(178 days)
Not Found
No
The device is a sterilization pouch with a chemical indicator that changes color based on exposure to hydrogen peroxide. There is no mention of any computational analysis, learning, or adaptive algorithms.
No
The device is described as a pouch/roll used to enclose medical devices for sterilization and to indicate exposure to sterilant. It does not directly treat or diagnose a medical condition.
No
This device is a chemical indicator that shows exposure to hydrogen peroxide vapor during sterilization processes. It does not diagnose any condition or disease.
No
The device is a physical pouch/roll with a chemical indicator printed on it, designed for packaging medical devices for sterilization. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a sterilization pouch with a chemical indicator. Its purpose is to enclose medical devices for sterilization and indicate exposure to the sterilant. It does not perform any tests on human samples.
- Intended Use: The intended use clearly states it's for enclosing medical devices for sterilization and indicating exposure to sterilant. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilization process, the pouch roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.
The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.
Product codes (comma separated list FDA assigned to the subject device)
FRG, JOJ
Device Description
The proposed pouches are constructed from Tyvek® / plastic films, with the STERRAD® Chemical Indicator printed onto the Tyvek® film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.
The STERRAD® Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD® Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to yellow (or lighter) when exposed to hydrogen peroxide.
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
Not Found
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)
| Study Type | Description | Results |
|---|---|---|
| Sterilant Penetration | Half-Cycle Efficacy The sterilant penetrated through the “double pouch” configuration under the worst case half-cycle conditions and the sterility | Passed |
| Chemical Indicator (CI) Functionality and Endpoint | assurance level (SAL) of 10-6 was demonstrated. The sterilant penetrated through the “double pouch” configuration and affected the CI color change to the endpoint color (from red to yellow or lighter) under the suboptimal conditions. | Passed |
| Package Integrity Seal Strength | Seal strength performance characteristics were maintained for the manufactured seal and user made seal after STERRAD® processing. | Passed |
| Microbial Barrier | The contents of pouches were sterile when the processed pouches were subjected to the microbial aerosol challenge test. | Passed |
| Burst | Ability to withstand the internal pressurization was maintained after STERRAD® processing. | Passed |
| Peel Open | Peel open characteristics of the Tyvek® Pouch/Roll were maintained after STERRAD® processing. | Passed |
| Maintenance of Package Integrity | Sterility was maintained in the Tyvek® Pouches/Rolls for 30 days after STERRAD® processing. | Passed |
| Material Compatibility | Seal strength test, microbial barrier properties, burst test, and peel open test were studied to demonstrate material compatibility characteristics of the Tyvek® Pouches/Rolls after STERRAD® processing. | Passed |
| End Point / Post Processing Color Stability | Tyvek® Pouches/Rolls, after STERRAD® processing, maintained the endpoint CI color reaction. | Passed |
| Shelf Life Chemical Indicator (CI) Functionality | CI functionality of the processed Tyvek® Pouches/Rolls (CI color change from red to yellow or lighter) was verified at the end of shelf life. | Passed |
| Seal Strength | Seal strength of the processed Tyvek® Pouches/Rolls was verified at the end of shelf life. | Passed |
| Biocompatibility | In vivo testing showed that the pouch samples, after STERRAD® processing, met the acceptance criteria per ISO 10993-11 and 10993-10 | Passed |
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three profiles facing to the right, resembling a bird or a symbol of human connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19,2014
Advanced Sterilization Products % Sun Choi Regulatory Affairs Specialist 33 Technology Dr. Irvine, California 92618
Re: K141693
Trade/Device Name: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: November 20, 2014 Received: November 21, 2014
Dear Sun Choi,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin Keith, MS Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141693
Device Name
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
Indications for Use (Describe) (Page 1 of 2)
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilization process, the pouch roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.
