Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral eptiphysis
Patients suffering from disability due to previous fusion
Patients with acute femoral neck fractures

Device Description

The BiContact Hip System with u-CaP® is available in one design. The femoral stem is manufactured from Ti with a Ti plasma spray coating (Plasmapore®) and a layer of Calcium Phosphate. This component is intended for uncemented use. A CoCrMo femoral head is available. The acetabular cup is manufactured solely of UHMWPE.

AI/ML Overview

The provided text is a 510(k) summary for the BiContact Hip System with u-CaP®, which is a medical device. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the device meets specific acceptance criteria through a clinical study with reported performance metrics.

Therefore, many of the requested details related to acceptance criteria, specific performance statistics, expert adjudication, stand-alone performance, and training/test set ground truth establishment cannot be found in this document. This is common for 510(k) submissions, which often rely on bench testing and comparison to predicates for clearance.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of a table with specific acceptance criteria and corresponding reported performance values (e.g., accuracy, sensitivity, specificity, mechanical strength tolerances). The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable," and lists several other guidance documents. This implies that the device met the requirements outlined in those guidances, but the specific metrics and their acceptance ranges are not detailed here.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document details various "Performance Data" which are likely results from bench testing (mechanical, material, coating properties) rather than a clinical "test set" with human data. The provenance of any such data is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. As the submission focuses on substantial equivalence based on technical characteristics and bench testing, there is no mention of a "ground truth" established by human experts in the context of device performance in a clinical scenario.

4. Adjudication Method for the Test Set

This information is not provided. There is no indication of a clinical "test set" or any adjudication process involving expert assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided, and it is highly unlikely such a study was performed or required for a 510(k) submission for this type of orthopedic implant. MRMC studies are typically associated with diagnostic imaging devices where human interpretation is a key factor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a physical orthopedic implant (hip system), not a software algorithm with standalone performance metrics.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would primarily be established through engineering specifications, material science testing, and adherence to relevant industry standards and guidance documents (as listed in the "Performance Data" section). For example, the "ground truth" for coating adherence might be defined by a specific load or cycling test failure threshold. There is no mention of pathology, expert consensus, or outcomes data being directly used as "ground truth" for the clearance in this document.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical orthopedic implant. There is no concept of a "training set" in the context of an algorithm for this product type.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary of available information from the document:

The document describes the intended use of the BiContact Hip System with u-CaP® to replace a hip joint in patients with various conditions like arthritis, avascular necrosis, congenital hip dysplasia, previous fusion, and acute femoral neck fractures.
The device is a Class II medical device.
Performance data refers to various required testing per established guidance documents for orthopedic devices, metallic surfaces, plasma-sprayed coatings, modular implant components, femoral stem prostheses, and calcium phosphate coatings. The specific results of these tests (e.g., acceptance criteria values and observed performance values) are not detailed in this summary.
The device claims substantial equivalence to four predicate devices: BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963), and Corail (K953111). This substantial equivalence is the primary basis for its clearance, rather than a novel clinical effectiveness study.

Summary

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DEC - 8 2004

Image /page/0/Picture/3 description: The image shows a handwritten string of characters, "K043079". The characters are written in a bold, somewhat messy style, with thick strokes. The numbers are easily readable, and the letter K is distinct.

Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

BICONTACT HIP SYSTEM with u-CAP®

November 5, 2004

Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
Kathy A. Racosky, Regulatory Affairs Associate CONTACT: 800-258-1946 (phone) 610-791-6882 (fax) kathy.racosky @ aesculap.com (email)
TRADE NAME: BiContact
BiContact Hip System with u-CaP® COMMON NAME:
DEVICE CLASS: Class II
PRODUCT CODE: 87MEH
Orthopedic REVIEW PANEL:

INTENDED USE

The BiContact Hip System with u-CaP® (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint.

The device is intended for:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . eptiphysis
. Patients suffering from disability due to previous fusion
Patients with acute femoral neck fractures .

DEVICE DESCRIPTION

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043079

Page 2 of 2

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;

"Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces . Apposing Bone or Bone Cement",
"Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic . Implants to Support Reconsideration of Postmarket Surveillance Requirements",
"Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant . Components",
. "Draft Guidance for Femoral Stem Prostheses",
. "Draft Guidance for Calcium Phosphate (Ca-P) Coating" was completed where applicable.

SUBSTANTIAL EQUIVALENCE

The Aesculap BiContact Hip System with u-CaP® is essentially identical to the BiContact Hip System (K040191), Accolade-TMZF Plus HA Hip System (K023102), Taperloc Porous Femoral Stem & Ha Taperloc Porous (K020963) and the Corail (K953111).

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2004

Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap Inc 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K043079

Trade/Device Name: BiContact Hip System with μ-Cap Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH Dated: November 5, 2004 Received: November 9, 2004

Dear Ms. Racosky:

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 10 mover ce 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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Page 2 – Ms. Kathy A. Racosky

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yours ough anding of substantial equivalence of your device to a legally prematicated predicated on "The classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spocific acrievier - at (240) 276-0210. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Whisofanding by reference to premains on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milhem

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K043079

Device Name: BiContact Hip System with u-CaP®

Indication for Use:

The BiContact Hip System with u-CaP® (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint.

The device is intended for:

. Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral ● eptiphysis
Patients suffering from disability due to previous fusion .
Patients with acute femoral neck fractures .

Mark A. Mullens

(Division Sign-Off)

Prescription Use __

(per 21 CFR 801.109)

or Over-the Dissio ral, Restorative. and Neurological Devices

510(k) Number K043079

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.