CareGUARD Sterilization Wrap

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information, Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. {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<br>Care Essentials Pty. Ltd.<br>103 Mornington Street<br>North Geelong<br>Victoria, Australia 3215<br>Phone: +61-3-5277-1455<br>Email: queries@careessentials.com.au | |-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Correspondent: | Abhay Sinha<br>Care Essentials Pty. Ltd.<br>103 Mornington Street<br>North Geelong<br>Victoria, Australia 3215<br>Phone: +61-3-5277-1455<br>Email: queries@careessentials.com.au | | Date of Summary: | December 7, 2021 | | Type of 510(k) Submission: | Traditional | | Device Trade or Proprietary Name:<br>Common name:<br>Classification Name:<br>Product Code:<br>Classification Panel:<br>Regulatory Class:<br>Regulation #: | CareGUARD*TM Sterilization Wrap<br>Sterilization Wrap<br>Wrap, Sterilization<br>FRG<br>General Hospital<br>Class II<br>21 CFR 880.6850 | | Predicate Device: | Kimberly-Clark* Corporation KIMGUARD<br>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<br>Bonded, Two Layers, Total GSM: 100 GSM | | 26 | SW606060-B/B | CareGUARD* Dual Layers, 60cm X 60cm (24" X 24"), 60GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 120 GSM | | 27 | SW606075-B/B | CareGUARD* Dual Layers, 60cm X 60cm (24" X 24"), 75GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 150 GSM | | 28 | SW767650-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 50GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 100 GSM | | 29 | SW767660-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 60GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 120 GSM | | 30 | SW767675-B/B | CareGUARD* Dual Layers, 76cm X 76cm (30” X 30”), 75GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 150 GSM | | 31 | SW919150-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 50GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 100 GSM | | 32 | SW919160-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 60GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 120 GSM | | 33 | SW919175-B/B | CareGUARD* Dual Layers, 91cm X 91cm (36" X 36"), 75GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 150 GSM | | 34 | SW10010050-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 50GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 100 GSM | | 35 | SW10010060-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 60GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 120 GSM | | 36 | SW10010075-B/B | CareGUARD* Dual Layers, 100cm X 100cm (40" X 40"), 75GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 150 GSM | | 37 | SW11611650-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 50GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 100 GSM | | 38 | SW11611660-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 60GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 120 GSM | | 39 | SW11611675-B/B | CareGUARD* Dual Layers, 116cm X 116cm (45" X 45"), 75GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 150 GSM | | 40 | SW12012050-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 50GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 100 GSM | | 41 | SW12012060-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 60GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 120 GSM | | 42 | SW12012075-B/B | CareGUARD* Dual Layers, 120cm X 120cm (48" X 48"), 75GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 150 GSM | | 43 | SW13713750-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 50GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 100 GSM | | 44 | SW13713760-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 60GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 120 GSM | | 45 | SW13713775-B/B | CareGUARD* Dual Layers, 137cm X 137cm (54" X 54"), 75GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 150 GSM | | 46 | SW13718250-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 50GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 100 GSM | | 47 | SW13718260-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 60GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 120 GSM | | 48 | SW13718275-B/B | CareGUARD* Dual Layers, 137cm X 182cm (54" X 72"), 75GSM, Blue/Blue<br>Bonded, Two Layers, Total GSM: 150 GSM | | 49 | SW606050-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 50GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 100 GSM | | 50 | SW606060-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 60GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 120 GSM | | 51 | SW606075-B/W | CareGUARD* Contrast, 60cm X 60cm (24" X 24"), 75GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 150 GSM | | 52 | SW767650-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 50GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 100 GSM | | 53 | SW767660-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 60GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 120 GSM | | 54 | SW767675-B/W | CareGUARD* Contrast, 76cm X 76cm (30" X 30"), 75GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 150 GSM | | 55 | SW919150-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 50GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 100 GSM | | 56 | SW919160-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 60GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 120 GSM | | 57 | SW919175-B/W | CareGUARD* Contrast, 91cm X 91cm (36" X 36"), 75GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 150 GSM | | 58 | SW10010050-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40"), 50GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 100 GSM | | 59 | SW10010060-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40"), 60GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 120 GSM | | 60 | SW10010075-B/W | CareGUARD* Contrast, 100cm X 100cm (40" X 40”), 75GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 150 GSM | | 61 | SW11611650-B/W | CareGUARD* Contrast, 116cm X 116cm (45" X 45"), 50GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 100 GSM | | 62 | SW11611660-B/W | CareGUARD* Contrast, 116cm X 116cm (45" X 45"), 60GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 120 GSM | | 63 | SW11611675-B/W | CareGUARD* Contrast, 116cm × 116cm (45" X 45"), 75GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 150 GSM | | 64 | SW12012050-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48”), 50GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 100 GSM | | 65 | SW12012060-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48”), 60GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 120 GSM | | 66 | SW12012075-B/W | CareGUARD* Contrast, 120cm X 120cm (48" X 48"), 75GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 150 GSM | | 67 | SW13713750-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 50GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 100 GSM | | 68 | SW13713760-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 60GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 120 GSM | | 69 | SW13713775-B/W | CareGUARD* Contrast, 137cm X 137cm (54" X 54"), 75GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 150 GSM | | 70 | SW13718250-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72”), 50GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 100 GSM | | 71 | SW13718260-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72"), 60GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 120 GSM | | 72 | SW13718275-B/W | CareGUARD* Contrast, 137cm X 182cm (54" X 72"), 75GSM, Blue/White<br>Bonded, Two Layers, Total GSM: 150 GSM | ## TABLE 1: DIMENSIONS, TYPES AND BASIS WEIGHTS {5}------------------------------------------------ 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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<br>Analysis | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Manufacturer | Care Essentials Pty Ltd | Halyard Health (Formerly<br>Kimberly Clark Health Care) | Different | | 510(k) Reference | K213907 | K082554 | Different | | Device Models | 50 gsm<br>60 gsm<br>75 gsm | H300<br>H400<br>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<br>medical device that is to | To enclose another medical<br>device that is to be sterilized<br>by a healthcare provider. | Same | | | be sterilized by a<br>healthcare provider. | | | | Indications for Use | CareGUARD* Sterilization<br>Wrap is a single-use, non-<br>woven sterilization wrap<br>intended to be sterilized by<br>a health care provider<br>using pre-vacuum steam<br>at 273°F / 134°C for 4<br>minutes. The<br>CareGUARD* Sterilization<br>Wrap was validated for a<br>dry time of 30 minutes.<br>The CareGUARD*<br>Sterilization wrap is<br>recommended to be used<br>with trays weighing up to<br>13.7 lbs.<br>The wrap is intended to<br>allow sterilization of the<br>enclosed medical<br>device(s) and maintain<br>sterility of the enclosed<br>device(s) until used.<br>Test results validated that<br>CareGUARD* Sterilization<br>wraps allowed sterilization<br>of the enclosed devices by<br>pre-vacuum cycles. | KimGUARD* Sterilization<br>Wrap is intended to be used<br>to enclose another medical<br>device that is to be sterilized<br>by a healthcare provider<br>using:<br>• Pre-vacuum Steam<br>270°F/132°C for 4 minutes<br>• Ethylene oxide (100%)<br>Concentration: 725 - 735<br>mg/L at 131°F/55°C and<br>40% - 80% relative<br>humidity for 60 minutes<br>The wrap is intended to<br>allow sterilization of the<br>enclosed medical device(s)<br>and maintain sterility of the<br>enclosed device(s) until<br>opened.