(3 days)
Not Found
No
The document describes a rigid sterilization container system and its validation for use with a specific sterilization process. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
This device is a sterilization container system intended for sterilizing surgical instruments and devices; it does not directly provide therapy.
No
The device is a rigid sterilization container system used for sterilizing surgical instruments, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical container system made of anodized aluminum with a filtration system, silicone gaskets, and a stainless steel latching mechanism. It is a hardware device used for sterilizing surgical instruments.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being for the "sterilization of surgical instruments and devices" in a specific sterilization system (STERRAD 100S). This is a process related to preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The device is described as a "rigid container system" used for "stcrilization packaging." This aligns with a device used in the sterilization process, not for in vitro diagnostics.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect diseases, or provide any diagnostic information.
- Focus on Sterilization: The entire document focuses on the device's compatibility and performance within a sterilization system, including validation studies related to microbial inactivation.
In summary, the device's purpose is to facilitate the sterilization of surgical instruments, which is a process separate from in vitro diagnostics.
N/A
Intended Use / 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 100S Sterilization under the following conditions. They are intended to be used for the sterilization of surgical instruments and devices in STERRAD 100S Sterilization for a hospital or other health care facilities.
Review the sterilizer manufacturer's Instructions for Use for specific information as to the limitations of instrumentation specifications and material compatibility. Review the Steril'ite® labeling as to the limitations in regard to using a sealed container system in STERRAD 100S Sterilization.
- Caution: In STERRAD 100S Stcrilization use only perforated bottom SteriTite® ● containers.
- Caution: In STERRAD 100S Sterilization use only nonwoven polypropylene . disposable filters.
- Caution: In STERRAD 100S Sterilization do not use materials made of cellulose . (paper filters and cotton) with SteriTite® perforated bottom containers.
- Caution: In STERRAD 100S Sterilization use only luments of 3mm or . larger and a length of up to 400 mm.
The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100S 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. -
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The SteriTite® Rigid Container System consists of a family of rigid containers that provide an effective stcrilization 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 filltration system that allows effective penetration by the sterilant. The SteriTite® perforated base containers with baskets have been validated for surfaces and lumens in STERRAD 100S Sterilization. For STERRAD 100 and 100S Sterilization each stainless stccl 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 stcel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamperproof disposable locks. The disposable filter # SCF02 is a nonwoven polypropylene material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or other health care facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SteriTite® Container with non-woven nolypropylene filter containing instrument basket and load was validated under half cycle conditions in the STERRAD 100S 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. The same combinations were previously validated in the prior 510k K991023 for the STERRAD 100 System.
Additional studies were performed to demonstrate the effects of sterilant volume on microbial inactivation kinetics.
Reuse testing of the container and inserts was accomplished previously for 100 cycles in the STERRAD 100 Sterilization System. The product proved to be effective and compatible upon completion. Equivalency of the sealed container to a wrapped instrument tray was dcmonstrated.
The SteriTite® Container was independently tested according the following standards for its performance in STERRAD 100S 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 Reusuble Rigid Sterilization Container Systems."
ANSVAAMI/ISO 11134-1994 "Sterilization of heulth 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. "
- Polypropylene Nonwoven Filter: Testing performed demonstrated adequate sterilant penetration as well us barrier propertics when used with the SteriTite® rigid reusable containcr system in the STERRAD 100 and 100S Sterilization process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY (21 C.F.R.§ 807.92) Case Medical, Inc. 65 Railroad Avenue Ridgefield, NJ 07657 TEL: 888.227.CASE FAX: 201-313-9090
MAR 2 1 2003
NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS
| Device trade or proprietary name: | SteriTite® perforated base rigid reusable sterilization container
system with SCF02- polypropylene non-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: | SteriTite® System previously approved under K991023 |
| 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 stcrilization 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 filltration system that allows effective penetration by the sterilant. The SteriTite® perforated base containers with baskets have been validated for surfaces and lumens in STERRAD 100S Sterilization. For STERRAD 100 and 100S Sterilization each stainless stccl 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 stcel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamperproof disposable locks.
The disposable filter # SCF02 is a nonwoven polypropylene material .
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 100S Sterilization under the following conditions. They are intended to be used for the sterilization of surgical instruments and devices in STERRAD 100S Sterilization for a hospital or other health care facilities.
Review the sterilizer manufacturer's Instructions for Use for specific information as to the limitations of instrumentation specifications and material compatibility. Review the
Steril'ite® labeling as to the limitations in regard to using a sealed container system in STERRAD 100S Sterilization.
- Caution: In STERRAD 100S Stcrilization use only perforated bottom SteriTite® ● containers.
1
- Caution: In STERRAD 100S Sterilization use only nonwoven polypropylene . disposable filters.
- Caution: In STERRAD 100S Sterilization do not use materials made of cellulose . (paper filters and cotton) with SteriTite® perforated bottom containers.
- Caution: In STERRAD 100S Sterilization use only luments of 3mm or . larger and a length of up to 400 mm.
SUMMARY OF PERFORMANCE TESTING
The SteriTite® Container with non-woven nolypropylene filter containing instrument basket and load was validated under half cycle conditions in the STERRAD 100S 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. The same combinations were previously validated in the prior 510k K991023 for the STERRAD 100 System.
