(90 days)
Not Found
No
The device description and performance studies focus solely on the physical and chemical properties of a sterilization wrap, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is a sterilization wrap used to maintain the sterility of other medical devices, not to provide therapeutic treatment itself.
No
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain sterility, not to diagnose a condition or disease.
No
The device is a physical sterilization wrap made of non-woven fabric, not software.
Based on the provided text, the CareGUARD* Sterilization Wrap is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description focuses on the material composition and physical properties of the wrap, designed to withstand sterilization processes and maintain a sterile barrier. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Reagents, calibrators, or controls
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 IVDs.
N/A
Intended Use / Indications for Use
CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273ºF / 134ºC for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Test results validated that CareGUARD* Sterilization wraps allowed sterilization of the enclosed devices by pre-vacuum cycles.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
CareGUARD* Sterilization Wrap is made from 100% polypropylene spunbond-meltblownspunbond (SMS) non-woven fabric. The sterilization wrap is provided in three different material basis weights of three product offerings in various dimensions. CareGUARD* Single Layer Sterilization wrap is comprised of a single sheet or one layer of SMS fabric. CareGUARD* Dual Layers Sterilization Wrap and CareGUARD* Contrast Sterilization Wrap, are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing edges. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All basis weights utilize the same material technology. This product is a single-use and a non-sterile medical device.
CareGUARD* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using pre-vacuum steam at 273°F/134°C for 4 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
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)
Summary of Non-clinical Testing:
Test: Physical Properties
Relevant Standard(s): ISO 11607-1, EN 868-2
Acceptance Criteria: Comply with the physical property requirements of ISO 11607-1 and EN 868-2.
Results: The processed and unprocessed CareGUARD* Sterilization Wrap met the acceptance criteria and demonstrated passing results.
Test: Chemical Properties
Relevant Standard(s): ISO 11607-1, EN 868-2
Acceptance Criteria: Comply with the chemical property requirements of ISO 11607-1 and EN 868-2.
Results: The chemical properties testing met the acceptance criteria and demonstrated passing results.
Test: Biocompatibility
Relevant Standard(s): ISO 10093-5, ISO 10993-10
Acceptance Criteria: Determine whether the use of the medical device is cytotoxic, skin irritating or skin-sensitizing.
Results: Based on the study, the medical device was found to be non-cytotoxic, non-skin irritating and non-skin sensitizing.
Test: Bacterial Filtration Efficiency (BFE)
Relevant Standard(s): ASTM F2101-14
Acceptance Criteria: Determining the bacterial filtration efficiency of the sterilisation wrap
Results: Pass
Test: Pre-vacuum Steam Sterilization Validation
Relevant Standard(s): AS/NZS 4187:2014, ANSI/AAMI/ST8:2013 (R2018), ANSI/AAMI ST79:2017
Acceptance Criteria: A pre-vacuum steam sterilization method was validated to a sterility assurance level (SAL) of 10-6
Results: Pass
Test: Sterilant Penetration
Relevant Standard(s): AS/NZS 4187:2014, ANSI/AAMI/ST8:2013 (R2018), ANSI/AAMI ST79:2017
Acceptance Criteria: The testing details a method used in determining the internal temperature profile for wrapped sterilization packs when processed in a steam sterilization pre-vacuum cycle at 273°F/134°C for 4 minutes.
Results: Testing has demonstrated adequate sterilant penetration
Test: Validation - Dry Time
Relevant Standard(s): AS/NZS 4187:2014, ANSI/AAMI/ST8:2013 (R2018), ANSI/AAMI ST79:2017, EN 285:2015+A1:2021
Acceptance Criteria: Determination of the proper drying time required.
Results: Test samples meet or exceed the minimum criteria for dry time
Test: Maintenance of Sterility
Relevant Standard(s): ISO 11607-1:2019, ANSI/AAMI ST79:2017, AS/NZS 4187:2014, ANSI/AAMI/ST8:2013, EN 285:2015+A1:2021
Acceptance Criteria: Determination of the maintenance of sterility for the wrapped loads.
