(242 days)
K142782- KIMGUARD ONE-STEP* Sterilization Wrap (Models: H100, H200, H300, H400, H500, H600)
No
The document describes a sterilization wrap and its physical properties and performance in sterilization cycles. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a sterilization wrap intended to maintain sterility of medical devices, not to provide therapy itself.
No
The device is a sterilization wrap intended to enclose medical devices for sterilization and maintain their sterility, not to diagnose a condition or disease.
No
The device description clearly states it is a physical sterilization wrap made of polypropylene 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 is to enclose medical devices for sterilization using a specific sterilization system and to maintain sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of disease or other conditions.
- Device Description: The device is a sterilization wrap made of polypropylene fabric. This material and form factor are consistent with packaging for medical devices, not with reagents, instruments, or software used for in vitro diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
The device's function is to facilitate the sterilization process and maintain the sterility of other medical devices. This falls under the category of medical device accessories or packaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
HALYARD SMART-FOLD* Sterlization Wrap (H450, H650) is intended to enclose and is to be sterlized by a healthare provider using Steris V-PRO Low Temperature Sterilization system. The wrap was validated in the following pre-programmed cycles:
- STERIS V-PRO 1 low temperature sterilization system (lumen cycle), ●
- STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle), ●
- STERIS V-PRO maX low temperature sterilization system (Lumen cycle, flexible cycle), .
- STERIS V-PRO 60 sterilizer (Lumen, Non-Lumen cycle, flexible cycle) ●
- STERIS V-PRO maX 2 low temperature sterilization system (Lumen cycle, flexible cycle) ●
HALYARD SMART-FOLD* Sterlization Wrap (H450, H650) is intended to allow terminal sterlization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterilly of the enclosed within the period of time for which performance data demonstrating maintenance of sterility has been provided.
Product codes
FRG
Device Description
HALYARD SMART-FOLD* Sterlization Wrap is supplied in bulk to the customer as pre-shaped sterilization wap which is then used to wrap a medical device or a collection of medical devices for sterilization Wrap is compised of two preshaped sheets of HAL YARD* Sequential Sterilization Wrap. Each sheet is composed of a three-laver SMS (spunbond-meltblownspunbond) polypropylene fabric treated with an antistatic treatment.
The SMART-FOLD* Sterilization Wrap features reinforcement reference line, a white inner layer, sidetabs with closure strips and pull-tabs which allow for aseptic presentation of the sterilized medical device. The white same material composition but contains no blue pigment.
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
-
Sterilant Penetration/Efficacy: The purpose of the sterilant penetration/Efficacy testing was to demonstrate sterilant penetration into instrument trays wrapped with Halyard SMART-FOLD* (H450, H650) Sterilization Wrap. The testing was performed using end of shelf life sterilant to demonstrate efficacy of the sterilant under half cycle condition in the V- PRO maX low temperature sterilizer, worst case lumen cycle.
Results: The Halyard SMART-FOLD* (H450, H650) Sterilization wrap demonstrated effective sterilant penetration into instrument trays wrapped with Halyard Health SMART-FOLD* (H450, H650) Sterilization Wrap after processing in the V-PRO maX low temperature sterilizer under half cycle condition in the V- PRO maX low temperature sterilizer, worst case lumen cycle. -
Maintenance of 365-Day Package Integrity: The purpose of the maintenance of Sterility testing was to demonstrate that the Halyard SMART-FOLD* (H450, H650) is an effective barrier for maintaining the sterility of various sterilization load for 30, 180, 365 days after processing in the worst-case V-Pro 60 Low Temperature Sterilizer Lumen cycle and followed by an event related shelf life study.
Results: The Halyard SMART-FOLD* (H450, H650) Sterilization wrap demonstrated effective barrier using the simulated test pack for the best and worst-case weight wraps for maintaining the sterility of their contents for 30, 180, 365 days after processing in the worst-case V-PRO 60 Low Temperature Sterilizer Lumen cycle and followed by an event related shelf life study. -
Material Biocompatibility: The purpose of the biocompatibility testing was to demonstrate that the Halyard SMART-FOLD* (H450, H650) is non-irritating and non- cytotoxic in accordance to Cytotoxicity, 10993-5, Biological Evaluation of medical devices - Tests for invitro cytotoxicity and 10993 -10:2010, Biological Evaluation of medical devices - Tests for Irritation and Sensitization.
