(217 days)
HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Stryker Sterizone VP4 Sterilizer Cycle 1.
The HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Stryker Sterizone VP4 Sterilizer Cycle 1. All models of the Halyard ONE-STEP and QUICK CHECK Sterilization Wrap have been validated for use with the Stryker Sterilizer Cycle 1 as described below:
Halyard Sterilization Wrap is supplied to the customer as bulk packages of single sheets, where in accordance with standard hospital practices, two sheets are then used to wrap a medical device or a collection of medical devices for sterilization. HALYARD ONE-STEP and HALYARD QUICK CHECK Sterilization Wraps are comprised of two sheets of HALYARD* Sequential Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.
Sterilization wrap is a square or rectangular sheet made of three-layer SMS (spunbond-meltblown-spunbond) polypropylene fabric treated with an antistatic treatment. The wrap allows a sterilized package to be opened aseptically.
The HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Stryker Sterizone VP4 Sterilizer Cycle 1 which is a dual-sterilant, low temperature sterilizer that uses vaporized hydrogen peroxide (H2O2) and ozone (O3) in a single cycle. All models of the Halyard ONE-STEP and QUICK CHECK Sterilization Wrap have been validated for use with the Stryker Sterizone VP4 Sterilizer Cycle 1 as described below.
The document describes the acceptance criteria and performance of the HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps. Since this device is a sterilization wrap, the criteria and studies are related to its ability to allow sterilization and maintain sterility, rather than AI/machine learning performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Purpose | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilant Penetration/Efficacy | ANSI/AAMI ST79ANSI/AAMI/ISO 11138-7 | Achieving a 10-6 sterility assurance level following processing in a worst-case half-cycle | Passed |
| Performance Testing (Non-sterile and Sterile) | ANSI/AAMI/ISO 11607-1 Annex BISO 13938-2ASTM D4966-12CPSC 1610 | Complies with the selected physical properties | Passed |
| Maintenance of Package Integrity | ANSI/AAMI/ISO 11607-1ANSI/AAMI ST79 | Maintain sterility for up to 12 months | Passed |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-7 | Non-cytotoxicNon-irritatingH2O2 ≤ 0.56 μg/cm2 | Passed |
2. Sample size used for the test set and the data provenance
The document provides details on the "Validation Loads" used, which can be considered the test sets for sterility:
- General instruments:
- Load consisted of three (3) trays each containing three (3) lb of general medical instruments.
- Load #7A consisted of three (3) trays each containing 25 lb of general medical instruments, for a total of 75 lb per load (excluding the loading rack).
- Rigid channel instruments:
- Load #4A consisted of 15 lumens from rigid and semi-rigid channeled devices.
- Single and double channel flexible endoscopes:
- Load #8A consisted of five (5) lumens from single and double channel flexible endoscopes.
- Multi-channel flexible endoscopes:
- Load #9A consisted of one (1) multichannel flexible endoscope with four (4) channels.
The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the nature of sterilization validation studies, they are typically prospective experimental tests conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" here is the achievement of sterility, which is determined by standard microbiological testing methods (e.g., biological indicators, sterility assurance level) rather than expert consensus on images or clinical cases.
4. Adjudication method for the test set
Not applicable. The evaluation criteria are objective and measured through laboratory testing as described above, not through human adjudication of qualitative data.
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 device is a sterilization wrap, not an AI or imaging diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (sterilization wrap) and does not involve an algorithm.
7. The type of ground truth used
The ground truth used for performance evaluation is based on objective laboratory measurements related to sterility, physical properties, and biocompatibility. Specifically:
- Sterility Assurance Level (SAL) of 10-6 (microbiological testing).
- Compliance with specific physical properties standards (e.g., tensile strength, burst strength).
- Maintenance of sterility for a defined period (12 months).
- Biocompatibility criteria (non-cytotoxic, non-irritating, H2O2 residuals).
8. The sample size for the training set
Not applicable. This device is a physical product and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 27, 2022
Owens & Minor (O&M) Halyard, Inc. Anureet Singh Regulatory Affairs Specialist II 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K214007
Trade/Device Name: HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: June 29, 2022 Received: June 30, 2022
Dear Anureet Singh:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
for Clarence W. Murray, III, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K214007
Device Name
HALYARD* ONE-STEP* Sterilization Wrap and HALYARD* QUICK CHECK* Sterilization Wrap
Indications for Use (Describe)
HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Stryker Sterizone VP4 Sterilizer Cycle 1.
The HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Stryker Sterizone VP4 Sterilizer Cycle 1. All models of the Halyard ONE-STEP and QUICK CHECK Sterilization Wrap have been validated for use with the Stryker Sterilizer Cycle 1 as described below:
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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| Type of Device | HALYARD ONE-STEP* and QUICK CHECK* Validation Loads Descriptionin the Stryker Sterizone VP4 Sterilizer Cycle 1 | ValidatedSterilizationWrap GradesB |
|---|---|---|
| Generalinstruments | Load consisted of three (3) trays each containing three (3) lb of general medicalinstruments. The load included:General devices representing the following geometries:Box-lock hingePivot hingeLuer-lockTesting was performed with trays wrapped in H100 sterilization wrap.Load #7A - Consisted of three (3) trays each containing 25 lb of general medicalinstruments, for a total of 75 lb per load (excluding the loading rack). The load included:General devices representing the following geometries:Box-lock hingePivot hingeLuer-lockTesting was performed with trays wrapped in H600 sterilization wrap. | H100CH200H300H400H500H600C |
| Rigid channelinstruments | Load #4A - Consisted of 15 lumens from rigid and semi-rigid channeled devices. The loadincluded:Three (3) double channel (six (6) lumens) semi-rigid endoscopes (ureteroscope - 0.7 mm × 500 mm and 1.1 mm × 500 mm) were packaged in three (3)sterilization trays including appropriate silicone brackets. Additional rigid channel instruments (nine (9) lumens) were added. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400CH500H600C |
| Single and doublechannel flexibleendoscopes | Load #8A - Consisted of five (5) lumens from single and double channel flexibleendoscopes. The load included:Two (2) double channel flexible endoscopes (ureteroscope) with insidediameter of 1 mm and lengths of 850 mm and 989 mm; One (1) single channel flexible endoscope (ureteroscope) with inside diameterof 1 mm and length of 850 mm; The endoscopes were individually packaged in sterilization trays, includingappropriate silicone brackets. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400CH500H600C |
| Multi-channelflexibleendoscopes | Load #9A - Consisted of one (1) multichannel flexible endoscope with four (4) channels.The load included:One (1) multi flexible endoscope (colonoscope) with no more than four (4)channels having inside diameter of 1.2 mm and lengths of 1955 mm or insidediameter of 1.45 mm and lengths of 3500 mm, packaged individually in asterilization tray. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400CH500H600C |
A: Representative Sterizone® VP4 Sterilizer Cycle 1 Valifand* ONE-STEP and QUICK CHECK* Sterliization Wrap are comprised of two sheets of Halyard Sequential Sterilization Wrap ultrasonically bonded together on two sides. Therefore, these grades are applicable to HALYARD* ONE-STEP*, QUICK CHECK* and Sequential Sterilization Wrap. C: Indicates the bracketed grades for validation testing.
Type of Use (Select one or both, as applicable)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – K214007
| Submitter: | O&M Halyard, Inc.9120 Lockwood BoulevardMechanicsville, VA 23116Phone: 804-723-7000/800-488-8850Fax: 804-723-7100 |
|---|---|
| Regulatory Contact: | Anureet SinghRegulatory Affairs Specialist IIO&M Halyard, Inc.1 Edison DriveAlpharetta, GA 30005 |
| Date of Summary: | 25 July 2022 |
| Device Trade Name: | HALYARD* ONE-STEP* Sterilization Wrap and HALYARD* QUICK CHECK*Sterilization Wrap |
| Common Name: | Sterilization Wrap |
| Classification Name: | Sterilization wrap (21 CFR 880.6850, Product Code FRG) |
| Predicate Device: | Halyard ONE-STEP Sterilization Wrap, K192147 |
