(240 days)
KIMGUARD* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 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 also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EtO sterilization of 8 hours at 55 ℃ or 12 hours at 43.3 ℃. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100, 200, and 300 and for dry times of 30 minutes for Models 400, 500, and 600.
KIMGUARD* Sterilization Wrap is not indicated for use for gravity steam sterilization.
The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.
The KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) underwent testing to demonstrate substantial equivalence to predicate devices and adherence to performance standards. The study primarily focused on the physical and functional aspects of the sterilization wrap.
1. Table of Acceptance Criteria and Reported Device Performance
The provided information indicates that "All results of testing met acceptance criteria." While specific numerical acceptance criteria are not explicitly detailed for each test, the general acceptance is that the device should function effectively as a sterilization wrap, allowing sterilization, maintaining sterility, and demonstrating appropriate physical integrity and biocompatibility.
| Test Category | Acceptance Criteria (Explicitly stated or inferred) | Reported Device Performance |
|---|---|---|
| Intended Use | To enclose a medical device for sterilization by pre-vacuum steam (270°F/132°C for 4 min) or 100% ethylene oxide (EtO, 725-735 mg/L at 131°F/55°C & 40-80% RH for 60 min). To allow sterilization and maintain sterility until opened. Validated aeration for EtO: 8 hours at 55°C or 12 hours at 43.3°C. Validated dry times for pre-vacuum steam: 20 min for KC100, KC200, KC300; 30 min for KC400, KC500, KC600. Not for gravity steam sterilization. | Device meets all stated intended use parameters, including sterilization methods, maintenance of sterility, and specific aeration and dry times. The wrap is not indicated for gravity steam sterilization, aligning with its intended use. |
| Biocompatibility | Compliance with ISO 10993 methods for irritation and sensitization. (Inferred: No adverse biological reactions upon contact). | Biocompatibility testing (irritation and sensitization) was conducted in compliance with ISO 10993, and all results met acceptance criteria. |
| Sterilant Penetration | (Inferred: Allows adequate penetration of sterilant to successfully sterilize enclosed device). | Testing for sterilant penetration was performed, and all results met acceptance criteria. |
| Dry Time | Specific validated dry times for pre-vacuum steam sterilization: 20 min for KC100, KC200, KC300; 30 min for KC400, KC500, KC600. | Testing for dry time was performed, and all results met acceptance criteria, confirming the validated dry times for each model. |
| Physical Integrity | (Inferred: The wrap maintains its structural integrity during and after sterilization, resisting tears, punctures, or other damage that would compromise sterility). Specific maximum wrapped package content weights for sterility maintenance validation: KC100 (3 lbs), KC200 (6 lbs), KC300 (9 lbs), KC400 (13 lbs), KC500 (17 lbs), KC600 (25 lbs). | Testing for physical integrity was performed, and all results met acceptance criteria. The wraps maintained sterility of pack contents for up to 30 days under standard conditions for the specified maximum package weights. |
| Sterility Maintenance | Ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions. (Inferred: No microbial ingress). | The wrap has been tested for the ability to maintain sterility of pack contents after sterilization for up to 30 days under standard conditions, and all results met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test set (biocompatibility, sterilant penetration, dry time, physical integrity, sterility maintenance). However, it does detail the maximum wrapped package content weights used in the sterility maintenance validation study for each wrap model, which implicitly defines the types and quantities of materials tested within the wraps.
- KC100: 3 lbs (16 huck towels)
- KC200: 6 lbs (2 huck towels, 2 fluid resistant U-drapes, 1 fluid resistant universal bar drape)
- KC300: 9 lbs (For Pre-Vacuum Steam: 15 huck towels, 1 small fluid resistant drape, 5 lbs of metal mass; For EtO: 16 huck towels, 2 fluid resistant large drapes, 1 fluid resistant small drape, 1 fluid resistant table cover)
- KC400: 13 lbs (4 tray liners, 10"x10"x3.5" tray with 11 lbs metal mass)
- KC500: 17 lbs (4 tray liners, 10"x10"x3.5" tray with 15 lbs metal mass)
- KC600: 25 lbs (4 tray liners, 10"x10"x3.5" tray with 23 lbs metal mass)
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by or for Kimberly-Clark Corporation according to regulatory guidance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (sterilization wrap performance) does not typically involve human experts establishing a "ground truth" for a test set in the way an AI diagnostic device would. Instead, the "ground truth" is established by adherence to recognized scientific and regulatory standards and testing methodologies, such as those recommended in "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)" and ISO 10993 for biocompatibility. The "experts" in this context would be the skilled technicians, scientists, and engineers who conducted the laboratory tests and interpreted the results against established pass/fail criteria. Their specific qualifications are not detailed in the summary.
4. Adjudication Method for the Test Set
Not applicable. As described above, this study does not involve human interpretation or subjective assessment that would require an adjudication method like 2+1 or 3+1. The tests are objective and quantitative based on defined performance standards.