Results: The Halyard SMART-FOLD* (H450, H650) Sterilization wrap was found to be non-cytotoxic and non-irritant based on the conditions of these tests. -
Physical properties: The purpose of the physical properties testing was to demonstrate passing results for the following physical properties for Halyard SMART-FOLD* (H450, H650) wrap: Bursting Properties of Fabrics - Part 2 - Pneumatic Method for Determination of Bursting Strength and Bursting Distension, ISO 13828-2:1999 Determination of the permeability of fabrics (Air Permeability), ISO 9237:1995 E Standard Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method), ASTM D4966-12 Standard Test Method for Mass Per Unit Area (Weight) of Fabric, ASTM D3776/D3776M-09a Flame resistance requirements for Class I products of > 3.5 seconds flame travel, CPSC 16 CFR 1610:2007 Water Resistance: Hydrostatic Pressure Test, AATCC-127 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state - Linting/Cleanliness, ISO 9073-10 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure, ASTM D5733-99 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test), ASTM D5034-95 Test Method of Failure in Sewn Seams of Woven Fabrics, ASTM D1683/D1683M-11 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus, ASTM F2101.
Results: The physical properties testing met the acceptance criteria and demonstrated passing results for the Halyard SMART-FOLD* (H450, H650) Sterilization wrap.
Key Metrics
Not Found
Predicate Device(s)
K142782- KIMGUARD ONE-STEP* Sterilization Wrap (Models: H100, H200, H300, H400, H500, H600)
Reference Device(s)
K140963 – KIMGUARD* SMART-FOLD* sterilization wrap (Models: KC450, KC650)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains 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.
March 22, 2019
Owens & Minor Halyard, Inc Angela L. Bunn, RAC Director, Regulatory Affairs, Products Division 5405 Windward Parkway Alpharetta, GA 30004
Re: K181959
Trade/Device Name: HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 19, 2019 Received: February 21, 2019
Dear Angela L. Bunn:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMANSERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K181959 Device Name
HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650)
Indications for Use (Describe)
HALYARD SMART-FOLD* Sterlization Wap (H450, H650) is intended to enclose and is to be sterlized by a healthare provider using Steris V-PRO Low Temperature Sterilization system. The wrap was validated in the following pre-programmed cycles:
- STERIS V-PRO 1 low temperature sterilization system (lumen cycle), ●
- STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle), ●
- STERIS V-PRO maX low temperature sterilization system (Lumen cycle, flexible cycle), .
- STERIS V-PRO 60 sterilizer (Lumen, Non-Lumen cycle, flexible cycle) ●
- STERIS V-PRO maX 2 low temperature sterilization system (Lumen cycle, flexible cycle) ●
HALYARD SMART-FOLD* Sterlization Wrap (H450, H650) is intended to allow terminal sterlization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterilly of the enclosed within the period of time for which performance data demonstrating maintenance of sterility has been provided.
| Table 1 Summary of V-PRO Low Temperature Sterilizer System Cycles | |||||
|---|---|---|---|---|---|
| Sterilization | |||||
| Cycle | Sterilizer Model | ||||
| V-PRO 1 | V-PRO 1 Plus | V-PRO maX | V-PRO 60 | V-PRO maX 2 | |
| Lumen | Yes | Yes | Yes | Yes | Yes |
| Non-Lumen | N/A | Yes | Yes | Yes | Yes |
| Flexible | N/A | N/A | Yes | Yes | Yes |
Test results validated that HALYARD SMART-FOLD $160, H650 allowed sterlization of the enclosed devices using Steris V-PRO Love Temperature Sterlization system.All models of the HALYARD Sterilization Wrap (H60, H550) have been valided for use with the STERIS V-PRO Lov Temperature Sterilization System cycles (Table 2, Table 3, and Table 4).
