STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL

K991023 · Case Medical, Inc. · FRG · Jan 27, 2000 · General Hospital

Device Facts

• Record ID: K991023
• Device Name: STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL
• Applicant: Case Medical, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Indications for Use

The perforated base containers are part of the SteriTite® Reusable Rigid Sterilization Container system. The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100 Sterilization for a hospital or other health care facilities.

Device Story

SteriTite® rigid reusable container system provides a microbial barrier for surgical instruments during STERRAD 100 sterilization. System comprises anodized aluminum base/lid with perforated vents, stainless steel filter retention plates, and silicone gaskets. Disposable non-woven polypropylene filter (SCF02) is secured in retention plates to allow sterilant penetration while maintaining sterility. Used in hospital sterile processing departments; operated by technicians. Healthcare providers load instruments into the container, secure the lid with stainless steel latches, and process in a STERRAD 100 sterilizer. Post-sterilization, the container protects instruments from contamination during storage. Benefits include reusable packaging, reduced waste compared to traditional wraps, and validated sterility assurance for blades and lumens.

Clinical Evidence

Bench testing only. Validation performed in triplicate using the overkill method in STERRAD 100 cycles. Testing included inoculated spore carriers (Bacillus stearothermophilus, 1x10^6) on blades and lumens (3mm x 400mm). Container efficacy demonstrated for 10" total height loads. Reuse testing conducted for 100 cycles. Biocompatibility testing (USP Acute Systemic Toxicity, Human Patch Test, Guinea Pig Sensitization) for Kimguard filter material yielded negative results.

Technological Characteristics

Rigid container system; materials: anodized aluminum, stainless steel, silicone, non-woven polypropylene filter. Dimensions: half, mid, and full-size cases (4", 6", 8" heights). Connectivity: none. Sterilization: STERRAD 100 (H2O2 gas plasma). Standards: AAMI ST34, ANSI/AAMI ST33-1996, ANSI/AAMI/ISO 11134-1994, pr EN 868-8.

Indications for Use

Indicated for sterilization of surgical instruments and devices in STERRAD 100 Sterilization systems within hospitals or healthcare facilities. Compatible with lumened instruments (3mm or larger, up to 400mm length) and blades. Contraindicated for use with cellulose-based materials (paper filters, cotton).

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

• Spunguard wrap/SteriTite® Container System (K960738)

Submission Summary (Full Text)

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## 510(k) SUMMARY K991023

(21 C.F.R.§ 807.92) Case Medical, Inc. 65 Railroad Avenue Ridgefield, N.J. 07657 TEL: 888.227.CASE FAX: [phone]

## NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS

| Device trade or proprietary name: | SteriTite® perforated base rigid reusable sterilization<br>container system with SCF02- polypropylene non-<br>woven Disposable Filter |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device Common/ usual name: | Sterilization rigid reusable case with disposable filter |
| Classification name: | Sterilization Wrap |
| Class of Device: | Class II device, product code 80FRG |
| Predicate Device: | Spunguard wrap/SteriTite® Container System |
| Official contact: | Marcia Frieze, CEO, ext. 25 |

#### DEVICE DESCRIPTION

The SteriTite® Rigid Container System consists of a family of rigid containers that provide an effective sterilization packaging method for operating room instruments. The SteriTite® perforated base containers include a vented base and a vented lid with filter retention plates. The SteriTite® unit consists of an anodized aluminum sealed case with a microbial barrier filtration system that allows effective penetration by the sterilant steam previously cleared K960738. In addition the SteriTite® perforated base containers have been validated for blades and lumens in STERRAD 100 Sterilization. For STERRAD 100 Sterilization each stainless steel filter retention plate secures a disposable round non-woven polypropylene disposable bacterial filter. Silicone gaskets are permanently attached to the filter retention plates and lid with silicone adhesive. A stainless steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamperproof disposable locks.

The polypropylene non-woven disposable filter # SCF02 is cut from Kimguard ® wrap. Kimguard ® wrap is manufactured from a hydrophobic nonwoven polypropylene material as is Spunguard wrap, the previously cleared device.

#### INDICATIONS FOR USE

The perforated base containers are part of a line of the SteriTite® Reusable Rigid Sterilization Container system. The SteriTite® perforated base containers have been validated for use in STERRAD 100 Sterilization under the following conditions. They are intended to be used for the sterilization of surgical instruments and devices in STERRAD 100 Sterilization for a hospital or other health care facilities.

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Review the sterilizer manufacturer's Instructions for Use for specific information as to the limitations of instrumentations and material compatibility. Review the SteriTite® labeling as to the limitations in regard to using a sealed container system in STERRAD 100 Sterilization.