<br>The wrap was validated for<br>aeration times for<br>• EtO sterilization<br>8 hours at 55°C or 12<br>hours at 43.3°C.<br>• Pre-vacuum steam<br>sterilization<br>20 minutes - Models 100,<br>200 and 300<br>30 minutes – Models 400,<br>500, 600 | Similar | | Device Design | Two sheets of nonwoven<br>polypropylene fabric. Each<br>sheet is composed of<br>three thermally-bonded<br>layers consisting of a<br>meltblown polypropylene<br>layer surrounded by<br>spunbond polypropylene<br>layers (SMS). | Two sheets of nonwoven<br>polypropylene fabric. Each<br>sheet is composed of three<br>thermally-bonded layers<br>consisting of a meltblown<br>polypropylene layer<br>surrounded by spunbond<br>polypropylene layers (SMS). | Same | | Wrapping Technique | Sequential/Simultaneous<br>double wrapping | Sequential/Simultaneous<br>double wrapping | Same | | Method for bonding SMS<br>layers | Thermal bonding with oval<br>shape pin in angular<br>pattern. | Thermal bonding with round<br>pin, hexagonal, triangle<br>bond pattern ("daisy"<br>pattern). | Similar | | Method for bonding<br>between sterilization<br>wraps | If applicable, ultrasonically<br>seamed along two edges. | If applicable, ultrasonically<br>seamed along two edges. | | | Material Composition | Polypropylene with blue<br>and white pigments. | Polypropylene with blue and<br>white pigments. | Same | | Single Use Device | Yes | Yes | Same | | Shelf Life | 2 years from date of<br>manufacture | NIL | Similar | | Biocompatibility | Applicable parts of ISO<br>10993 — Biological<br>evaluation of medical<br>devices (see Table 4) | Applicable parts of ISO<br>10993 — Biological<br>evaluation of medical<br>devices | Same | | Maintenance of Package<br>Sterility | Real-time testing following<br>sterilization using pre-<br>vacuum steam supports<br>maintenance of package<br>sterility for 30 days. | Real-time testing following<br>sterilization using pre-<br>vacuum steam or Ethylene<br>Oxide supports<br>maintenance of package<br>sterility for 30 days. | Similar | {9}------------------------------------------------ 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. {10}------------------------------------------------ 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<br>EN 868-2 | Comply with the physical<br>property requirements of ISO<br>11607-1 and EN 868-2. | The processed and<br>unprocessed<br>CareGUARD*<br>Sterilization Wrap<br>met the<br>acceptance criteria<br>and demonstrated<br>passing results. | | Chemical Properties | ISO 11607-1<br>EN 868-2 | Comply with the chemical<br>property requirements of ISO<br>11607-1 and EN 868-2. | The chemical<br>properties testing<br>met the<br>acceptance criteria<br>and demonstrated<br>passing results. | | Biocompatibility | ISO 10093-5<br>ISO 10993-10 | Determine whether the use of<br>the medical device is cytotoxic,<br>skin irritating or skin-<br>sensitizing. | Based on the<br>study, the medical<br>device was found<br>to be non-cytotoxic,<br>non-skin irritating<br>and non-skin<br>sensitizing. | | Bacterial Filtration<br>Efficiency (BFE) | ASTM F2101-14 | Determining the bacterial<br>filtration efficiency of the<br>sterilisation wrap | Pass | | Pre-vacuum Steam | | | | | Sterilization<br>Validation | AS/NZS 4187:2014<br>ANSI/AAMI/ST8:2013<br>(R2018)<br>ANSI/AAMI ST79:2017 | A pre-vacuum steam<br>sterilization method was<br>validated to a sterility<br>assurance level (SAL) of 10-6 | Pass | | Sterilant Penetration | AS/NZS 4187:2014<br>ANSI/AAMI/ST8:2013<br>(R2018)<br>ANSI/AAMI ST79:2017 | The testing details a method<br>used in determining the<br>internal temperature profile for<br>wrapped sterilization packs<br>when processed in a steam<br>sterilization pre-vacuum cycle<br>at 273°F/134°C for 4 minutes. | Testing has<br>demonstrated<br>adequate sterilant<br>penetration | | Validation - Dry Time | AS/NZS 4187:2014<br>ANSI/AAMI/ST8:2013<br>(R2018)<br>ANSI/AAMI ST79:2017<br>EN 285:2015+A1:2021 | Determination of the proper<br>drying time required. | Test samples meet<br>or exceed the<br>minimum criteria<br>for dry time | | Maintenance of<br>Sterility | ISO 11607-1:2019<br>ANSI/AAMI ST79:2017<br>AS/NZS 4187:2014<br>ANSI/AAMI/ST8:2013<br>EN 285:2015+A1:2021 | Determination of the<br>maintenance of sterility for<br>the wrapped loads. | Real-time testing<br>following<br>sterilization using<br>pre- vacuum<br>steam supports<br>maintenance of<br>package sterility<br>for 30 days. | {11}------------------------------------------------ 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)].