Additional studies were performed to demonstrate the effects of sterilant volume on microbial inactivation kinetics.
Reuse testing of the container and inserts was accomplished previously for 100 cycles in the STERRAD 100 Sterilization System. The product proved to be effective and compatible upon completion. Equivalency of the sealed container to a wrapped instrument tray was dcmonstrated.
The SteriTite® Container was independently tested according the following standards for its performance in STERRAD 100S 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 Reusuble Rigid Sterilization Container Systems."
ANSVAAMI/ISO 11134-1994 "Sterilization of heulth 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. "
2
COMPARISON: STERITITE PERFORATED BASE CONTAINERS TO SPUNGUARD WRAP *
| USE | SteriTite Perforated
Container with
polypropylene filter
STERRAD 100 | SteriTite Perforated
Container with
polypropylene filter
STERRAD 100S | Spunguard wrap |
|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------|
| Indicated for holding instruments to be
sterilized and stored | YES | YES | YES |
| Intended to be reused | YES | YES | NO |
| Methods of sterilization: | | | |
| Prevacuum steam | YES | YES | YES |
| Gravity steam | YES | YES | YES |
| STERRAD 100Sterilization | YES FOR BLADES,
YES FOR LUMENS | | YES FOR
BLADES. YES
FOR LUMENS |
| STERRAD 100S Sterilization | | YES FOR BLADES,
YES FOR LUMENS | YES FOR
BLADES. YES
FOR LUMENS |
| DESIGN | | | |
| Incorporates a filter / wrap system to
permit entry of sterilant agent and
prevent microbial migration during
storage | YES | YES | YES |
| MATERIALS: container /basket | Aluminum, SS, silicone | Aluminum, SS, silicone | |
| Filter / wrap | Polypropylene | Polypropylene | Polypropylene |
| PERFORMANCE
STANDARDS/ SPECIFICATIONS | | | |
| AAMI ST33 Standard testing
requirements | | | |
| 3.2. Permits transfer of contaminated
materials | YES | YES | YES |
| 3.3.1 Removable filter assembly
disassembles | YES | YES | NO |
| 3.3.4 Labeling | YES | YES | YES |
| 3.4-3.5 Decontamination instructions | YES | YES | YES |
| 3.6-4.2 Instructions for inspections | YES | YES | YES |
| 6.2.5 Sterility maintenance-discussed in
labeling | YES | YES | YES |
| 6.3 User responsibilities listed in
labeling | YES | YES | YES |
| 7.3.1 Routine inspection in labeling | YES | YES | YES |
| VALIDATION TESTING | | | |
| Testing performed using “overkill”
approach | YES | YES | YES |
| STERRAD® half-cycle parameters | YES | YES | YES |
| STERRAD® half-cycle parameters -
incremental | YES | YES | YES |
| Load | STU load | STU load | STU load |
| TESTING ORGANISM | | | |
| Bacillus Stcarothermophilus | YES | YES | YES |
| Inoculated spore carriers with 1 x 10º
B. Stearothermophilus | YES | YES | YES |
| INOCULATED BLADES under half-
cycle conditions | YES | YES | YES |
| INOCULATED LUMENS under half
cycle conditions with 3mm DIA x
400mm | YES | YES | YES |
| OCCLUSION under half-cycle
conditions - | | YES | YES |
3
- Note: Each container and wrap contained STU load with blades and lumens. For STERRAD 100S occlusions were added.
-
- Polypropylene Nonwoven Filter: Testing performed demonstrated adequate sterilant penetration as well us barrier propertics when used with the SteriTite® rigid reusable containcr system in the STERRAD 100 and 100S Sterilization process.
BIOCOMPATIBILITY
As stated previously in the cleared 510k # K991023 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 matcrials 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 non-cytoxic and found to be compatible with the STERRAD System. This was included in the STERRAD 100 510(k). The toxicity of the stcrilant has not changed.
4
Image /page/4/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 representing its body and wings. The eagle is facing to the right. 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
MAR 2 1 2003
Ms. Marcia Frieze CEO Case Medical, Incorporated 65 Railroad Avenue Ridgefield, New Jersey 07657
Re: K030853
Trade/Device Name: SteriTite® Perforated Base Rigid Sterilization Container System: SC04HG, SC06HG, SC08HG, SC04QG, SC06QG, SC08QG, SC04FG, SC06FG, SC08FG, SC03MG, SC03QG & PolyPro™ Disposable Filter # SCF02 Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 17, 2003 Received: March 18, 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.
5
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
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
6
Page
510(k) Number : K030853
Device Name : SteriTite ® Perforated Base Rigid Sterilization Container System: SC04HG, SC08HG, SC04QG, SC6QG, SC08QG, SC04FG, SC06FG, SC03MG, SC03QG & PolyPro™ Polypropylene Disposable Filter # SCF02 with MediTray product.
| DESCRIPTION | |
|---|---|
| The perforated base containers are part of the SteriTite @Reusable Rigid Sterilization Container system. Product # of intended device | |
| 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 |
| SC08G | 8"High Full-size case perforated bottom |
| SC03MG | 3"High Mini-size case perforated bottom |
| SC03QG | 3"High ¾ Mini-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 100S 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 OR Description Use ver- The-Counter Use
(Optional Format 1-2-96)
(Pcr 21 CFR 801.109)
OR