(266 days)
Not Found
No
The device is a physical sterilization wrap and the summary describes its material properties, sizes, and validation for sterilization processes. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to treat or diagnose a disease or condition in a patient.
No.
The device is a sterilization wrap intended to maintain sterility of medical devices, not to diagnose medical conditions or diseases.
No
The device description clearly indicates it is a physical product made of non-woven fabric (SMS) and describes its physical properties and manufacturing process. It is a sterilization wrap, not a software program.
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 medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions.
- Device Description: The device is a non-woven wrap made of polypropylene. Its function is a physical barrier and a medium for sterilization. It does not involve the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly intended for use in a healthcare setting by healthcare providers for the purpose of sterilizing and storing other medical devices. This falls under the category of medical devices used in the preparation and handling of other medical devices, not in vitro diagnostics.
N/A
Intended Use / 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: 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
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.
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
Healthcare provider
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 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: Size and Gram weight, Bacterial Filtration Efficiency (BFE), Hydrostatic Pressure, Tensile Strength, Air Permeability, Bursting Strength, Tearing Strength, Lint Generation, Skin Irritation AND Skin Sensitization, Shelf-Life Validation, Sterilization Process Validation for EO, Sterilization Process Validation for Steam, Material compatibility, EO/ECH residue.
All tests had a result of "Pass".
Shelf-Life Validation: 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 the device. SAL=10-6.
EO Sterilization Process Validation: Conducted the EO sterilization process validation as the method/principle of ISO11135: 2014. Use the half cycle method to validate the EO sterilization cycle 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 at 42 °C. The device performance shall be meet the requirements of the device with the worst loading, SAL=10-6.
Steam Sterilization Process Validation: Conducted the Steam sterilization process validation as the method/principle of 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
BFE ≥ 90%
Hydrostatic Pressure ≥ 50 cm H2O
Tensile Strength MD≥ 90N; CD≥ 63N
Air Permeability≥ 30 cfm
Bursting Strength≥ 130 kpa (18.86psi)
Tearing Strength MD≥ 50N; CD≥ 30N
Coefficient of linting ≤4.0
SAL=10-6
EO ≤ 4mg/d, ECH ≤ 9mg/d
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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
2
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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3
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
4
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 | | Maximum
Weight(lbs.) |
|---------|---------------|--------|--------------------------------|------------------|-------------------|-------------------------|
| | | | | Long
(inches) | Width
(inches) | |
| ZSW1610 | 45 gsm
SMS | 2 | Pink and Blue
double 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
5
| 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 | 54 | |||||
| SMS | gsm | |||||
| 2 | Pink and Blue | |||||
| double 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.
6
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:
| Device
characteristic | Proposed Device | Predicate Device
510(K) No. K160755 | Comparis
on Result |
|--------------------------|--------------------------------------------|------------------------------------------------------------------------------------|-----------------------|
| Manufacturer | Wuhan Zonsen Medical
Products Co., Ltd. | Ahlstrom Nonwovens,
LLC | -- |
| Product name | Sterilization wrap | Reliance® Solo
Sterilization
Wrap, Reliance®
Tandem
Sterilization Wrap | -- |
| 510(k) Reference | K223600 | K160755 | -- |
Table 2 General Comparison between proposed and predicate device
7
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. | ||
| Regulation | |||||||
| Number | 21 CFR PART 880.6850 | 21 CFR PART 880.6850 | Same | Material | |||
| Composition | Polypropylene | ||||||
| spunbondmeltblown- | |||||||
| spunbond (SMS) | |||||||
| fabric | Polypropylene | ||||||
| spunbondmeltblown- | |||||||
| 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 is | ||
| square or rectangular three- | |||||||
| layer (SMS) non-woven | |||||||
| sheet which manufactured | |||||||
| with Polypropylene | |||||||
| spunbond-meltblown- | |||||||
| spunbond (SMS) fabric. | |||||||
| The device has two-layer | |||||||
| sheet which ultrasonically | |||||||
| bonded blue and pink non- | |||||||
| woven sheet together along | |||||||
| two edges, thus for | |||||||
| convenient simultaneous | |||||||
| wrapping. | The Reliance® Solo and | ||||||
| Reliance® Tandem | |||||||
| Sterilization Wraps are | |||||||
| square or rectangular. | |||||||
| nonwoven sheets | |||||||
| produced using a three- | |||||||
| layer SMS (spunbond- | |||||||
| meltblown-spunbond) | |||||||
| process. The Reliance® | |||||||
| SMS Sterilization Wraps | |||||||
| are separated into two | |||||||
| distinct product offerings: |
Reliance® Solo: Consists
of two sheets of SMS
wrap, ultrasonically
bonded together along
two edges for convenient
simultaneous wrapping of
one or a collection of
medical devices that will
be sterilized following
standard healthcare
practices.
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 360363 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:735 mg/L @ 131°F/55°C and 40%~80% relative humidity for 60 minutes.
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
C) Gravity Steam 250°F/121°C for 30 minutes
D)Advanced Sterilization Products (ASP) STERRAD® 100S
E) 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 | | | | | |
8
9
510 (k) Summary
10
| | | of SMS wrap, where two
sheets are used together
for the sequential
wrapping of one or a
collection of medical.
devices that will be
sterilized following
standard healthcare
practices. | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Size and color | Pink and blue | Blue and green | Similar |
| | Sterilization Wrap separated
into two distinct types
depending on different
grams of weight of material, | Dimensional
Specifications of
Reliance® Tandem and
Reliance® Solo Wrap:
six type Models depend
on various grams of
weight, | |
| | Size (inches): 1212, 1515, | Size (inches): 99, 1212, | |
| | 1818, 2020, 2424, | 1515, 1818, 2020, | |
| | 3030, 3636, 4040, | 2424, 3030, 3636, | |
| | 4545, 4848, 5454, | 4040, 4545, 4848, | |
| | 7254. | 5454, 6060, 7254. | |
| | | | |
| Single Use vs.
