(94 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Barrier Supreme Sterilization Wrappers:
Please Note: The provided document is a 510(k) premarket notification summary for a medical device (sterilization wrappers), not a typical AI/software medical device submission. Therefore, many of the requested fields (like sample size for test set/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable or explicitly mentioned in this type of document, as it concerns a physical product and its non-clinical performance testing.
Acceptance Criteria and Reported Device Performance for Barrier Supreme Sterilization Wrappers
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from predicate or general standards) | Reported Device Performance (Barrier Supreme Wrappers) |
|---|---|---|
| Material Strength | >20 psi (from predicate device WrapPel "T") | >50 psi (demonstrated in testing, per ASTM #D-5034-2013) * |
| Sterile Barrier | Effective sterile barrier for 30 days | Demonstrated ability to be an effective sterile barrier after 75 cycles of soiling, washing, drying, and sterilization (as sequential double wrap) |
| Use Life (Cycles) | 75 wash, dry, & sterilization cycles | Achieved 75 processing (wash, dry and sterilization) cycles |
| Linting | < 5.0 log IPM (from predicate device description implied) | < 5.0 log IPM (resists rigors of linting) |
| Cytotoxicity | Non-Toxic | Non-Toxic (MEM Elution (MG023) test) |
| Sterilization Efficiency/Penetration | No growth of indicator organism in worst-case load configurations | No growth of indicator organism in worst case challenge load configurations with a half-cycle exposure condition |
| Steam Sterilization Cycle (Prevaccuum) | 4 min exposure at 270°F validated | Validated for 4 min exposure at 270°F |
| Colorfastness | Yes (colorfast) (from predicate device description implied) | >3.5 (AATCC #61-1993(4A)) |
Note: The table lists ">20 psi" for the predicate in the comparative table on page 6, but the specific test description on page 5 lists ">50 psi" for the Barrier Supreme product. This indicates the Barrier Supreme product met and exceeded the general strength requirement, likely derived from the predicate or industry standards.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of wrappers tested) for each specific test (e.g., how many wrappers were subjected to 75 cycles, how many were used in the whole package challenge). However, the language implies that testing was conducted on "Barrier Supreme Sterilization Wrappers" as a product line.
- Data Provenance: The tests are non-clinical performance tests, likely conducted in a laboratory setting by the manufacturer (Standard Textile Co., Inc.) or a contracted testing facility. The document does not specify a country of origin for the data beyond the manufacturer's location in Cincinnati, Ohio, USA. The studies are by nature prospective as they are simulating real-world use conditions to determine performance before market introduction.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable to this type of device submission. The "ground truth" for a physical product like sterilization wrappers is established through objective, measurable non-clinical performance tests (e.g., tensile strength, biological indicator results, linting measurements), not through expert consensus on interpretations of data or images.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging. For physical product performance, results are typically objective measurements against a predefined standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This question is not applicable. This is a submission for a physical medical device (sterilization wrap) and does not involve AI, human readers, or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. No algorithm or AI is involved in this device.
7. The Type of Ground Truth Used
- The "ground truth" for the performance of the Barrier Supreme Sterilization Wrappers is established through objective non-clinical performance test results. These include:
- Laboratory measurements of physical properties (e.g., strength, linting).
- Biological challenge tests (e.g., sterilization efficiency, cytotoxicity) with clear pass/fail criteria (e.g., "no growth of indicator organism," "non-toxic").
- Simulated use cycles (e.g., 75 wash, dry, and sterilization cycles) to assess durability and continued sterile barrier effectiveness.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" in the context of a physical medical device that undergoes non-clinical performance testing. Training sets are relevant for AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As there is no training set for this type of device, no ground truth was established for it.
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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
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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
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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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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 WrapRegulation 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.
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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 < 5.0 log IPM. Resists the rigors of linting associated with flexing and abrasion.
- d. Cytotoxicity MEM Elution (MG023) Non-Toxic
- e. Sterilization Sterilization efficiency/penetration for the Barrier Supreme Sterilization Wrap was demonstrated with a half-cycle exposure condition showing no growth of the indicator organism in worst case challenge load configurations. 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.
- f. Use Life - 75 processing (wash, dry and sterilization).
- Colorfastness to Commercial Laundering AATCC #61-1993(4A) >3.5. q.
The non-clinical tests demonstrate that Barrier Supreme Sterilization Wrappers are substantially equivalent to the predicate device.
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| Substantial Equivalence Table | ||
|---|---|---|
| Barrier Supreme Sterilization Wrappers | ||
| vs.WrapPel "T" Sterilization Wrappers (K923408) | ||
| Barrier Supreme SterilizationWrappers | WrapPel "T" SterilizationWrappers | |
| 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 performancecharacteristics of Barrier Supreme Sterilization Wrappers. Performance through 75processings demonstrate that Barrier Supreme Sterilization Wrappers and WrapPel “T”Sterilization Wrappers have the strength for reuse. Both wrappers can be steam sterilized arecolorfast, 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 minuteexposure 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 thepredicate device. |
Г
§ 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).