Results: Real-time testing following sterilization using pre- vacuum steam supports maintenance of package sterility for 30 days.
Summary of Clinical Testing:
Clinical testing is not applicable to the CareGUARD* Sterilization Wrap.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 14, 2022
Care Essentials Pty Ltd Abhay Sinha Managing Director 103 Mornington Street North Geelong, Victoria 3215 Australia
Re: K213907
Trade/Device Name: CareGUARD* Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 7, 2021 Received: December 14, 2021
Dear Abhay Sinha:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213907
Device Name CareGUARD* Sterilization Wrap
Indications for Use (Describe)
CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273ºF / 134ºC for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Test results validated that CareGUARD* Sterilization wraps allowed sterilization of the enclosed devices by pre-vacuum cycles.
Refer to Table 1 for recommendations for use per Pre-vacuum steam Sterility Maintenance Study.
Table 1: Basis weight recommendations for pre-vacuum steam
| Basis Weight | Maximum Wrapped Package Content Weight |
|---|---|
| 50 GSM | |
| 60 GSM | 6.2 kg / 13.7 lbs |
| 75 GSM |
The following load was used in the Pre-vacuum steam Sterility Maintenance Study:
- · 50 GSM: 21 in. x 10 in. x 4 ¾ in. (54 cm x 25 cm x 12 cm) tray containing 13.7 lbs (6.2 kg) of metal mass The metal mass included surgical instruments used for orthopedic joint replacement
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Care Essentials. The logo features a stylized letter "C" in two colors: gold on the inside and blue on the outside. Below the "C" are the words "CARE ESSENTIALS" in a sans-serif font, with "CARE" in a larger font size than "ESSENTIALS".
K213907 CareGUARD* Sterilization Wrap 510(k) SUMMARY
| 510(k) Applicant: | Abhay Sinha
Care Essentials Pty. Ltd.
103 Mornington Street
North Geelong
Victoria, Australia 3215
Phone: +61-3-5277-1455
Email: queries@careessentials.com.au |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Correspondent: | Abhay Sinha
Care Essentials Pty. Ltd.
103 Mornington Street
North Geelong
Victoria, Australia 3215
Phone: +61-3-5277-1455
Email: queries@careessentials.com.au |
| Date of Summary: | December 7, 2021 |
| Type of 510(k) Submission: | Traditional |
| Device Trade or Proprietary Name:
Common name:
Classification Name:
Product Code:
Classification Panel:
Regulatory Class:
Regulation #: | CareGUARDTM Sterilization Wrap
Sterilization Wrap
Wrap, Sterilization
FRG
General Hospital
Class II
21 CFR 880.6850 |
| Predicate Device: | Kimberly-Clark Corporation KIMGUARD
Sterilization Wrap - K082554 |
4
Image /page/4/Picture/0 description: The image shows the logo for Care Essentials. The logo features a stylized letter "e" in two colors: gold and blue. The gold color is used for the inner part of the "e", while the blue color is used for the outer part. Below the stylized "e", the words "CARE ESSENTIALS" are written in blue, with "CARE" on the top line and "ESSENTIALS" on the bottom line.
Device Description
CareGUARD* Sterilization Wrap is made from 100% polypropylene spunbond-meltblownspunbond (SMS) non-woven fabric. The sterilization wrap is provided in three different material basis weights of three product offerings in various dimensions. CareGUARD* Single Layer Sterilization wrap is comprised of a single sheet or one layer of SMS fabric. CareGUARD* Dual Layers Sterilization Wrap and CareGUARD* Contrast Sterilization Wrap, are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing edges. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All basis weights utilize the same material technology. This product is a single-use and a non-sterile medical device.
