression plate and screw Class: Class 2
Regulation -21 CFR 888.3030, Product Code HRS (Bone Fixation Plate) -21 CFR 888.3040, Product Code HWC (Bone Fixation Screw)
Review Panel: Orthopedic
The IRENE Locking Compression Plate System is designed for internal fixation of bones that subject to fracture. The system includes bone plates and screws that can be used with the plate. Various sizes of plate are available for different fracture areas or clinical conditions. Bone screws are incorporated in the system and are intended to fix with plate with appropriate size. The plate has a limited-contact design. The plate system is provided unsterile. And the system is intended for
4
Image /page/4/Picture/1 description: The image shows the word "IRENE" in white font against a blue background. The font is sans-serif and appears to be bold. The background is a solid, light blue color, providing a clean and simple backdrop for the text.
single-use.
Indications for Use:
The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.
-
- Predicate Device
| Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | |
|---|---|---|---|
| 510(k) Number | K101400 | K100721 | K112819 |
| Predicate Device Name | Locking Bone Plate | Locking Bone Screw | 3.5mm Locking Screw |
| Manufacturer | Changzhou Orthmed Medical Instrument Co., Ltd. | Xiamen Double Engine Medical Material Co., Ltd. | |
| Classification | 888.3030(HRS) | 888.3040(HWC) | 888.3040(HWC) |
-
- Preclinical Data
Mechanical testing is conducted to demonstrate differences in technological characteristics of the proposed device to predicate device do not raise new question regarding safety and effectiveness, and Substantially Equivalent to the predicate device is thus concluded. The testing incorporates the following standards as test method to evaluate the performance of both proposed and predicate device:
- Preclinical Data
-
- ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
-
- ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws.
-
- Clinical Data
No clinical data is presented in this submission.
-
- Substantial Equivalence Comparison
5
IRENE
| Element | Proposed Device
IRENE Plate and
Screw | Predicate Device
Orthmed Plate and
Screw | Predicate Device
Double Engine
3.5mm Locking
Screw |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Class | 2 | 2 | 2 |
| Regulation
number | Plate: 21 CFR
888.3030
Screw: 21 CFR
888.3040 | Plate: 21 CFR
888.3030
Screw: 21 CFR
888.3040 | Not referenced
Screw: 21 CFR
888.3040 |
| Intended use | Internal fixation of
bone fractures | Internal fixation of
bone fractures | Internal fixation of
bone fractures |
| Design | Plate: straight, tubular
cross-section, locking
compression screw
hole, has limited
contact area. | Plate: straight,
tubular cross-
section, locking
compression screw
hole, has limited
contact area.
Dimensions and
contour has slight
difference.
Screw: self-tapping,
fully threaded
locking screw. The
contour has very
slight difference. | Not referenced
Screw: 3.5mm
diameter, self-
tapping locking
screw. |
| Material | Plate: titanium
Screw: titanium alloy | Plate: titanium alloy
Screw: titanium
alloy | Not referenced
Screw: titanium
alloy |
| How Supplied | Non-sterile | Non-sterile | Non-Sterile |
| Single-Use
Only | Yes | Yes | Yes |
| Sterilization | Moist heat
sterilization prior to
use | Moist heat
sterilization prior to
use | Moist heat
sterilization prior
to use |
| Performance
data | Plate: static and
dynamic testing
conducted as per
ASTM F382-13
Screw: torsional | Plate: static and
dynamic testing
conducted as per
ASTM F382-13
Screw: torsional | Not referenced
Screw: |
| properties, driving
torque and pull-out
strength are conducted
as per ASTM F543-13 | properties, driving
torque and pull-out
strength are
conducted as per
ASTM F543-13 | performance
testing conducted
as per ASTM
F543-07 | |
6
IRENE
The proposed device is found to possess highly similar technological characteristics on design under the premises of sharing same intended use. Device performance is compared through the testing of mechanical properties of the proposed and predicate device by methods stipulated in published standards in order to evaluate whether differences existing in the design raise safety issue by compromising performance. Results of testing indicates no gap between the level of performance of proposed device and the predicate device, through which the differences are deemed not relevant to device performance and has been justified, and the conclusion of Substantial Equivalence is reached.