The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

The BiPolar-i is intended for use in the following indications:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement,
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
Revision of failed partial hip replacements in which the acetabulum does not require replacement

The BiPolar-i is indicated for cementless use only.

Device Description

The BiPolar-i is a preassembled bipolar head comprised of an ultra-high molecular weight polyethylene (UHMWPE) liner and a highly polished cobalt-chromium alloy (CoCr) outer shell. The BiPolar-i is used in combination with a 22mm or 28mm CoCr modular head (dependent on the BiPolar i size) and compatible hip stem, both supplied separately. When assembled, the modular head is maintained captive and articulates within the UHMWPE liner. The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. The BiPolar-i is intended for use with a Corin femoral head and hip stem prosthesis with a compatible 12/14 taper connection and is designed to articulate in the patient's natural acetabulum.

AI/ML Overview

The provided document is a 510(k) summary for the Corin BiPolar-i, a hip joint femoral (hemi-hip) metal/polymer prosthesis. This document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, intended use, and non-clinical testing. It explicitly states that clinical testing was not necessary for this particular submission.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not available within this document because a clinical study of the device's performance against pre-defined acceptance criteria was not conducted or reported for this 510(k) submission.

This type of submission relies heavily on non-clinical testing to demonstrate that the new device performs as safely and effectively as legally marketed predicate devices, rather than establishing numerical performance metrics against acceptance criteria from a clinical trial.

However, I can provide the non-clinical testing information that was conducted:

1. Acceptance Criteria and Device Performance (from non-clinical testing):

Acceptance Criteria (from recognized standards)	Reported Device Performance
ASTM F1820-13 (Pull-out & Lever-out Force)	Results show substantial equivalence to the predicate device.
Assembly Testing	Results show substantial equivalence to the predicate device.
ISO 21535:2007/Amd1:2016 (Range of Motion)	Results show substantial equivalence to the predicate device.
Evaluation of Impingement & Wear	Results show substantial equivalence to the predicate device.
Bacterial Endotoxin Testing (BET)	Conducted on finished, sterilized product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology (results not numerically detailed but assumed to meet standards for sterility).

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical human test set was used. This refers to non-clinical laboratory testing. The document does not specify the sample sizes used for each non-clinical test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical human test set requiring expert ground truth was used.

4. Adjudication method for the test set: Not applicable, as no clinical human test set 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 physical hip prosthesis, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip prosthesis, not an algorithm.

7. The type of ground truth used: For the non-clinical testing, the "ground truth" is defined by the requirements and test methodologies outlined in the referenced ASTM and ISO standards, and the performance of the predicate device. For BET, it's the absence of bacterial endotoxins.

8. The sample size for the training set: Not applicable, as no training set for an algorithm was used.

9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Corin USA Limited Homer Trieu Regulatory Affairs Specialist 12750 Citrus Park Lane Tampa, Florida 33625

Re: K183114

Trade/Device Name: Corin BiPolar-i Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: April 24, 2019 Received: April 29, 2019

Dear Homer Trieu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

June 5, 2019

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

FOR CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K183114

Device Name Corin BiPolar-i

Indications for Use (Describe)

The BiPolar-i is intended for use in the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement,

· Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
· Revision of failed partial hip replacements in which the acetabulum does not require replacement

The BiPolar-i is indicated for cementless use only.

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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3. 510(K) SUMMARY

1. Applicant/Sponsor:Distributor	Corin USA Limited12750 Citrus Park LaneSuite 120, Tampa, FL 33625Establishment Registration No.: 1056629
2. Contact Person:	Homer Trieu, BEng (Hons)Regulatory Affairs SpecialistCorin Ltd+44 1285 655685homer.trieu@coringroup.com
	Lucinda Gerber, BA (Hons)Global Regulatory Affairs ManagerCorin Ltd / Corin USA1 (772) 321-2478lucinda.gerber@coringroup.com
3. Date:	November 08, 2018
4. Proprietary Name:	Corin BiPolar-i
5. Common Name:	Hip Prosthesis
6. Product Code(s):	KWY

Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented 7. Classification Name: prosthesis (21CFR 888.3390)
1. Legally Marketed Devices to which Substantial Equivalence is claimed:
- . Primary Predicate Device
  - Corin Bipolar (K925897) o
- Secondary Predicate Devices 0
  - Stryker UHR Universal Bipolar (K800207) o
  - Apex Hip System Bipolar Head (K082468) O

9. Device Description:

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10. Intended Use:

11. Indications for Use:

The BiPolar-i is intended for use in the following indications:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement,
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
0 Revision of failed partial hip replacements in which the acetabulum does not require replacement

The BiPolar-i is indicated for cementless use only.

12. Summary of Technologies / Substantial Equivalence:

The BiPolar-i is identical to the Corin Bipolar (K925897) in terms of material and similar in terms of design, intended use and indications for use. The outer shell size range is similar to that of Corin Bipolar (K925897), Stryker UHR Universal Bipolar (K800207) and Apex Hip System Bipolar Head (K082468). The femoral head sizes which are indicated for use with the Bipolar-i are similar to that of the Stryker UHR Universal Bipolar (K800207) and Apex Hip System Bipolar Head (K082468). Based on these similarities, the BiPolar-i is believed to be substantially equivalent to the predicate devices.

13. Non-Clinical Testing:

Non-clinical testing and analysis included pull-out & lever-out force (ASTM F1820-13), assembly testing, range of motion (ISO 21535:2007/Amd1:2016) and evaluation of impingement & wear. The results of these tests show that the Corin BiPolar-i is substantially equivalent to the predicate device.

Bacterial Endotoxin Testing (BET) has been conducted on finished, sterilized product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.

14. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the additional components of the BiPolar-i and the predicate devices.

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.