| Device Description: | Halyard Sterilization Wrap is supplied to the customer as bulk packages of singlesheets, where in accordance with standard hospital practices, two sheets are thenused to wrap a medical device or a collection of medical devices for sterilization.HALYARD ONE-STEP and HALYARD QUICK CHECK Sterilization Wrapsare comprised of two sheets of HALYARD* Sequential Sterilization Wrapultrasonically seamed on two edges. This allows for convenient wrapping withtwo sheets simultaneously.Sterilization wrap is a square or rectangular sheet made of three-layer SMS(spunbond-meltblown-spunbond) polypropylene fabric treated with an antistatictreatment. The wrap allows a sterilized package to be opened aseptically.The HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps areintended to enclose another medical device that is to be sterilized by a healthcareprovider using the Stryker Sterizone VP4 Sterilizer Cycle 1 which is a dual-sterilant, low temperature sterilizer that uses vaporized hydrogen peroxide (H2O2)and ozone (O3) in a single cycle. All models of the Halyard ONE-STEP andQUICK CHECK Sterilization Wrap have been validated for use with the StrykerSterizone VP4 Sterilizer Cycle 1 as described below. |
| Indication for Use: | HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps are intendedto enclose another medical device that is to be sterilized by a healthcare providerusing the single cycle Stryker Sterizone VP4 Sterilizer Cycle 1.The HALYARD ONE-STEP and QUICK CHECK Sterilization Wraps areintended to allow sterilization of the enclosed devices by the Stryker Sterizone |
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VP4 Sterilizer Cycle 1. All models of the Halyard ONE-STEP and QUICK CHECK Sterilization Wrap have been validated for use with the Stryker Sterizone VP4 Sterilizer Cycle 1 as described below:
| Type of Device | HALYARD ONE-STEP* and QUICK CHECK* Validation Loads Descriptionin the Stryker Sterizone VP4 Sterilizer Cycle 1 | ValidatedSterilizationWrap GradesB |
|---|---|---|
| Generalinstruments | Load consisted of three (3) trays each containing three (3) lb of general medicalinstruments. The load included:General devices representing the following geometries: Box-lock hinge Pivot hinge Luer-lock Testing was performed with trays wrapped in H100 sterilization wrap.Load #7A - Consisted of three (3) trays each containing 25 lb of general medicalinstruments, for a total of 75 lb per load (excluding the loading rack). The load included: General devices representing the following geometries: Box-lock hinge Pivot hinge Luer-lock Testing was performed with trays wrapped in H600 sterilization wrap. | H100CH200H300H400H500H600C |
| Rigid channelinstruments | Load #4A - Consisted of 15 lumens from rigid and semi-rigid channeled devices. The loadincluded: Three (3) double channel (six (6) lumens) semi-rigid endoscopes (ureteroscope- 0.7 mm × 500 mm and 1.1 mm × 500 mm) were packaged in three (3)sterilization trays including appropriate silicone brackets. Additional rigid channel instruments (nine (9) lumens) were added. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400CH500H600C |
| Single and doublechannel flexibleendoscopes | Load #8A - Consisted of five (5) lumens from single and double channel flexibleendoscopes. The load included: Two (2) double channel flexible endoscopes (ureteroscope) with insidediameter of 1 mm and lengths of 850 mm and 989 mm; One (1) single channel flexible endoscope (ureteroscope) with inside diameterof 1 mm and length of 850 mm; The endoscopes were individually packaged in sterilization trays, includingappropriate silicone brackets. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400CH500H600C |
| Multi-channelflexibleendoscopes | Load #9A - Consisted of one (1) multichannel flexible endoscope with four (4) channels.The load included: One (1) multi flexible endoscope (colonoscope) with no more than four (4)channels having inside diameter of 1.2 mm and lengths of 1955 mm or insidediameter of 1.45 mm and lengths of 3500 mm, packaged individually in asterilization tray. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400CH500H600C |
A: Representative Sterizone® VP4 Sterilizer Cycle 1 Validation Load from K172191. B'HALYARD* ONE-STEP* and QUICK CHECK* Sterilization Wrap are comprised of two sheets of Halyard Sequential Sterilization Wrap ultrasonically bonded together on two sides are applicable to HALYARD* ONE-STEP*, QUICK CHECK* and Sequential Sterilization Wrap. C: Indicates the bracketed grades for validation testing.