- Caution: In STERRAD 100 Sterilization use only perforated bottom SteriTite® containers.
- Caution: In STERRAD 100 Sterilization use only nonwoven polypropylene ● disposable filters.
- Caution: In STERRAD 100 Sterilization do not use materials made of . cellulose (paper filters and cotton) with SteriTite® perforated bottom containers.
- Caution: In STERRAD 100 Sterilization use only lumened instruments of . 3mm or larger and a length of up to 400 mm.

### SUMMARY OF PERFORMANCE TESTING

The SteriTite® Container with non-woven polypropylene filter containing instrument basket and load was validated under half cycle conditions in triplicate in the STERRAD System. The efficacy of the Case Medical container was clearly demonstrated for blades and lumens using the overkill method. Containers in combination of 10" in total height or 8" high for any one container were tested and found to be efficacious.

Further, in order to demonstrate adequate sterilant penetration, the SteriTite® Container was validated for efficacy in the STERRAD System by comparing it against a tray wrapped in Spunguard, as the predicate. This study was done in triplicate and conducted in increments below the half cycle in diffusion time and concentration of sterilant. The objective was to compare a lidded container with basket versus a wrapped tray.

Reuse testing of the container and inserts for 100 cycles in the STERRAD 100 Sterilization System proved to be effective and compatible upon completion.

- 1. The SteriTite® Container was independently tested according the following standards for its performance in STERRAD 100 Sterilization. ASP conducted testing in accordance with the following U.S. and international standards:
AAMI ST 34 " Guideline for the use of ethylene oxide and steam biological indicators in industrial sterilization processes. "

ANSVAAMI ST33-1996 " Good Hospital Practice: Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems."

ANSVAAMI/ISO 11134-1994 "Sterilization of health care products-Requirements for validation and routine control-Industrial moist heat sterilization. "

European Standard, pr EN 868-8, second draft May 1995. "Packaging materials and systems for medical devices which are to be sterilized. Part 8: Re-usable sterilization containers -Requirements and test methods. "

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| USE | SteriTite Perforated Container<br>with polyproplyene filter | Spunguard wrap |
|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------|
| Indicated for holding instruments to<br>be sterilized and stored | YES | YES |
| Intended to be reused | YES | NO |
| Methods of sterilization: | | |
| Prevacuum steam | YES | YES |
| Gravity steam | YES | YES |
| STERRAD 100 Sterilization | YES FOR BLADES, YES FOR<br>LUMENS | YES FOR BLADES. YES FOR<br>LUMENS |
| DESIGN | | |
| Incorporates a filter / wrap system to<br>permit entry of sterilant agent and<br>prevent microbial migration during<br>storage | YES | YES |
| MATERIALS: container /basket | Aluminum, SS, silicone | Aluminum, SS, silicone |
| Filter / wrap | Polypropylene | Polypropylene |
| PERFORMANCE STANDARDS/<br>SPECIFICATIONS | | |
| AAMI ST33 Standard testing<br>requirements | | |
| 3.2. Permits transfer of contaminated<br>materials | YES | YES |
| 3.3.1 Removable filter assembly<br>disassembles | YES | NO |
| 3.3.4 Labeling | YES | YES |
| 3.4 -3.5 Decontamination<br>instructions | YES | YES |
| 3.6-4.2 Instructions for inspections | YES | YES |
| 6.2.5 Sterility maintenance-discussed<br>in labeling | YES | YES |
| 6.3 User responsibilities listed in<br>labeling | YES | YES |
| 7.3.1 Routine inspection in labeling | YES | YES |
| VALIDATION TESTING | | |
| Testing performed using "overkill"<br>approach | YES | YES |
| STERRAD® half-cycle parameters | YES | YES |
| STERRAD® increments below half-<br>cycle parameters | YES | YES |
| Incremental Testing -diffusion time | 10 minute kill | 10 minute kill |
| Incremental Testing -diffusion H2O2 | 720 μl | 360 μl |
| Load | STU load + basket | STU load + basket |
| TESTING ORGANISM | | |
| Bacillus stearothermophilus | YES | YES |
| Inoculated spore carriers with 1 x 106<br>B. stearothermophilus | YES | YES |
| INOCULATED BLADES under<br>half-cycle conditions | YES | YES |
| INOCULATED LUMENS under<br>half cycle conditions with 3mm DIA<br>x 400mm | YES | YES |

# COMPARISON: STERITITE PERFORATED BASE CONTAINERS TO SPUNGUARD WRAP *

* Note: Each container and wrap contained STU load with blades and lumens.

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- Polypropylene Nonwoven Filter: Testing performed demonstrated adequate sterilant 2. penetration as well as barrier properties when used with the SteriTite® rigid reusable container system in the STERRAD 100 Sterilization process.
The previously cleared and tested wrap was Spunguard. Kimguard is the selected filter material and is currently used with Genesis and Aesculap containers for steam sterilization. See Spunguard/Kimguard Equivalence Chart below.

## BIOCOMPATIBILITY

Kimguard was extensively tested in the standard spectrum of biocompatibility testing. This included USP Acute Systemic Toxicity. Human Patch Test and Guinea Pig Sensitization Test. All test results were negative.

