(90 days)
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.
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.
The "CareGUARD* Sterilization Wrap" device, which is a single-use, non-woven sterilization wrap, has undergone non-clinical testing to demonstrate its performance and substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties | 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 | 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 | Determine whether the use of the medical device is cytotoxic, skin irritating or skin-sensitizing (based on ISO 10993-5 and ISO 10993-10). | Based on the study, the medical device was found to be non-cytotoxic, non-skin irritating and non-skin sensitizing. |
| Bacterial Filtration Efficiency (BFE) | Pass (based on ASTM F2101-14). | Pass |
| Pre-vacuum Steam Sterilization Validation | A pre-vacuum steam sterilization method was validated to a sterility assurance level (SAL) of 10^-6 (based on AS/NZS 4187:2014, ANSI/AAMI/ST8:2013 (R2018), ANSI/AAMI ST79:2017). | Pass |
| Sterilant Penetration | 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 | Determination of the proper drying time required (based on AS/NZS 4187:2014, ANSI/AAMI/ST8:2013 (R2018), ANSI/AAMI ST79:2017, EN 285:2015+A1:2021). | Test samples meet or exceed the minimum criteria for dry time. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. |
| Maintenance of Sterility | Determination of the maintenance of sterility for the wrapped loads (based on ISO 11607-1:2019, ANSI/AAMI ST79:2017, AS/NZS 4187:2014, ANSI/AAMI/ST8:2013, EN 285:2015+A1:2021). | Real-time testing following sterilization using pre-vacuum steam supports maintenance of package sterility for 30 days. |
2. Sample size used for the test set and data provenance:
The document doesn't explicitly state the exact sample sizes for each test in the test set. However, it indicates:
- For the Pre-vacuum steam Sterility Maintenance Study, the load used was: "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." This describes the type of load rather than a numerical sample size.
- The studies are non-clinical (laboratory-based performance tests), not clinical trials involving human subjects or patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective does not apply in the same way it would for clinical studies. The standards referenced (e.g., ISO, EN, ASTM, AS/NZS, ANSI/AAMI) suggest international standardization of testing methodologies.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This information is not applicable. For non-clinical performance and material characteristic tests like those conducted for a sterilization wrap, "ground truth" is established by adherence to recognized international and national standards and validated testing protocols, not by expert consensus on observational data.
4. Adjudication method for the test set:
This information is not applicable. Non-clinical performance tests follow predefined analytical methods and acceptance criteria from standards, rather than requiring adjudication of subjective observations by experts. The results are quantitative measurements or qualitative pass/fail outcomes against objective criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is a physical sterilization wrap, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study and effects of AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is established by:
- Compliance with recognized international and national standards: Such as ISO 11607-1, EN 868-2, ISO 10993 series, ASTM F2101-14, AS/NZS 4187:2014, ANSI/AAMI/ST8:2013, ANSI/AAMI ST79:2017, and EN 285:2015+A1:2021.
- Scientifically validated test methods and predefined acceptance criteria: These standards outline specific methodologies and thresholds for determining performance characteristics like physical properties, chemical properties, biocompatibility, bacterial filtration efficiency, sterilization validation, sterilant penetration, dry time, and maintenance of sterility.
8. The sample size for the training set:
This information is not applicable. The CareGUARD* Sterilization Wrap is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above; there is no AI training set for this device.
