(266 days)
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
A) Pre-vacuum Steam: 134℃ for 4 minutes, 30 minutes dry time.
B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ℃
Model: ZSW1610, ZSW 1611. Material: 45gms SMS, 54gms SMS. Color of wrap: Pink/Blue (double layers). Size (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization.
Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization: General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusion restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size.
For size212, 1515, 1818, maximum weight is 216, for 2020, 3636, 4040, 4545, 4848, maximum weight is 6lb, and for 5454, 7254, maximum weight is 9lb.
Sterilization Wrap is square or rectangular three-layer (SMS) non-woven sheet which manufactured with Polypropylene spunbond-meltblown-spunbond (SMS) fabric. Sterilization wrap provides a strong barrier which protects against cuts, tears with particularly device sets. The device is designed to be implemented as an outer sterilization wrap which allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post Pre-Vacuum Steam Sterilization or Ethylene Oxide Sterilization.
Sterilization Wrap is two-layer sheet which ultrasonically bonded blue and pink nonwoven sheet together along two edges, thus for convenient simultaneous wrapping.
Sterilization Wrap separated into two distinct types depending on different grams of weight of material, for ZSW 1610, it is two 45gsm SMS non-woven sheet ultrasonically bonded together, and for model ZSW 1611, it is two 54gsm SMS sheet. Each model contains series specification, including 12 Sizes (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254. With non-lumened reusable metal and nonmetal devices as part of the load, which with a maximum weight of each type, range from 21bs to 9lbs, which dependent on each model's size.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Sterilization Wrap (K223600).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document presents the acceptance criteria and device performance as "Test Items" and "Test Result" (always "Pass"). The specific numerical/quantitative acceptance criteria are listed under "Standard and Acceptance Criteria".
| Test Items | Standard and Acceptance Criteria | Reported Device Performance (Test Result) |
|---|---|---|
| Size and Gram weight | ASTM D3776M-20: Standard Test Methods for Mass Per Unit Area (Weight) of Fabric Size: Marking dimension tolerance ±10%; Weight: Marking gram tolerance ±2g/m² | Pass |
| Bacterial Filtration Efficiency (BFE) | ASTM F 2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus BFE ≥ 90% | Pass |
| Hydrostatic Pressure | AATCC 127-03 Test Method for Water Resistance: Hydrostatic Pressure Hydrostatic Pressure ≥ 50 cm H2O | Pass |
| Tensile Strength | ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) MD≥ 90N; CD≥ 63N | Pass |
| Air Permeability | ASTM D737-18 Standard Test Method for Air Permeability of Textile Fabrics Air Permeability ≥ 30 cfm | Pass |
| Bursting Strength | ASTM D3786-18 Standard Test Method for Bursting Strength of Textile Fabrics—Diaphragm Bursting Strength Tester Method Bursting Strength ≥ 130 kpa (18.86psi) | Pass |
| Tearing Strength | ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure MD≥ 50N; CD≥ 30N | Pass |
| Lint Generation | ISO9073-10: 2019 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state Coefficient of linting ≤4.0 | Pass |
| Skin Irritation AND Skin Sensitization | ISO 10993-1, ISO 10993-5, ISO 10993-10:2010. "Under the conditions of the study, the test article (pouches and chemical indicator) extract did not show no significant evidence of causing skin sensitization in the guinea pig before and after sterilized." | Pass |
| Shelf-Life Validation | Shelf Life Validation Test: Real time aging method. Shelf Life: 2 Years; Shelf Life after Sterilized: 90 days. The device performance shall be meet the requirements of the device. SAL=10-6. | Pass |
| Sterilization Process Validation for EO | ISO11135: 2014 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process. Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 °C. The device performance shall be meet the requirements of the device with the worst loading, SAL=10-6. | Pass |
| Sterilization Process Validation for Steam | AAMI / ANSI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities and ISO 17665-1:2006. Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time. The device performance shall be meet the requirements of the device with the worst loading, SAL=10-6. | Pass |
| Material compatibility | After Pre-vacuum Steam or 100% Ethylene Oxide (EO) sterilization, the materials were not degraded. Performance test including: Size and Gram weight, Bacterial Filtration Efficiency (BFE), Hydrostatic Pressure, Tensile Strength, Air Permeability, Bursting Strength, Tearing Strength, Lint Generation should meet requirements. | Pass |
| EO/ECH residue | ISO 10993-7: 2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals EO≤4mg/d, ECH ≤9mg/d | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the non-clinical tests. It only states that the tests were conducted and "all results can meet standards requirements" or "Passed".