3
| TABLE 2: Validated Low Temperature Sterilization Products STERIS V-PRO 1, STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2,
| and STERIS V-PRO 60, Lumen¹ Cycles. | |
|---|---|
| Note: Refer to the Manufacturer's User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions | |
| provided below are not intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System | |
| Lumen Cycle | Intended Load |
| STERIS V-PRO 1 | |
| STERIS V-PRO 1 Plus | |
| STERIS V-PRO maX | |
| STERIS V-PRO maX 2 | STERIS V-PRO maX, |
| Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is $\ge$ 0.77mm internal diameter (ID) and $\le$ 500mm in length Dual channeled devices with stainless steel lumens that are $\ge$ 0.77mm ID and $\le$ 527mm in length Triple channeled devices with stainless steel lumens that are $\ge$ 1.2 mm ID and $\le$ 275 mm in length $\ge$ 1.8 mm ID and $\le$ 310 mm in length or $\ge$ 2.8 mm ID and $\le$ 317 mm in length STERIS V-PRO maX 2 Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is $\ge$ 0.77mm internal diameter (ID) and $\le$ 500mm in length Dual channeled devices with stainless steel lumens that are $\ge$ 0.77mm ID and $\le$ 527mm in length Triple channeled devices with stainless steel lumens that are $\ge$ 1.2 mm ID and $\le$ 275 mm in length $\ge$ 1.8 mm ID and $\le$ 310 mm in length or $\ge$ 2.8 mm ID and $\le$ 317 mm in length STERIS V-PRO 1 STERIS V-PRO 1 Plus The V-PRO 1 Cycle and the V-PRO 1 Plus Lumen Cycle can sterilize* instruments/devices with the following features: Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices with a single lumen with: an inside diameter of 3 mm or larger and a length of 400 mm or shorter an inside diameter of 2 mm or larger and a length of 250 mm or shorter an inside diameter of 1 mm or larger and a length of 125 mm or shorter | |
| STERIS V-PRO 60 | The V-PRO 60 sterilizer's Lumen cycle can sterilize: Instruments with diffusion- restricted spaces such as the hinged portion of forceps and scissors. Non- Lumened devices including non- lumened rigid and semi-rigid endoscopes Medical Devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: $\Upsilon$ Single or dual lumen devices with stainless steel lumens that are $\ge$ 0.77 mm (~1/32") internal diameter (ID) and $\le$ 410 mm (16-9/64") in length $\Upsilon$ Triple lumen devices with stainless steel lumens that are $\ge$ 1.2 mm (~3/64") ID and $\le$ 275 mm (~10 – 55/64") in length $\ge$ 1.8 mm (~5/64") ID and $\le$ 310 mm (~12 – 13/64") in length or $\ge$ 2.8 mm (~7/64") ID and $\le$ 317 mm (~12 – 31/64") in length |
| TABLE 3: Validated Low Temperature Sterilization Products STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2, andSTERIS V-PRO 60, Non- | |
| Lumen Cycles | |
| Note: Refer to the User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions provided below are not | |
| intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System Non-Lumen | |
| Cycle | Intended Load |
| STERIS V-PRO 1 Plus | |
| STERIS V-PRO maX | |
| STERIS V-PRO maX 2 | STERIS V-PRO maX 2 |
| Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. | |
| STERIS V-PRO maX | |
| The Non-Lumen Cycle can sterilize instruments/devices with the following features: | |
| Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. STERIS V-PRO 1 Plus | |
| The V-PRO 1 Plus Non-Lumen Cycle can sterilize instruments/devices with the following features: | |
| Non-Lumen instruments including non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. | |
| STERIS V-PRO 60 | The V-PRO 60 Non-Lumen Cycle can sterilize instruments/devices with the following features: |
| Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | |
| TABLE 4: Validated Low Temperature Sterilization Products STERIS V-PRO maX. STERIS V-PRO maX 2, and STERIS V-PRO 60, Flexible Cycles | |
| Note: Refer to the User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions provided below are not | |
| intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System Flexible | |
| Cycle | Intended Load |
| STERIS V-PRO maX | |
| STERIS V-PRO maX 2 | STERIS V-PRO maX 2 |
| The Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical | |
| Care) or bronchoscopes in either of two load configurations: |
- Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load. The flexible endoscopes may
contain either:
• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• Or two lumens with:
- One lumen that is ≥ 1 mm ID and ≤ 998 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
- One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. The flexible
endoscopes may contain either:
• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• Or two lumens with:
- One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
STERIS V-PRO maX
The Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) or bronchoscopes
in either of two load configurations:
- Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load3. The flexible endoscopes my contain
either:
• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• Or two lumens with:
- One lumen that is ≥ 1 mm ID and ≤ 998 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
- One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with
diffusion-restricted areas such as the hinged portion of forceps or scissors4. The flexible endoscopes my contain either:
• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• Or two lumens with:
- One lumen that is ≥ 1 mm ID and ≤ 998 mm in length
- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length |
| STERIS V-PRO 60 | The V-PRO 60 sterilizer's 60 flexible cycle can sterilize:
One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope
may be a:
• Single or dual lumen device with lumens that are $≥ 1 mm (~3/64") ID and ≤990 mm (38-63/64")$ in length |
4
5
6
HALYARD SMART-FOLD* Sterlization Wraps (H450, H650) Recommendations for Use with STERS V-PRO Lov Temperature Sterlization (Table 5).
