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.

AI/ML Overview

This document describes a 510(k) premarket notification for the "WASTON Metallic Intramedullary Nail System." It is a medical device submission, and therefore, the acceptance criteria and study data provided are related to the substantial equivalence of the proposed device to a predicate device, rather than a standalone clinical AI or diagnostic performance study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" isn't typically phrased as a specific numerical performance target, but rather as demonstrating substantial equivalence (SE) to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

The document presents a comparison between the proposed device and the predicate device (K132078) to demonstrate this substantial equivalence.

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance (Comparison to Predicate)
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: Supplied non-sterile, sterilized by hospital to achieve SAL 1x10-6	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: 240~340 mm	Same
Physical Specification (Screw): Diameter: φ6mm; Length: 20~95 mm	Similar (Implies slight variations within acceptable limits, not explicitly stated as "same")
Mechanical Specification (Nail): Static bending, Dynamic bending and Static Torsional performance tested per ASTM F1264	Same (Implies meeting the same test standards and performance levels)
Mechanical Specification (Screw): Dynamic bending performance tested per ASTM F1264; Driving torque and pull-out performance tested per ASTM F543	Same (Implies meeting the same test standards and performance levels)
Non-clinical tests verify design specifications and SE to predicate.	Complies with ASTM F1264-03, ASTM F543-13, ASTM F136-13, ASTM F138-13, ISO 17665-1:2006 (See Section 6 of the 510(k) Summary)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document explicitly states: "No clinical study is included in this submission."

Therefore, there is no "test set" in the context of clinical or diagnostic performance data. The "tests" mentioned are non-clinical (mechanical, material, sterilization) and are typically performed on samples of the device components (e.g., a certain number of nails, screws). The sample sizes for these non-clinical tests are not detailed in this summary. The data provenance would be from the manufacturing and testing facilities of Changzhou Waston Medical Appliance Co., Ltd. in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As stated, no clinical study or ground truth establishment based on expert review was performed or included in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a metallic intramedullary nail system for fracture fixation, not an AI or diagnostic imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" would be established by reference to international consensus standards (e.g., ASTM, ISO) for material properties and mechanical performance.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI or machine learning device.

Summary

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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

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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

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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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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:

1. Date of Preparation: 01/13/2015
1. 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

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Jing Cheng (Alternative Contact Person)

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

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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

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

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1. 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:
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.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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Ref.:M0232014

Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device(s)	Predicate DeviceK132078
Product Code	HSB	Same
Regulation Number	21 CFR 888.3020	Same
Intended Use	Simple, compound first- and second-degree tibial shaft fracturesPseudarthrosis 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
PhysicalSpecification	Nail Proximal/Distal diameter: φ10/φ8 mm, φ10/φ9 mm, φ10/φ10 mm;Length: 240~340 mm	Same
	Screw Diameter: φ6mmLength: 20~95 mm	Similar

MechanicalSpecification	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.

Regulation Number and Section

§ 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.