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| ProposedHALYARD ONE-STEP andQUICK CHECK Sterilization Wrap(K214007) | PredicateHALYARD ONE-STEPSterilization Wrap(K192147) | SameSimilar, orDifferent | |
|---|---|---|---|
| Manufacturer | O&M Halyard, Inc. | O&M Halyard, Inc. | Same |
| Device ModelNumbers | H100H200H300H400H500H600 | H100H200H300H400H500H600 | Same |
| Common orUsual Name | Sterilization Wrap | Sterilization Wrap | Same |
| Classification | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Class | II | II | Same |
| Product Code | FRG | FRG | Same |
| Indication forUse | HALYARD ONE-STEP and QUICKCHECK Sterilization Wraps areintended to enclose another medicaldevice that is to be sterilized by ahealthcare provider using the StrykerSterizone VP4 Sterilizer Cycle 1.The HALYARD ONE-STEP andQUICK CHECK Sterilization Wrapsare intended to allow sterilization ofthe enclosed devices by the StrykerSterizone VP4 Sterilizer Cycle 1. Allmodels of the Halyard ONE-STEP andQUICK CHECK Sterilization Wraphave been validated for use with theStryker Sterizone VP4 Sterilizer Cycle1 as described below:Type of Device: General instrumentsHALYARD ONE-STEP* and QUICKCHECK* Validation Loads Description inthe Stryker Sterizone VP4 Sterilizer Cycle1:Load consisted of three (3) trays eachcontaining three (3) lb of general medicalinstruments. The load included generaldevices representing the followinggeometries: Box-lock hinge, Pivot hinge,Luer-lock.Testing was performed with trays wrappedin H100 sterilization wrap.Load #7A - Consisted of three (3) trayseach containing 25 lb of general medicalinstruments, for a total of 75 lb per load(excluding the loading rack). The loadincluded general devices representing thefollowing geometries: Box-lock hinge,Pivot hinge, Luer-lock.Testing was performed with trays wrappedin H600 sterilization wrap. | The Halyard ONE-STEP SterilizationWraps are intended to allowsterilization of the enclosed devices bythe Sterilucent HC 80TT HydrogenPeroxide Sterilizer (ie, both the Lumenand Flexible Cycles) Additionally, theHalyard ONE-STEP SterilizationWrap was validated to allow effectiveaeration under the pre-programmedHC 80TT Sterilization Cycles. Allmodels of the Halyard ONE-STEPSterilization Wrap have been validatedfor use with the Sterilucent HC 80TTHydrogen Peroxide Sterilizer cycles asdescribed below.Lumen CycleReusable metal and nonmetal devicesincluding devices with diffusion-restricted spaces such as the hingedportion of forceps and scissors and upto fifteen (15) stainless steel lumensper load with the followingdimensions:Single or dual channeled rigid andsemi-rigid endoscopes, with stainlesssteel lumens that are$\ge$ 0.77 mm internal diameter (ID) and$\le$ 410 mm long, or $\ge$ 1.33 mm ID and $\le$430 mm long;and, Triple channeled rigid and semi-rigid endoscopes, with stainless steellumens that are $\ge$ 1.00 mm ID and $\le$310 mm long (Refer to the HC 80TTUser Manual for complete instructionson load(s) and cycle(s), includingchamber loading instructions (i.e. 20.1lb per load)Flexible Cycle | Different |
Technological Characteristics Comparison Table:
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| Validated Sterilization Wrap GradesB:H100C, H200, H300, H400, H500, H600CType of Device: Rigid channelinstrumentsHALYARD ONE-STEP* and QUICKCHECK* Validation Loads Description inthe Stryker Sterizone VP4 Sterilizer Cycle1:Load #4A - Consisted of 15 lumens fromrigid and semi-rigid channeled devices.The load included:Three (3) double channel (six (6) lumens)semi-rigid endoscopes (ureteroscope - 0.7mm × 500 mm and 1.1 mm × 500 mm)were packaged in three (3) sterilizationtrays including appropriate siliconebrackets.Additional rigid channel instruments (nine(9) lumens) were added.Testing was performed with trays wrappedin H400 and H600 sterilization wrap.Validated Sterilization Wrap GradesB:H400C, H500, H600C | Reusable rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or matedsurfaces such as the hinged portion offorceps or scissors;Single channel flexible endoscopeswith flexible lumens that are ≥ 1.00mm ID and ≤ 1280 mm long; and Dualchannel flexible endoscopes withflexible lumens that are ≥ 0.80 mm IDand ≤ 1000 mm long.(Refer to the HC 80TT User Manualfor complete instructions on load(s)and cycle(s), including chamberloading instructions (i.e. 25 lb perload). |
|---|---|
| Type of Device: Single and doublechannel flexible endoscopesHALYARD ONE-STEP* and QUICKCHECK* Validation Loads Description inthe Stryker Sterizone VP4 Sterilizer Cycle1:Load #8A - Consisted of five (5) lumensfrom single and double channel flexibleendoscopes. The load included: Two (2)double channel flexible endoscopes(ureteroscope) with inside diameter of 1mm and lengths of 850 mm and 989 mm;One (1) single channel flexible endoscope(ureteroscope) with inside diameter of 1mm and length of 850 mm; Theendoscopes were individually packaged insterilization trays, including appropriatesilicone brackets.Testing was performed with trays wrappedin H400 and H600 sterilization wrap.Validated Sterilization Wrap GradesB:H400C, H500, H600C | |
| Type of Device: Multi-channel flexibleendoscopesHALYARD ONE-STEP* and QUICKCHECK* Validation Loads Description inthe Stryker Sterizone VP4 Sterilizer Cycle1:Load #9A - Consisted of one (1)multichannel flexible endoscope with four(4) channels. The load included: One (1)multi flexible endoscope (colonoscope)with no more than four (4) channels havinginside diameter of 1.2 mm and lengths of1955 mm or inside diameter of 1.45 mm |
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| and lengths of 3500 mm, packagedindividually in a sterilization tray.Testing was performed with trays wrappedin H400 and H600 sterilization wrap.Validated Sterilization Wrap GradesB:H400C, H500, H600CA: Representative Sterizone® VP4Sterilizer Cycle 1 Validation Load fromK172191. B: HALYARD* ONE-STEP*and QUICK CHECK* Sterilization Wrapare comprised of two sheets of HalyardSequential Sterilization Wrapultrasonically bonded together on twosides. Therefore, these grades areapplicable to HALYARD* ONE-STEP*,QUICK CHECK* and SequentialSterilization Wrap. C: Indicates thebracketed grades for validation testing. | |||
|---|---|---|---|
| SterilizationParameters | Stryker Sterizone VP4 Sterilizer Cycle1 which is a dual-sterilant, lowtemperature sterilizer that usesvaporized hydrogen peroxide (H2O2)and ozone (O3) in a single cycle | Sterilucent PSD-85 HydrogenPeroxide Sterilizer that includes● Lumen Cycle● Flexible Cycle | Different |
| Technology | Tortuous sheet material used toenclose medical devices that are to besterilized by a healthcare provider toallow sterilization of the enclosedmedical device(s) and maintainsterility of the enclosed device(s) untilused | Tortuous sheet material used toenclose medical devices that are to besterilized by a healthcare provider toallow sterilization of the enclosedmedical device(s) and maintainsterility of the enclosed device(s) untilused | Same |
| Device Design | Two sheets of nonwovenpolypropylene fabric. Each sheet iscomposed of three thermally-bondedlayers consisting of a meltblownpolypropylene layer surrounded byspunbond polypropylene layers (SMS) | Two sheets of nonwovenpolypropylene fabric. Each sheet iscomposed of three thermally-bondedlayers consisting of a meltblownpolypropylene layer surrounded byspunbond polypropylene layers (SMS) | Same |
| Method forBonding SMSLayers | Thermal bonding with round pin,hexagonal, triangle bond pattern( |
Summary of Performance Testing
Performance Testing
(Bench):
Performance testing of HALYARD ONE-STEP and QUICK CHECK Sterilization Wrap was evaluated and the results showed that acceptance criteria were met demonstrating that the HALYARD ONE-STEP and QUICK CHECK Sterilization Wrap allows sterilization of its contents using the Stryker Sterizone VP4 Sterilizer Cycle 1 and that sterility is maintained for the testing period of 12 months.
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| Purpose | Test | Acceptance Criteria | Results |
|---|---|---|---|
| SterilantPenetration/Efficacy | ANSI/AAMI ST79ANSI/AAMI/ISO 11138-7 | Achieving a 10-6 sterility assurancelevel following processing in a worst-case half-cycle | Passed |
| PerformanceTesting (Non-sterileand Sterile) | ANSI/AAMI/ISO 11607-1 Annex BISO 13938-2ASTM D4966-12CPSC 1610 | Complies with the selected physicalproperties | Passed |
| Maintenance ofPackage Integrity | ANSI/AAMI/ISO 11607-1ANSI/AAMI ST79 | Maintain sterility for up to 12 months | Passed |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-7 | Non-cytotoxicNon-irritatingH2O2 ≤ 0.56 μg/cm2 | Passed |
Summary of Non-Clinical Testing Performed
Performance Testing (Clinical): Clinical evaluations were not required and therefore are not submitted with this 510(k). Discussion: The HALYARD ONE-STEP and QUICK CHECK Sterilization Wrap in this submission and the predicate device submission are intended to enclose another medical device that is to be sterilized by a healthcare provider, to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). The ONE-STEP and QUICK CHECK Sterilization Wrap in this submission and the predicate device submission have identical intended use, design, materials, specifications, and composition, and are manufactured using identical production methods. The different technological characteristics, that is, the Indication for Use and the Sterilization Parameters, do not affect the safety and effectiveness of the device as evidenced by the results of the nonclinical testing. Overall Performance Conclusions: The conclusions drawn from the nonclinical tests demonstrate that the HALYARD ONE-STEP and QUICK CHECK Sterilization Wrap (K214007) is as safe, as effective, and performs as well as or better than the legally marketed HALYARD ONE-STEP Sterilization Wrap (K192147).
§ 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).