(63 days)
The Halyard ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the Halyard ONESTEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed HC 80TT Sterilization Cycles. All models of the Halyard ONE-STEP Sterilization Wrap have been validated for use with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer cycles as described below:
Lumen Cycle:
Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up to fifteen (15) stainless steel lumens per load with the following dimensions:
Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are: ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or ≥ 1.33 mm ID and ≤ 430 mm long;
and, Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are ≥ 1.00 mm ID and ≤ 310 mm long. (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 20.1 lb. per load).
Flexible Cycle:
Reusable rigid or semi-rigid non-lumen medical devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;
Single channel flexible endoscopes with flexible lumens that are ≥ 1.00 mm ID and ≤ 1280 mm long; and Dual channel flexible endoscopes with flexible lumens that are ≥ 0.80 mm ID and ≤ 1000 mm long.
(Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 25 lb. per load).
Halyard ONE-STEP* Sterilization Wrap is comprised of two sheets of Halyard Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.
The sheets of sterilization wrap are square or rectangular fabric produced using a three layer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with phthalocyanine blue pigment, titanium dioxide pigment, and antistatic treatment. The wrap allows a sterilized package to be opened aseptically.
The acceptance criteria and device performance for the Halyard ONE-STEP* Sterilization Wrap are presented below based on the provided text.
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilant Penetration / Efficacy | No growth of challenge microorganisms in inoculation BI placement sites of claimed challenge loads after exposure to worst case half-cycles sterilization cycle conditions for both lumen and flexible sterilization cycles. | Passed |
| Maintenance of Package Integrity | No growth of microorganisms after 30-day event-related shelf life testing using simulated worst-case handling conditions. | Passed |
| Simulated Use Testing | No growth of challenge microorganisms after sterilization, using an inoculum in the presence of a defined soil challenge. | Passed |
Analysis of the Study to Prove Device Meets Acceptance Criteria:
-
Sample Size and Data Provenance:
The document does not explicitly state the specific sample sizes used for each test. The studies were bench tests, meaning they were conducted in a laboratory setting. There is no information regarding country of origin or whether the data was retrospective or prospective in the sense of human subject studies, as these tests are for a sterilization wrap's performance. -
Number of Experts and Qualifications for Ground Truth:
Not applicable. These are performance tests for a medical device (sterilization wrap), not diagnostic AI tools requiring expert interpretation. The "ground truth" is based on objective microbiological and physical test results, not expert consensus. -
Adjudication Method:
Not applicable, as this is related to expert review of diagnostic results, which is not relevant for this type of device performance testing. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-powered diagnostic device, and therefore, no MRMC study comparing human readers with and without AI assistance was conducted. -
Standalone Performance Study:
Yes, the studies reported are standalone performance tests of the Halyard ONE-STEP* Sterilization Wrap. The document states, "Performance of Halyard ONE-STEP* Sterilization Wrap... has been evaluated to show that all results of testing met acceptance criteria..." These tests assess the device's ability to allow sterilization and maintain sterility. -
Type of Ground Truth Used:
The ground truth used for these tests is based on objective microbiological assays (demonstration of no growth of challenge microorganisms) and physical integrity assessments (maintenance of package integrity). -
Sample Size for Training Set:
Not applicable. This device is a physical product (sterilization wrap), not an AI algorithm that requires a training set. -
How Ground Truth for Training Set was Established:
Not applicable, as no training set was used.
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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 the FDA logo, which 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.
October 10, 2019
Owens & Minor (O&M) Halyard, Inc % Peter Kalkbrenner Director of Engineering Sterilucent, Inc Minneapolis, Minnesota 55413
Re: K192147
Trade/Device Name: ONE-STEP Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: August 9, 2019 Received: August 13, 2019
Dear Peter Kalkbrenner:
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 Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192147
Device Name Halyard ONE-STEP* Sterilization Wrap
Indications for Use (Describe)
The Halyard ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the Halyard ONESTEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed HC 80TT Sterilization Cycles. All models of the Halyard ONE-STEP Sterilization Wrap have been validated for use with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer cycles as described below:
Lumen Cycle:
Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up to fifteen (15) stainless steel lumens per load with the following dimensions:
Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are: > 0.77 mm internal diameter (ID) and ≤ 410 mm long, or ≥ 1.33 mm ID and ≤ 430 mm long;
and, Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are ≥ 1.00 mm ID and ≤ 310 mm long. (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 20.1 lb. per load).
