SMARTMIX PRE-FILLED MIXING SYSTEM

K042591 · DePuy Orthopaedics, Inc. · KIH · Oct 22, 2004 · Orthopedic

Device Facts

• Record ID: K042591
• Device Name: SMARTMIX PRE-FILLED MIXING SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KIH · Orthopedic
• Decision Date: Oct 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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 Story

SmartMix Pre-filled Mixing System (Cemvac or Bowl) is a vacuum mixing and delivery system for PMMA bone cement. System components include pre-packed bone cement powder, monomer liquid cartridges, and accessories (mixing stand, vacuum hose/filter, mixing rod/spatula). Device reduces monomer fume exposure and cement porosity during preparation; eliminates manual handling of cement during delivery. Used in clinical settings by surgical staff. Vacuum mixing process ensures consistent cement properties compared to conventional bowl/spatula methods. Output is prepared bone cement delivered via syringe or manual application for prosthesis fixation. Benefits include improved safety for staff and standardized cement quality for patient.

Clinical Evidence

No clinical data. Bench testing demonstrated that pre-packed bone cements are stable during storage and that mixing via SmartMix Cemvac and SmartMix Bowl yields physicomechanical properties and elution profiles (for medicated cement) equivalent to the conventional bowl and spatula technique.

Technological Characteristics

Vacuum mixing and syringe delivery system. Components: syringe barrel/bowl, monomer cartridge, vacuum hose/filter. Materials: compatible with PMMA bone cement components. Operation: vacuum-assisted mixing of powder and liquid. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for patients undergoing orthopedic musculoskeletal surgical procedures including rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction, or revision arthroplasty. Gentamicin-loaded cement indicated for second stage of two-stage revision for total joint arthroplasty post-infection clearance.

Regulatory Classification

Identification

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.

Predicate Devices

• Endurance Bone Cement (P960001 Supplement 1)
• SmartSet GMV Endurance Gentamicin Bone Cement (K033382)
• SmartSet GMV Endurance Gentamicin Bone Cement (K041656)
• Cemvac Ultra pre-packed with DePuy 1 Bone Cement (K021499)

Submission Summary (Full Text)

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OCT 2 2004

K042591

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# SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>P.O. Box 988<br>Warsaw, Indiana 46581-0988 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER: | DePuy International Ltd<br>Trading As DePuy CMW<br>Cornford Road<br>Blackpool, Lancashire<br>FY4 4QQ, England |
| 510(k) CONTACT: | Tiffani Rogers<br>DePuy Orthopaedics, Inc<br>Regulatory Affairs Associate<br>Tel: [phone] Fax: [phone]<br>E-mail: [e-mail] |
| TRADE NAME: | SmartMix Pre-filled Mixing System |
| COMMON NAME: | Pre-filled Bone Cement Mixer for Clinical Use<br>Pre-filled Bone Cement Dispenser |
| CLASSIFICATION: | Cement Mixer for Clinical Use: Class I Exempt per CFR 888.4210<br>Cement Dispenser: Class I Exempt per 21 CFR 888.4200<br>PMMA Bone Cement: Class II per 21 CFR 888.3027 |
| DEVICE CODE: | KIH pre-filled with LOD<br>JDZ pre-filled with LOD |
| SUBSTANTIALLY<br>EQUIVALENT 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

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

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.

#### 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 [phone] 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:

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.

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

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| 510(k) Number | K042591 |