(30 days)
The 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).
The SPACE CpsXL bone cement is a self-curing polymethyl-methacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. 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 liquid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter.
The provided text is a 510(k) Premarket Notification Summary for the SPACE CpsXL bone cement. This document describes a medical device and its substantial equivalence to a predicate device, rather than a study evaluating an AI-powered diagnostic or assistive tool against specific acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document.
Here's what can be extracted and a clear statement about what is not available based on the request:
Acceptance Criteria and Device Performance:
The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device. This is a regulatory standard for medical devices. The performance criteria are therefore primarily related to the physical, chemical, and mechanical properties of the bone cement, ensuring they are comparable to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (SPACE CpsXL bone cement, K061531) | "Documentation is provided which demonstrated the SPACE CpsXL bone cement to be substantially equivalent to other legally cleared devices." |
| Similar chemical composition to predicate device | "Both the SPACE CpsXL bone cement and the predicate are bone cements intended for use in vertebroplasty, and are similar with respect to chemical composition..." |
| Similar fundamental scientific technology to predicate device | "...and fundamental scientific technology." |
| Differences do not significantly affect safety and effectiveness | "Any differences do not significantly affect the safety and effectiveness of the device." |
| Performs as intended for vertebroplasty/kyphoplasty procedures for pathological fractures of vertebrae | "Based upon the testing and comparison to the predicate device and commercially available bone cements, the SPACE CpsXL bone cement, performs as intended..." |
| Meets physical, chemical, and mechanical testing standards | "Physical, chemical and mechanical testing of the SPACE CpsXL bone cement has been conducted." |
Information NOT available in the provided text, as it pertains to AI/diagnostic studies:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would likely refer to material science standards, not clinical interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device would be established through established engineering and biomaterial standards and testing, not clinical consensus or pathology.
- The sample size for the training set: Not applicable for this type of device submission.
- How the ground truth for the training set was established: Not applicable.
Study Details (as per the provided document):
The "study" or evaluation described is a series of physical, chemical, and mechanical tests conducted on the SPACE CpsXL bone cement. The purpose of these tests was to demonstrate its performance and substantial equivalence to a legally marketed predicate device (SPACE CpsXL bone cement, cleared under 510(k) K061531).
The document states:
- "Physical, chemical and mechanical testing of the SPACE CpsXL bone cement has been conducted."
- This testing, along with comparison to the predicate device and commercially available bone cements, formed the basis for the conclusion that the device "performs as intended and is substantially equivalent to the predicate device."
Without the actual detailed testing reports, the specific parameters, methodologies, or quantitative results of these "physical, chemical, and mechanical tests" are not available in this summary.
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Image /page/0/Picture/1 description: The image shows a handwritten number, which appears to be 1072496. The numbers are written in a cursive style, with some connections between the digits. The handwriting is somewhat uneven, but the numbers are still legible.
DFine Inc. 3047 Orchard Parkway San Jose, California 95134
Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
510(k) number
1. Submitted by:
DFine, Inc. 3047 Orchard Parkway San Jose, CA 95134
| Contact Person: | Robert D. Poser, DVM |
|---|---|
| Vice-President, Scientific and Medical Affairs | |
| Telephone: | 408-321-9999 ext 224 |
| Facsimile: | 408-321-9403 |
Date Prepared: 31 August 2007
2. Device Name
| Trade/Proprietary Name | SPACE CpsXL bone cement |
|---|---|
| Common/Usual Name | Bone cement for Vertebroplasty |
| Classification Name | Filler, Bone cement |
3. Predicate Device:
The SPACE CpsXL bone cement is substantially equivalent to other bone cements intended for vertebroplasty, including SPACE CpsXL. bone cement, cleared under 510(k) K061531 by DFine, Inc. San Jose, CA.
4. Intended use of the device
The 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 mav result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
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5. Description of the Device
The SPACE CpsXL bone cement is a self-curing polymethyl-methacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure.
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 liquid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter.
6. Summary of the technological characteristics of the device compared to the predicate device.
Documentation is provided which demonstrated the SPACE CpsXL bone cement to be substantially equivalent to other legally cleared devices. Both the 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 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 SPACE CpsXL bone cement, performs as intended and is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 * 2007
DFine, Inc. % Mr. Robert Poser Vice President, Scientific and Medical Affairs 3047 Orchard Parkway San Jose, CA 95134
Re: K072496
Trade/Device Name: SPACE CpsXL Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: September 1, 2007 Received: September 5, 2007
Dear Mr. 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
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Page 2 - Mr. Robert Poser
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Ruelup
Mark N. Mel Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known):
Device Name: SPACE CpsXL bone cement
Indications for Use:
The 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(Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
A510(k) N
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)
Barbara Kniepp
Division of General, Restorative. and Neurological Devices
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DFine, Inc.
00022
§ 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.”