(184 days)
K181959 (SMART-FOLD Sterilization Wrap)
K140963 (SMART-FOLD Sterilization Wrap)
No
The device is a sterilization wrap, a passive material used to enclose devices for sterilization. The description focuses on its material properties and compatibility with a specific sterilization cycle, with no mention of any computational or analytical functions that would involve AI/ML.
No.
The device is sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility, not to provide therapeutic benefit itself.
No
The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain their sterility until used. It does not perform any diagnostic function.
No
The device is a physical sterilization wrap, not software. The description clearly states it is comprised of sheets of material intended to enclose other medical devices for sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description confirms it's a sterilization wrap used to enclose other medical devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the HALYARD SMART-FOLD Sterilization Wrap is a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA GI Cycle.
The H450 and H650 models of the HALYARD SMART-FOLD Sterilization Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle as follows:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions of >=1mm inner diameter x =2mm inner diameter x
§ 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).
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August 7, 2024
O&M Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K240330
Trade/Device Name: HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 2, 2024 Received: February 5, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature includes the name "Stephen A. Anisko -S" on two lines on the left side of the image. On the right side of the image, the text "Digitally signed by Stephen A. Anisko -S" is present, along with the date "2024.08.07" and the time "16:07:04 -04'00'".
for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K240330
Device Name
HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
Indications for Use (Describe)
HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA GI Cycle.
The H450 and H650 models of the HALY ARD SMART-FOLD Sterilization Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle as follows:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions of ≥1mm inner diameter x ≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.
· One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle
Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes
The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary K240330
| 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 Manager |
| Date of Summary: | 05 August 2024 |
| Device Trade Name: | HALYARD* SMART-FOLD* Sterilization Wrap (H450);
HALYARD* SMART-FOLD* Sterilization Wrap (H650) |
| Common Name: | Sterilization Wrap |
| Classification Name: | Sterilization wrap (21 CFR 880.6850, Product Code FRG) |
| Predicate Device:
Reference Device: | K181959 (SMART-FOLD Sterilization Wrap)
K140963 (SMART-FOLD Sterilization Wrap) |
| 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 SMART-FOLD Sterilization Wraps are comprised of two sheets of
HALYARD* Sequential Sterilization Wrap. This allows for convenient wrapping
with two sheets simultaneously.
The HALYARD SMART-FOLD Sterilization Wraps are intended to enclose
another medical device that is to be sterilized by a healthcare provider using the
Advanced Sterilization Products, Inc. (ASP) STERRAD 100NX Sterilizer
ULTRA™ GI Cycle. |
| Indications for Use: | HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended to
enclose another medical device that is to be sterilized by a healthcare provider
using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA
GI Cycle.
The H450 and H650 models of the HALYARD SMART-FOLD Sterilization
Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle
as follows:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no
more than 4 channels, with lumen dimensions of ≥1mm inner diameter x
≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.
• One flexible duodenoscope per tray, and no more than two flexible
duodenoscope per cycle |
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Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes
The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.
Technological Characteristics Comparison Table:
| | Proposed
HALYARD SMART-
FOLD Sterilization Wrap | Predicate
HALYARD SMART-
FOLD Sterilization Wrap
(K181959) | Reference
KIMGUARD Smart-Fold
Sterilization Wrap
(K140963) | Comparison |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Manufacturer | O&M Halyard, Inc. | Halyard Health, Inc. | Kimberly-Clark Health Care | Different |
| Device
Model
Numbers | H450
H650 | H450
H650 | KC450
KC650 | Same |
| Common or
Usual Name | Sterilization Wrap | Sterilization Wrap | Sterilization Wrap | Same |
| Classification | 21 CFR 880.6850 | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Class | II | II | II | Same |
| Product Code | FRG | FRG | FRG | Same |
| Intended Use | Intended to allow sterilization
of the enclosed medical
device(s) and also maintain
sterility of the enclosed
device(s) until used. | Intended to allow sterilization
of the enclosed medical
device(s) and also maintain
sterility of the enclosed
device(s) until used. | Intended to allow sterilization
of the enclosed medical
device(s) and also maintain
sterility of the enclosed
device(s) until used. | Same |
| Indications
for Use | HALYARD SMART-FOLD
Sterilization Wrap (H450 and
H650) is intended to enclose
another medical device that is
to be sterilized by a healthcare
provider using the Advanced
Sterilization Products
STERRAD 100NX Sterilizer
ULTRA GI Cycle.
The H450 and H650 models of
the HALYARD SMART-
FOLD Sterilization Wrap have
been validated for use with the
STERRAD 100NX ULTRA
GI Cycle as follows:
• Hydrogen peroxide
compatible flexible multi-
channel duodenoscopes, with
no more than 4 channels, with
lumen dimensions of ≥1mm
inner diameter x ≤1500mm in | HALYARD SMART-FOLD*
Sterilization Wrap (H450,
H650) is intended to enclose
another medical device that is
to be sterilized by a healthcare
provider using Steris V-PRO
Low Temperature Sterilization
system that includes:
• V-PRO 1 (Lumen Cycle)
• V- PRO 1 Plus (Lumen and
Non-Lumen Cycle)
• V-PRO maX, V-PRO maX 2
and V-PRO 60 (Lumen, Non-
Lumen, and Flexible Cycle)
The HALYARD SMART-
FOLD* Sterilization Wrap
(H450, H650) is intended to
allow sterilization of the
enclosed medical device(s) and | KIMGUARD* Smart Fold*
Sterilization Wrap (KC450 and
KC650) is intended to be used
to enclose another medical
device that is to be sterilized
by a healthcare provider using:
Advanced Sterilization
Products' STERRAD
Sterilization Systems that
include:
o STERRAD 100S
o STERRAD NX [Standard
Cycle, Advanced Cycle]
o STERRAD 100NX).