Flexible Cycle:
Reusable rigid or semi-rigid non-lumen medical devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;
Single channel flexible endoscopes with flexible lumens that are ≥ 1.00 mm ID and ≤ 1280 mm long; and Dual channel flexible endoscopes with flexible lumens that are ≥ 0.80 mm ID and ≤ 1000 mm long.
(Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 25 lb. per load).
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart G) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K192147 510K Summary
| Submitted by: | O&M Halyard, Inc. |
|---|---|
| Contact Person: | Steven DowdleyAssociate Director of Regulatory AffairsO&M Halyard Inc.Steven.dowdley@hyh.com678-451-8062 |
| Date of Summary: | October 8, 2019 |
| Device Trade Name: | Halyard ONE-STEP* Sterilization Wrap |
| Common or Usual Name: | Sterilization Wrap |
| Classification: | 21 CFR 880.6850 |
| Class: | Class II |
| Product Code: | FRG |
| Predicate Device(s): | Halyard ONE-STEP* Sterilization Wrap - K141712 |
| Device Description: | Halyard ONE-STEP* Sterilization Wrap is comprised of two sheets of HalyardSterilization Wrap that is ultrasonically seamed on two edges. This seamedconfiguration allows for convenient wrapping of an article using two sheetssimultaneously. |
| The sheets of sterilization wrap are square or rectangular fabric producedusing a three layer SMS (spunbound-meltblown-spunbound) process. Thewrap fabric is composed of polypropylene with phthalocyanine blue pigment,titanium dioxide pigment, and antistatic treatment. The wrap allows asterilized package to be opened aseptically. | |
| Indications for Use | The Halyard ONE-STEP Sterilization Wraps are intended to allow sterilizationof the enclosed devices by the Sterilucent HC 80TT Hydrogen PeroxideSterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the HalyardONE-STEP Sterilization Wrap was validated to allow effective aeration underthe pre-programmed HC 80TT Sterilization Cycles. All models of the HalyardONE-STEP Sterilization Wrap have been validated for use with the SterilucentHC 80TT Hydrogen Peroxide Sterilizer cycles as described below:Lumen Cycle:Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up tofifteen (15) stainless steel lumens per load with the following dimensions:Single or dual channeled rigid and semi-rigid endoscopes, with stainless steellumens that are:$\geq$ 0.77 mm internal diameter (ID) and $\leq$ 410 mm long, or $\geq$ 1.33 mm ID and $\leq$430 mm long;and, Triple channeled rigid and semi-rigid endoscopes, with stainless steellumens that are $\geq$ 1.00 mm ID and $\leq$ 310 mm long. (Refer to the HC 80TTUser Manual for complete instructions on load(s) and cycle(s), includingchamber loading instructions (i.e. 20.1 lb. per load).Flexible CycleReusable rigid or semi-rigid non-lumen medical devices including non-lumendevices with metallic diffusion-restricted spaces such or mated surfaces suchas the hinged portion of forceps or scissors,Single channel flexible endoscopes with flexible lumens that are $\geq$ 100 mm IDand $\leq$ 1280 mm long, and Dual channel flexible endoscopes with flexiblelumens that are $\geq$ 0.80 mm ID and $\leq$ 1000 mm long(Refer to the HC 80TT User Manual for complete instructions on load(s) andcycle(s), including chamber loading instructions (ie: 25 lb per load) |
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পিন্ধার করে না করে আর এক প্রকাশ করেন। এখানে পারে প
িত থাকায় করে অনুষ্ঠিত হয়েছে একটি পার্টির প্রায় প্রতিষ্ঠা
Technological Characteristics Table:
| Proposed | Predicate | |
|---|---|---|
| Halyard ONE-STEP*Sterilization Wrap (K192147) | KIMGUARD ONE-STEP*Sterilization Wrap (K141712) | |
| Manufacturer | Halyard | Halyard |
| Device Modelnumbers | H100H200H300H400H500H600 | KC100KC200KC300KC400KC500KC600(Please note that the device modelnumber are the same The alphabeticalprefix on the product was changed whenthe company's name changed fromKimberly Clark to Halyard) |
| Common orUsual Name: | Sterilization Wrap | Sterilization Wrap |