| TABLE 5: Halyard Smart-Fold* Sterilization Wrap Recommendations2 for Use with Steris V-PRO Sterilizer | ||||||||
|---|---|---|---|---|---|---|---|---|
| SMART- | ||||||||
| FOLD* | ||||||||
| Sterilization | ||||||||
| Wrap Model | Intended | |||||||
| Loads3 | Maximum Wrapped Package Content Weights 4 | |||||||
| STERIS | ||||||||
| V-PRO® 1, | ||||||||
| V-PRO® 1 | ||||||||
| Plus | ||||||||
| V-PRO® | ||||||||
| maX | ||||||||
| V-PRO® | ||||||||
| maX 2 | ||||||||
| Lumen | STERIS | |||||||
| V-PRO® 1 | ||||||||
| Plus V- | ||||||||
| PRO® | ||||||||
| maX | ||||||||
| V-PRO® | ||||||||
| maX 2 | ||||||||
| Non- | ||||||||
| Lumen | STERIS | |||||||
| V-PRO® | ||||||||
| maX | ||||||||
| V-PRO® | ||||||||
| maX 2 | ||||||||
| Flexible | STERIS | |||||||
| V-PRO® | ||||||||
| 60 Lumen | STERIS | |||||||
| V-PRO® | ||||||||
| 60 Non- | ||||||||
| Lumen | STERIS | |||||||
| V-PRO® 60 Flexible | STERIS | |||||||
| V-PRO® | ||||||||
| maX 2 | ||||||||
| Fast Non-Lumen | ||||||||
| H450 | Moderate to | |||||||
| Heavyweight | ||||||||
| Package (for | ||||||||
| example: | ||||||||
| general use | ||||||||
| medical | ||||||||
| instruments) | 13 lbs | 13 lbs. | 13 lbs. | 11 lbs. | 12 lbs. | The validation studies were conducted with one flexible | ||
| endoscope packaged into a tray with silicone wrap, and | ||||||||
| instrument organizers and light cord ( if not integral to | ||||||||
| scope) and no additional load. | N/A | |||||||
| H650 | Moderate to | |||||||
| Heavyweight | ||||||||
| Package (for | ||||||||
| example: | ||||||||
| general use | ||||||||
| medical | ||||||||
| instruments) | 19.65 lbs. | 25 lbs.- | ||||||
| max2, | ||||||||
| 19.65 - max, | ||||||||
| 1 and 1 plus | 24 lbs. | 11 lbs. | 12 lbs. | The validation studies were conducted with one flexible | ||||
| endoscope packaged into a tray with silicone wrap, and | ||||||||
| instrument organizers and light cord (if not integral to | ||||||||
| scope) and no additional load. | N/A | |||||||
| 2Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped | ||||||||
| contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use. | ||||||||
| 3Intended loads include: Medical Instruments with and without lumens that include telescopes, endoscopes, cameras, light cords and general use medical instruments. | ||||||||
| 4It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight, and | ||||||||
| size of individual content types that were validated for HALYARD SMART-FOLD* Sterilization Wraps. | ||||||||
| 5The Fast-Non-Lumen cycle is intended to sterilize pouched instruments trays only and is therefore not intended to be used for sterilization of HALYARD SMART-FOLD* Sterilization | ||||||||
| wraps. |
*Registered Trademark or Trademark of O&M Halyard or its affiliates. ©2018. All rights reserved.
7
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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8
510(K) SUMMARY HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
Applicant's Name, Address, Telephone, FAX, Contact Person
Owens & Minor Halyard, Inc 5405 Windward Parkway Alpharetta, GA 30004
Contact Name: Angela L. Bunn, RAC
Director, Regulatory Affairs Products Division Tel: 470.448.5856 Fax: 470.200.3177 Email: angela.bunn@hyh.com
510(k) Number: K181959
Establishment Registration Number: 3014421917
Date: March 22, 2019
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification: Class II per 21 CFR 880.6850 Classification Name: Sterilization Wrap Common/Usual Name: Sterilization Wrap Product Code: FRG Proprietary Name: HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650)
PREDICATE DEVICE:
K142782- KIMGUARD ONE-STEP* Sterilization Wrap (Models: H100, H200, H300, H400, H500, H600)
REFERENCE DEVICE:
K140963 – KIMGUARD* SMART-FOLD* sterilization wrap (Models: KC450, KC650)
9
INDICATIONS FOR USE
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to enclose that is to be sterlized by a healthcare provider using Steris V-PRO Low Temperature Sterilization system. The following pre-programmed cycles:
- STERIS V-PRO 1 low temperature sterilization system (lumen cycle), .
- STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle), ●
- STERIS V-PRO maX low temperature sterilization system (Lumen cycle, flexible cycle), ●
- STERIS V-PRO 60 low temperature sterilization system (Lumen cycle, flexible cycle) ●
- STERIS V-PRO maX 2 low temperature sterilization system (Lumen cycle, flexible cycle) ●
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to allow terminal sterilization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterility of the enclosed device(s) until used within the period of time for which performance data demonstrating maintenance of sterility has been provided.
| Table 1 Summary of V-PRO Low Temperature Sterilizer System Cycles | |||||
|---|---|---|---|---|---|
| Sterilization Cycle | Sterilizer Model | ||||
| V-PRO 1 | V-PRO 1 Plus | V-PRO maX | V-PRO 60 | V-PRO maX 2 | |
| Lumen | Yes | Yes | Yes | Yes | Yes |
| Non-Lumen | N/A | Yes | Yes | Yes | Yes |
| Flexible | N/A | N/A | Yes | Yes | Yes |
Test results validated that HALYARD SMART-FOLD* Sterilization Wrap (H450) allowed sterilization of the enclosed devices using Steris V-PRO Low Temperature Sterilization system. All models of the HAL YARD Smart Fold Sterilization Wrap (H450, H650) have been validated for use with the Steris V-PRO Low Temperature Sterilization System cycles (Table 1.2, Table 1.3).
