SmartSet MV Endurance Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

SmartSet GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

SmartMix Cemvac is a vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid. The device is for single use only and reduces exposure to monomer fumcs and cement porosity during preparation and avoids handling of bone cement during cement delivery. The device is available in a single 60g or 100g unit. Each unit pack consists of the following:
. A syringe barrel assembly pre-packed with bone cement powder.
. A monomer cartridge pre-loaded with two ampoules of bone cement liquid.
= Accessories consisting of a disposable mixing stand, a vacuum hose with filter attached, a vacuum tube adaptor and a central mixing rod.

SmartMix Bowl is a vacuum mixing system pre-packed with bone cement powder and liguid. The device is for single us only and reduces exposure to monomer fumes and cement porosity during preparation. The device is available in single 80g units. Each unit pack consists of the following:
. A bowl base pre-packed with bone cement powder.
T A monomer cartridge pre-loaded with two ampoules of bone cement liquid.
. Accessories consisting of a bowl lid with vacuum hose and filter attached, a vacuum tube adaptor and a spatula.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "SmartMix Pre-filled Mixing System." This document primarily focuses on demonstrating substantial equivalence to already approved predicate devices and does not contain information about specific acceptance criteria, device performance, or a clinical study in the format requested.

The document discusses the device's design, materials, intended use, and states that "On testing, the pre-packed bone cements have been found to be stable on storage in both systems and when mixed in SmartMix Cemvac and SmartMix Bowl, the physicomechanical properties and elution profile (for the medicated bone cement) have shown to be equivalent to mixing by the conventional bowl and spatula technique." However, it does not provide:

A table of acceptance criteria and reported device performance: The document only makes a general statement about equivalence regarding physicomechanical properties and elution profiles. It does not quantify these properties or define specific thresholds for acceptance.
Details of a study: There is no description of a study design, sample sizes, data provenance, ground truth establishment, or expert involvement. The testing mentioned appears to be bench testing rather than a clinical study evaluating diagnostic performance.
Information related to AI or a "multi-reader multi-case (MRMC) comparative effectiveness study": This device is a bone cement mixing system, not an AI-powered diagnostic tool. Therefore, these sections are not applicable.
Sample size for training set or how ground truth was established for a training set: Again, this relates to AI/machine learning studies, which is not what this document describes.

In summary, the provided text does not contain the information necessary to fulfill the request as it describes a non-AI medical device and a regulatory submission focused on substantial equivalence rather than a detailed performance study with acceptance criteria and clinical outcomes.

Summary

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OCT 2 2004

K042591

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SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveP.O. Box 988Warsaw, Indiana 46581-0988
MANUFACTURER:	DePuy International LtdTrading As DePuy CMWCornford RoadBlackpool, LancashireFY4 4QQ, England
510(k) CONTACT:	Tiffani RogersDePuy Orthopaedics, IncRegulatory Affairs AssociateTel: (574) 371-4927 Fax: (574) 371-4978E-mail: trogers1@dpyus.jnj.com
TRADE NAME:	SmartMix Pre-filled Mixing System
COMMON NAME:	Pre-filled Bone Cement Mixer for Clinical UsePre-filled Bone Cement Dispenser
CLASSIFICATION:	Cement Mixer for Clinical Use: Class I Exempt per CFR 888.4210Cement Dispenser: Class I Exempt per 21 CFR 888.4200PMMA Bone Cement: Class II per 21 CFR 888.3027
DEVICE CODE:	KIH pre-filled with LODJDZ pre-filled with LOD
SUBSTANTIALLYEQUIVALENT DEVICES:	Endurance Bone Cement: P960001 Supplement 1

SmartSet GMV Endurance Gentamicin Bone Cement: K033382 and K041656 Cemvac Ultra pre-packed with DePuy 1 Bone Cement: K021499

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DEVICE DESCRIPTIONS AND INDICATIONS:

SmartMix Cemvac

. A syringe barrel assembly pre-packed with bone cement powder.
. A monomer cartridge pre-loaded with two ampoules of bone cement liquid.
= Accessories consisting of a disposable mixing stand, a vacuum hose with filter attached, a vacuum tube adaptor and a central mixing rod.

SmartMix Bowl

. A bowl base pre-packed with bone cement powder.
T A monomer cartridge pre-loaded with two ampoules of bone cement liquid.
. Accessories consisting of a bowl lid with vacuum hose and filter attached, a vacuum tube adaptor and a spatula.

