(507 days)
Not Found
No
The device is a sterilization wrap, a physical barrier for maintaining sterility. The description and performance studies focus on material properties and sterilization efficacy, with no mention of AI or ML.
No
The device is a sterilization packaging system, not a therapeutic device. Its purpose is to maintain sterility of other medical devices, not to treat or diagnose a medical condition.
No
Explanation: The device is a sterilization wrap intended to maintain the sterility of other medical devices. It is not used to diagnose any medical condition.
No
The device is a physical sterilization wrap made of SMS material, not software. The performance studies focus on physical properties and sterilization efficacy, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose and maintain the sterility of other medical devices that are to be sterilized. It facilitates the sterilization process and protects the sterilized device.
- Device Description: It is described as a sterilization packaging system, essentially a wrap or barrier.
- Lack of Diagnostic Function: There is no mention of this device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. Its function is purely related to the sterilization and storage of other medical devices.
IVD devices are specifically designed to be used in vitro (outside the body) to test samples like blood, urine, or tissue for diagnostic purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Sterilization Wraps will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 100S, NX, and 100NX Systems.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
ArjoRad Sterilization Wrap is a sterilization packaging system consisting of one SMS sheet to be double wrapped during use. ArjoRad Sterilization Wrap will be sold in a non-sterile condition in packaged form of various sizes depending on the needs of the end user.
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
Not Found
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)
The intended use is to contain medical devices and to maintain sterility. Physical protection is consequently needed during the handling of non-sterile product. It is controlled with following performance testing: substance weight, strip tensile strength, Mullen burst and Elmendorf tear. Arjorad developed higher tensile strength and burst and tearing strength than predicate sterilization wrap. In addition ArjoRad meets the acceptance criteria with regard to the minimum requirement for strength properties dedicated to non-woven sterilization wrap. When applied to the minimum performance level, the properties of ArjoRad still meet the criteria of acceptation after sterilization which equals the minimum requirement level for sterilization wrap defined according to EN 868-2:2009 and ASTM D737: Standard Test Method for Air Permeability of Textile Fabrics.
During microbial aerosol challenge test, similarly to predicate, ArjoRad demonstrated germ resistance after hydrogen peroxide sterilization cycle. The microbial aerosol challenge test and the shelf life study demonstrate that, the subject wrap is considered as a sterile barrier system that is capable to maintaining sterility for 30 days after sterilization, as long as the sterile barrier is not compromised in any way.
The ability to let the sterilant penetrate has been validated as well. This was demonstrated by sterilization efficacy studies after different cycles of STERRAD hydrogen peroxide gas plasma sterilization. Studies carried out demonstrated that Arjorad can assure an SAL of 10 after each half cycle tested.
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
510(k) SUMMARY (as required by 807.92(c))
AUG 2 4 2012
ਨ
Regulatory and Marketing Services, Inc. Regulatory Correspondent: 962 Allegro Lane Apollo Beach, FL 33572 Jonathan Ward wardip@ajwtech.com 813-645-2855 813-677-4787
Submitter of 510(k):
Arjo Wiggins Medical 1301 Charleston Regional Parkway, Suite 500 Charleston, SC 29492 Patrick Ritchie PRitchie@arjomedical.com
August 17, 2012 Date of Summary:
Trade/Proprietary Name:
Classification Name:
Product Code:
Device Description:
ArjoRad Sterilization Wrap is a sterilization packaging system consisting of one SMS sheet to be double wrapped during use. ArjoRad Sterilization Wrap will be sold in a non-sterile condition in packaged form of various sizes depending on the needs of the end user.
Sterilization Wrap
FRG
ArjoRad Sterilization Wrap
Intended Use: -
Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Sterilization Wraps will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 100S, NX, and 100NX Systems.
| Cycle | Recommended
Instrument
Configuration | Inside Diameter | Length | Recommended
Individual
Tray Load Weight | Number of Lumens per
Validation Load | Cycle Length |
|------------------------------|--------------------------------------------|------------------|------------------|-----------------------------------------------|-----------------------------------------|--------------|
| STERRAD 100S | Stainless Steel Lumens | 3 mm | 400 mm | 9.1 lbs | 2 trays, 5 lumens each | 55 minutes |
| STERRAD NX
Standard | Single Channel PTFE
Lumens | 1 mm | 150 mm | 10.7 lbs | 10 lumens | 28 minutes |
| STERRAD NX
Advanced | Single Channel
Flexible Endoscope | 1.2 mm | 845 mm | 10.7 lbs | 1 endoscope | 38 minutes |
| | Stainless Steel
Lumens | 1 mm | 500 mm | | 10 lumens | |
| STERRAD
100NX
Standard | Stainless Steel
Lumens | 0.7 mm | 500 mm | 10.7 lbs | 2 trays, 5 lumens each | 47 minutes |
| STERRAD 100
NX Flex | Single Channel
Flexible Endoscope(s) | 1.2 mm
1.2 mm | 830 mm
840 mm | 6.4 lbs | 2 trays, 1 endoscope per
tray | 42 minutes |
| STERRAD 100
NX Express | Stainless Steel
Surfaces
(2mm x 8mm) | N/A | N/A | 10.7 lbs | N/A | 24 minutes |
510(k) Summary
1
Predicate Device:
K092167 - Kimguard one step sterilization wrap - Kimberly - Clark Corporation
Substantial Equivalence:
The subject wraps have the same fundamental technological characteristics as the predicate device(s). Performance testing between the predicate device and the subject device have verified substantial equivalence in design, materials and intended use, and confirmed there are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy.
