PARALLAX CRANIOSET

K994022 · Parallax Medical, Inc. · GXP · Aug 31, 2000 · Neurology

Device Facts

• Record ID: K994022
• Device Name: PARALLAX CRANIOSET
• Applicant: Parallax Medical, Inc.
• Product Code: GXP · Neurology
• Decision Date: Aug 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Parallax Cranioset is a resinous material for repair of cranial defects.

Device Story

Parallax Cranioset is a methyl methacrylate-based resinous material used for the repair of cranial defects. It is intended for surgical use by neurosurgeons or qualified clinicians in a clinical or hospital setting. The material is applied to the cranial defect site to restore structural integrity. It functions as a bone void filler or prosthetic material for cranioplasty procedures. The device provides a stable, biocompatible medium for defect reconstruction, potentially improving patient outcomes by restoring cranial contour and protection.

Clinical Evidence

Bench testing only. Performance testing demonstrated functional equivalence to the predicate device.

Technological Characteristics

Methyl methacrylate resinous material for cranioplasty. Formulated with materials identical to the predicate device. Class II device (Product Code GXP).

Indications for Use

Indicated for the repair of cranial defects in patients requiring cranioplasty.

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• Codman Cranioplastic, Acrylic Cranioplasty Material (K873689)

Submission Summary (Full Text)

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# AUG 3 1 2000

# Section 3 - 510(k) Summary

k 99 4022 510(k) Number:

Date Prepared: June 21, 2000

### Applicant Information:

- Applicant: Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, CA 94043
- Brvan M. Barr Contact: Senior Materials Scientist
- [phone] Phone: Fax: [phone]

### Device Information:

Trade Name: Parallax Cranioset

Common Name: Methyl methacrylate for cranioplasty

#### Equivalent Devices:

The subject device is substantially equivalent to Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689).

#### Intended Use:

Parallax Cranioset is a resinous material for repair of cranial defects.

### Comparison to Predicate Devices:

This device has the same intended use and functional characteristics as the predicate device. The materials contained within Parallax Cranioset are all materials that appear in the predicate device.

### Non-clinical Test Results:

Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard to functional characteristics.

#### Summary:

Based on the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

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Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Mr. Bryan Barr Senior Materials Scientist Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, California 94043

Re: K994022 Trade Name: Parallax Cranioset Regulatory Class: II Product Code: GXP Dated: June 21, 2000 Received: June 22, 2000

Dear Mr. Barr:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

AUG 3 1 2000

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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## Page 2 -- Mr. Bryan Barr

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m This alagilestions on the promotion and advertising of your device, [phone]. Traditionally, 107-4639. Also, please note the regulation prease contact the Office of Complexion researce notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnes and its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dune R. bochner.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section 4 - Statement of Indications for Use

## Indications for Use

994022 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Parallax Cranioset

Indications for Use:

Parallax Cranioset is a resinous material for repair of cranial defects.

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Concurrence of CDRH, Office of Device Evaluation (ODE (Division Sign-Off) Division of General Restorative Devices 510(k) Number_199 Prescription Use OR Over-The Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)