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective for each specific test. However, the submitter is "Wuhan Zonsen Medical Products Co., Ltd." located in Wuhan, Hubei, China, which implies the testing likely occurred in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a medical accessory (sterilization wrap) and the validation involves non-clinical laboratory and performance testing, not expert interpretation of medical images or data requiring ground truth establishment by medical experts. The "ground truth" for this device's performance is established by meeting the specified international and national standards for physical properties, sterilization efficacy, and biocompatibility.
4. Adjudication method for the test set
This information is not applicable for the type of testing performed for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers for diagnostic accuracy, which is not relevant here.
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 tool. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As stated above, this is a physical medical accessory, not an algorithm or software device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on established international and national standards for medical device physical properties, biocompatibility, and sterilization process validation (e.g., ASTM, AATCC, ISO standards). The "truth" is whether the device's measured properties and performance meet the predefined thresholds set by these standards.
8. The sample size for the training set
This information is not applicable. This is a physical medical device that undergoes manufacturing and quality control testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wuhan Zonsen Medical Products Co., Ltd. Linna Ye Registration Manager No 8 Jinchao Rd, Zhucheng Street Wuhan, Hubei China
Re: K223600
Trade/Device Name: Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: July 7, 2023 Received: July 21, 2023
Dear Linna Ye:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
August 25, 2023
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed Eileen by Eileen Cadel -Cadel -S Date: 2023.08.25 13:20:06 -04'00' for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223600
Device Name Sterilization Wrap
Indications for Use (Describe)
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healtheare provider via the following:
A) Pre-vacuum Steam: 134℃ for 4 minutes, 30 minutes dry time. B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ℃
Model: ZSW1610, ZSW 1611. Material: 45gms SMS, 54gms SMS. Color of wrap: Pink/Blue (double layers). Size (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization.
Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization: General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusionr estricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size.
For size212, 1515, 1818, maximum weight is 216, for 2020, 3636, 4040, 4545, 4848, maximum weight is 6lb, and for 5454, 7254, maximum weight is 9lb.
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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510(K) Summary
510 (K) Summary
This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92
- Date of Submission: August, 23, 2023.
2. Submitter / 510(K) Holder
Wuhan Zonsen Medical Products Co., Ltd.
No. 8 Jinchao Road, Zhucheng Avenue, Xinzhou District, Wuhan City, Hubei Province, P.R. China 431400
Contact Person: Ms. Lisa Zhang Position: Registration Manager Email: registration01@zonsenmed.com
3. Proposed Device Name
Trade name: Sterilization Wrap Common name: Sterilization Wrap Classification Name: Wrap, Sterilization/Indicator, Physical/Chemical Sterilization Process Device Class: Class II Classification Panel: General Hospital Product Code: FRG Regulation Number: 21 CFR 880.6850
4. Predicate Devices
Primary Predicate Device: K160755
Product Name: Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap
Submitter: Ahlstrom Nonwovens LLC
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5. Device Description
Sterilization Wrap is square or rectangular three-layer (SMS) non-woven sheet which manufactured with Polypropylene spunbond-meltblown-spunbond (SMS) fabric. Sterilization wrap provides a strong barrier which protects against cuts, tears with particularly device sets. The device is designed to be implemented as an outer sterilization wrap which allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post Pre-Vacuum Steam Sterilization or Ethylene Oxide Sterilization.
Sterilization Wrap is two-layer sheet which ultrasonically bonded blue and pink nonwoven sheet together along two edges, thus for convenient simultaneous wrapping.
