(25 days)
No
The 510(k) summary describes a bone cement and a mixing/delivery system, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes.
The device (bone cement) is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures to treat various conditions like arthritis and avascular necrosis, which constitutes a therapeutic purpose.
No
The device is a bone cement used for fixation of prostheses, not for diagnosing medical conditions.
No
The device description clearly states it is a "vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid," indicating it is a physical hardware device with components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid." This is a material used in a surgical procedure, not a test performed on a sample taken from the body.
- Anatomical Site: The anatomical site is "living bone in orthopaedic musculoskeletal surgical procedures," which is within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
SmartMix Cemvac Pre-filled with SmartSet HV Bone Cement: SmartSet HV 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.
SmartMix Cemvac Pre-filled with SmartSet GHV Gentamicin Bone Cement: SmartSet GHV 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.
Product codes
LOD, MBB, KIH, JDZ
Device Description
SmartMix Cemvac is a vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid. The device is available in a single 60g or 80g unit. This submission adds SmartMix Cemvac pre-filled with SmartSet HV Bone Cement and SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement to the SmartMix Cemvac line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
living bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic musculoskeletal surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF SPONSOR: | DePuy Orthopaedics. Inc.
700 Orthopaedic Drive
P.O. Box 988
Warsaw, Indiana 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER: | DePuy International Ltd
Trading As DePuy CMW
Cornford Road
Blackpool, Lancashire
FY4 4QQ, England |
| 510(k) CONTACT: | Natalie S. Heck
DePuy Orthopaedics, Inc.
Manager, Regulatory Affairs
Tel.: (574) 372-7469
Fax: (574) 371-4978
Email: nheck@dpyus.jnj.com |
| TRADE NAME: | SmartMix Cemvac Pre-filled with SmartSet HV Bone Cement
SmartMix Cemvac Pre-filled with SmartSet GHV Gentamicin
Bone Cement |
| COMMON NAME: | PMMA Bone Cement |
| CLASSIFICATION: | PMMA Bone Cement:
Class II per 21 CFR 888.3027 |
| | Cement Mixer for Clinical Use:
Class I Exempt per CFR 888.4210 |
| | Cement Dispenser:
Class I Exempt per 21 CFR 888.4200 |
| DEVICE CODES: | LOD, MBB, KIH, JDZ |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | SmartSet HV Bone Cement:
K023012
SmartSet GHV Gentamicin Bone Cement:
K033563 |
SmartMix Pre-filled Mixing System K042591
Cemvac Ultra Pre-packed with DePuy | Bone Cement K021499
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DEVICE DESCRIPTIONS AND INDICATIONS:
SmartMix Cemvac is a vacuum mixing and syringe delivery system pre-packed with bone cement powder and liquid. The device is available in a single 60g or 80g unit. This submission adds SmartMix Cemvac pre-filled with SmartSet HV Bone Cement and SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement to the SmartMix Cemvac line.
SmartSet HV 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 GHV 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 EQUIVLENCE:
Based on the similarities of design, materials, intended use and testing results, SmartMix Cemvac pre-filled with SmartSet HV Bone Cement and SmartMix Cemvac pre-filled with SmartSet GHV Gentamicin Bone Cement are substantially equivalent to the same bone cements, packaged in traditional bone cement packaging.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wave-like lines emanating from it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 JAN 6
Ms. Natalie S. Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K053445
Trade/Device Name: SmartMix Cemvac Pre-filled with SmartSet HV Bone Cement SmartMix Cemvac Pre-filled with SmartSet GHV Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Code: LOD, MBB, KIH, JDZ Dated: December 8, 2005
Received: December 12, 2005
Dear Ms. Heck:
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.
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
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Page 2 - Ms. Heck
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson,
Acting 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 STATEMENT
510(k) Number (if known):
Device Name:
SmartMix Cemvac Pre-filled with SmartSet HV Bone Cement
Indications for Use:
SmartSet HV 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:
SmartMix Cemvac Pre-filled with SmartSet GHV Gentamicin Bone Cement
Indications for Use:
SmartSet GHV 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 USE ON ANOTHER PAGE IF NEEDED)
RANO fice of Device Evaluation (ODE) nial 977 of Station (Division Sign-( Division of General, Restorative, and Neurological Devices
510(k) Number K053445