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
Not applicable. This is a study for a physical device (sterilization wrap), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The ground truth used in this study is based on:
- Established Performance Standards: Adherence to the requirements recommended in "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)."
- International Standards: Compliance with ISO 10993 for biocompatibility (irritation and sensitization).
- Functional Validation: Demonstrating effective sterilization, maintenance of sterility for a specified period (30 days), and specified dry times for steam sterilization, all of which are observable and measurable outcomes based on validated testing protocols.
- Physical Properties: Measurement of physical integrity (e.g., resistance to compromise).
These are objective, empirically verifiable criteria for the performance of a sterilization wrap.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
{0}------------------------------------------------
Predicate
Devices:
510(k) Summary for the Kimberly-Clark* Corporation KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)
| Date Summary was Prepared: | April 14, 2009 |
|---|---|
| 510(k) Submitter: | Thomas KozmaDirector, Regulatory AffairsKimberly-Clark Health Care1400 Holcomb Bridge RoadRoswell, GA 30076Ph: 770.587.8393FAX: 920.225.3408Email: thomas.kozma@kcc.com |
| Primary Contact for this 510(k) Submission: | Lisa Peacock, Consultant to Kimberly-Clark Health CareSciMed, Inc.Ph: 706.216.3413FAX: 800.713.7754Email: lisa.peacock@kcc.com |
| Device Common Name: | Sterilization Wrap |
| Classification Name: | Sterilization Wrap (21 CFR 880.6850) |
| Product Code: | FRG |
| Intended Use: | KIMGUARD* Sterilization Wrap is intended to be used to encloseanother medical device that is to be sterilized by a health care providerby pre-vacuum steam at 270°F/132°C for 4 minutes or by 100%ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes. The wrap isintended to allow sterilization of the enclosed medical device(s) andalso to maintain sterility of the enclosed device(s) until opened. Thewrap was validated for aeration times for EtO sterilization of 8 hours at55 °C or 12 hours at 43.3 °C. The wrap was validated for dry times forpre-vacuum steam sterilization of 20 minutes for Models 100, 200, and300 and for dry times of 30 minutes for Models 400, 500, and 600.KIMGUARD* Sterilization Wrap is not indicated for use for gravitysteam sterilization. |
See Wrap Model Recommendations on Page 3.
MAY - 1 2009
The KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, The KIMGUAHD Glonically are substantially equivalent to the KC400, RC300, and RO000) are oabstanding - Treations of Sterile Wraps
Page 1 of 3 - 510(k) Summary
ਾ ਵ
{1}------------------------------------------------
(K881471)
and the control control control control controllers and
・・
| SubstantialEquivalence: | The KIMGUARD* Sterilization Wrap is substantially equivalent to thepredicates in intended use, design, and materials. The predicatedevices were constructed of a three-layer laminate composed of a layerof meltblown polypropylene bonded on both surfaces with a layer ofspunbonded polypropylene. The sheets of sterilization wrap are squareor rectangular fabric produced using a polypropylene three-layer SMS(spunbond-meltblown-spunbond) process. |
|---|---|
| Summary ofTesting: | KIMGUARD* Sterilization Wrap performance has been tested inaccordance with the applicable requirements recommended inPremarket Notification [510(k)] Submissions for Medical SterilizationPackaging Systems in Health Care Facilities; Draft Guidance forIndustry and FDA (March 7, 2002). Testing included biocompatibility(i.e., irritation and sensitization) in compliance with the methods of ISO10993, sterilant penetration, dry time, and physical integrity. The Wraphas also been tested for the ability to maintain sterility of pack contentsafter sterilization for up to 30 days under standard conditions. Allresults of testing met acceptance criteria. |
{2}------------------------------------------------
| Table 1. Wrap Model Recommendations' | |||
|---|---|---|---|
| -- | -- | -- | --------------------------------------- |
| KIMGUARD*SterilizationWrap Models | Intended Loads | MaximumWrappedPackageContentWeights Used inSterilityMaintenanceValidationStudy2 | Descriptions of Loads Used in SterilityMaintenance Validation Study2 |
|---|---|---|---|
| KC100 | Very Light WeightPackage (forexample: towelpacks) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight Package(for example:standard linen packs) | 6 lbs | 2 huck towels (17"x 29")2 fluid resistant U-drape (68"x109")1 fluid resistant universal bar drape(70" x 108") |
| KC300 | Light to ModerateWeight Package (forexample: general usemedical instruments) | 9 lbs | For Pre-Vacuum Steam:15 huck towels (17"x 29")1 small fluid resistant drape (60"x 76")5 lbs of metal massFOR EtO:16 huck towels2 fluid resistant large drapes (76"x100")1 fluid resistant small drape (76"x60")1 fluid resistant table cover (60"x 90") |
| KC4003 | Moderate to HeavyWeight Package (forexample: general usemedical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing 11 lbs ofmetal mass |
| KC5003 | HeavyweightPackage (forexample: general usemedical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing15 lbs of metal mass |
| KC6003 | Very Heavy WeightPackage (forexample: generaluse medicalinstruments) | 25 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing23 lbs of metal mass |
ndividual results may differ due to factions in handling practices, wrapping techniques, and folding Individual results may aller one to facilis such as vaniating which may put added stress on the memors. Hasulti may also onlie use of itself which wrapped online on associated on accommended use.
wrap. Each healthcare facility should determine for itself which wrappen
wap. Each neallity should columnis for noal which within weights indicated for each wag model.
