STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS

K022978 · Case Medical, Inc. · FRG · May 9, 2003 · General Hospital

Device Facts

• Record ID: K022978
• Device Name: STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
• Applicant: Case Medical, Inc.
• Product Code: FRG · General Hospital
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The SteriTite® containers with FlashTite® valve plate(s) are intended to be used in conjunction with MediTray basic tray for the flash sterilization of one instrument or instrument set. The SteriTite container system with MediTray product are intended to be used to contain medical devices for steam sterilization. The full line of MediTray products is intended for complex customization in pre-vacuum steam sterilization. MediTray basic trays are intended to be used in the sealed container for sterilization in steam pre-vacuum and gravity sterilization. MediTray products may be used separately for sterilization when wrapped in FDA cleared medical grade wrappers. The MediTray products include case/trays with lid and base, insert boxes, cassettes, trays, baskets, instrument racks, silicone mats, brackets, posts, and partitions.

Device Story

SteriTite rigid reusable container system with optional FlashTite valve plates and MediTray accessories (baskets, trays, racks, mats, partitions). System contains medical devices during steam sterilization processes. Containers and trays are stackable. Used in clinical settings to facilitate sterilization of surgical instruments. Healthcare providers place instruments into MediTray components, secure them within the SteriTite container, and subject the assembly to steam sterilization. The valve plates allow for steam penetration and air removal while maintaining a sterile barrier post-sterilization. Benefits include organized instrument handling and protection of sterile contents.

Clinical Evidence

Bench testing only. Sterilization performance studies were conducted at independent laboratories for the SteriTite container with FlashTite valve plates. Testing included both containerized MediTray products and wrapped MediTray products. All acceptance criteria were met, demonstrating validation for the intended use.

Technological Characteristics

Rigid reusable sterilization container system. Components include lid, base, and valve plates. MediTray accessories include baskets, trays, racks, silicone mats, brackets, posts, and partitions. Designed for steam pre-vacuum and gravity sterilization cycles. Stackable design.

Indications for Use

Indicated for the containment of medical devices during steam sterilization (pre-vacuum and gravity) and flash sterilization of single instruments or instrument sets.

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.

Predicate Devices

• FlashPak (K871202)
• FlashGuard (K841669)
• Sterilization Cassettes (K962545)

Submission Summary (Full Text)

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9 2003

sfield, NJ 07657 • 800-639-3264 • 201-313-1978 • Fax [phone]

510(k) SUMMAR (21 C.F.R.S 807-92)

## NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS

SteriTite Rigid Sterilization Container System with FlashTitc valve plate(s) and MediTray Products

| Manufacturer:<br>Date Summary Prepared:<br>Device trade or proprietary name:<br>Device Common/ usual name:<br>Establishment registration number:<br>Classification name:<br>Class of Device:<br>Predicate for Flash Sterilization:<br>Predicate for MediTray Products:<br>Official contact: | Case Medical, Inc.<br>May 6, 2003<br>SteriTite® container with FlashTite valve plate(s) and MediTray<br>Products<br>Sterilization, rigid reusable case.<br>2248608<br>Sterilization Wrap<br>Class II device, product code 80FRG<br>SteriTite® previously cleared under K960738 & K974638.<br>FlashPak K871202, FlashGuard K841669<br>Sterilization Cassettes, K962545<br>Marcia Frieze, CEO, 201-313-1999 ext. 225 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | The SteriTite® containers with FlashTite® valve plate(s) are<br>intended to be used in conjunction with MediTray basic tray for<br>the flash sterilization of one instrument or instrument set.<br>The SteriTite container system with MediTray product are<br>intended to be used to contain medical devices for steam<br>sterilization. The full line of MediTray products is intended for<br>complex customization in pre-vacuum steam sterilization.<br>MediTray basic trays are intended to be used in the sealed<br>container for sterilization in steam pre-vacuum and gravity<br>sterilization. MediTray products may be used separately for<br>sterilization when wrapped in FDA cleared medical grade<br>wrappers.<br>The MediTray products include case/trays with lid and base,<br>insert boxes, cassettes, trays, baskets, instrument racks, silicone<br>mats, brackets, posts, and partitions. |
| DEVICE DESCRIPTION: | The SteriTite® container system consists of the SteriTite line of<br>rigid reusable containers with an additional option of a FlashTite<br>valve plate(s). The line features an assortment of container<br>designs and sizes.<br>The MediTray product line includes instrument baskets, trays,<br>and case/trays (incorporating a lid and base), organizing insert<br>boxes, cassettes, trays, baskets, instrument racks, silicone mats,<br>brackets, posts, and partitions designed to contain medical<br>devices within sealed containers or to be wrapped.<br>SteriTite Containers with FlashTite valve plate(s) and MediTray<br>products may be stacked. |

Originators of MediTray eand SteriTite ... The Sterilization System of Choice

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# dical, Inc.

55 Railroad Ave • Ridgefield, NJ 07657 • 800-639-3264 • 201-313-1978 • Fax [phone]

Substantial cquivalence:

The Case Medical, Inc.'s SteriTite® container with FlashTite valve plate(s) is substantial equivalent to the Flashpak Container System by Riley Medical and Flushguard Container System by Sparco Inc. in that the:

- Intended use is the same.
O Performance attributes are the same.

The Case Medical, Inc.'s MediTray Products line is substantial equivalent to the Sterilization Cussettes by Sterilization Cassette Systems, Inc. in that the:

- Intended use is the same.
- Performance attributes are the same ט

Summary of testing:

Sterilization Performance studies were conducted at independent laboratories for the SteriTite Reusable Rigid Container with FlashTite valve plate(s). All tests were conducted with containerized MediTray as well as MediTray products wrapped. All acceptance criteria were met. Results demonstrate that the product is in compliance with established standards and is validated for its intended use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

MAY - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marcia A. Frieze CEO Case Medical, Incorporated 65 Railroad Avenue Ridgefield, New Jersey 07657-0402

Re: K022978

Trade/Device Name: SteriTite® Rigid Sterilization Container System with FlashTite® valve plate (s) & MediTray Products Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 13, 2003 Received: February 13, 2003

Dear Ms. Frieze:

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 - Ms. Frieze

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,

Suser Ranse

Susan Runner, DDS, MA Interim 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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### 510(K) Number: K022978

#### Device Name: Sterilite® Rigid Sterilization Container System with FlashTite® valve plate(s) & MediTray Products

#### INDICATIONS FOR USE:

The SteriTite® containers with FlashIlite® valve plate(s) are intended to be used in conjunction with MediTray basic tray for the flash sterilization of one instrument or instrument set.

The SteriTite container system with MediTray product are intended to be used to contain medical devices for steam sterilization. The full line of MediTray product is intended for complex customization in prevacuum steam sterilization. MediTray basic trays are intended to be used in the sealed container for sterilization in steam pre-vacuum and gravity sterilization. MediTray products may be used scoarately for sterilization when wrapped in FDA cleared medical grade wrappers.

The MediTray products include case/trays with lid and base, insert boxes, cassettes, trays, baskets, instrument racks, silicone mats, brackets, posts, partitions.

#### (PI.FASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | |
|--------------------------------------------------------|---------|----|----------------------|--|
| (Division Sign-Off) | | | | |
| Division of Dental, Infection Control, | | | | |
| And General Hospital Devices | | | | |
| 510(k) Number | | | | |
| Description Use | | OR | Over-The-Counter Use | |
| (Division Sign-Off) | | | | |
| Division of Anesthesiology, General Hospital, | | | | |
| Infection Control, Dental Devices | | | | |
| 510(k) Number: | K022978 | | | |