| Classification: | 21 CFR 880.6850 | 21 CFR 880.6850 |
| Class: | II | II |
| Product Code | FRG | FRG |
| Manufacturer | Halyard | Halyard |
| Indication forUse | The Halyard ONE-STEP SterilizationWraps are intended to allow sterilizationof the enclosed devices by theSterilucent HC 80TT Hydrogen PeroxideSterilizer (ie. both the Lumen andFlexible Cycles) Additionally, theHalyard ONESTEP Sterilization Wrapwas validated to allow effective aerationunder the pre-programmed HC 80TTSterilization Cycles. All models of theHalyard ONE-STEP Sterilization Wraphave been validated for use with theSterilucent HC 80TT Hydrogen PeroxideSterilizer cycles as described below | KIMGUARD ONE-STEP* SterilizationWraps are intended to enclose anothermedical device that is to be sterilized bya healthcare provider usingSterilucent PSD-85 Hydrogen PeroxideSterilizer that include• Lumen Cycle and• Non-Lumen CycleKIMGUARD ONE-STEP* SterilizationWrap (KC100, KC200, KC300, KC400,KC500 and KC600) are intended to allowsterilization of the enclosed medicaldevice(s) and also maintain sterility of theenclosed device(s) until usedTest results validated that KIMGUARD |
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Lumen Cycle
Reusable metal and nonmetal devices including devices with diffusion- restricted spaces such as the hinged portion of forceps and scissors and up to fifteen (15) stainless steel lumens per load with the following dimensions:
Single or dual channeled rigid and semirigid endoscopes. with stainless steel lumens that are ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or ≥ 1.33 mm ID and ≤ 430 mm long, and, Triple channeled rigid and semi- rigid endoscopes, with stainless steel lumens that are ≥ 1.00 mm ID and ≤ 310 mm long (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (ie. 20.1 Ib per load)
Flexible Cycle
Reusable rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors. Single channel flexible endoscopes with flexible lumens that are ≥ 1.00 mm ID and ≤1280 mm long, and Dual channel flexible endoscopes with flexible lumens that are ≥ 0.80 mm ID and ≤1000 mm long (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (ie. 25 Ib per load)
ONE-STEP* Sterilization Wraps (KC100, KC200, KC300, KC400, KC500,and KC600) allowed sterilization of the enclosed devices by the Sterilucent PSD- 85 Hydrogen Peroxide Sterilizer (ie. both the Lumen and Non-Lumen Cycles) Additionally, the KIMGUARD ONE-STEP* Sterilization Wrap was validated to allow effective aeration under the pre- programmed PSD-85 Sterilization Cycles
The PSD-85 Lumen Cycle has been validated to sterilize a load of up to ten (10) pounds (combined pouch and wrapped tray load) containing a maximum of ten (10) single channel stainless steel lumens per load with the following dimensions
- . An inside diameter of 1 mm or larger and a length of 60 mm or shorter,
- An inside diameter of 2 mm or . larger and a length of 250 mm or shorter,
- . An inside diameter of 3 mm or larger and a length of 350 mm or shorter
The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load)
All models of the KIMGUARD ONE- STEP* Sterilization Wrap (KC100, KC200, KC300, KC400. KC500. and KC600) have been validated for use with the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer cycles listed below
Lumen
Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up to 10 single channel stainless steel lumened devices of the following dimensions per chamber load
o An inside diameter of 1 mm or larger and a length of 60 mm or shorter
o An inside diameter of 2 mm or larger and a length of 250 mm or shorter
o An inside diameter of 3 mm or larger and a length of 350 mm or shorter