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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
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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
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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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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 SinhaCare Essentials Pty. Ltd.103 Mornington StreetNorth GeelongVictoria, Australia 3215Phone: +61-3-5277-1455Email: queries@careessentials.com.au |
|---|---|
| 510(k) Correspondent: | Abhay SinhaCare Essentials Pty. Ltd.103 Mornington StreetNorth GeelongVictoria, Australia 3215Phone: +61-3-5277-1455Email: 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 #: | CareGUARD*TM Sterilization WrapSterilization WrapWrap, SterilizationFRGGeneral HospitalClass II21 CFR 880.6850 |
| Predicate Device: | Kimberly-Clark* Corporation KIMGUARDSterilization Wrap - K082554 |
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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/BlueBonded, Two Layers, Total GSM: 100 GSM |
| 26 | SW606060-B/B | CareGUARD* Dual Layers, 60cm X 60cm (24" X 24"), 60GSM, Blue/BlueBonded, Two Layers, Total GSM: 120 GSM |
| 27 | SW606075-B/B | CareGUARD* Dual Layers, 60cm X 60cm (24" X 24"), 75GSM, Blue/BlueBonded, Two Layers, Total GSM: 150 GSM |
| 28 | SW767650-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 50GSM, Blue/BlueBonded, Two Layers, Total GSM: 100 GSM |
| 29 | SW767660-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 60GSM, Blue/BlueBonded, Two Layers, Total GSM: 120 GSM |
| 30 | SW767675-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 75GSM, Blue/BlueBonded, Two Layers, Total GSM: 150 GSM |
| 31 | SW919150-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 50GSM, Blue/BlueBonded, Two Layers, Total GSM: 100 GSM |
| 32 | SW919160-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 60GSM, Blue/BlueBonded, Two Layers, Total GSM: 120 GSM |
| 33 | SW919175-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 75GSM, Blue/BlueBonded, Two Layers, Total GSM: 150 GSM |
| 34 | SW10010050-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 50GSM, Blue/BlueBonded, Two Layers, Total GSM: 100 GSM |
| 35 | SW10010060-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 60GSM, Blue/BlueBonded, Two Layers, Total GSM: 120 GSM |
| 36 | SW10010075-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 75GSM, Blue/BlueBonded, Two Layers, Total GSM: 150 GSM |
| 37 | SW11611650-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 50GSM, Blue/BlueBonded, Two Layers, Total GSM: 100 GSM |
| 38 | SW11611660-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 60GSM, Blue/BlueBonded, Two Layers, Total GSM: 120 GSM |
| 39 | SW11611675-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 75GSM, Blue/BlueBonded, Two Layers, Total GSM: 150 GSM |
| 40 | SW12012050-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 50GSM, Blue/BlueBonded, Two Layers, Total GSM: 100 GSM |
| 41 | SW12012060-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 60GSM, Blue/BlueBonded, Two Layers, Total GSM: 120 GSM |
| 42 | SW12012075-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 75GSM, Blue/BlueBonded, Two Layers, Total GSM: 150 GSM |
| 43 | SW13713750-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 50GSM, Blue/BlueBonded, Two Layers, Total GSM: 100 GSM |
| 44 | SW13713760-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 60GSM, Blue/BlueBonded, Two Layers, Total GSM: 120 GSM |
| 45 | SW13713775-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 75GSM, Blue/BlueBonded, Two Layers, Total GSM: 150 GSM |
| 46 | SW13718250-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 50GSM, Blue/BlueBonded, Two Layers, Total GSM: 100 GSM |
| 47 | SW13718260-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 60GSM, Blue/BlueBonded, Two Layers, Total GSM: 120 GSM |
| 48 | SW13718275-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 75GSM, Blue/BlueBonded, Two Layers, Total GSM: 150 GSM |
| 49 | SW606050-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 50GSM, Blue/WhiteBonded, Two Layers, Total GSM: 100 GSM |