The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.
| STERRAD® / Cycle | Single-channel stainless steel lumens | Other lumens | Load requirements |
|---|---|---|---|
| STERRAD® 100S | ≥1 mm ID x ≤125 mm long | ||
| ≥2 mm ID x ≤250 mm long | |||
| ≥3 mm ID x ≤400 mm long | Metal and nonmetal | ||
| ≥6 mm ID x ≤310 mm | |||
| long | ≤10 lumens per load | ||
| STERRAD® 50 | ≥1 mm ID x ≤125 mm long | ||
| ≥2 mm ID x ≤250 mm long | |||
| ≥3 mm ID x ≤400 mm long | Metal and nonmetal | ||
| ≥6 mm ID x ≤310 mm | |||
| long | ≤10 lumens per load | ||
| STERRAD® 200 | ≥1 mm ID x ≤125 mm long | ||
| ≥2 mm ID x ≤250 mm long | |||
| ≥3 mm ID x ≤400 mm long | Teflon® and | ||
| polyethylene | |||
| ≥6 mm ID x ≤310 mm | |||
| long | ≤12 lumens per load | ||
| ≤36.48 lbs |
Table 1: Indications for Use
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|× Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
28
3
Indications for Use
510(k) Number (if known) K141693
Device Name
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
Indications for Use (Describe) (Page 2 of 2)
Table 1: Indications for Use (continued)
| | STERRAD® / Cycle | Single-channel stainless
steel lumens | Other lumens | Load requirements |
|--------------------|------------------|----------------------------------------------------|--------------|-----------------------------------------------------------------------------------|
| STERRAD®
NX® | Standard | ≥1 mm ID x ≤150 mm long
≥2 mm ID x ≤400 mm long | N/A | ≤10 lumens per load
≤10.7 lbs |
| | Advanced | ≥1 mm ID x ≤500 mm long | N/A | ≤10 lumens per load
≤10.7 lbs |
| STERRAD®
100NX® | Standard | ≥0.7 mm ID x ≤500 mm long | N/A | ≤10 lumens per load
≤21.4 lbs |
| | EXPRESS | N/A | N/A | ≤10.7 lbs on bottom
shelf only |
| | DUO | N/A | N/A | Accessory devices
(e.g., cameras and
light cords) only
2 cameras maximum |
Table 2: Product Codes for Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator
| Product Type | Product Codes |
|---|---|
| Tyvek® Self-Seal Pouches with | |
| STERRAD® Chemical Indicator (123XX) | 12320, 12326, 12335, 12332, 12342, 12340, |
| 12348, 12356 | |
| Tyvek® Rolls with STERRAD® Chemical | |
| Indicator (124XX) | 12407, 12410, 12415, 12420, 12425, 12435, |
| 12442, 12450 | |
| Tyvek® Heat-Seal Pouches with | |
| STERRAD® Chemical Indicator (125XX) | 12521, 12526, 12532, 12541, 12548 |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|× Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
4
510(k) Summary
Applicant's Name, Address, Telephone, FAX, Contact Person
Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618
Establishment Registration Number: 2084725
Contact Person
Sun Choi Regulatory Affairs Specialist IV Email: sjchoi@its.jnj.com (949) 453-6378 (Telephone) (949) 789-3900 (Fax)
Date: December 19, 2014
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Sterilization Wrap
Sterilization Process Indicator |
|----------------------------|-------------------------------------------------------|
| Common/Usual Name: | Sterilization Pouch / Roll with Chemical Indicator |
| Product Classification: | Class II |
| Product Code: | FRG / JOJ |
| Panel: | General Hospital |
| Classification Regulation: | 21 CFR 880.6850
21 CFR 880.2800 |
| Proprietary Name: | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator |
2. PREDICATE DEVICES
The predicate device [510(k) Notification K112087, cleared October 15, 2012] is the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator, for use in the STERRAD® 100NX® Sterilizer.
3. INTENDED USE
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.
5
The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.
| | STERRAD® / Cycle | Single-channel stainless
steel lumens | Other lumens | Load requirements |
|--------------------|------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------|
| | STERRAD® 100S | ≥1 mm ID x ≤125 mm long
≥2 mm ID x ≤250 mm long
≥3 mm ID x ≤400 mm long | Metal and nonmetal
≥6 mm ID x ≤310 mm
long | 2 mm ID x In vivo testing showed that the pouch samples, after STERRAD® processing, met the acceptance criteria per ISO 10993-11 and 10993-10 | Passed |
9
10
6. OVERALL PERFORMANCE CONCLUSIONS
The nonclinical studies demonstrate that the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator performs as intended as a sterilization packaging system of medical devices that are being terminally sterilized in STERRAD® Sterilization Systems. The Chemical Indicator performs as intended for differentiating processed from unprocessed packages in the STERRAD® Sterilization Systems. These studies also show that the proposed pouches have the same intended use and met the same criteria as the predicate device (K112087) and are substantially equivalent.
Tyvek® is a registered trademark of DuPont