Sterilization Wrap separated into two distinct types depending on different grams of weight of material, for ZSW 1610, it is two 45gsm SMS non-woven sheet ultrasonically bonded together, and for model ZSW 1611, it is two 54gsm SMS sheet. Each model contains series specification, including 12 Sizes (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254. With non-lumened reusable metal and nonmetal devices as part of the load, which with a maximum weight of each type, range from 21bs to 9lbs, which dependent on each model' size (table 1)
| Model | Material | Layers | Color | Size | MaximumWeight(lbs.) | |
|---|---|---|---|---|---|---|
| Long(inches) | Width(inches) | |||||
| ZSW1610 | 45 gsmSMS | 2 | Pink and Bluedouble layers | 12 | 12 | 2 |
| 15 | 15 | 2 | ||||
| 18 | 18 | 2 | ||||
| 20 | 20 | 6 | ||||
| 24 | 24 | 6 | ||||
| 30 | 30 | 6 | ||||
| 36 | 36 | 6 |
Table 1 Device Specification
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| K223600 | 510 (k) Summary | |||||
|---|---|---|---|---|---|---|
| 40 | 40 | 6 | ||||
| 45 | 45 | 6 | ||||
| 48 | 48 | 6 | ||||
| 54 | 54 | 9 | ||||
| 72 | 54 | 9 | ||||
| 12 | 12 | 2 | ||||
| 15 | 15 | 2 | ||||
| 18 | 18 | 2 | ||||
| 20 | 20 | 6 | ||||
| 24 | 24 | 6 | ||||
| ZSW1611 | 54SMS | gsm2 | Pink and Bluedouble layers | 30 | 30 | 6 |
| 36 | 36 | 6 | ||||
| 40 | 40 | 6 | ||||
| 45 | 45 | 6 | ||||
| 48 | 48 | 6 | ||||
| 54 | 54 | 9 | ||||
| 72 | 54 | 9 |
6. Indications for Use
Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
A) Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time.
B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360~363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 °C.
Model: ZSW1610, ZSW 1611.
Material (single layer): 45gms SMS, 54gms SMS.
Color of wrap: Pink/Blue.
Size (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254.
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The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization.
Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization:
General purpose non-lumened reusable metal and nonmetal devices including devices with stainless steel diffusionr estricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc.
Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each type, range from 21bs to 91bs, which dependent on each model's size.
For size: 212, 1515, 1818, maximum weight is 21b, for 2020, 2424, 3030, 3636, 4040. 4545. 4848. maximum weight is 6lb. and for 5454. 7254. maximum weight is 9lb.
7. Technological Characteristics Comparison Table
The Sterilization Wrap is compared with the predicate device Reliance® Solo Sterilization Wrap, Reliance® Tandem Sterilization Wrap (K160755). The results are shown below in the Technological Characteristics Comparison Table:
| Devicecharacteristic | Proposed Device | Predicate Device510(K) No. K160755 | Comparison Result |
|---|---|---|---|
| Manufacturer | Wuhan Zonsen MedicalProducts Co., Ltd. | Ahlstrom Nonwovens,LLC | -- |
| Product name | Sterilization wrap | Reliance® SoloSterilizationWrap, Reliance®TandemSterilization Wrap | -- |
| 510(k) Reference | K223600 | K160755 | -- |
Table 2 General Comparison between proposed and predicate device
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510 (k) Summary
| Class | Class II | Class II | Same | K223600 | 510 (k) Summary | ||
|---|---|---|---|---|---|---|---|
| Product Code | FRG | FRG | Same | days post sterilization. | device(s) until used. | ||
| RegulationNumber | 21 CFR PART 880.6850 | 21 CFR PART 880.6850 | Same | MaterialComposition | Polypropylenespunbondmeltblown-spunbond (SMS)fabric | Polypropylenespunbondmeltblown-spunbond (SMS)fabric | Same |
| Intended Use | Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. | Reliance® Tandem and Solo Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care Provider. | Same | Design feature | Zonsen Sterilization Wrap issquare or rectangular three-layer (SMS) non-wovensheet which manufacturedwith Polypropylenespunbond-meltblown-spunbond (SMS) fabric.The device has two-layersheet which ultrasonicallybonded blue and pink non-woven sheet together alongtwo edges, thus forconvenient simultaneouswrapping. | The Reliance® Solo andReliance® TandemSterilization Wraps aresquare or rectangular.nonwoven sheetsproduced using a three-layer SMS (spunbond-meltblown-spunbond)process. The Reliance®SMS Sterilization Wrapsare separated into twodistinct product offerings:Reliance® Solo: Consistsof two sheets of SMSwrap, ultrasonicallybonded together alongtwo edges for convenientsimultaneous wrapping ofone or a collection ofmedical devices that willbe sterilized followingstandard healthcarepractices.Reliance® Tandem:Consists of single sheets | Same |