4 It is recommended to not exceed the maximum wrapped package twape that was It is recommended to not exceed the number, weight, and size of individual content types that were Futhermore, It is recommended to for exceed the number and size of the fluid resistant linens of the weight of the metal mass).
the metal mass).
The KC400, KC500, and KC500 model waps were validated for sterilianting overs with these model Intelling and RC600 model waps well validation in steriit ating in steriit atincently this oncles will these models. It is linen, and it is recommended to hot exceed 3 tos of normal resistant inemal of the mail of the mail.
recommended that the user not include fluid-resistant linens in KC400 mod fluid resistant materials has not been evaluated with these models.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
MAY - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kimberly-Clark Corporation C/o Ms. Lisa Peacock Scimed, Incorporated 172 Conductor Drive Dawsonville, Georgia 30534
Re: K082554
Trade/Device Name: KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: April 15, 2009 Received: April 17, 2009
Dear Ms. Peacock:
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.
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.
{4}------------------------------------------------
Page 2- Ms. Peacock
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Runner
Susan Runner, D.D.S., M.A.
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): _K082554
Device Name: _ KIMGUARD* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600)
Indications for Use:
KIMGUARD* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 2709E/1329C for 4 minutes or by 100% ethylene oxide (EtO) with a concentration of 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 also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EtO sterilization of 8 hours at 55 ℃ or 12 hours at 43.3 ℃. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100, 200, and 300 and for dry times of 30 minutes for Models 400, 500, and 600.
KIMGUARD* Sterilization Wrap is not indicated for use for gravity steam sterilization.
See Wrap Model Recommendations on Page 2.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shale A Murphy
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082554
{6}------------------------------------------------
Indications for Use
| Wrap Model RecommendationsKIMGUARD*Sterilization WrapModels | Intended Loads | Maximum Wrapped Package Content Weights Used in Sterility Maintenance Validation Study | Descriptions of Loads Used in Sterility Maintenance Validation Study |
|---|---|---|---|
| KC100 | Very Light Weight Package (for example: towel packs) | 3 lbs | 16 huck towels (17"x 29") |
| KC200 | Light Weight Package (for example: standard linen packs) | 6 lbs | 2 huck towels (17"x 29")2 fluid resistant U-drape (68"x109")1 fluid resistant universal bar drape (70" x 108") |
| KC300 | Light to Moderate Weight Package (for example: general use medical instruments) | 9 lbs | FOR Steam:15 huck towels (17" x 29")1 small fluid resistant drape (60" x 76")5 lbs metal massFOR EtO:16 huck towels2 fluid resistant large drapes (76"x100")1 fluid resistant small drape (76"x60")1 fluid resistant table cover (60"x 90") |
| KC4003 | Moderate to Heavy Weight Package (for example: general use medical instruments) | 13 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing 11 lbs of metal mass |
| KC5003 | Heavyweight Package (for example: general use medical instruments) | 17 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing 15 lbs of metal mass |
| KC6003 | Very Heavy Weight Package (for example: general use medical instruments) | 25 lbs | 4 tray liners 20" x 25" stacked10" x 10" x 3 ½ " tray containing 23 lbs of metal mass |
Individual results may differ due to factors such as variations in handling practices, wrepping techniques and holling methods individual riskuller the use of irregularly shaped contents, which may put added stress on the wap. Each healthcare Hesults may also differ do the abo of wrop model is most appropriate for each intended use.
Itality shulld delefthing for itself which wapped package contant weights indicated for each wrap model. Furthernes, it is If is recommended to not exceed the namun wapped package contact were whole were with and the mail of the Maria Maria National is recommended to not exceed the number, weight, and size of the weight of the weight the metal mass).
Sterilization Wraps (i.e.: the number and size of the fluid resistant l
Stenization Vriaps (i.e. the namber and size of the nailed for sterilant penetration with 3 lbs of non-fluid resistent linen, and it consemped that is recommented to not exceed 3 lbs of norther perfilms proles with bless model hit is recommended to recommended be is recommended to tot exceed 3 ibs of nor-libration of the model wrops, as use of such fluid resistent materials and not been evaluated with these models.
§ 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).