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| SterilizationParameters | Stenlucent HC 80TT HydrogenPeroxide Sterilizer that includes• Lumen Cycle• Flexible Cycle | Sterilucent PSD-85 Hydrogen PeroxideSterilizer that includes• Lumen Cycle• Non-Lumen Cycle(Refer to the PSD-85 User Manual forcomplete instructions on load(s) andcycle(s), including chamber loadinginstructions (ie. 10 lbs per load))Non-LumenNon-lumened reusable metal and nonmetaldevices including devices with stainlesssteel diffusion-restricted spaces such asthe hinged portion of forceps and scissors(Refer to the PSD-85 User Manual forcomplete instructions on load(s) andcycle(s), including chamber loadinginstructions (ie. 25 lbs per load)) |
|---|---|---|
| Technology | Tortuous sheet material used to enclosemedical devices that are to be sterilizedby a healthcare provider to allowsterilization of the enclosed medicaldevice(s) and maintain sterility of theenclosed device(s) | Tortuous sheet material used to enclosemedical devices that are to be sterilizedby a healthcare provider to allowsterilization of the enclosed medicaldevice(s) and maintain sterility of theenclosed device(s) |
| Device Design | Two sheets of nonwoven polypropylenefabric Each sheet is composed of threethermally- bonded layers consisting of ameltblown polypropylene layersurrounded by spunbound polypropylenelayers (SMS) | Two sheets of nonwoven polypropylenefabric Each sheet is composed of threethermally- bonded layers consisting of ameltblown polypropylene layer surroundedby spunbound polypropylene layers(SMS) |
| Method forbonding SMS layers | Thermal bonding with round pin,hexagonal, triangle bond pattern ("daisy"pattern) | Thermal bonding with round pinhexagonal, triangle bond pattern ("daisy"pattern) |
| Materials | Polypropylene with blue and whitepigments | Polypropylene with blue and whitepigments |
| Distribution | Non-Sterile and Over-the-Counter | Non-Sterile and Over-the-Counter |
| Single UseDevice | Yes | Yes |
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Performance Testing Summary
Performance Testing (Bench):
Performance of Halyard ONE-STEP* Sterilization Wrap (H100, H200, H300, H400, H500, H600) has been evaluated to show that all results of testing met acceptance criteria, demonstrating that the Halyard ONE-STEP* Sterilization Wrap allows sterilization of contents by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer and maintains sterility of contents for the designated test period (30 Days).
| est | Description | Result |
|---|---|---|
| Sterilant Penetration / Efficacy | Demonstration of no growth of challenge microorganisms in | Passed |
| inoculation BI placement sites of claimed challenge loads | ||
| after exposure to worst case half-cycles sterilization cycle | ||
| conditions for both the lumen and flexible sterilization cycles. | ||
| Maintenance of Package Integrity | Demonstration of no growth of microorganisms after 30 Day Passed | |
| event-related shelf life testing using simulated worst case | ||
| handling conditions. | ||
| Simulated use testing | Demonstration no growth of challenge microorganisms, after Passed | |
| sterilization, using an inoculum in the presence of a defined | ||
| soil challenge |
| Performance Testing(Clinical): | Clinical evaluations were not required and therefore are not submitted withthis 510(k) |
|---|---|
| Discussion: | The Halyard ONE-STEP* Sterilization Wrap and the predicate device areboth intended to enclose another medical device that is to be sterilized by ahealthcare provider, to allow sterilization of the enclosed medical device(s)and to maintain sterility of the enclosed device(s). Both devices have thesame intended use, design, materials, specifications, and composition, andare manufactured using the exact same production methods |
| Overall PerformanceConclusions | Based on the nonclinical tests performed the subject device, the HalyardONE-STEP* Sterilization Wrap for use with the Sterilucent HC 80TTHydrogen Peroxide Sterilizer, is as safe, as effective and performs as well orbetter than the legally marketed predicate device, the Halyard ONE-STEP*Sterilization Wrap for use with the PSD-85 Hydrogen Peroxide Sterilizer |
§ 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).