| 50 | SW606060-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 60GSM, Blue/WhiteBonded, Two Layers, Total GSM: 120 GSM |
| 51 | SW606075-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 75GSM, Blue/WhiteBonded, Two Layers, Total GSM: 150 GSM |
| 52 | SW767650-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 50GSM, Blue/WhiteBonded, Two Layers, Total GSM: 100 GSM |
| 53 | SW767660-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 60GSM, Blue/WhiteBonded, Two Layers, Total GSM: 120 GSM |
| 54 | SW767675-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 75GSM, Blue/WhiteBonded, Two Layers, Total GSM: 150 GSM |
| 55 | SW919150-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 50GSM, Blue/WhiteBonded, Two Layers, Total GSM: 100 GSM |
| 56 | SW919160-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 60GSM, Blue/WhiteBonded, Two Layers, Total GSM: 120 GSM |
| 57 | SW919175-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 75GSM, Blue/WhiteBonded, Two Layers, Total GSM: 150 GSM |
| 58 | SW10010050-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40"), 50GSM, Blue/WhiteBonded, Two Layers, Total GSM: 100 GSM |
| 59 | SW10010060-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40"), 60GSM, Blue/WhiteBonded, Two Layers, Total GSM: 120 GSM |
| 60 | SW10010075-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40”), 75GSM, Blue/WhiteBonded, Two Layers, Total GSM: 150 GSM |
| 61 | SW11611650-B/W | CareGUARD* Contrast, 116cm X 116cm (45" X 45"), 50GSM, Blue/WhiteBonded, Two Layers, Total GSM: 100 GSM |
| 62 | SW11611660-B/W | CareGUARD* Contrast, 116cm X 116cm (45" X 45"), 60GSM, Blue/WhiteBonded, Two Layers, Total GSM: 120 GSM |
| 63 | SW11611675-B/W | CareGUARD* Contrast, 116cm × 116cm (45" X 45"), 75GSM, Blue/WhiteBonded, Two Layers, Total GSM: 150 GSM |
| 64 | SW12012050-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48”), 50GSM, Blue/WhiteBonded, Two Layers, Total GSM: 100 GSM |
| 65 | SW12012060-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48”), 60GSM, Blue/WhiteBonded, Two Layers, Total GSM: 120 GSM |
| 66 | SW12012075-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48"), 75GSM, Blue/WhiteBonded, Two Layers, Total GSM: 150 GSM |
| 67 | SW13713750-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 50GSM, Blue/WhiteBonded, Two Layers, Total GSM: 100 GSM |
| 68 | SW13713760-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 60GSM, Blue/WhiteBonded, Two Layers, Total GSM: 120 GSM |
| 69 | SW13713775-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 75GSM, Blue/WhiteBonded, Two Layers, Total GSM: 150 GSM |
| 70 | SW13718250-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72”), 50GSM, Blue/WhiteBonded, Two Layers, Total GSM: 100 GSM |
| 71 | SW13718260-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72"), 60GSM, Blue/WhiteBonded, Two Layers, Total GSM: 120 GSM |
| 72 | SW13718275-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72"), 75GSM, Blue/WhiteBonded, 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 | ComparisonAnalysis |
|---|---|---|---|
| Manufacturer | Care Essentials Pty Ltd | Halyard Health (FormerlyKimberly Clark Health Care) | Different |
| 510(k) Reference | K213907 | K082554 | Different |
| Device Models | 50 gsm60 gsm75 gsm | H300H400H500 | 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 anothermedical device that is to | To enclose another medicaldevice that is to be sterilizedby a healthcare provider. | Same |
| be sterilized by ahealthcare provider. | |||
| Indications for Use | CareGUARD* SterilizationWrap is a single-use, non-woven sterilization wrapintended to be sterilized bya health care providerusing pre-vacuum steamat 273°F / 134°C for 4minutes. TheCareGUARD* SterilizationWrap was validated for adry time of 30 minutes.The CareGUARD*Sterilization wrap isrecommended to be usedwith trays weighing up to13.7 lbs.The wrap is intended toallow sterilization of theenclosed medicaldevice(s) and maintainsterility of the encloseddevice(s) until used.Test results validated thatCareGUARD* Sterilizationwraps allowed sterilizationof the enclosed devices bypre-vacuum cycles. | KimGUARD* SterilizationWrap is intended to be usedto enclose another medicaldevice that is to be sterilizedby a healthcare providerusing:• Pre-vacuum Steam270°F/132°C for 4 minutes• Ethylene oxide (100%)Concentration: 725 - 735mg/L at 131°F/55°C and40% - 80% relativehumidity for 60 minutesThe wrap is intended toallow sterilization of theenclosed medical device(s)and maintain sterility of theenclosed device(s) untilopened.The wrap was validated foraeration times for• EtO sterilization8 hours at 55°C or 12hours at 43.3°C.• Pre-vacuum steamsterilization20 minutes - Models 100,200 and 30030 minutes – Models 400,500, 600 | Similar |
