SPACE 360 DELIVERY SYSTEM

K070351 · Dfine, Inc. · NDN · Jun 29, 2007 · Orthopedic

Device Facts

• Record ID: K070351
• Device Name: SPACE 360 DELIVERY SYSTEM
• Applicant: Dfine, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

The SPACE 360 Delivery System is a medical device used for the percutaneous delivery of bone cement during vertebroplasty or kyphoplasty procedures. The system comprises a reusable controller and disposable components, including a delivery cannula, stylet, hydraulic assembly, and bone cement syringe. It is operated by a physician in a clinical setting to treat pathological vertebral fractures. By facilitating the controlled injection of bone cement into the vertebrae, the device stabilizes the fracture, potentially reducing pain and restoring structural integrity to the affected bone.

Clinical Evidence

Bench testing only. Mechanical performance and safety testing were conducted to demonstrate that the device meets its performance requirements for its intended use as a bone cement delivery system.

Technological Characteristics

The system consists of a reusable controller and disposable components including a delivery cannula, stylet, hydraulic assembly, and bone cement syringe. It is designed for the percutaneous delivery of PMMA bone cement. The device is a mechanical delivery system; no software or electronic algorithms are described.

Indications for Use

Indicated for patients with painful vertebral compression fractures resulting from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma) requiring vertebroplasty or kyphoplasty procedures.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Equestra (K040483)
• Confidence Fenestrated Introducer Needle (K063067)
• Disc-O-Tech Cementer Injector (Product Code KIH)
• ArthroCare System (K040338)

Submission Summary (Full Text)

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## 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.<br>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 <b>d</b> |

#### 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.

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### 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.

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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 [phone] . 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 [phone] or [phone] 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<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|------------------------------------------------|
| AND/OR | Over-The-Counter Use<br>(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