| Indication for use | Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes dry time.B) 100% Ethylene Oxide (EO) with a concentration of 360~363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 °C. | Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:A) Pre-vacuum Steam 270°F/132°C for 4 minutes, validated for dry time of 20 minutes for Models T100/S100, T200/S200, T300/S300, Validated for dry time of 30 minutes for Models T400/S400, T500/S500, T600/S600 | Similar | ||||
| B) 100% Ethylene Oxide (EO) with a concentration of 725~735 mg/L @ 131°F/55°C and 40%~80% relative humidity for 60 minutes.C) Gravity Steam 250°F/121°C for 30 minutesD)Advanced Sterilization Products (ASP) STERRAD® 100SE) Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)F) STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non-Lumen and Flexible Cycles) | |||||||
| The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 | The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed | Similar |
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510 (k) Summary
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| of SMS wrap, where twosheets are used togetherfor the sequentialwrapping of one or acollection of medical.devices that will besterilized followingstandard healthcarepractices. | |||
|---|---|---|---|
| Size and color | Pink and blue | Blue and green | Similar |
| Sterilization Wrap separatedinto two distinct typesdepending on differentgrams of weight of material, | DimensionalSpecifications ofReliance® Tandem andReliance® Solo Wrap:six type Models dependon various grams ofweight, | ||
| Size (inches): 1212, 1515, | Size (inches): 99, 1212, | ||
| 1818, 2020, 24*24, | 1515, 1818, 20*20, | ||
| 3030, 3636, 40*40, | 2424, 3030, 36*36, | ||
| 4545, 4848, 54*54, | 4040, 4545, 48*48, | ||
| 72*54. | 5454, 6060, 72*54. | ||
| Single Use vs.Reusable | Single use | Single use | Same |
| Disposable vs.Non-Disposable | Disposable | Disposable | Same |
| MaximumRecommendedWrapped Package | Types of medical devices tobe sterilized in the Pre-Vacuum Steam Sterilization | All models of Reliance®Tandem and Solovalidated for pre-vacuum | Similar |
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| Content Weights | Ethylene Oxide Sterilization: | steam Sterilization and ethylene oxide | S10 (k) Summary | |
|---|---|---|---|---|
| General purpose non-lumened reusable metal and nonmetal devices including devices with stainless steel diffusion restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc.Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each type, range from 2lbs to 9lbs, which dependent on each model's size. | sterilization with stainless steel lumens (3 mm in diameter or larger and 400 mm in length or less) as part of the load with a maximum weight of 25lbs dependent on the model. | |||
| Size and Gram weight | ASTM D3776/ D3776M-20Size: Marking dimension tolerance ±10%; Weight : Marking gram tolerance ±2g/m2 the inspection result is PASS | ASTM D3776/ D3776M-20Size: Marking dimension tolerance ±10%; Weight : Marking gram tolerance ±2g/m2 the inspection result is PASS | Same | |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 Bacterial Filtration Efficiency (BFE) Using a Biological Aerosol | ASTM F2101-19 Bacterial Filtration Efficiency (BFE) Using a Biological Aerosol | Same | |
| K223600 | 510 (k) Summary | |||
| of Staphylococcus aureus ≥90%the inspection result isPASS | Biological Aerosol ofStaphylococcus aureus ≥90%the inspection result isPASS | |||
| HydrostaticPressure | AATCC 127-03, WaterResistance: HydrostaticPressure ≥ 50 cm H2Othe inspection result isPASS | AATCC 127-03, WaterResistance: HydrostaticPressure ≥ 50 cm H2Othe inspection result isPASS | Same | |
| Tensile Strength | ASTM D5034-09 Standard,Breaking Strength andElongation of TextileFabrics (Grab Test)MD≥ 90N; CD≥ 63Nthe inspection result isPASS | ASTM D5034-09Standard, BreakingStrength and Elongationof Textile Fabrics (GrabTest)MD≥ 90N; CD≥ 63Nthe inspection result isPASS | Same | |
| Air Permeability | ASTM D737-18Standard,Air Permeability of TextileFabrics ≥ 30 cfmthe inspection result isPASS | ASTM D737-18Standard,Air Permeability ofTextile Fabrics ≥ 30 cfmthe inspection result isPASS | Same | |
