(94 days)
Not Found
No
The device is a sterilization wrap made of fabric, and the description focuses on its material properties, sterilization performance, and durability. There is no mention of any computational or analytical functions that would involve AI/ML.
No.
This device is a sterilization wrap intended to maintain the sterility of other medical devices, not to provide a therapeutic effect itself.
No
Explanation: The device is a sterilization wrap intended to maintain the sterility of other medical devices. It does not diagnose or detect any medical condition.
No
The device description clearly states it is a physical product made from fabric, dyes, and a fluoropolymer finish. It is a tangible item used for wrapping other medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the sterilization and storage of medical devices, not the diagnosis of diseases or conditions using in vitro methods.
- Device Description: The description focuses on the material composition and physical properties of the sterilization wrappers. It does not mention any components or functionalities related to analyzing biological samples or performing diagnostic tests.
- Performance Studies: The performance studies evaluate the effectiveness of the wrappers as a sterile barrier, their strength, linting, cytotoxicity, and sterilization efficiency. These are all relevant to the function of a sterilization wrap, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
In summary, the Barrier Supreme Sterilization Wrappers are designed to facilitate the sterilization and storage of other medical devices, which falls under the category of medical device accessories or sterilization equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Barrier Sterilization Wrappers are intended to be used to enclose another medical device that is to be sterlized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Barrier Supreme Sterilization Wrappers will function wrap when processed according to instructions. Barrier Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterily sterilization wraps that are intended to be sterlized and processed by health care facilities and/or contract sterilization/laundry companies.
Product codes
FRG
Device Description
Barrier Supreme Sterilization Wrappers are made from Barrier Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric, dyed and treated with a fluoropolymer finish. The fabric comes in three colors - misty, ceil and jade. The dyes used to achieve the three shades include Teresil Navy, Novasol Blue, VatGreen1, Vat Yellow1, and Vat Red31.
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
health care provider / health care facilities and/or contract sterilization/laundry companies.
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)
Non-clinical performance tests conducted:
- Whole Package Challenge and 30 Day Shelf Life Study: Barrier Supreme Sterilization Wrappers demonstrated their ability in these tests to be an effective sterile barrier after 75 cycles of soiling, washing, drying and sterilization when used as a sequential double wrap for textile packs.
- Strength through 75 wash, dry and sterilization cycles: ASTM #D-5034-2013 >50 psi
- Linting: 3.5. q.
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 U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Standard Textile Co., Inc. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109
Re: K162162
Trade/Device Name: Barrier Supreme Sterilization Wrapper Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: September 27, 2016 Received: September 27, 2016
Dear Jonathan Kahan:
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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K162162
Device Name
Barrier Supreme Sterilization Wrappers (for models, colors, and sizes, see Table 1 below)
Indications for Use (Describe)
Barrier Sterilization Wrappers are intended to be used to enclose another medical device that is to be sterlized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Barrier Supreme Sterilization Wrappers will function wrap when processed according to instructions. Barrier Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterily sterilization wraps that are intended to be sterlized and processed by health care facilities and/or contract sterilization/laundry companies.
Pack Assembly:
Pack assembly should follow established folding, assembly and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. The oblog and envelope folds have been validated for use on textile packs. Closure can include autoclave tape and elastomer closures.
Sterilization:
A prevacuum steam sterilization cycle (4 minute exposure at 270°F) has been validated for use on textile packs. The maximum pack size validated for use was 0.58 cubic feet with a pack weight of 23.2 pounds – pack density of 40.0 lbs./cu.ft. The maximum chamber loading configuration included 96 pounds of packs in a 9.1 cubic foot chamber – load density of 10.6 lbs./cu.ft.