The Biocompatibility validation of the SteriTite container materials was addressed by ASP reference to "Toxicity of Sterilant and Process By-Products" in which aluminum, silicone, stainless steel, polypropylene were tested and found to be noncytoxic and found to be compatible with the STERRAD System. This was included in the STERRAD 50 510(k). The toxicity of the sterilant has not changed. See Attachment # P-1199.

## COMPARISON TO LEGALLY MARKETED DEVICE

| | SPUNGUARD WRAP | KIMGUARD WRAP |
|-----------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Construction | 3 layer construction | 3 layer construction |
| Tear / Puncture<br>resistance | Tear resistance | Tear resistance |
| Hydrophobic properties | Resist penetration of particles and<br>liquids. | Resist penetration of particles and<br>liquids. |
| Material | 100% non-woven Polypropylene | 100% non-woven Polypropylene |
| Drapeability | Drapeable, soft | Drapeable, soft |
| Weights | Super duty<br>Heavy duty<br>Regular | Ultra<br>Heavy duty<br>Midweight<br>Regular |
| STERRAD<br>penetration study | Efficacious - Validated by ASP | Efficacious - Validated by ASP |
| Event related sterility<br>maintenance study* | Higher sterility assurance than Muslin<br>Spun.:1.1% / Mus.22.8% | Higher sterility assurance than Muslin<br>or Spunguard. Excellent.<br>Kim.:0% / Mus.:10% |

# SPUNGUARD / KIMGUARD EQUIVALENCE

*The weight of Spunguard and Kimguard used for the above studies was the weight posing the greatest challenge to sterilant penetration or sterility maintenance.

Reference Kimberly-Clark Spunguard Sterilization Wrap Technical Data and Kimguard Sterilization Wrap Technical Data.

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## BARRIER PROPERTIES

For KIMGUARD® bacterial filtration efficiency tests refer to equivalence Spunguard / Kimguard chart. Filtration Efficiency is equal for both. Water resistance is better in Kimguard®.

| | SPUNGUARD WRAP | KIMGUARD WRAP |
|--------------------------------------------------------------------|-------------------|---------------|
| Filtration Efficiency / Bacteria<br>per 1000 dry spore penetration | 3-heavy duty | 3-regular |
| Water Resistance / water repelled<br>before leakage cms. | 44cms.-heavy duty | 55cms-regular |

# PHYSICAL AND MECHANICAL SPECIFICATIONS

For KIMGUARD® physical and mechanical properties refer to the following equivalence Spunguard / Kimguard chart.

Strength: better in Spunguard. Not important due to the offset hole design of the SteriTite container.

Resistance to Linting is better in KIMGUARD®

| | SPUNGUARD WRAP | KIMGUARD WRAP |
|-------------------------------------------------------|----------------|---------------|
| Strength :<br>Tensile load / lbs. | 18-heavy duty | 14.5-regular |
| Peak energy absorption / in-lbs. | 20-heavy duty | 14.5-regular |
| Resistance to Linting /<br>no. of lint particles >10μ | 28-heavy duty | 21-regular |

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Image /page/5/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 forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 2000

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

K991023 Re:

> SteriTite® Perforated Base Rigid Reusable Trade Name: Sterilization Container System With SCF02 - Polypropylene Non-Woven Disposable Filter Requlatory Class: II Product Code: FRG Dated: November 23, 1999 November 23, 1999 Received:

Dear Ms. Frieze:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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

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Page 2 - Ms. Frieze

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 findinq 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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(k) Number : K991023

Device Name : SteriTite ® Perforated Base Rigid Sterilization Container System: SC04HG, SC06HG, SC08HG, SC04OG, SC6QG, SC08QG, SC04FG, SC06FG, SC08FG & Kimguard ® Disposable Filter # SCF02

#### INDICATIONS FOR USE

The perforated base containers are part of the SteriTite® Reusable Rigid Sterilization Container system.

| Product # of intended<br>device | DESCRIPTION |
|---------------------------------|------------------------------------------|
| SC04HG | 4" High Half size case perforated bottom |
| SC06HG | 6" High Half size case perforated bottom |
| SC08HG | 8" High Half size case perforated bottom |
| SC04QG, Rev.B | 4" High Mid-size case perforated bottom |
| SC06QG, Rev.B | 6" High Mid-size case perforated bottom |
| SC08QG,Rev.B | 8" High Mid-size case perforated bottom |
| SC04FG | 4" High Full-size case perforated bottom |
| SC06FG | 6" High Full-size case perforated bottom |
| SC08FG | 8" High Full-size case perforated bottom |

The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100 Sterilization for a hospital or other health care facilities.

- -After each sterilization cycle the filters must be discarded.
- Before each sterilization cycle use new filters. -

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 | K991023 |
| Description Use | OR Over-The-Counter Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | |