(217 days)
Not Found
No
The device is a sterilization wrap, a physical product used to enclose medical devices for sterilization. The description focuses on the material properties and validation with a specific sterilizer, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a sterilization wrap used to enclose other medical devices for sterilization, not to treat a disease or condition.
No
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain sterility, not to diagnose a disease or condition.
No
The device is a physical sterilization wrap made of fabric, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization. This is a process related to preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The device is a sterilization wrap made of fabric. It's designed to maintain sterility, not to analyze or test biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on biological sample analysis.
The device's function is purely related to the physical process of sterilization and maintaining the sterility of other medical devices.
N/A
Intended Use / Indications for Use
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:
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical evaluations were not required and therefore are not submitted with this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Halyard ONE-STEP Sterilization Wrap, K192147
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
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
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 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
2
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.
3
| Type of Device | HALYARD ONE-STEP* and QUICK CHECK* Validation Loads Description
in the Stryker Sterizone VP4 Sterilizer Cycle 1 | Validated
Sterilization
Wrap GradesB |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| General
instruments | Load consisted of three (3) trays each containing three (3) lb of general medical
instruments. 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 medical
instruments, 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. | H100C
H200
H300
H400
H500
H600C |
| Rigid channel
instruments | Load #4A - Consisted of 15 lumens from rigid and semi-rigid channeled devices. The load
included:
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. | H400C
H500
H600C |
| Single and double
channel flexible
endoscopes | Load #8A - Consisted of five (5) lumens from single and double channel flexible
endoscopes. The load included:
Two (2) double channel flexible endoscopes (ureteroscope) with inside
diameter of 1 mm and lengths of 850 mm and 989 mm; One (1) single channel flexible endoscope (ureteroscope) with inside diameter
of 1 mm and length of 850 mm; The endoscopes were individually packaged in sterilization trays, including
appropriate silicone brackets. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400C
H500
H600C |
| Multi-channel
flexible
endoscopes | 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 inside
diameter of 1.45 mm and lengths of 3500 mm, packaged individually in a
sterilization tray. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400C
H500
H600C |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary – K214007
| Submitter: | O&M Halyard, Inc.
9120 Lockwood Boulevard
Mechanicsville, VA 23116
Phone: 804-723-7000/800-488-8850
Fax: 804-723-7100 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Anureet Singh
Regulatory Affairs Specialist II
O&M Halyard, Inc.
1 Edison Drive
Alpharetta, 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 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. |
| Indication for Use: | 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 single cycle 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 |
5
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 Description
in the Stryker Sterizone VP4 Sterilizer Cycle 1 | Validated
Sterilization
Wrap GradesB |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| General
instruments | Load consisted of three (3) trays each containing three (3) lb of general medical
instruments. 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 medical
instruments, 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. | H100C
H200
H300
H400
H500
H600C |
| Rigid channel
instruments | Load #4A - Consisted of 15 lumens from rigid and semi-rigid channeled devices. The load
included: 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. | H400C
H500
H600C |
| Single and double
channel flexible
endoscopes | Load #8A - Consisted of five (5) lumens from single and double channel flexible
endoscopes. The load included: Two (2) double channel flexible endoscopes (ureteroscope) with inside
diameter of 1 mm and lengths of 850 mm and 989 mm; One (1) single channel flexible endoscope (ureteroscope) with inside diameter
of 1 mm and length of 850 mm; The endoscopes were individually packaged in sterilization trays, including
appropriate silicone brackets. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400C
H500
H600C |
| Multi-channel
flexible
endoscopes | 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 inside
diameter of 1.45 mm and lengths of 3500 mm, packaged individually in a
sterilization tray. Testing was performed with trays wrapped in H400 and H600 sterilization wrap. | H400C
H500
H600C |
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.