| Table 1: Barrier Supreme Sterilization Wrappers Color and Model #'s | |||
|---|---|---|---|
| A !! |
| Sizes | Misty | Jade | Ceil |
|---|---|---|---|
| 12"x12" | --- | -- | -- |
| 18"x18" | 21621502 | 21631502 | 21651502 |
| 23"x23" | 21622002 | 21632002 | 21652002 |
| 30"x30" | 21622802 | 21632802 | 21652802 |
| 35"x35" | 21623002 | 21633002 | 21653002 |
| 45"x45" | 21625002 | 21635002 | 21655002 |
| 54"x54" | 21626002 | 21636002 | 21656002 |
| 54"x72" | 21628202 | 21638202 | 21658202 |
| 60"x60" | 21628502 | -- | -- |
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510K SUMMARY BARRIER SUPREME STERILIZATION WRAPPERS
Contact Information
| Standard Textile Co., Inc. | Contact Person: Brad Bushman |
|---|---|
| One Knollcrest Drive | Phone (513) 761-9255 Ext 2455; Fax (513) 679-8389 |
| Cincinnati, Ohio 45237 | Summary Prepared on 10/27/2016 |
Device Information
| Device Name: | Barrier Supreme Sterilization Wrappers |
|---|---|
| Class: | Class II |
| Common/Usual Name: | Non-sterile Sterilization Wrappers |
| Classification Name: | Sterilization Wrap |
| Regulation 21 CFR 880.6850, Product Code FRG |
Device Description
Barrier Supreme Sterilization Wrappers are made from Barrier Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric, dyed and treated with a fluoropolymer finish. The fabric comes in three colors - misty, ceil and jade. The dyes used to achieve the three shades include Teresil Navy, Novasol Blue, VatGreen1, Vat Yellow1, and Vat Red31.
| Barrier Supreme Wrapper Product Line Table | |
|---|---|
| Item | Description |
| 21621502 | Barrier Supreme Wrapper, Misty 18x18 |
| 21622002 | Barrier Supreme Wrapper, Misty 23X23 |
| 21622802 | Barrier Supreme Wrapper, Misty 30x30 |
| 21623002 | Barrier Supreme Wrapper, Misty 35x35 |
| 21625002 | Barrier Supreme Wrapper, Misty 45x45 |
| 21626002 | Barrier Supreme Wrapper, Misty 54x54 |
| 21628202 | Barrier Supreme Wrapper, Misty 54x72 |
| 21628502 | Barrier Supreme Wrapper, Misty 60x60 |
| 21631502 | Barrier Supreme Wrapper, Jade 18x18 |
| 21632002 | Barrier Supreme Wrapper, Jade 23x23 |
| 21632802 | Barrier Supreme Wrapper, Jade 30x30 |
| 21633002 | Barrier Supreme Wrapper, Jade 35x35 |
| 21635002 | Barrier Supreme Wrapper, Jade 45x45 |
| 21636002 | Barrier Supreme Wrapper, Jade 54x54 |
| 21638202 | Barrier Supreme Wrapper, Jade 57x72 |
| 21651502 | Barrier Supreme Wrapper, Ceil Blue 18x18 |
| 21652002 | Barrier Supreme Wrapper, Ceil Blue 23x23 |
| 21652802 | Barrier Supreme Wrapper, Ceil Blue 30x30 |
| 21653002 | Barrier Supreme Wrapper, Ceil Blue 35x35 |
| 21655002 | Barrier Supreme Wrapper, Ceil Blue 45x45 |
| 21656002 | Barrier Supreme Wrapper, Ceil Blue 54x54 |
| 21658202 | Barrier Supreme Wrapper, Ceil Blue 54x72 |
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Intended Use/Indications for Use
Barrier Supreme Sterilization Wrappers are intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Barrier Supreme Sterilization Wrappers will function as a sterilization wrap when processed according to instructions. Barrier Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterilization wraps that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Pack Assembly:
Pack assembly should follow established folding, assembly and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. The oblong and envelope folds have been validated for use on textile packs. Closure can include autoclave tape and elastomer closures.
