(89 days)
Not Found
No
The 510(k) summary describes a bone cement, a material used in surgical procedures, and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a bone cement used in vertebroplasty or kyphoplasty procedures to treat pathological fractures of the vertebrae, which directly addresses a medical condition (pathological fractures and associated pain).
No
This device is a bone cement used for treating pathological fractures of the vertebrae, primarily through vertebroplasty or kyphoplasty procedures. It is a therapeutic device, not one designed to diagnose a condition.
No
The device description clearly states it is a two-component bone cement made of PMMA, barium sulphate, benzoyl peroxide, methylmethacrylate monomer, hydroquinone, and N,Ndimethyl-p-toluidine, which are physical materials, 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 treatment of pathological fractures of the vertebrae using a surgical procedure (vertebroplasty or kyphoplasty). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bone cement, a material implanted into the body to stabilize fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a therapeutic material.
N/A
Intended Use / Indications for Use
The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product codes
NDN
Device Description
The DFine SPACE CpsXL Bone Cement is a self-curing polymethylmethacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure.
DFine SPACE CpsXL Bone Cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liguid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N,Ndimethyl-p-toluidine as a promoter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebrae
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)
Physical, chemical and mechanical testing of the DFine SPACE CpsXL Bone Cement has been conducted.
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
Image /page/0/Picture/0 description: The image shows the date August 30, 2006. The month is represented by the abbreviation AUG. The day is represented by the number 30. The year is represented by the number 2006.
Image /page/0/Picture/1 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The top line reads 'K061531', with the '0' possibly representing the number zero. Below this, the text 'PG 1 of 2' is written, indicating a page number within a document. The handwriting is clear and legible, suggesting it could be a reference or identification code for a document or file.
Cupertino, California 950
Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
510(k) number
Submitted by: 1.
DFine, Inc. 19450 Stevens Creek Blvd., Suite 100 Cupertino, CA 95014
| Contact Person: | Robert D. Poser, DVM |
|---|---|
| Vice-President, Scientific and Medical Affairs | |
| Telephone: | 408-725-1515 ext 224 |
| Facsimile: | 408-725-1517 |
30 May 2006 Date Prepared:
2. Device Name
Trade/Proprietary Name Common/Usual Name Classification Name
DFine SPACE CpsXL Bone Cement Bone Cement for Vertebroplasty Filler, Bone Cement
3. Predicate Device:
The DFine SPACE CpsXL Bone Cement is substantially equivalent to other bone cements intended for vertebroplasty, including the Mendec Spine bone cement, cleared under 510(k) K042415 by TECRES S.p.A., Verona, Italy.
4. Intended use of the device
The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
1
Description of the Device 5.
The DFine SPACE CpsXL Bone Cement is a self-curing polymethylmethacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure.
DFine SPACE CpsXL Bone Cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liguid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N,Ndimethyl-p-toluidine as a promoter.
Summary of the technological characteristics of the device 6. compared to the predicate device.
Documentation is provided which demonstrated the DFine SPACE CpsXL Bone Cement to be substantially equivalent to other legally marketed devices. Both the DFine SPACE CpsXL Bone Cement and the predicate are bone cements intended for use in vertebroplasty, and are similar with respect to chemical composition and fundamental scientific technology. Any differences do not significantly affect the safety and effectiveness of the device.
7. Testing
Physical, chemical and mechanical testing of the DFine SPACE CpsXL Bone Cement has been conducted.
8. Conclusions
Based upon the testing and comparison to the predicate device and commercially available bone cements, the DFine SPACE CpsXL Bone Cement, performs as intended and is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" and is arranged in a circular fashion around the symbol. The symbol is an abstract representation of a human figure, with three stylized lines forming the head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2006
Dfine, Inc. % Dr. Robert D. Poser, DVM Vice President, Scientific and Medical Affairs 19450 Stevens Creek Boulevard Suite 100 Cupertino, California 95014
Re: K061531
Trade/Device Name: DFine SPACE CpsXL Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: August 18, 2006 Received: August 21, 2006
Dear Dr. Poser:
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 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.
3
Page 2 – Dr. Robert D. Poser, DVM
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/cdrl/industry/support/index.html.
Sincerely yours,
Harbare Bocheum
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: DFine SPACE CpsXL Bone Cement
Indications for Use:
The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma) and malignant lesions (metastatic cancers, myeloma).
Prescription Use X (Part 21 CFR 801 Subpart D)
510(k) Numl
AND/OR
Over-The-Counter Use (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 (ODE)
Ckeubera Buempomym
(Division Sign-Off)
Page 1 of 1
ion of General, Restorative. and Neurological Devices
DFine, Inc.
DFine SPACE CosXL Bon