CareGUARD* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using pre-vacuum steam at 273°F/134°C for 4 minutes.
| No. | Model | Product Description |
|---|---|---|
| 1 | SW606050-B | CareGUARD* Single Layer, 60cm X 60cm (24" X 24"), 50GSM, Blue |
| 2 | SW606060-B | CareGUARD* Single Layer, 60cm X 60cm (24" X 24"), 60GSM, Blue |
| 3 | SW606075-B | CareGUARD* Single Layer, 60cm X 60cm (24" X 24”), 75GSM, Blue |
| 4 | SW767650-B | CareGUARD* Single Layer, 76cm X 76cm (30” X 30"), 50GSM, Blue |
| 5 | SW767660-B | CareGUARD* Single Layer, 76cm X 76cm (30" X 30"), 60GSM, Blue |
| 6 | SW767675-B | CareGUARD* Single Layer, 76cm X 76cm (30” X 30”), 75GSM, Blue |
| 7 | SW919150-B | CareGUARD* Single Layer, 91cm X 91cm (36" X 36"), 50GSM, Blue |
| 8 | SW919160-B | CareGUARD* Single Layer, 91cm X 91cm (36" X 36"), 60GSM, Blue |
| 9 | SW919175-B | CareGUARD* Single Layer, 91cm X 91cm (36" X 36"), 75GSM, Blue |
| 10 | SW10010050-B | CareGUARD* Single Layer, 100cm X 100cm (40" X 40"), 50GSM, Blue |
| 11 | SW10010060-B | CareGUARD* Single Layer, 100cm X 100cm (40" X 40"), 60GSM, Blue |
| 12 | SW10010075-B | CareGUARD* Single Layer, 100cm X 100cm (40" X 40"), 75GSM, Blue |
| 13 | SW11611650-B | CareGUARD* Single Layer, 116cm X 116cm (45" X 45"), 50GSM, Blue |
| 14 | SW11611660-B | CareGUARD* Single Layer, 116cm X 116cm (45" X 45"), 60GSM, Blue |
| 15 | SW11611675-B | CareGUARD* Single Layer, 116cm X 116cm (45" X 45"), 75GSM, Blue |
| 16 | SW12012050-B | CareGUARD* Single Layer, 120cm X 120cm (48" X 48"), 50GSM, Blue |
| 17 | SW12012060-B | CareGUARD* Single Layer, 120cm X 120cm (48" X 48"), 60GSM, Blue |
| 18 | SW12012075-B | CareGUARD* Single Layer, 120cm X 120cm (48" X 48"), 75GSM, Blue |
| 19 | SW13713750-B | CareGUARD* Single Layer, 137cm X 137cm (54" X 54"), 50GSM, Blue |
| 20 | SW13713760-B | CareGUARD* Single Layer, 137cm X 137cm (54" X 54"), 60GSM, Blue |
| 21 | SW13713775-B | CareGUARD* Single Layer, 137cm X 137cm (54" X 54"), 75GSM, Blue |
| 22 | SW13718250-B | CareGUARD* Single Layer, 137cm X 182cm (54" X 72"), 50GSM, Blue |
| 23 | SW13718260-B | CareGUARD* Single Layer, 137cm X 182cm (54" X 72"), 60GSM, Blue |
| 24 | SW13718275-B | CareGUARD* Single Layer, 137cm X 182cm (54" X 72"), 75GSM, Blue |
| 25 | SW606050-B/B | CareGUARD* Dual Layers, 60cm X 60cm (24" X 24"), 50GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 26 | SW606060-B/B | CareGUARD* Dual Layers, 60cm X 60cm (24" X 24"), 60GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 27 | SW606075-B/B | CareGUARD* Dual Layers, 60cm X 60cm (24" X 24"), 75GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 28 | SW767650-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 50GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 29 | SW767660-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 60GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 30 | SW767675-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 75GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 31 | SW919150-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 50GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 32 | SW919160-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 60GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 33 | SW919175-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 75GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 34 | SW10010050-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 50GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 35 | SW10010060-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 60GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 36 | SW10010075-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 75GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 37 | SW11611650-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 50GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 38 | SW11611660-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 60GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 39 | SW11611675-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 75GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 40 | SW12012050-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 50GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 41 | SW12012060-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 60GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 42 | SW12012075-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 75GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 43 | SW13713750-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 50GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 44 | SW13713760-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 60GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 45 | SW13713775-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 75GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 46 | SW13718250-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 50GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 47 | SW13718260-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 60GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 48 | SW13718275-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 75GSM, Blue/Blue |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 49 | SW606050-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 50GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 50 | SW606060-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 60GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 51 | SW606075-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 75GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 52 | SW767650-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 50GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 53 | SW767660-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 60GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 54 | SW767675-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 75GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 55 | SW919150-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 50GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 56 | SW919160-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 60GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 57 | SW919175-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 75GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 58 | SW10010050-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40"), 50GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 59 | SW10010060-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40"), 60GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 60 | SW10010075-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40”), 75GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 61 | SW11611650-B/W | CareGUARD* Contrast, 116cm X 116cm (45" X 45"), 50GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 62 | SW11611660-B/W | CareGUARD* Contrast, 116cm X 116cm (45" X 45"), 60GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 63 | SW11611675-B/W | CareGUARD* Contrast, 116cm × 116cm (45" X 45"), 75GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 64 | SW12012050-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48”), 50GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 65 | SW12012060-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48”), 60GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 66 | SW12012075-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48"), 75GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 67 | SW13713750-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 50GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 68 | SW13713760-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 60GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 69 | SW13713775-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 75GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 150 GSM | ||
| 70 | SW13718250-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72”), 50GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 100 GSM | ||
| 71 | SW13718260-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72"), 60GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 120 GSM | ||
| 72 | SW13718275-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72"), 75GSM, Blue/White |
| Bonded, Two Layers, Total GSM: 150 GSM |
TABLE 1: DIMENSIONS, TYPES AND BASIS WEIGHTS
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Image /page/5/Picture/0 description: The image shows a logo for Care Essentials. The logo features a stylized letter 'C' in a golden color, with a smaller 'e' nested inside it. Below the graphic, the words 'CARE ESSENTIALS' are printed in a simple, sans-serif font.
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Image /page/6/Picture/0 description: The image shows a logo for Care Essentials. The logo features a stylized letter "C" in blue and yellow, with the words "CARE ESSENTIALS" written in blue below it. The letter "C" is made up of two curved lines that overlap each other. The logo is simple and modern, and it conveys a sense of care and professionalism.
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Image /page/7/Picture/0 description: The image shows the logo for Care Essentials. The logo features a stylized letter 'e' in gold and blue, with the word 'CARE' in blue text above the word 'ESSENTIALS' in a smaller font. The logo is simple and modern, and the colors are bright and inviting.
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Image /page/8/Picture/0 description: The image shows the logo for Care Essentials. The logo features a stylized letter 'e' in blue and yellow, with the word 'CARE' in blue capital letters above the word 'ESSENTIALS' in smaller blue capital letters. The logo is simple and modern, with a focus on the company's name.
Indications for Use
CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273°F / 134°C for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
Test results validated that CareGUARD* Sterilization wraps allowed sterilization of the enclosed devices by pre-vacuum cycles.
TABLE 2: WRAP BASIS WEIGHT RECOMMENDATIONS FOR PRE-VACUUM STEAM
| Basis Weight | Maximum Wrapped Package Content Weight |
|---|---|
| 50 GSM | |
| 60 GSM | 6.2 kg / 13.7 lbs |
| 75 GSM |
The following load was used in the Pre-vacuum steam Sterility Maintenance Study:
- 50 GSM: 21 in. x 10 in. x 4 ¾ in. (54 cm x 25 cm x 12 cm) tray containing 13.7 Ibs . (6.2 kq) of metal mass
The metal mass included surgical instruments used for orthopedic joint replacement.
