(135 days)
Not Found
No
The summary describes a bone cement product and its intended use, with no mention of AI or ML technology in its description, intended use, or performance studies.
Yes.
The device is indicated for the fixation of pathological fractures to alleviate pain, which is a therapeutic purpose.
No
The device description indicates it is a bone cement used for fixation in surgical procedures, not for identifying pathologies or making diagnoses.
No
The device description clearly states it is a bone cement, which is a physical material (hardware), not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone cement, a material used to fill and stabilize bone fractures. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
Product codes
NDN
Device Description
The Confidence High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (20 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
JUN 2 1 2006
510(K) Summary
Disc-O-Tech Medical Technologies Ltd. ¿ Confidence High Viscosity Bone Cement
Applicant Name
Disc-O-Tech Medical Technologies Ltd.
11 Ha'l-loshlim St..
Herzeliya 46724, Israel
Contact Person
- Hila Wachsler-Avrahami
Disc-O-Tech Medical Technologies Ltd.
11 Ha'Hoshlim St., Herzeliya 46724, Israel
Tel: 972-9-9511511, Fax: 972-9-9548939
- Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P 555 Thirteenth Street, NW, Washington, DC 20004 Tel: 202-637-5794. Fax: 202-637-5910
Date Prepared
January 2006
Trade/Proprietary Name
Confidence High Viscosity Bone Cement
Common Name
PMMA Bone Cement
1
K060300
Page 2 of 2
Disc-O-Tech Medical Technologies Ltd. Confidence High Viscosity Bone Cement 510(k)
Classification Name
Filler, Bone Cement (For Vertebroplasty)
Classification
Class II, per 21 CFR §888.3027
Predicate Devices
- ✔ Kyphon Inc.'s KyphX® HV-RTM Bone Cement (K041584)
- V Stryker Corp.'s Spineplex "M Radiopaque Bone Cement (K032945)
- ✔ Cook Inc.'s Vertefix"M Radiopaque Bone Cement (K042691)
Intended Use
The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
System Description
The Confidence High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (20 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.
Substantial Equivalence
Based on the information provided in this premarket notification, the Confidence High Viscosity Bone Cement intended use. chemical composition, material properties, biocompatibility, principles of operation, technological characteristics, performance, and clinical application are substantially equivalent to those of the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
JUN 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Disc-O-Tech Medical Technologies, Inc. c/o Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K060300
Trade/Device Name: Confidence High Viscosity Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Code: NDN Dated: May 19, 2006 Received: May 19, 2006
Dear Mr. Kahan:
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 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
3
Page 2 - Mr. Jonathan S. Kahan, Esq.
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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Humphrey
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(K) Number (if known):
Device Name: Confidence High Viscosity Bone Cement
Indication for Use:
The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ く (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation JODE)
Hulut Lener us
Division of General, Restorative, and Neurological Devices
510(k) Number K060300