STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM

K023614 · Case Medical, Inc. · FRG · Apr 7, 2003 · General Hospital

Device Facts

• Record ID: K023614
• Device Name: STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
• Applicant: Case Medical, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Apr 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The SteriTite® container system is designed for use in hospitals and health care facilities to contain medical devices for sterilization, storage, transportation, and aseptic presentation of contents. It is intended to be used to sterilize medical devices including surfaces and lumens in steam, gas (EO) and gas plasma (STERRAD Sterilization). The SteriTite container is designed to maintain sterility of the contents until it is used.

Device Story

Rigid reusable sterilization container system; consists of aluminum/stainless steel/silicone cases and lids with disposable filter system. Used in hospitals/healthcare facilities to house medical instruments during sterilization (steam, EO, gas plasma), storage, and transport. Sterilant enters through lid/base vents; filter prevents microbial migration. System maintains sterility until point of use. Supports MediTray inserts/baskets. Replaces traditional sterilization wraps; provides event-related sterility maintenance. Benefits include standardized containment, protection of instruments, and aseptic presentation.

Clinical Evidence

Bench testing only. Validation included pre-vacuum steam, gravity displacement steam, EO, and STERRAD sterilization cycles. Testing used 1x10^6 Bacillus subtilis var. niger spore carriers. Validated for metal lumens (2.2mm diameter) and porous/silicone lumens (3mm diameter). Sterility maintenance validated via real-time testing (90-day with weekly handling; 30-day with daily handling).

Technological Characteristics

Rigid reusable container; materials: aluminum, stainless steel, silicone. Disposable filter system. Vented lid/base design. Dimensions/form factor: scaled containers. Sterilization: steam, EO, gas plasma. Conformance: AAMI ST33. No software/electronics.

Indications for Use

Indicated for containing medical devices for sterilization, storage, transportation, and aseptic presentation in healthcare facilities. Validated for steam, EO, and gas plasma (STERRAD) sterilization of surfaces and lumens. Validated for metal lumens ≥2.2mm diameter (up to 45.7cm length) and porous (silicone) lumens ≥3mm diameter (up to 40cm length).

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

• Genesis™ (K012931)

Submission Summary (Full Text)

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K023614

### 510(k) SUMMARY

(21 C.F.R.S 807.92) Casc Medical, Inc. 65 Railroad Avenue Ridgefield, NJ 07657 TEL: 888.227.CASE FAX: [phone]

APR 0 7 2003

### NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS

| Device trade or proprietary name: | SteriTite ^® rigid reusable sterilization container system. |
|------------------------------------|-----------------------------------------------------------------------|
| Device Common/ usual name: | Sterilization, rigid reusable case. |
| Establishment registration number: | 2248608 |
| Classification name: | Sterilization Wrap |
| Class of Device: | Class II device, product code 80FRG |
| Predicate | Genesis ^™ - 510k # K012931 |
| Official contact: | Marcia A. Frieze, CEO, 201-313-1999 ext. 225 |

#### INTENDED USE

ﮯ۔

The SteriTite® container system is designed for use in hospitals and health care facilities to contain medical devices for sterilization, storage, transportation, and aseptic presentation of contents.

It is intended to be used to sterilize medical devices including surfaces and lumens in steam, gas (EO) and gas plasma (STERRAD Sterilization). The SteriTite container is designed to maintain sterility of the contents until it is used.

### DEVICE DESCRIPTION

The SteriTite container system consists of a family of rigid reusable scaled containers that provide an effective sterilization packaging method for medical devices. Cases and lids are interchangeable. A part number and lot number identify each component of the container, including lid, base, retaincr/valve plate and insert basket or tray.

The SteriTite system is designed for sterilant penetration through vents/perforations in the lid and in perforated bottom models in the base of SteriTite sealed containers as well. MedifFray case trays, baskets and insert boxes may be placed within sealed containers or wrapped.

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# EQUIVALENCE STATEMENT FOR STERITITE® CONTAINER WITH FILTER IN EO STERILIZATION

Case Medical, Inc.'s SteriTitc filtered container is substantially equivalent to the Genesis (510k # K012931) container with disposable filter.

| Comparison of SteriTite® Rigid Reusable Containers with disposable filter to Predicate | | |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--|
| | A CONTRACT A LAW - LAW - LAW LINE LE - CAR FREE - CAR FREE - CAR FREE - CAR FREE - C | |

| PROPERTIES/<br>SPECIFICATIONS | STERITITE CASE<br>W/ FILTER | GENESIS CASE W/<br>FILTER |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indicated for containing instruments to<br>be sterilized in EO, and be transported | YES | YES |
| Intended to be reused | YES | YES |
| Closed System | YES | YES |
| Sealed | YES | YES |
| DESIGN | | |
| Incorporates a filter system to permit<br>entry of sterilant agent | YES | YES |
| Incorporates a filter system to prevent<br>microbial migration during transport | YES | YES |
| MATERIALS | | |
| Container | Aluminum, SS, silicone | Aluminum, SS,<br>silicone |
| Filter | Disposable filter | Disposable filter |
| PERFORMANCE STANDARDS | | |
| Conformance to AAMI ST33<br>Standard testing requirements | YES | YES |
| VALIDATION TESTING | | |
| Pre-vacuum steam | YES | YES |
| Gravity Displacement steam | YES | YES |
| EO Sterilization | YES (solid and<br>perforated bottom<br>containers) | YES (perforated<br>bottom containers) |
| STERRAD Sterilization | YES | YES |
| Load | STU load up to 22 lbs. | Up to 11 Lbs. |
| Sterility Maintenance - Barrier<br>properties | Event Related Sterility<br>Maintenance: 90-day<br>real time w/weekly<br>handling events. 30-day<br>real time with daily<br>handling events | Event Related Sterility<br>Maintenance: 180-day<br>(30-day) real time |
| PROPERTIES/<br>SPECIFICATIONS | STERITITE® CASE<br>W/ FILTER | GENESIS CASE W/<br>FILTER |
| Aeration Time | 12 Hours | 24 Hours |
| TEST organism/inoculated product | | |
| Inoculated spore carriers with 1 x 106<br>Bacillus Subtilis var. niger | YES | YES |
| INOCULATED BLADES | YES | YES |
| INOCULATED LUMENS | YES - 2.2mm diameter<br>metal | YES - 3mm diameter<br>metal |
| INOCULATED NYLON | YES | N/A |
| INOCULATED SILICONE | YES | N/A |
| INOCULATED RADEL | YES - | N/A |

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Image /page/3/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 lines forming its body and wing. The eagle is facing to the left. 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

APR 0 7 2003

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

Re: K023614

Trade/Device Name: SteriTite® Rigid Sterilization Container System with MediTray Products Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 6, 2003 Received: January 7, 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,

Susan Runge-

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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Page

# 510(K) Number: KO23614

# Device Name: SteriTite® Rigid Sterilization Container System with MediTray Products

.

#### INDICATIONS FOR USE:

The SteriTite container system and MediTray product is intended to be used to contain medical devices for sterilization, storage, transportation and aseptic presentation of contents in health care facilization of surfaces and lumented dev in EO. Metal lumens 2.2mm diameter or larger and length up to 45.7 cm and porous (silicone) lumened devices 3 mm diameter or larger and length up to 40 cm were validated. The SterTite container is designed to maintain sterility of the contents until it is used

(PLEASE 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 |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

| 510(k) Number | K023614 |
|---------------|---------|
|---------------|---------|