[Standard Cycle, Flex Cycle,
EXPRESS cycle, DUO Cycle]
KIMGUARD* Smart Fold*
Sterilization Wraps (KC450
and KC650) are intended to
allow sterilization of the
enclosed medical device(s) and | Different,
includes
additional
indications for
Use for ULTRA
GI cycle. |
| | length, or ≥2mm inner
diameter x ≤1630mm in
length.
• One flexible duodenoscope
per tray, and no more than two
flexible duodenoscope per
cycle
Note 1: The STERRAD
100NX Sterilizer ULTRA GI
Cycle was validated using a
load weight of 15.4 lbs (2 x 7.7
lbs), one endoscope per shelf.
Note 2: Only duodenoscopes
that have been cleared as
compatible with vaporized
hydrogen peroxide are
acceptable. Check STERRAD
Sterilizer Cycle Selection table
for ULTRA GI Cycle
compatible duodenoscopes
The HALYARD SMART-
FOLD Sterilization Wrap
(H450, H650) is intended to
allow sterilization of the
enclosed medical device(s) and
to maintain sterility of the
enclosed device(s) until used. | to maintain sterility of the
enclosed device(s) until used. | also maintain sterility of the
enclosed device(s) until used. | |
| Device
Design | Two pre-shaped sheets of
Halyard Sterilization Wrap,
which include reinforcement
zones, medical device
placement reference line, a
white inner layer, side-tabs
with closure strips and pull-
tabs to allow convenient
wrapping with two sheets
simultaneously | Two pre-shaped sheets of
Halyard Sterilization Wrap,
which include reinforcement
zones, medical device
placement reference line, a
white inner layer, side-tabs
with closure strips and pull-
tabs to allow convenient
wrapping with two sheets
simultaneously | Two pre-shaped sheets of
Halyard Sterilization Wrap,
which include reinforcement
zones, medical device
placement reference line, a
white inner layer, side-tabs
with closure strips and pull-
tabs to allow convenient
wrapping with two sheets
simultaneously | Same |
| Sterilant | Hydrogen Peroxide | Hydrogen Peroxide | Hydrogen Peroxide | Same |
| Technology | Polypropylene SMS material
that allows sterilant to
penetrate and maintain sterile
barrier | Polypropylene SMS material
that allows sterilant to
penetrate and maintain sterile
barrier | Polypropylene SMS material
that allows sterilant to
penetrate and maintain sterile
barrier | Same |
| Materials | Each sheet is composed of a
three-layer SMS
(spunbond-meltblown-
spunbond) polypropylene
fabric treated with an antistatic
treatment. | Each sheet is composed of a
three-layer SMS
(spunbond-meltblown-
spunbond) polypropylene
fabric treated with an antistatic
treatment. | Each sheet is composed of a
three-layer SMS
(spunbond-meltblown-
spunbond) polypropylene
fabric treated with an antistatic
treatment. | Same |
| Distribution | Non-Sterile
Over-the-Counter | Non-Sterile
Over-the-Counter | Non-Sterile
Over-the-Counter | Same |
| Single Use
Device | Yes | Yes | Yes | Same |
O&M Halyard, Inc.
6
7
Summary of Non-Clinical Performance Testing:
Performance testing of HALYARD SMART-FOLD Sterilization Wrap was evaluated and the results showed that acceptance criteria were met demonstrating that the HALYARD SMART-FOLD Sterilization Wrap allows sterilization of its contents using the STERRAD 100NX Sterilizer ULTRA GI Cycle and that sterility is maintained for the testing period of 90 days.
| Purpose | Test | Acceptance Criteria | Result |
|---|---|---|---|
| Sterilant | |||
| Penetration/Efficacy | ISO 14937 | ||
| AAMI TIR No 12-2010 | Achieving a 10-6 sterility assurance level | ||
| following processing in a worst-case | |||
| half-cycle | Pass | ||
| Performance Testing | |||
| (Pre-Sterilization | |||
| and Post- | |||
| Sterilization) | ANSI/AAMI/ISO 11607-1 Annex B | ||
| ISO 13938-2 | |||
| ASTM D4966-12 | |||
| CPSC 1610 | Complies with the selected physical | ||
| properties | Pass | ||
| Maintenance of | |||
| Package Integrity | ANSI/AAMI/ISO 11607-1 | ||
| ANSI/AAMI ST79 | |||
| AAMI TIR No 12-2010 | |||
| ANSI/AAMI/ISO 14937 | Maintain sterility for up to 90 days | Pass | |
| Biocompatibility | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| ISO 10993-12 | |||
| ISO 14937 | Non-cytotoxic | ||
| Non-irritating | |||
| Residual level ≤ 9100 µg/cm2 | Pass |
Summary of Non-Clinical Testing Performed
Summary of Clinical Performance Testing:
Clinical evaluations were not required and therefore are not submitted with this 510(k).
Discussion:
The HALY ARD SMART-FOLD 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 SMART-FOLD 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 Indications for Use, do not affect the safety and effectiveness of the device as evidenced by the results of the nonclinical testing.
Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the HALYARD SMART-FOLD Sterilization Wrap (K240330) is as safe, as effective, and performs as well as or better than the legally marketed device, the HALYARD SMART-FOLD Sterilization Wrap (K181959).