CPD COMMANDER

K974253 · Scieran Technologies, Inc. · MRH · Feb 25, 1998 · General Hospital

Device Facts

• Record ID: K974253
• Device Name: CPD COMMANDER
• Applicant: Scieran Technologies, Inc.
• Product Code: MRH · General Hospital
• Decision Date: Feb 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fluid/Gas Exchange and Viscous Fluid Delivery/Injection during ophthalmic surgery.

Device Story

CPD Commander is an ophthalmic surgical system designed for fluid/gas exchange and viscous fluid delivery/injection. Used in clinical settings by ophthalmic surgeons during surgical procedures. Device facilitates precise delivery of fluids or gases into the eye to assist in surgical maneuvers. System operation supports surgeon control over fluid dynamics during ophthalmic interventions, aiding in intraocular pressure management or tissue manipulation. Benefits include improved surgical precision and efficiency during complex eye surgeries.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Ophthalmic surgical system for fluid/gas exchange and viscous fluid delivery. Technical specifications and materials not detailed in the provided documentation.

Indications for Use

Indicated for fluid/gas exchange and viscous fluid delivery/injection during ophthalmic surgery.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's three main goals: health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1998

Mr. Rod Ross President SCIERAN TECHNOLOGIES, INC. 27071 Cabot Road, Suite 127 Laguna Hills, CA 92653 USA

Re: K974253 Trade Name: CPD COMMANDER Regulatory Class: II Product Code: 86 MRH Dated: February 3, 1998 Received: February 5, 1998

Dear Mr. Ross:

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.

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 requirements, 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.

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Page 2 - Mr. Rod Ross

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K974253

CPD Commander™ System Device Name:

Indication For Use:

Fluid/Gas Exchange and Viscous Fluid Delivery/Injection during ophthalmic surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | Everett R Beam |
|--------------------------------|----------------|
| Division of Ophthalmic Devices | |
| 510(k) Number | K974253 |

| Prescription Use | <div style="display:inline-block; vertical-align:middle;">✓</div> | OR | Over-The-Counter Use |
|------------------|-------------------------------------------------------------------|----|----------------------|
|------------------|-------------------------------------------------------------------|----|----------------------|

Prescription Use_ V Per 21 CFR 801.109

Over-The-Counter Use_

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