Reusable | Single use | Single use | Same |
| Disposable vs.
Non-Disposable | Disposable | Disposable | Same |
| Maximum
Recommended
Wrapped Package | Types of medical devices to
be sterilized in the Pre-
Vacuum Steam Sterilization | All models of Reliance®
Tandem and Solo
validated for pre-vacuum | Similar |
11
| 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-20
Size: Marking dimension tolerance ±10%; Weight : Marking gram tolerance ±2g/m2 the inspection result is PASS | ASTM D3776/ D3776M-20
Size: 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 is
PASS | Biological Aerosol of
Staphylococcus aureus ≥
90%
the inspection result is
PASS | | |
| Hydrostatic
Pressure | AATCC 127-03, Water
Resistance: Hydrostatic
Pressure ≥ 50 cm H2O
the inspection result is
PASS | AATCC 127-03, Water
Resistance: Hydrostatic
Pressure ≥ 50 cm H2O
the inspection result is
PASS | Same | |
| | Tensile Strength | ASTM D5034-09 Standard,
Breaking Strength and
Elongation of Textile
Fabrics (Grab Test)
MD≥ 90N; CD≥ 63N
the inspection result is
PASS | ASTM D5034-09
Standard, Breaking
Strength and Elongation
of Textile Fabrics (Grab
Test)
MD≥ 90N; CD≥ 63N
the inspection result is
PASS | Same |
| Air Permeability | | ASTM D737-18Standard,
Air Permeability of Textile
Fabrics ≥ 30 cfm
the inspection result is
PASS | ASTM D737-18Standard,
Air Permeability of
Textile Fabrics ≥ 30 cfm
the inspection result is
PASS | Same |
| | Bursting Strength | ASTM D3786-18
Standard Test Method for
Bursting Strength of Textile
Fabrics—Diaphragm
Bursting Strength Tester
Method ≥ 130 kpa
(18.86psi)
the inspection result is | ASTM D3786-18
Standard Test Method for
Bursting Strength of
Textile Fabrics—
Diaphragm Bursting
Strength Tester Method ≥
130 kpa (18.86psi)
the inspection result is | Same |
| | | PASS | PASS | |
| Tearing Strength | ASTM D5587-15, Tearing
Strength of Fabrics, MD≥
50N, CD≥ 30N.
the inspection result is
PASS | ASTM D5587-15,
Tearing Strength of
Fabrics, MD≥ 50N, CD≥
30N.
the inspection result is
PASS | Same | |
| Lint Generation | ISO9073-10, Textiles Lint,
Cofficient of linting ≤4.0
the inspection result is
PASS | ISO9073-10,
Textiles
Lint, Cofficient of linting
≤4.0
the inspection result is
PASS | Same | |
| 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
can meet requirements | 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
can meet requirements | Same | |
| Biocompatibility | ISO 10993-5 non-cytotoxic
post sterilization | ISO 10993-5, non-
cytotoxic post | Same | |
| | | sterilization | | |
| Maintenance of
Sterility | 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 Fabric | |
| Size : Marking dimension tolerance ±10%; Weight : Marking gram tolerance ±2g/m² | Pass | |
| Bacterial | ASTM F 2101- 19 Standard Test Method for Evaluating | Pass |
| Filtration | ||
| Efficiency | ||
| (BFE) | the Bacterial Filtration Efficiency (BFE) of Medical | |
| Face Mask Materials, Using a Biological Aerosol of | ||
| Staphylococcus aureus | ||
| BFE ≥ 90% | ||
| 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 D737-18Standard 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 Biological evaluation of medical devices - | |
| Part 1: Evaluation and testing within a risk management | ||
| process. | ||
| ISO 10993-5 Biological evaluation of medical devices - Part | ||
| 5: Tests for in vitro cytotoxicity of medical devices. | ||
| ISO 10993-10:2010 Biological Evaluation of Medical | ||
| Devices – 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 significant | ||
| evidence of causing skin sensitization in the guinea pig | ||
| before and after sterilized. | ||
| Shelf-Life | ||
| Validation | 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 the | ||
| device. SAL=10-6 | Pass | |
| Sterilization | ||
| Process | ||
| Validation for | ||
| EO | EO Sterilization Process Validation Test. | |
| Conducted the EO sterilization process validation as the | ||
| method/principle of ISO11135: 2014 Sterilization of health | ||
| care products - Ethylene oxide - Part 1: Requirements for | ||
| development, validation and routine control of a sterilization | ||
| process for medical devices (Healthcare Product Sterilization |
- Ethylene Oxide-Medical Device Sterilization Process
Development. Validation and Routine Control
Requirements).
Use the half cycle method to validate the EO sterilization
cycle 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 at
42 °C
The device performance shall be meet the requirements of the
device with the worst loading, SAL=10-6 | Pass |
| K223600 | 510 (k) Summary | |
| Sterilization
Process
Validation for
steam | Steam Sterilization Process Validation Test.
Conducted the Steam sterilization process validation as the
method/principle of 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 Sterilization of health care
products Moist heat Part 1: Requirements for the
development, validation and routine control of a
sterilization process for medical devices 's requirements.
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 |
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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.