Performance Testing:
The intended use is to contain medical devices and to maintain sterility. Physical protection is consequently needed during the handling of non-sterile product. It is controlled with following performance testing: substance weight, strip tensile strength, Mullen burst and Elmendorf tear. Arjorad developed higher tensile strength and burst and tearing strength than predicate sterilization wrap. In addition ArjoRad meets the acceptance criteria with regard to the minimum requirement for strength properties dedicated to non-woven sterilization wrap. When applied to the minimum performance level, the properties of ArjoRad still meet the criteria of acceptation after sterilization which equals the minimum requirement level for sterilization wrap defined according to EN 868-2:2009 and ASTM D737: Standard Test Method for Air Permeability of Textile Fabrics.
During microbial aerosol challenge test, similarly to predicate, ArjoRad demonstrated germ resistance after hydrogen peroxide sterilization cycle. The microbial aerosol challenge test and the shelf life study demonstrate that, the subject wrap is considered as a sterile barrier system that is capable to maintaining sterility for 30 days after sterilization, as long as the sterile barrier is not compromised in any way.
The ability to let the sterilant penetrate has been validated as well. This was demonstrated by sterilization efficacy studies after different cycles of STERRAD hydrogen peroxide gas plasma sterilization. Studies carried out demonstrated that Arjorad can assure an SAL of 10 after each half cycle tested.
Conclusion: The minor differences between the proposed and predicate devices do not introduce new issues of safety and efficacy. The ArjoRad Sterilization Wrap is substantially equivalent to the predicates in that it meets all of the requirements for use in a STERRAD 100S, NX and 100NX Systems. All testing performed indicates that the ArjoRad Sterilization Wrap will provide a sterile barrier for use in the STERRAD device. There are a series of detailed Comparison Tables for testing results included in Section 18 Performance Testing, which was completed by comparing the ArjoRad Sterilization Wrap against the primary predicate device. The KC300 sterilization wrap chosen as a test predicate has been cleared for low temperature V-Pro sterilization, the comparative performance data demonstrates that the proposed device performs equally or better than the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Arjo Wiggins Medical, Incorporated C/O Mr. Jonathan Ward President Regulatory and Marketing Services, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K110954
Trade/Device Name: ArjoRad Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: August 17, 2012 Received: August 22, 2012
Dear Mr. Ward:
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. 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.
AUG 2 4 2012
3
Page 2- Mr. Ward
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
For
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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Indications for Use
510(k) Number (if known): K110954
Device Name: ArjoRad Sterilization Wrap
Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Of the choose will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 100S, NX, and 100NX Systems
| Cycle | Recommended
Instrument
Configuration | Inside
Diameter | Length | Recommended
Individual
Tray Load Weight | Number of Lumens
per
Validation Load | Cycle Length |
|------------------------------|--------------------------------------------|--------------------|------------------|-----------------------------------------------|--------------------------------------------|--------------|
| STERRAD 100S | Stainless Steel Lumens | 3 mm | 400 mm | 9.1 lbs | 2 trays, 5 lumens each | 55 minutes |
| STERRAD
NX
Standard | Single Channel
PTFE Lumens | 1 mm | 150 mm | 10.7 lbs | 10 lumens | 28 minutes |
| STERRAD
NX Advanced | Single Channel
Flexible Endoscope | 1.2 mm | 845 mm | 10.7 lbs | 1 endoscope | 38 minutes |
| | Stainless Steel
Lumens | 1 mm | 500 mm | | 10 lumens | |
| STERRAD
100NX
Standard | Stainless Steel
Lumens | 0.7 mm | 500 mm | 10.7 lbs | 2 trays, 5 lumens each | 47 minutes |
| STERRAD
100 NX Flex | Single Channel
Flexible
Endoscope(s) | 1.2 mm
1.2 mm | 830 mm
840 mm | 6.4 lbs | 2 trays, 1 endoscope
per tray | 42 minutes |
| STERRAD
100 NX
Express | Stainless Steel
Surfaces
(2mm x 8mm) | N/A | N/A | 10.7 lbs | N/A | 24 minutes |
Sterilization Loads
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mau' Smith (Attorney)
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: K110454