| Device Design | Two sheets of nonwovenpolypropylene fabric. Eachsheet is composed ofthree thermally-bondedlayers consisting of ameltblown polypropylenelayer surrounded byspunbond polypropylenelayers (SMS). | Two sheets of nonwovenpolypropylene fabric. Eachsheet is composed of threethermally-bonded layersconsisting of a meltblownpolypropylene layersurrounded by spunbondpolypropylene layers (SMS). | Same |
| Wrapping Technique | Sequential/Simultaneousdouble wrapping | Sequential/Simultaneousdouble wrapping | Same |
| Method for bonding SMSlayers | Thermal bonding with ovalshape pin in angularpattern. | Thermal bonding with roundpin, hexagonal, trianglebond pattern ("daisy"pattern). | Similar |
| Method for bondingbetween sterilizationwraps | If applicable, ultrasonicallyseamed along two edges. | If applicable, ultrasonicallyseamed along two edges. | |
| Material Composition | Polypropylene with blueand white pigments. | Polypropylene with blue andwhite pigments. | Same |
| Single Use Device | Yes | Yes | Same |
| Shelf Life | 2 years from date ofmanufacture | NIL | Similar |
| Biocompatibility | Applicable parts of ISO10993 — Biologicalevaluation of medicaldevices (see Table 4) | Applicable parts of ISO10993 — Biologicalevaluation of medicaldevices | Same |
| Maintenance of PackageSterility | Real-time testing followingsterilization using pre-vacuum steam supportsmaintenance of packagesterility for 30 days. | Real-time testing followingsterilization using pre-vacuum steam or EthyleneOxide supportsmaintenance of packagesterility 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 11607-1EN 868-2 | Comply with the physicalproperty requirements of ISO11607-1 and EN 868-2. | The processed andunprocessedCareGUARD*Sterilization Wrapmet theacceptance criteriaand demonstratedpassing results. |
| Chemical Properties | ISO 11607-1EN 868-2 | Comply with the chemicalproperty requirements of ISO11607-1 and EN 868-2. | The chemicalproperties testingmet theacceptance criteriaand demonstratedpassing results. |
| Biocompatibility | ISO 10093-5ISO 10993-10 | Determine whether the use ofthe medical device is cytotoxic,skin irritating or skin-sensitizing. | Based on thestudy, the medicaldevice was foundto be non-cytotoxic,non-skin irritatingand non-skinsensitizing. |
| Bacterial FiltrationEfficiency (BFE) | ASTM F2101-14 | Determining the bacterialfiltration efficiency of thesterilisation wrap | Pass |
| Pre-vacuum Steam | |||
| SterilizationValidation | AS/NZS 4187:2014ANSI/AAMI/ST8:2013(R2018)ANSI/AAMI ST79:2017 | A pre-vacuum steamsterilization method wasvalidated to a sterilityassurance level (SAL) of 10-6 | Pass |
| Sterilant Penetration | AS/NZS 4187:2014ANSI/AAMI/ST8:2013(R2018)ANSI/AAMI ST79:2017 | The testing details a methodused in determining theinternal temperature profile forwrapped sterilization packswhen processed in a steamsterilization pre-vacuum cycleat 273°F/134°C for 4 minutes. | Testing hasdemonstratedadequate sterilantpenetration |
| Validation - Dry Time | AS/NZS 4187:2014ANSI/AAMI/ST8:2013(R2018)ANSI/AAMI ST79:2017EN 285:2015+A1:2021 | Determination of the properdrying time required. | Test samples meetor exceed theminimum criteriafor dry time |
| Maintenance ofSterility | ISO 11607-1:2019ANSI/AAMI ST79:2017AS/NZS 4187:2014ANSI/AAMI/ST8:2013EN 285:2015+A1:2021 | Determination of themaintenance of sterility forthe wrapped loads. | Real-time testingfollowingsterilization usingpre- vacuumsteam supportsmaintenance ofpackage sterilityfor 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)].
§ 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).