| Bursting Strength | ASTM D3786-18Standard Test Method forBursting Strength of TextileFabrics—DiaphragmBursting Strength TesterMethod ≥ 130 kpa(18.86psi)the inspection result is | ASTM D3786-18Standard Test Method forBursting Strength ofTextile Fabrics—Diaphragm BurstingStrength Tester Method ≥130 kpa (18.86psi)the inspection result is | Same | |
| PASS | PASS | |||
| Tearing Strength | ASTM D5587-15, TearingStrength of Fabrics, MD≥50N, CD≥ 30N.the inspection result isPASS | ASTM D5587-15,Tearing Strength ofFabrics, MD≥ 50N, CD≥30N.the inspection result isPASS | Same | |
| Lint Generation | ISO9073-10, Textiles Lint,Cofficient of linting ≤4.0the inspection result isPASS | ISO9073-10,TextilesLint, Cofficient of linting≤4.0the inspection result isPASS | Same | |
| MaterialCompatibility | After Pre-vacuum Steam or100% Ethylene Oxide (EO)sterilization, the materialswere not degraded.Performance test includingSize and Gram weightBacterial FiltrationEfficiency (BFE)Hydrostatic PressureTensile StrengthAir PermeabilityBursting StrengthTearing StrengthLint Generationcan meet requirements | After Pre-vacuum Steamor 100% Ethylene Oxide(EO) sterilization, thematerials were notdegraded.Performance testincludingSize and Gram weightBacterial FiltrationEfficiency (BFE)Hydrostatic PressureTensile StrengthAir PermeabilityBursting StrengthTearing StrengthLint Generationcan meet requirements | Same | |
| Biocompatibility | ISO 10993-5 non-cytotoxicpost sterilization | ISO 10993-5, non-cytotoxic post | Same | |
| sterilization | ||||
| Maintenance ofSterility | 90days | 90days | Same | |
| Shelf Life | 2 years from date of manufacture | unknown | Similar |
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The design and technological characteristics of the Sterilization wrap is similar to the predicate chosen. There are minor differences between the devices including Indication for use (sterilization parameter). Size and color. Maximum Recommended Wrapped Package Content Weights,
Note 1 : Indication for use (sterilization parameter)
The proposed device and the predicate device have same sterilizaiton method application, including Pre-vacuum Steam or 100% Ethylene Oxide (EO) sterilization. For those two devices, parameter recommend are different. However, the proposed device has been conducted verification in accordance with ISO11135 and ISO 17665, performance test has been done before and after sterilizaiton, all results can meet standards requirements. Therefore, there are no different questions of safety and effectiveness questions pertaining to performance of the proposed device.
Note 2: Size and color
The proposed device and the predicate device have same dimention, but they are differences in color. However, the proposed device meets the requirements of the standard ISO 10993-5, articles after the steam and EO sterilized were used for the biocompatibility validation testing. Test result shows that the device has non-cytotoxicity. Therefore, the different technological specifications of the proposed device do not raise different questions of safety.
Note 3 Maximum Recommended Wrapped Package Content Weights
Although the maximum recommended wrap package loading are different from the predicate device,the proposed device has been conducted verification in accordance with ISO11135 and ISO 17665, Types of medical devices to be sterilized in the Pre-Vacuum 12/17
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Steam Sterilization and Ethylene Oxide Sterilization including general purpose nonlumened reusable metal and nonmetal devices including devices with stainless steel diffusionr estricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. All models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size.
Performance test has been done before and after sterilizaiton, all results can meet standards requirements. There are no different questions of safety and effectiveness questions pertaining to performance of the proposed device.
Note 4 Performance test
Both the predicate device and the proposed device has been tested including. Size and Gram weight, Bacterial Filtration Efficiency (BFE), Hydrostatic Pressure, Tensile Strength, Air Permeability, Bursting Strength, Tearing Strength, Lint Generation, Result shows that there are no different questions of safety and effectiveness questions related to performance.
Based on above analysis mentioned above, we can conclude that subject device substantial equivalence with the predicate device.
