(143 days)
Not Found
No
The summary describes a mechanical delivery system for bone cement and does not mention any AI or ML components or functions.
Yes
The device is used for the treatment of pathological fractures of the vertebrae, which is a therapeutic purpose.
No
Explanation: The device is a delivery system for bone cement used in vertebroplasty or kyphoplasty procedures. It does not perform any diagnostic functions.
No
The device description explicitly states it consists of a reusable controller and disposable hardware components, including a delivery cannula, stylet, hydraulic assembly, bone cement syringe, and control cables. This indicates it is a hardware-based system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details components like a controller, cannula, stylet, hydraulic assembly, and syringe, all designed for delivering material into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device described is a surgical delivery system used during a medical procedure, not for in vitro (outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
The SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product codes (comma separated list FDA assigned to the subject device)
NDN, KIH
Device Description
The SPACE 360 Delivery System consists of a reusable controller and disposable, single-use components, including a delivery cannula and stylet, a hydraulic assembly and bone cement syringe, and control cables.
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)
Mechanical performance and safety testing demonstrates that the SPACE 360 Delivery System meets its performance requirements to support its use as a bone cement delivery system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for Dfine, followed by the address 19450 Stevens Creek Blvd., Suite 100. The next line shows the city, state, and zip code, which is Cupertino, California 95014. The logo is a stylized D with the word "fine" next to it.
Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
510(k) number K070351
1. Submitted by:
DFine, Inc. 3047 Orchard Parkway San Jose, CA 95134
| Contact Person: | Robert D. Poser, D.V.M.
Vice-President, Scientific and Medical Affairs |
|-----------------|---------------------------------------------------------------------------|
| Telephone: | 408-321-9999 ext 224 |
| Facsimile: | 408-321-9402 |
June 28, 2007 Date Prepared:
2. Device Name
| Trade/Proprietary Name: | SPACE 360 Delivery System |
|---|---|
| Common/Usual Name: | Polymethylmethacrylate Bone Cement |
| Classification Name: | Polymethylmethacrylate Bone Cement, Cement Dispense d |
3. Predicate Device:
The SPACE 360 Delivery System is substantially equivalent to the Equestra, cleared under 510(k) K040483 by Medtronic Sofamor Danek, the Confidence Fenestrated Introducer Needle cleared under 510(k) K063067by Disc-O-Tech, the Disc-O-Tech Cementer Injector classified under Product Code KIH and the ArthroCare System, cleared under 510(k) K040338 by ArthoCare.
4. Intended use of the device
The SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
5. Description of the Device
The SPACE 360 Delivery System consists of a reusable controller and disposable, single-use components, including a delivery cannula and stylet, a hydraulic assembly and bone cement syringe, and control cables.
1
6. Testing and Conclusion
Mechanical performance and safety testing demonstrates that the SPACE 360 Delivery System meets its performance requirements to support its use as a bone cement delivery system.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
DFine, Inc. c/o Robert D. Poser, DVM Vice President, Scientific and Medical Affairs 3047 Orchard Parkway San Jose, CA 95134
Re: K070351
Trade/Device Name: SPACE 360 Delivery System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, KIH Dated: May 12, 2007 Received: May 14, 2007
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 vour 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
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Page 2 - Robert D. Poser, DVM
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 tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number: K070351
Device Name: SPACE 360 Delivery System
Indications for Use:
The SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. 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 |
|---|---|
| AND/OR | Over-The-Counter Use |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General Restorative,
and Neurological Devices
510(k) Number: 6070351