SmartSet MV Endurance Bone Cement

SmartSet MV Endurance Bone Cement is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe ioint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

SmartSet GMV Endurance Gentamicin Bone Cement

SmartSet GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

BASIS FOR SUBSTANTIAL EQUIVALENCE:

With the exception of the primary packaging of the powder component when pre-packed in SmartMix Cemvac or SmartMix Bowl, the bone cement formulations and indications for use are identical to their equivalent standard pack bone cements cleared by the FDA as follows:

I SmartSet MV Endurance Bone Cement listed as a note to file in February 2004 (a rebrand of the Endurance Bone Cement initially cleared by the FDA under P960001 Supplement 1 on 12th November 1997). Labeling was amended to reflect the re-branded cement. The formulation, specifications and indications of the bone cement remain the same.

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SmartSet GMV Endurance Gentamicin Bone Cement was initially cleared under . K033382 on 5th February 2004 and later under K041656 on 1st July 2004 when the Gentamicin particle size was change from micronised to non-micronised.
Based on the similarities of design, materials, intended use and testing, the following devices are substantially equivalent to FDA cleared devices currently on the market.
. SmartMix Cemvac + SmartSet MV Endurance Bone Cement
프 SmartMix Bowl + SmartSet MV Endurance Bone Cement
SmartMix Cemvac + SmartSet GMV Endurance Gentamicin Bone Cement
I SmartMix Bowl + SmartSct GMV Endurance Gentamicin Bonc Cement

On testing, the pre-packed bone cements have been found to be stable on storage in both systems and when mixed in SmartMix Cemvac and SmartMix Bowl, the physicomechanical properties and elution profile (for the medicated bone cement) have shown to be equivalent to mixing by the conventional bowl and spatula technique.

The materials used in the primary packaging of the powder component for both SmartMix Ccmvac and SmartMix Bowl are the same as those used in Cemvac Ultra pre-packed with DePuy 1 Bone Cement (cleared by FDA under K021499 on 24" July 2002). The materials that come into contact with the powder and liquid components have been found to be compatible in their use application.

Predicate devices include SmartSet MV Endurance Bone Cement, SmartSet GMV Endurance Gentamicin Bone Cement and Cemvac Ultra pre-packed with DePuy 1 Bone Cement.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

Ms. Tiffani Rogers Regulatory Affairs Associate Depuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581

Re: K042591

K042591
Trade/Device Name: SmartMix Pre-Filled Mixing System Trade/Device Name: "Smartivity Pre Philos Carries 888.4200 and 21 CFR 888.3027 Regulation Name: Cement mixer for clinical use, Cement dispenser, Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: KIH, JDZ, LOD and MBB Dated: September 21, 2004 Received: September 23, 2004

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premainted insubstantially equivalent (for the indications ferenced above and nave determines ally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard cate of the Medical Device Amendments, or to commerce prior to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvise the general controls provisions of the Act. The I ou may, merclore, manel the Act include requirements for annual registration, listing of general controls provisions of the 110 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 If your device is classified (soc worrols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obacements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Driviseanse over device complies with other requirements of the Act that I 1271 has made a wond regulations administered by other Federal agencies. You must

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Page 2 - Ms. Tiffani Rogers

comply with all the Act's requirements, including, but not limited to: registration and listing (21 let comply with an the Act s requirements, merading, career
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 form in the quality systems (QD) regardin (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification. "The PDF miding of basification 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 specific advice for your ac 1100 0.000. Also, please note the regulation entitled, Contact the Office of Compitalies as (Set notification" (21CFR Part 807.97). You may obtain Misoranuing by reference to premantontibilities under the Act from the Division of Small other general information on your respense at its toll-free number (800) 638-2041 or Manufacturers, International and Goless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Mali n. Milkenm

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ Device Name: SmartMix Pre-filled System

Indications for Use:

Device Name (unmedicated pre-filled systems):

SmartMix Cemvac + SmartSet MV Endurance Bone Cement SmartMix Bowl + SmartSet MV Endurance Bone Cement

Indications:

Device Name (medicated pre-filled systems):

SmartMix Cemvac + SmartSet GMV Endurance Gentamicin Bone Cement SmartMix Bowl + SmartSet GMV Endurance Gentamicin Bone Cement

Indications:

SmartSet GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Prescription Use	X (Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use	(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page	of
510(k) Number	K042591

Regulation Number and Section

§ 888.4200 Cement dispenser.

(a)
Identification. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.