THE ULTRA SYSTEM SP

K032813 · Promedica, Inc. · KCT · Feb 13, 2004 · General Hospital

Device Facts

• Record ID: K032813
• Device Name: THE ULTRA SYSTEM SP
• Applicant: Promedica, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Indications for Use

The ULTRA SYSTEM SP™ is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRAD™ 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to feciliate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRAD™ 50 or 16.70 pounds in the STERRAD™ 100S. A maximum of Junens may be sterilized in each load.

Device Story

Ultra System SP™ is a reusable sterilization container system designed for use with STERRAD™ 50 and 100S hydrogen peroxide gas plasma sterilizers. System includes containers and internal baskets to organize and hold surgical instruments during sterilization cycles. Healthcare providers place instruments in baskets within the container; container is then processed in the compatible STERRAD sterilizer. Device maintains sterility of enclosed instruments post-sterilization until point of use. Benefits include protection of surgical instruments and maintenance of sterile barrier during storage and transport.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable sterilization container system with internal baskets. Designed for compatibility with STERRAD™ 50 and 100S hydrogen peroxide gas plasma sterilization systems. Specifies maximum load capacities (8.35 lbs for STERRAD 50; 16.70 lbs for STERRAD 100S).

Indications for Use

Indicated for use by healthcare providers to sterilize enclosed surgical instruments in STERRAD™ 50 and 100S Sterilizers and maintain sterility until use. Supports maximum loads of 8.35 lbs (STERRAD 50) or 16.70 lbs (STERRAD 100S).

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Reference Devices

• STERRAD™ 50 Sterilizer
• STERRAD™ 100S Sterilizer

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

Mr. Richard Bloom VP/GM of Contract Partnerships Promedica, Incorporated 114 Douglas Road East Oldsmar, Florida 34677-2939

Re: K032813

Trade/Device Name: Ultra System SPTM Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: December 23, 2003 Received: December 24, 2003

Dear Mr. Bloom:

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.

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Page 2 -Mr. Bloom

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 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
fosththasen

1, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K032813

Device Name: ULTRA SYSTEM SPTM

Indications for Use:

The ULTRA SYSTEM SP™ is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRAD™ 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to feciliate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRAD™ 50 or 16.70 pounds in the STERRAD™ 100S. A maximum of Junens may be sterilized in each load.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ※ (21 CFR 807 Subpart C)

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

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

16032813 510(k) Number:________________________________________________________________________________________________________________________________________________________________