Technological Characteristics Comparison
TABLE 3: COMPARISON OF PROPOSE AND PREDICATE DEVICES
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | Care Essentials Pty Ltd | Halyard Health (Formerly
Kimberly Clark Health Care) | Different |
| 510(k) Reference | K213907 | K082554 | Different |
| Device Models | 50 gsm
60 gsm
75 gsm | H300
H400
H500 | Similar |
| Common name | Sterilization Wrap | Sterilization Wrap | Same |
| Regulation Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Class | II | II | Same |
| Product Code | FRG | FRG | Same |
| Intended Use | To enclose another
medical device that is to | To enclose another medical
device that is to be sterilized
by a healthcare provider. | Same |
| | be sterilized by a
healthcare provider. | | |
| Indications for Use | CareGUARD* Sterilization
Wrap is a single-use, non-
woven sterilization wrap
intended to be sterilized by
a health care provider
using pre-vacuum steam
at 273°F / 134°C for 4
minutes. The
CareGUARD* Sterilization
Wrap was validated for a
dry time of 30 minutes.
The CareGUARD*
Sterilization wrap is
recommended to be used
with trays weighing up to
13.7 lbs.
The wrap is intended to
allow sterilization of the
enclosed medical
device(s) and maintain
sterility of the enclosed
device(s) until used.
Test results validated that
CareGUARD* Sterilization
wraps allowed sterilization
of the enclosed devices by
pre-vacuum cycles. | KimGUARD* Sterilization
Wrap is intended to be used
to enclose another medical
device that is to be sterilized
by a healthcare provider
using:
• Pre-vacuum Steam
270°F/132°C for 4 minutes
• Ethylene oxide (100%)
Concentration: 725 - 735
mg/L at 131°F/55°C and
40% - 80% relative
humidity for 60 minutes
The wrap is intended to
allow sterilization of the
enclosed medical device(s)
and maintain sterility of the
enclosed device(s) until
opened.
The wrap was validated for
aeration times for
• EtO sterilization
8 hours at 55°C or 12
hours at 43.3°C.
• Pre-vacuum steam
sterilization
20 minutes - Models 100,
200 and 300
30 minutes – Models 400,
500, 600 | Similar |
| Device Design | Two sheets of nonwoven
polypropylene fabric. Each
sheet is composed of
three thermally-bonded
layers consisting of a
meltblown polypropylene
layer surrounded by
spunbond polypropylene
layers (SMS). | Two sheets of nonwoven
polypropylene fabric. Each
sheet is composed of three
thermally-bonded layers
consisting of a meltblown
polypropylene layer
surrounded by spunbond
polypropylene layers (SMS). | Same |
| Wrapping Technique | Sequential/Simultaneous
double wrapping | Sequential/Simultaneous
double wrapping | Same |
| Method for bonding SMS
layers | Thermal bonding with oval
shape pin in angular
pattern. | Thermal bonding with round
pin, hexagonal, triangle
bond pattern ("daisy"
pattern). | Similar |
| Method for bonding
between sterilization
wraps | If applicable, ultrasonically
seamed along two edges. | If applicable, ultrasonically
seamed along two edges. | |
| Material Composition | Polypropylene with blue
and white pigments. | Polypropylene with blue and
white pigments. | Same |
| Single Use Device | Yes | Yes | Same |
| Shelf Life | 2 years from date of
manufacture | NIL | Similar |
| Biocompatibility | Applicable parts of ISO
10993 — Biological
evaluation of medical
devices (see Table 4) | Applicable parts of ISO
10993 — Biological
evaluation of medical
devices | Same |
| Maintenance of Package
Sterility | Real-time testing following
sterilization using pre-
vacuum steam supports
maintenance of package
sterility for 30 days. | Real-time testing following
sterilization using pre-
vacuum steam or Ethylene
Oxide supports
maintenance of package
sterility for 30 days. | Similar |
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Image /page/9/Picture/0 description: The image shows the logo for Care Essentials. The logo features a stylized letter "e" in blue and gold, with the words "CARE ESSENTIALS" written in blue below it. The letter "e" is designed with a flowing, curved shape, and the text is in a simple, sans-serif font.
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Image /page/10/Picture/0 description: The image shows a logo for a company called "Care Essentials". The logo features two overlapping letter "C" shapes, with the inner "C" being gold and the outer "C" being blue. The words "CARE ESSENTIALS" are written in blue below the "C" shapes.
