(35 days)
Standard Supreme Sterilization Wrappers are intended 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 steriity of the enclosed device until used.
Standard Supreme Sterilization Wrappers will function as a sterlization wrap when processed according to instructions. Standard 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 heath care facilities and/or contract sterilization/laundry companies.
Standard Supreme Sterilization Wrappers are made from Standard Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric and then dyed. 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.
This document describes the Standard Supreme Sterilization Wrappers, a medical device used to enclose other medical devices for sterilization and maintain sterility. The information provided is from an FDA 510(k) premarket notification summary (K172207).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirement) | Reported Device Performance |
|---|---|
| Sterile Barrier Function (Whole Package Challenge & Shelf Life) | Standard 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. (Note: Substantial Equivalence Table states ">20 psi" for both, but the performance section states ">50 psi" for the device, implying it exceeds the predicate's strength.) |
| Linting | < 5.0 log IPM. Resists the rigors of linting associated with flexing and abrasion. |
| Cytotoxicity | MEM Elution (MG023) Non-Toxic. |
| Sterilization Efficiency/Penetration | Sterilization efficiency/penetration for the Standard Supreme Sterilization Wrappers was demonstrated with a half-cycle exposure condition showing no growth of the indicator organism in worst case challenge load configurations. A pre-vacuum 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 12.9 pounds – pack density of 22.4 lbs./cu.ft. The maximum chamber loading configuration included 85.6 pounds of packs in a 9.1 cubic foot chamber – load density of 10.4 lbs./cu.ft. |
| Use Life | 75 processing (wash, dry and sterilization). |
| Colorfastness to Commercial Laundering | AATCC #61-1993(4A) >3.5. |
| Wrapping Practices (Oblong and Envelope folds for Fabric Packs) (Intended Use) | Yes, validated for use on textile packs. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for each individual test (e.g., how many wrappers were tested for strength, linting, or sterile barrier). It only describes the tests performed and the outcomes.
The data provenance is retrospective, as this is a 510(k) summary submitted to the FDA, detailing testing that has already been completed. The country of origin of the data is not specified, but the applicant (Standard Textile Co., Inc.) is based in Cincinnati, Ohio, USA, suggesting the testing was likely conducted in the US or under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are non-clinical performance tests (e.g., ASTM standards, cytotoxic tests, sterilization efficacy tests). These types of tests typically rely on established protocols and laboratory measurements rather than human expert consensus for "ground truth" in the same way a diagnostic imaging study would.
4. Adjudication Method for the Test Set
This information is not applicable to the non-clinical performance tests described. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., radiologists reviewing images) to establish ground truth or resolve discrepancies. The performance tests here appear to be objective measurements against established criteria.
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 information is not applicable. The device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and effects on human reader improvement with AI are irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical product (a sterilization wrapper), not an algorithm or software. There is no algorithm-only performance to assess.
7. The Type of Ground Truth Used
The ground truth used for these tests appears to be:
- Established industry standards and test methods: e.g., ASTM #D-5034-2013 for strength, AATCC #61-1993(4A) for colorfastness, MEM Elution for cytotoxicity.
- Microbiological challenge studies: For sterilization efficiency/penetration, the "no growth of the indicator organism" serves as the ground truth for effective sterilization.
- Physical and material property measurements: Performance against specified thresholds for linting, strength, and use life.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI models. The development and testing involve manufacturing and material science, not algorithm training.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for the same reasons as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Standard Textile Co., Inc. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109
Re: K172207
Trade/Device Name: Standard Supreme Sterilization Wrapper Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: July 21, 2017 Received: July 21, 2017
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
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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 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.
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 (DICE) 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 (DICE) 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,
Tara A. Ryan -S
Lori Wiggins, MPT, CLT 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) K172207
Device Name
Standard Supreme Sterilization Wrappers
Indications for Use (Describe)
Standard Supreme Sterilization Wrappers are intended 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 steriity of the enclosed device until used.
Standard Supreme Sterilization Wrappers will function as a sterlization wrap when processed according to instructions. Standard 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 heath 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 oblorg 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 12.9 pounds – pack density of 22.4 lbs./cu.ft. The maximum chamber loading configuration included 85.6 pounds of packs in a 9.1 cubic foot chamber – load density of 10.4 lbs./cu.ft.
| Sizes | Misty | Jade | Ceil |
|---|---|---|---|
| 12"x12" | 21520502 | -- | -- |
| 18"x18" | 21521502 | 21531502 | 21541502 |
| 23"x23" | 21522002 | 21532002 | 21542002 |
| 27"x27" | -- | 21532302 | -- |
| 30"x30" | 21522802 | 21532802 | 21542802 |
| 35"x35" | 21523002 | 21533002 | 21543002 |
| 45"x45" | 21525002 | 21535002 | 21545002 |
| 54"x54" | 21526002 | 21536002 | 21546002 |
| 54"x72" | 21528202 | 21538202 | 21548202 |
| 70"x70" | 21528802 | 21538802 | 21548802 |
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 STANDARD SUPREME STERILIZATION WRAPPERS (K172207)
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 8/24/2017 |
Device Information
| Device Name: | Standard 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
Standard Supreme Sterilization Wrappers are made from Standard Supreme fabric. This fabric uses intimately blended cotton and polyester yarns, is woven into fabric and then dyed. 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.
