(241 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of a metallic intramedullary nail system, with no mention of AI or ML technologies.
Yes
The device is designed for "fracture fixation and stabilization of the tibia," which is a therapeutic purpose.
No
This device is a surgical implant designed for fracture fixation and stabilization of the tibia, not for diagnosing conditions.
No
The device description explicitly states it is a "Metallic Intramedullary Nail System" consisting of physical components like an intramedullary nail, locking screw, end cap, and instruments, all made from Ti-6Al-4V alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation and stabilization of tibial shaft fractures, pseudarthrosis, and delayed union. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a metallic intramedullary nail system, which is an implantable medical device used in orthopedic surgery.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze samples from the human body (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
IVD devices are used to perform tests on samples taken from the human body to provide diagnostic information. This device is a therapeutic device used within the human body to treat a physical condition.
N/A
Intended Use / Indications for Use
- Simple, compound first- and second-degree tibial shaft fractures
- Pseudarthrosis and delayed union
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The WASTON Metallic Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments.
The intramedullary nail is available in a variety of lengths to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections.
All implants of Metallic Intramedullary Nail System are manufactured from Ti-6Al-4V alloy that meets the requirements of ASTM F-136.
The proposed devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibial shaft
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F1264-03 (Reapproved 2012): Standard specification and test methods for A intramedullary fixation devices.
- ASTM F543-13: Standard specification and test method for metallic medical bone screws.
- ASTM F136-13: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI A (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56401).
- ASTM F138-13, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
- ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
No clinical study is included in this submission.
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.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
December 17, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Changzhou Waston Medical Appliance Company, Limited % Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K151062
Trade/Device Name: WASTON Metallic Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 30, 2015 Received: November 3, 2015
Dear Ms. Hong:
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 N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARIMENI OE HEALIH 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) K151062
Device Name
WASTON Metallic Intramedullary Nail System
Indications for Use (Describe) · Simple, compound first- and second-degree tibial shaft fractures · Pseudarthrosis and delayed union
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPEETED 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."
3
Tab #7 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
K151062 The assigned 510(k) Number:
-
- Date of Preparation: 01/13/2015
-
- Sponsor Identification
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD. 9 Xihu Road, Wujin Hi-tech Industry Zone, Changzhou, Jiangsu, 213168, China
Establishment Registration Number: Not yet registered
Contact Person: Mr. Jack Lu Position: International Department Director Tel: +86-519-8652226 Fax: +86-519-86221108 Email: Waston18@gmail.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
Ref.:M0232014
4. Identification of Proposed Device
Trade Name: WASTON Metallic Intramedullary Nail System Common Name: Intramedullary nail
Regulatory Information
Classification Name: rod, fixation, intramedullary and accessories; Classification: II Product Code: HSB Regulation Number: 21 CFR 888.3020 Review Panel: Orthopedic
Intended Use Statement:
- · Simple, compound first- and second-degree tibial shaft fractures
- Pseudarthrosis and delayed union
Device Description
The WASTON Metallic Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments.
The intramedullary nail is available in a variety of lengths to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections.
All implants of Metallic Intramedullary Nail System are manufactured from Ti-6Al-4V alloy that meets the requirements of ASTM F-136.
The proposed devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.
- ર . Identification of Predicate Device
510(k) Number: K132078 Product Name: Metallic Intramedullary Nail System
5
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ASTM F1264-03 (Reapproved 2012): Standard specification and test methods for A intramedullary fixation devices.
-
ASTM F543-13: Standard specification and test method for metallic medical bone screws. >
-
ASTM F136-13: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI A (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56401).
-
ASTM F138-13, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
-
ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
Ref.:M0232014
Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device(s) | Predicate Device
K132078 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Code | HSB | Same |
| Regulation Number | 21 CFR 888.3020 | Same |
| Intended Use | Simple, compound first- and second-degree tibial shaft fractures
Pseudarthrosis and delayed union | Same |
| Configuration | Nail, Screw and End Cap | Same |
| Sterile | The devices are supplied non-sterile, it should be sterilized prior to use by professional and the sterilization should achieve SAL 1×10-6 | Same |
| Single Use | Yes | Same |
| Material | Titanium Alloy (TI -6A1-4 V ELI) | Same |
| Physical
Specification | Nail Proximal/Distal diameter: φ10/φ8 mm, φ10/φ9 mm, φ10/φ10 mm;
Length: 240340 mm | Same |95 mm | Similar |
| | Screw Diameter: φ6mm
Length: 20
| | | |
| Mechanical
Specification | Nail Static bending, Dynamic bending and Static Torsional performance were tested per ASTM F1264 | Same |
| | Screw Dynamic bending performance was tested per ASTM F1264;
Driving torque and pull-out performance were tested per ASTM F543 | Same |
| | | |
Table 1 Comparison of Technology Characteristics
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.