(63 days)
Not Found
No
The device is a sterilization wrap, a passive material used in a sterilization process. The description focuses on the material composition and physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a sterilization wrap intended to maintain the sterility of enclosed medical devices, not to provide therapeutic treatment to a patient.
No
Explanation: This device, Halyard ONE-STEP* Sterilization Wrap, is intended to allow sterilization of enclosed devices and maintain their sterility, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical sterilization wrap made of fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Halyard ONE-STEP* Sterilization Wraps are for allowing sterilization of enclosed medical devices using a specific hydrogen peroxide sterilizer. This is a process related to the preparation and handling of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The device is described as a fabric wrap for packaging medical devices. This aligns with its intended use for sterilization and maintaining sterility, not for in vitro diagnostic procedures.
- Lack of IVD Characteristics: The description does not mention any components or functions typically associated with IVDs, such as reagents, assays, analysis of biological samples (blood, urine, tissue, etc.), or diagnostic results.
- Performance Studies: The performance studies focus on the efficacy of sterilization and the maintenance of package integrity, which are relevant to a sterilization wrap, not an IVD.
Therefore, the Halyard ONE-STEP* Sterilization Wrap is a medical device used in the sterilization process of other medical devices, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 ONE-STEP 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 = 1.33 mm ID and = 1.00 mm ID and = 1.00 mm ID and = 0.80 mm ID and
§ 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
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
1
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
2
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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3
K192147 510K Summary
| Submitted by: | O&M Halyard, Inc. |
|---|---|
| Contact Person: | Steven Dowdley |
| Associate Director of Regulatory Affairs | |
| O&M Halyard Inc. | |
| Steven.dowdley@hyh.com | |
| 678-451-8062 | |
| 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 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. | |
| Indications for Use | 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 | |
| ONE-STEP 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: | |
| $\geq$ 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 steel | |
| lumens that are $\geq$ 1.00 mm ID and $\leq$ 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 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 $\geq$ 100 mm ID | |
| and $\leq$ 1280 mm long, and Dual channel flexible endoscopes with flexible | |
| lumens 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) and | |
| cycle(s), including chamber loading instructions (ie: 25 lb per load) |
4
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 Model | ||
| numbers | H100 | |
| H200 | ||
| H300 | ||
| H400 | ||
| H500 | ||
| H600 | KC100 | |
| KC200 | ||
| KC300 | ||
| KC400 | ||
| KC500 | ||
| KC600 | ||
| (Please note that the device model | ||
| number are the same The alphabetical | ||
| prefix on the product was changed when | ||
| the company's name changed from | ||
| Kimberly Clark to Halyard) | ||
| Common or | ||
| Usual 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 for | ||
| Use | The Halyard ONE-STEP Sterilization | |
| Wraps are intended to allow sterilization | ||
| of the enclosed devices by the | ||
| Sterilucent HC 80TT Hydrogen Peroxide | ||
| Sterilizer (ie. 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 | KIMGUARD ONE-STEP* Sterilization | |
| Wraps are intended to enclose another | ||
| medical device that is to be sterilized by | ||
| a healthcare provider using | ||
| Sterilucent PSD-85 Hydrogen Peroxide | ||
| Sterilizer that include | ||
| • Lumen Cycle and | ||
| • Non-Lumen Cycle |
KIMGUARD ONE-STEP* Sterilization
Wrap (KC100, KC200, KC300, KC400,
KC500 and KC600) are intended to allow
sterilization of the enclosed medical
device(s) and also maintain sterility of the
enclosed device(s) until used
Test results validated that KIMGUARD |
5
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
6
| Sterilization
Parameters | Stenlucent HC 80TT Hydrogen
Peroxide Sterilizer that includes
• Lumen Cycle
• Flexible Cycle | Sterilucent PSD-85 Hydrogen Peroxide
Sterilizer that includes
• Lumen Cycle
• Non-Lumen Cycle
(Refer to the PSD-85 User Manual for
complete instructions on load(s) and
cycle(s), including chamber loading
instructions (ie. 10 lbs per load))
Non-Lumen
Non-lumened reusable metal and nonmetal
devices including devices with stainless
steel diffusion-restricted spaces such as
the hinged portion of forceps and scissors
(Refer to the PSD-85 User Manual for
complete instructions on load(s) and
cycle(s), including chamber loading
instructions (ie. 25 lbs per load)) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | Tortuous sheet material used to enclose
medical devices that are to be sterilized
by a healthcare provider to allow
sterilization of the enclosed medical
device(s) and maintain sterility of the
enclosed device(s) | Tortuous sheet material used to enclose
medical devices that are to be sterilized
by a healthcare provider to allow
sterilization of the enclosed medical
device(s) and maintain sterility of the
enclosed device(s) |
| Device Design | Two sheets of nonwoven polypropylene
fabric Each sheet is composed of three
thermally- bonded layers consisting of a
meltblown polypropylene layer
surrounded by spunbound polypropylene
layers (SMS) | Two sheets of nonwoven polypropylene
fabric Each sheet is composed of three
thermally- bonded layers consisting of a
meltblown polypropylene layer surrounded
by spunbound polypropylene layers
(SMS) |
| Method for
bonding SMS layers | Thermal bonding with round pin,
hexagonal, triangle bond pattern ("daisy"
pattern) | Thermal bonding with round pin
hexagonal, triangle bond pattern ("daisy"
pattern) |
| Materials | Polypropylene with blue and white
pigments | Polypropylene with blue and white
pigments |
| Distribution | Non-Sterile and Over-the-Counter | Non-Sterile and Over-the-Counter |
| Single Use
Device | Yes | Yes |
7
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 with
this 510(k) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion: | The Halyard ONE-STEP* Sterilization Wrap and the predicate device are
both 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). Both devices have the
same intended use, design, materials, specifications, and composition, and
are manufactured using the exact same production methods |
| Overall Performance
Conclusions | Based on the nonclinical tests performed the subject device, the Halyard
ONE-STEP* Sterilization Wrap for use with the Sterilucent HC 80TT
Hydrogen Peroxide Sterilizer, is as safe, as effective and performs as well or
better than the legally marketed predicate device, the Halyard ONE-STEP*
Sterilization Wrap for use with the PSD-85 Hydrogen Peroxide Sterilizer |