| Standard Supreme Wrapper Product Line Table | ||
|---|---|---|
| Item | Description | Size (inch) |
| 21520502 | Standard Supreme Wrapper, Misty | 12x12 |
| 21521502 | Standard Supreme Wrapper, Misty | 18x18 |
| 21522002 | Standard Supreme Wrapper, Misty | 23x23 |
| 21522802 | Standard Supreme Wrapper, Misty | 30x30 |
| 21523002 | Standard Supreme Wrapper, Misty | 35x35 |
| 21525002 | Standard Supreme Wrapper, Misty | 45x45 |
| 21526002 | Standard Supreme Wrapper, Misty | 54x54 |
| 21528202 | Standard Supreme Wrapper, Misty | 54x72 |
| 21528802 | Standard Supreme Wrapper, Misty | 70x70 |
| 21531502 | Standard Supreme Wrapper, Jade | 18x18 |
| 21532002 | Standard Supreme Wrapper, Jade | 23x23 |
| 21532302 | Standard Supreme Wrapper, Jade | 27x27 |
| 21532802 | Standard Supreme Wrapper, Jade | 30x30 |
| 21533002 | Standard Supreme Wrapper, Jade | 35x35 |
| 21535002 | Standard Supreme Wrapper, Jade | 45x45 |
| 21536002 | Standard Supreme Wrapper, Jade | 54x54 |
| 21538202 | Standard Supreme Wrapper, Jade | 54x72 |
| 21538802 | Standard Supreme Wrapper, Jade | 70x70 |
| 21541502 | Standard Supreme Wrapper, Ceil | 18x18 |
| 21542002 | Standard Supreme Wrapper, Ceil | 23x23 |
| 21542802 | Standard Supreme Wrapper, Ceil | 30x30 |
| 21543002 | Standard Supreme Wrapper, Ceil | 35x35 |
| 21545002 | Standard Supreme Wrapper, Ceil | 45x45 |
| 21546002 | Standard Supreme Wrapper, Ceil | 54x54 |
| 21548202 | Standard Supreme Wrapper, Ceil | 54x72 |
| 21548802 | Standard Supreme Wrapper, Ceil | 70x70 |
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Intended Use/Indications for Use
Standard Supreme Sterilization Wrappers are intended 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. Standard Supreme Sterilization Wrappers will function wrap when processed according to instructions. Standard Supreme Sterilization Wrappers are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile 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 12.9 pounds – pack density of 22.4 lbs./cu.ft. The maximum chamber loading configuration included 85,6 pounds of packs in a 9,1 cubic foot chamber - load density of 10,4 lbs./cu.ft.
Performance
Standard Supreme Sterilization Wrappers have successfully completed the non-clinical performance tests listed below.
- a. Whole Package Challenge and 30 Day Shelf Life Study Standard 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 Standard Supreme Sterilization Wrappers was demonstrated with a half-cycle exposure condition showing no growth of the indicator organism in worst case challenge load configurations. A pre-vacuum 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 12.9 pounds - pack density of 22.4 Ibs./cu.ft. The maximum chamber loading configuration included 85.6 pounds of packs in a 9.1 cubic foot chamber - load density of 10.4 lbs./cu.ft.
- f. Use Life - 75 processing (wash, dry and sterilization).
- g. Colorfastness to Commercial Laundering AATCC #61-1993(4A) >3.5.
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Substantial Equivalence Comparison
Standard 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 processing demonstrated that Standard Supreme Sterilization Wrappers and WrapPel "T" Sterilization Wrappers have the strength for reuse. Both subject and predicate wrappers can be steam sterilized.
In practice Standard 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 TableStandard Supreme Sterilization Wrappers (K172207)vs.WrapPel "T" Sterilization Wrappers (K923408) | ||
|---|---|---|
| Standard 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 performance characteristicsof Standard Supreme Sterilization Wrappers. Performance through 75 processing demonstrated thatStandard Supreme Sterilization Wrappers and WrapPel "T" Sterilization Wrappers have the strengthfor 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 - Pre-vacuum 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 |
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Substantial Equivalence Conclusion Statement
Based on intended use, bench testing and technological characteristics, Standard Supreme Sterilization Wrappers are substantially equivalent to the predicate device. The non-clinical tests demonstrate that Standard Supreme Sterilization Wrappers are substantially equivalent to the predicate device.
§ 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).