(161 days)
Not Found
No
The document describes a rigid reusable container system for sterilizing medical devices and does not mention any computational or analytical functions that would involve AI or ML.
No
The device is described as a system for containing medical devices for sterilization, storage, and transport, not for directly treating a condition or disease.
No
This device is a container system designed for sterilizing, storing, and transporting medical devices, not for diagnosing medical conditions.
No
The device description clearly indicates it is a system of rigid reusable containers, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to contain medical devices for sterilization, storage, transportation, and aseptic presentation. It is used on medical devices to prepare them for use, not on biological specimens to diagnose a condition.
- Device Description: The description focuses on the physical characteristics of the container system and how it facilitates sterilization and maintains sterility. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic, prognostic, or screening information
- Using reagents or calibrators
The SteriTite container system is a medical device used in the sterilization process of other medical devices. It is a critical component in ensuring the safety and sterility of instruments used in healthcare settings, but it does not perform a diagnostic function.
N/A
Intended Use / Indications for 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.
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
Product codes (comma separated list FDA assigned to the subject device)
FRG
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.
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
hospitals and 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)
Comparison of SteriTite® Rigid Reusable Containers with disposable filter to Predicate
- Indicated for containing instruments to be sterilized in EO, and be transported: YES
- Intended to be reused: YES
- Closed System: YES
- Sealed: YES
- Incorporates a filter system to permit entry of sterilant agent: YES
- Incorporates a filter system to prevent microbial migration during transport: YES
- Container Material: Aluminum, SS, silicone
- Filter Material: Disposable filter
- Conformance to AAMI ST33 Standard testing requirements: YES
- Pre-vacuum steam: YES
- Gravity Displacement steam: YES
- EO Sterilization: YES (solid and perforated bottom containers)
- STERRAD Sterilization: YES
- Load: STU load up to 22 lbs.
- Sterility Maintenance - Barrier properties: Event Related Sterility Maintenance: 90-day real time w/weekly handling events. 30-day real time with daily handling events
- Aeration Time: 12 Hours
- TEST organism/inoculated product:
- Inoculated spore carriers with 1 x 10^6 Bacillus Subtilis var. niger: YES
- INOCULATED BLADES: YES
- INOCULATED LUMENS: YES - 2.2mm diameter metal
- INOCULATED NYLON: YES
- INOCULATED SILICONE: YES
- INOCULATED RADEL: YES
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.S 807.92) Casc Medical, Inc. 65 Railroad Avenue Ridgefield, NJ 07657 TEL: 888.227.CASE FAX: 201-313-9090
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.
- 1 -
1
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/
SPECIFICATIONS | STERITITE CASE
W/ FILTER | GENESIS CASE W/
FILTER |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indicated for containing instruments to
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
entry of sterilant agent | YES | YES |
| Incorporates a filter system to prevent
microbial migration during transport | YES | YES |
| MATERIALS | | |
| Container | Aluminum, SS, silicone | Aluminum, SS,
silicone |
| Filter | Disposable filter | Disposable filter |
| PERFORMANCE STANDARDS | | |
| Conformance to AAMI ST33
Standard testing requirements | YES | YES |
| VALIDATION TESTING | | |
| Pre-vacuum steam | YES | YES |
| Gravity Displacement steam | YES | YES |
| EO Sterilization | YES (solid and
perforated bottom
containers) | YES (perforated
bottom containers) |
| STERRAD Sterilization | YES | YES |
| Load | STU load up to 22 lbs. | Up to 11 Lbs. |
| Sterility Maintenance - Barrier
properties | Event Related Sterility
Maintenance: 90-day
real time w/weekly
handling events. 30-day
real time with daily
handling events | Event Related Sterility
Maintenance: 180-day
(30-day) real time |
| PROPERTIES/
SPECIFICATIONS | STERITITE® CASE
W/ FILTER | GENESIS CASE W/
FILTER |
| Aeration Time | 12 Hours | 24 Hours |
| TEST organism/inoculated product | | |
| Inoculated spore carriers with 1 x 106
Bacillus Subtilis var. niger | YES | YES |
| INOCULATED BLADES | YES | YES |
| INOCULATED LUMENS | YES - 2.2mm diameter
metal | YES - 3mm diameter
metal |
| INOCULATED NYLON | YES | N/A |
| INOCULATED SILICONE | YES | N/A |
| INOCULATED RADEL | YES - | N/A |
2
.
:
and the comments of the comments of
3
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.
4
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 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
5
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 |
|---|---|
| --------------- | --------- |