Sterilization:
A prevacuum steam sterilization cycle (4 minute exposure at 270°F) has been validated for use on textile packs. The maximum pack size validated for use was 0.58 cubic feet with a pack weight of 23.2 pounds - pack density of 40.0 lbs./cu.ft. The maximum chamber loading configuration included 96 pounds of packs in a 9.1 cubic foot chamber - load density of 10.6 lbs./cu.ft.
Substantial Equivalence Comparison
Barrier Supreme Sterilization Wrappers have been shown to be "substantially equivalent" to WrapPel "T" sterilization wraps K923408. All fabrics used are woven, dyed and treated with a fluoropolymer finish. Fabrics are spread, cut and sewn into the similar if not the exact wrapper size. All products can use color coded thread around the edges to provide easy size identification.
Performance through 75 processings demonstrate that Barrier Supreme Sterilization Wrappers and WrapPel "T" Sterilization Wrappers have the strength for reuse. Both subject and predicate wrappers can be steam sterilized.
In practice Barrier Supreme Sterilization Wrappers differ from WrapPel "T" Sterilization Wrappers in that it is a 55/45 blended cotton/polyester fabric versus WrapPel "T" Sterilization Wrappers which are 100% polyester.
Substantial Equivalence Conclusion Statement
Based on intended use, bench testing and technological characteristics, Barrier Supreme Sterilization Wrappers are substantially equivalent to the predicate device.
5
Performance
Barrier Supreme Sterilization Wrappers have successfully completed the non-clinical performance tests listed below.
- a. Whole Package Challenge and 30 Day Shelf Life Study Barrier Supreme Sterilization Wrappers demonstrated their ability in these tests to be an effective sterile barrier after 75 cycles of soiling, washing, drying and sterilization when used as a sequential double wrap for textile packs.
- b. Strength through 75 wash, dry and sterilization cycles ASTM #D-5034-2013 >50 psi
- c. Linting 3.5. q.
The non-clinical tests demonstrate that Barrier Supreme Sterilization Wrappers are substantially equivalent to the predicate device.
6
| Substantial Equivalence Table | ||
|---|---|---|
| Barrier Supreme Sterilization Wrappers | ||
| vs. | ||
| WrapPel "T" Sterilization Wrappers (K923408) | ||
| Barrier Supreme Sterilization | ||
| Wrappers | WrapPel "T" Sterilization | |
| Wrappers | ||
| Manufacturing | ||
| Quality System | 21 CFR 820 | 21 CFR 820 |
| Fabric | Woven (1:1) | Woven (1:1) |
| Finishing | Vat Dyed | Disperse Dyed & |
| Flurocarbon Treated | ||
| Cut-n-Sew | Yes | Yes |
| Finished Dimensions | Similar/Same | Similar/Same |
| Performance - Non-clinical tests were used to evaluate the physical and performance | ||
| characteristics of Barrier Supreme Sterilization Wrappers. Performance through 75 | ||
| processings demonstrate that Barrier Supreme Sterilization Wrappers and WrapPel “T” | ||
| Sterilization Wrappers have the strength for reuse. Both wrappers can be steam sterilized are | ||
| colorfast, low lint and non-toxic. | ||
| Strength | >20 psi | >20 psi |
| Colorfastness | Yes | Yes |
| Linting | Completed | Completed |
| Toxicity | Non-Toxic | Non-Toxic |
| Use Life | 75 wash, dry, & sterilizations | 75 wash, dry, & sterilizations |
| Sterilization – Prevacuum Steam Cycles | ||
| Cycle – 4 minute | ||
| exposure at 270°F. | Yes | Yes |
| Intended Use, i.e., traditional wrapping practices using oblong and envelope folds | ||
| Fabric Packs | Yes | Yes |
| Substantially Equivalent Conclusion Statement - Based on intended use, bench testing, | ||
| and technological characteristics, the subject device is substantially equivalent to the | ||
| predicate device. |
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