8. Performance Data
Non-Clinical Performance Test Conclusion
Non- clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate Sterilization Wraps complies with the following standards:
| Test Items | Standard and Acceptance Criteria | Test Result |
|---|---|---|
| Size and Gram weight | ASTM D3776M-20: Standard Test Methods for Mass Per Unit Area (Weight) of FabricSize : Marking dimension tolerance ±10%; Weight : Marking gram tolerance ±2g/m² | Pass |
| Bacterial | ASTM F 2101- 19 Standard Test Method for Evaluating | Pass |
| FiltrationEfficiency(BFE) | the Bacterial Filtration Efficiency (BFE) of MedicalFace Mask Materials, Using a Biological Aerosol ofStaphylococcus aureusBFE ≥ 90% | |
| HydrostaticPressure | AATCC 127-03 Test Method for Water Resistance:Hydrostatic PressureHydrostatic Pressure ≥ 50 cm H2O | Pass |
| TensileStrength | ASTM D5034-09 Standard Test Method for BreakingStrength and Elongation of Textile Fabrics (Grab Test)MD≥ 90N; CD≥ 63N | Pass |
| AirPermeability | ASTM D737-18Standard Test Method for Air Permeabilityof Textile FabricsAir Permeability≥ 30 cfm | Pass |
| BurstingStrength | ASTM D3786-18 Standard Test Method for BurstingStrength of Textile Fabrics—Diaphragm Bursting StrengthTester MethodBursting Strength≥ 130 kpa (18.86psi) | Pass |
| TearingStrength | ASTM D5587-15 Standard Test Method for Tearing Strengthof Fabrics by Trapezoid ProcedureMD≥ 50N; CD≥ 30N | Pass |
| Lint Generation | ISO9073-10: 2019 Textiles — Test methods for nonwovens— Part 10: Lint and other particles generation in the dry stateCoefficient of linting ≤4.0 | Pass |
| Skin IrritationAND SkinSensitization | ISO 10993- 1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk managementprocess.ISO 10993-5 Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity of medical devices.ISO 10993-10:2010 Biological Evaluation of MedicalDevices – Part 10: Tests for irritation and skin sensitization.Under the conditions of the study, the test article (pouches | Pass |
| K223600 | 510 (k) Summary | |
| and chemical indicator) extract did not show no significantevidence of causing skin sensitization in the guinea pigbefore and after sterilized. | ||
| Shelf-LifeValidation | Shelf Life Validation Test;Conducted the shelf-life testing as real time aging method.After the shelf life indicated as following,Shelf Life: 2 Years; Shelf Life after Sterilized: 90 days;The device performance shall be meet the requirements of thedevice. SAL=10-6 | Pass |
| SterilizationProcessValidation forEO | EO Sterilization Process Validation Test.Conducted the EO sterilization process validation as themethod/principle of ISO11135: 2014 Sterilization of healthcare products - Ethylene oxide - Part 1: Requirements fordevelopment, validation and routine control of a sterilizationprocess for medical devices (Healthcare Product Sterilization- Ethylene Oxide-Medical Device Sterilization ProcessDevelopment. Validation and Routine ControlRequirements).Use the half cycle method to validate the EO sterilizationcycle claimed in indication for use is effective.Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO)with a concentration of 360-363 mg/L @ 54°C and 40%relative humidity for 480 minutes, 24 hours aeration time at42 °CThe device performance shall be meet the requirements of thedevice with the worst loading, SAL=10-6 | Pass |
| K223600 | 510 (k) Summary | |
| SterilizationProcessValidation forsteam | Steam Sterilization Process Validation Test.Conducted the Steam sterilization process validation as themethod/principle of AAMI / ANSI ST79: 2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013, Comprehensive Guide ToSteam Sterilization And Sterility Assurance In Health CareFacilities and ISO 17665-1:2006 Sterilization of health careproducts Moist heat Part 1: Requirements for thedevelopment, validation and routine control of asterilization process for medical devices 's requirements.Pre-vacuum Steam: 134°C for 4 minutes, 30 minutes drytime.The device performance shall be meet the requirements of thedevice with the worst loading, SAL=10-6 | Pass |
| Materialcompatibility | After Pre-vacuum Steam or 100% Ethylene Oxide (EO)sterilization, the materials were not degraded.Performance test including:Size and Gram weightBacterial Filtration Efficiency (BFE)Hydrostatic PressureTensile StrengthAir PermeabilityBursting StrengthTearing StrengthLint Generationshould meet requirements. | Pass |
| EO/ECH residue | ISO 10993-7: 2008 Biological evaluation of medical devices— Part 7: Ethylene oxide sterilization residuals$EO≤4mg/d$ , $ECH ≤9mg/d$ | Pass |
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Non-clinical tests including physical characteristics shown in table above, shelf life validation, biocompatibility evaluation, EO Sterilization Process Validation and Steam
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Sterilization Process Validation has been taken to shown all results can meet the standards. Aged device were used for material compatibility research, after Pre-vacuum Steam or 100% Ethylene Oxide (EO) sterilization, the materials were not degraded and all physical characteristics test result can still meet requirements.
Clinical Test Conclusion
No clinical study is included in this submission.
9. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the predicate device K160755.
§ 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).