(290 days)
No
The 510(k) summary describes a system of bone screws and focuses on mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
No.
This device is for fracture fixation and osteotomies of bones, which is a structural or mechanical function rather than a therapeutic one that restores or heals a biological function or condition.
No
This device is a Cannulated Screw System intended for fracture fixation, fusion, and osteotomies, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it includes physical screws and optional washers made of Titanium Alloy, which are 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 for "fracture fixation, fusion and osteotomies of bones." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Cannulated Screw System" made of titanium alloy. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples outside the body. This device is a surgical implant used for treatment inside the body.
N/A
Intended Use / Indications for Use
IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.
Acutec Headless Compression Screw:
Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.
Cannulated Screw:
Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
IRENE Cannulated Screw System includes two kinds of screws, Acutec Headless Compression Screw and Cannulated Screw. Acutec Headless Compression Screw has six different diameters in various lengths and is manufactured from Titanium Alloy (ASTM F 136 and ISO 5832-3). Cannulated Screw has four different diameters in various lengths and contains two optional washers. Cannulated Screw and washers are manufactured from Titanium Alloy (ISO 5832-3).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bones appropriate for the size of the device, clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus, and other small bones.
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)
Mechanical testing is conducted to demonstrate that differences in technological characteristics of the proposed device to predicate device do not raise new questions regarding safety and effectiveness, and Substantially Equivalent to the predicate device is thus concluded. The testing including torsional properties, driving torque test and axial pullout test incorporates the following standard as test method to evaluate the performance of both proposed and predicate device: ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws.
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.
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
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 human profiles facing to the right, with a symbolic representation of a parent cradling a child.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Tianjin ZhengTian Medical Instrument Co., Ltd Wang Qi Regulatory Affairs Specialist No.318, Jingyi Road, Airport Economic Zone Tianjin, CN 100082 P.R. China
October 23, 2017
Re: K170056
Trade/Device Name: IRENE Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 26, 2017 Received: 09/26/2017
Dear Wang Qi:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (21 CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name IRENE Cannulated Screw System
Indications for Use (Describe)
IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.
Acutec Headless Compression Screw:
Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.
Cannulated Screw:
Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
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3
510(k) Summary
In accordance with 21 CFR$807.92 and the Safe Medical Devices Act of 1990, the following information is provided for IRENE Cannulated Screw System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, "Format for Traditional and Abbreviated 510(k)", issued on August 12, 2005.
1. 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 Manager Tel: +86 10 82292929 Fax: +86 10 82290740 E-mail: xiangzhaojun@naton.cn Date of preparation of the Summary: Oct 17, 2017
2. Submission Contact
Wang, Qi Position: Regulatory Affairs Specialist Tel: +86 10 82292929 E-mail: wangqi@naton.cn
3. Proposed Device
Trade Name: IRENE Cannulated Screw System Common Name: Screw, Fixation, Bone Class: Class 2 Regulation: 21 CFR 888.3040 Product Code: HWC (Bone Fixation Screw) Review Panel: Orthopedic
Device description:
IRENE Cannulated Screw System includes two kinds of screws, Acutec Headless Compression Screw and Cannulated Screw. Acutec Headless Compression Screw has six different diameters in various lengths and is
4
manufactured from Titanium Alloy (ASTM F 136 and ISO 5832-3). Cannulated Screw has four different diameters in various lengths and contains two optional washers. Cannulated Screw and washers are manufactured from Titanium Alloy (ISO 5832-3).
Indication for use:
IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.
Acutec Headless Compression Screw:
Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.
Cannulated Screw:
Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.
| Predicate Device 1 | Predicate Device 2 | Reference Device | |
|---|---|---|---|
| 510(k) | |||
| Number | K063298 | K100359 | K151508 |
| Predicate | |||
| Device Name | OsteoMed Headless | ||
| Cannulated Screw | |||
| System | DARCO® Headed | ||
| Cannulated Screws | IRENE Locking | ||
| Compression Plate | |||
| System | |||
| Manufacture | OsteoMed | Wright | Zhengtian |
| Classification | 888.3040(HWC) | 888.3040(HWC) | 888.3040(HWC) |
| 888.3030(HRS) |
4. Predicate Device and Reference Device
5. Preclinical Data
Mechanical testing is conducted to demonstrate that differences in technological characteristics of the proposed device to predicate device do not raise new questions regarding safety and effectiveness, and Substantially Equivalent to the predicate device is thus concluded. The testing including torsional properties, driving torque test and axial pullout test incorporates the following standard as test method to evaluate the performance of both proposed and predicate device: ASTM F543-13, Standard
5
Specification and Test Methods for Metallic Medical Bone Screws.
6. Clinical Data
No clinical data is presented in this submission.
7. Substantial Equivalence Comparison
Table 1: comparison between Acutec Headless Compression Screw and predicate devices 1
| Element | Proposed Device
Acutec Headless Compression
Screw | Predicate Device 1
OsteoMed Headless Cannulated
Screw System |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class | 2 | 2 |
| Regulation
number | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Indication
for use | Used for fusion, fractures, or
osteotomies of the clavicle,
humerus, radius, ulna, ilium,
femur, patella, fibula, tibia, talus,
malleolus, calcaneus and other
small bones. | The OsteoMed Headless Screw
System is indicated for use in
bone reconstruction, osteotomy,
arthrodesis, joint fusion, fracture
repair, and fracture fixation of
bone appropriate for the size of
the device. Screws are intended
for single use only. |
| Material | Ti6Al4V | Ti6Al4V |
| Design | Fully threaded, headless,
cannulated | Headless, cannulated |
| Diameter | 2.57.5mm | 2.06.5mm |
| Length | 8120mm | 10120mm |
| Supplied | Non-sterile | Non-sterile |
| Single-use
only | Yes | Yes |
| Sterilization | Steam sterilization | Steam sterilization |
Table 2: comparison between Cannulated Screw and predicate devices 2
| Element | Proposed Device | Predicate Device 2 |
|---|---|---|
| Cannulated Screw | Wright DARCO® Headed | |
| Cannulated Screws | ||
| Class | 2 | 2 |
| Regulation number | 21 CFR 888.3040 | 21 CFR 888.3040 |
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| Indication for use | |||
|---|---|---|---|
| Intended for bone fracture | |||
| fixation and bone fragment | |||
| fixation. Washers may be | |||
| used with the Cannulated | |||
| Screw in cases where the | |||
| patient has poor bone | |||
| quality. | Intended for use over a guide pin | ||
| or wire for bone fracture fixation | |||
| and bone fragment fixation. | |||
| Washers may be used with the | |||
| screws in cases where the | |||
| patients has poor bone quality. | |||
| Material | Ti6Al4V | Ti6Al4V | |
| Design | self-tapping, | ||
| cannulated | self-tapping/self-drilling, | ||
| cannulated | |||
| Diameter | 3.5~7.3mm | 2.7~7.5mm | |
| Length | 20~110mm | 8~120mm | |
| Supplied | Non-sterile | Non-sterile | |
| Single-use only | Yes | Yes | |
| Sterilization | Steam sterilization | Steam sterilization |
8. Substantial Equivalence Conclusion
The proposed device is found to possess 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 difference 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.