Summary of Non-clinical Testing
TABLE 4: SUMMARY OF NON-CLINICAL TESTING
| Test | Relevant Standard(s) | Acceptance Criteria | Results |
|---|---|---|---|
| Physical Properties | ISO 11607-1 | ||
| EN 868-2 | Comply with the physical | ||
| property requirements of ISO | |||
| 11607-1 and EN 868-2. | The processed and | ||
| unprocessed | |||
| CareGUARD* | |||
| Sterilization Wrap | |||
| met the | |||
| acceptance criteria | |||
| and demonstrated | |||
| passing results. | |||
| Chemical Properties | ISO 11607-1 | ||
| EN 868-2 | Comply with the chemical | ||
| property requirements of ISO | |||
| 11607-1 and EN 868-2. | The chemical | ||
| properties testing | |||
| met the | |||
| acceptance criteria | |||
| and demonstrated | |||
| passing results. | |||
| Biocompatibility | ISO 10093-5 | ||
| ISO 10993-10 | Determine whether the use of | ||
| the medical device is cytotoxic, | |||
| skin irritating or skin- | |||
| sensitizing. | Based on the | ||
| study, the medical | |||
| device was found | |||
| to be non-cytotoxic, | |||
| non-skin irritating | |||
| and non-skin | |||
| sensitizing. | |||
| Bacterial Filtration | |||
| Efficiency (BFE) | ASTM F2101-14 | Determining the bacterial | |
| filtration efficiency of the | |||
| sterilisation wrap | Pass | ||
| Pre-vacuum Steam | |||
| Sterilization | |||
| Validation | AS/NZS 4187:2014 | ||
| ANSI/AAMI/ST8:2013 | |||
| (R2018) | |||
| ANSI/AAMI ST79:2017 | A pre-vacuum steam | ||
| sterilization method was | |||
| validated to a sterility | |||
| assurance level (SAL) of 10-6 | Pass | ||
| Sterilant Penetration | AS/NZS 4187:2014 | ||
| ANSI/AAMI/ST8:2013 | |||
| (R2018) | |||
| ANSI/AAMI ST79:2017 | The testing details a method | ||
| used in determining the | |||
| internal temperature profile for | |||
| wrapped sterilization packs | |||
| when processed in a steam | |||
| sterilization pre-vacuum cycle | |||
| at 273°F/134°C for 4 minutes. | Testing has | ||
| demonstrated | |||
| adequate sterilant | |||
| penetration | |||
| Validation - Dry Time | AS/NZS 4187:2014 | ||
| ANSI/AAMI/ST8:2013 | |||
| (R2018) | |||
| ANSI/AAMI ST79:2017 | |||
| EN 285:2015+A1:2021 | Determination of the proper | ||
| drying time required. | Test samples meet | ||
| or exceed the | |||
| minimum criteria | |||
| for dry time | |||
| Maintenance of | |||
| Sterility | ISO 11607-1:2019 | ||
| ANSI/AAMI ST79:2017 | |||
| AS/NZS 4187:2014 | |||
| ANSI/AAMI/ST8:2013 | |||
| EN 285:2015+A1:2021 | Determination of the | ||
| maintenance of sterility for | |||
| the wrapped loads. | Real-time testing | ||
| following | |||
| sterilization using | |||
| pre- vacuum | |||
| steam supports | |||
| maintenance of | |||
| package sterility | |||
| for 30 days. |
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Image /page/11/Picture/0 description: The image shows a logo for "CARE ESSENTIALS". The logo features a stylized letter "e" in a golden color, with a curved design. Below the "e", the words "CARE ESSENTIALS" are written in a blue sans-serif font, with "CARE" on top of "ESSENTIALS".
Summary of Clinical Testing
Clinical testing is not applicable to the CareGUARD* Sterilization Wrap.
Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the CareGUARD* Sterilization Wrap (K213907), is as safe, as effective and performs as well as or better than the legally marketed device identified [Kimberly-Clark* Corporation KIMGUARD* Sterilization Wrap (K082554)].