6
| | Proposed
HALYARD ONE-STEP and
QUICK CHECK Sterilization Wrap
(K214007) | Predicate
HALYARD ONE-STEP
Sterilization Wrap
(K192147) | Same
Similar, or
Different |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Manufacturer | O&M Halyard, Inc. | O&M Halyard, Inc. | Same |
| Device Model
Numbers | H100
H200
H300
H400
H500
H600 | H100
H200
H300
H400
H500
H600 | Same |
| Common or
Usual 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 for
Use | 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 Sterizone VP4 Sterilizer Cycle
1 as described below:
Type of Device: General instruments
HALYARD ONE-STEP* and QUICK
CHECK* Validation Loads Description in
the Stryker Sterizone VP4 Sterilizer Cycle
1:
Load consisted of three (3) trays each
containing three (3) lb of general medical
instruments. 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 medical
instruments, 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. | 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 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
$\ge$ 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 steel
lumens that are $\ge$ 1.00 mm ID and $\le$
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 | Different |
Technological Characteristics Comparison Table:
7
| Validated Sterilization Wrap GradesB:
H100C, H200, H300, H400, H500, H600C
Type of Device: Rigid channel
instruments
HALYARD ONE-STEP* and QUICK
CHECK* Validation Loads Description in
the Stryker Sterizone VP4 Sterilizer Cycle
1:
Load #4A - Consisted of 15 lumens from
rigid and semi-rigid channeled devices.
The load included:
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.
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 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 Device: Single and double
channel flexible endoscopes
HALYARD ONE-STEP* and QUICK
CHECK* Validation Loads Description in
the Stryker Sterizone VP4 Sterilizer Cycle
1:
Load #8A - Consisted of five (5) lumens
from single and double channel flexible
endoscopes. The load included: Two (2)
double channel flexible endoscopes
(ureteroscope) with inside diameter of 1
mm and lengths of 850 mm and 989 mm;
One (1) single channel flexible endoscope
(ureteroscope) with inside diameter of 1
mm and length of 850 mm; The
endoscopes were individually packaged in
sterilization trays, including appropriate
silicone brackets.
Testing was performed with trays wrapped
in H400 and H600 sterilization wrap.
Validated Sterilization Wrap GradesB:
H400C, H500, H600C | |
| Type of Device: Multi-channel flexible
endoscopes
HALYARD ONE-STEP* and QUICK
CHECK* Validation Loads Description in
the Stryker Sterizone VP4 Sterilizer Cycle
1:
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 inside diameter of 1.45 mm | |
8
| | and lengths of 3500 mm, packaged
individually in a sterilization tray.
Testing was performed with trays wrapped
in H400 and H600 sterilization wrap.
Validated Sterilization Wrap GradesB:
H400C, H500, H600C
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. Therefore, these grades are
applicable to HALYARD* ONE-STEP*,
QUICK CHECK* and Sequential
Sterilization Wrap. C: Indicates the
bracketed grades for validation testing. | | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Sterilization
Parameters | 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 | Sterilucent PSD-85 Hydrogen
Peroxide Sterilizer that includes
● Lumen Cycle
● Flexible Cycle | Different |
| 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) until
used | 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) until
used | Same |
| 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
spunbond 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
spunbond polypropylene layers (SMS) | Same |
| Method for
Bonding SMS
Layers | 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.
9
| Purpose | Test | Acceptance Criteria | Results |
|---|---|---|---|
| Sterilant | |||
| Penetration/Efficacy | ANSI/AAMI ST79 | ||
| ANSI/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 B | ||
| ISO 13938-2 | |||
| ASTM D4966-12 | |||
| CPSC 1610 | Complies with the selected physical | ||
| properties | Passed | ||
| Maintenance of | |||
| Package Integrity | ANSI/AAMI/ISO 11607-1 | ||
| ANSI/AAMI ST79 | Maintain sterility for up to 12 months | Passed | |
| Biocompatibility | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| ISO 10993-7 | Non-cytotoxic | ||
| Non-irritating | |||
| H2O2 ≤ 0.56 μg/cm2 | Passed |