10
| TABLE 2: Validated Low Temperature Sterilization Products STERIS V-PRO 1, STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2, and
| STERIS V-PRO 60, Lumen1 Cycles. | |
|---|---|
| Note: Refer to the Manufacturer's User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions | |
| provided below are not intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System Lumen | |
| Cycle | Intended Load |
| STERIS V-PRO 1 | |
| STERIS V-PRO 1 Plus | |
| STERIS V-PRO maX | |
| STERIS V-PRO maX 2 | STERIS V-PRO maX, |
| Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is ≥ 0.77mm internal diameter (ID) and ≤500mm in length Dual channeled devices with stainless steel lumens that are ≥ 0.77mm ID and ≤ 527mm in length Triple channeled devices with stainless steel lumens that are ≥ 1.2 mm ID and ≤ 275 mm in length ≥1.8 mm ID and ≤ 310 mm in length or ≥ 2.8 mm ID and ≤ 317 mm in length STERIS V-PRO maX 2 Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is ≥ 0.77mm internal diameter (ID) and ≤500mm in length Dual channeled devices with stainless steel lumens that are ≥ 0.77mm ID and ≤ 527mm in length Triple channeled devices with stainless steel lumens that are ≥ 1.2 mm ID and ≤ 275 mm in length ≥1.8 mm ID and ≤ 310 mm in length or ≥ 2.8 mm ID and ≤ 317 mm in length STERIS V-PRO 1 STERIS V-PRO 1 Plus The V-PRO 1 Cycle and the V-PRO 1 Plus Lumen Cycle can sterilize* instruments/devices with the following features: Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices with a single lumen with: an inside diameter of 3 mm or larger and a length of 400 mm or shorter an inside diameter of 2 mm or larger and a length of 250 mm or shorter an inside diameter of 1 mm or larger and a length of 125 mm or shorter | |
| TABLE 2: Validated Low Temperature Sterilization Products STERIS V-PRO 1, STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2, and | |
| STERIS V-PRO 60, Lumen¹ Cycles. | |
| Note: Refer to the Manufacturer's User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions | |
| provided below are not intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System Lumen Cycle | Intended Load |
| STERIS V-PRO 60 | The V-PRO 60 sterilizer's Lumen cycle can sterilize : |
| Instruments with diffusion- restricted spaces such as the hinged portion of forceps and scissors. Non- Lumened devices including non- lumened rigid and semi-rigid endoscopes Medical Devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Y Single or dual lumen devices with stainless steel lumens that are Ο ≥ 0.77 mm ( | |
| Ο ≥ 2.8 mm (~ 7/64") ID and ≤ 317 mm (~12-31/64") in length | |
| 1 The Non-Lumen articles can be processed in the Lumen cycle as it takes mixed loads |
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12
| TABLE 3: Validated Low Temperature Sterilization Products STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2, and STERIS V-PRO
60, Non-Lumen Cycles
Note: Refer to the User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions provided below are not
| intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
|---|---|
| STERIS V-PRO System Non-Lumen | |
| Cycle | Intended Load |
| STERIS V-PRO 1 Plus | |
| STERIS V-PRO maX | |
| STERIS V-PRO maX 2 | STERIS V-PRO maX 2 |
| Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. | |
| STERIS V-PRO maX | |
| The Non-Lumen Cycle can sterilize instruments/devices with the following features: | |
| Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. STERIS V-PRO 1 Plus | |
| The V-PRO 1 Plus Non-Lumen Cycle can sterilize instruments/devices with the following features: | |
| Non-Lumen instruments including non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. | |
| STERIS V-PRO 60 | The V-PRO 60 Non-Lumen Cycle can sterilize instruments/devices with the following features: |
| Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion restricted spaces such as the hinged portion of forceps and scissors. | |
| TABLE 4: Validated Low Temperature Sterilization Products STERIS V-PRO maX. STERIS V-PRO maX 2, and STERIS V-PRO 60, Flexible Cycles Note: | |
| Refer to the User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions provided below are not | |
| intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System Flexible | |
| Cycle | Intended Load |
| STERIS V-PRO maX | |
| STERIS V-PRO maX 2 | STERIS V-PRO maX 2 |
| The Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical | |
| Care) or bronchoscopes in either of two load configurations: |
- Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load. The flexible
endoscopes may contain either:
A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length Or two lumens with: One lumen that is ≥ 1 mm ID and ≤ 998 mm in length And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. The
flexible endoscopes may contain either:
A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length Or two lumens with: One lumen that is ≥ 1 mm ID and ≤ 990 mm in length And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length STERIS V-PRO maX
The Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) or
bronchoscopes in either of two load configurations: - Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load3. The flexible endoscopes my contain either:
A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length Or two lumens with: One lumen that is ≥ 1 mm ID and ≤ 998 mm in length And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including
instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors4. The flexible endoscopes my contain either:
A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length Or two lumens with: One lumen that is ≥ 1 mm ID and ≤ 998 mm in length And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length |
| | |
| STERIS V-PRO 60 | The V-PRO 60 sterilizer's 60 flexible cycle can sterilize: |
| | One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible
endoscope may be a: |
| | • Single or dual lumen device with lumens that are > 1 mm (~3/64") ID and 3.5 seconds flame travel, CPSC 16 CFR 1610:2007 Water Resistance: Hydrostatic Pressure Test, AATCC-127 Textiles - Test methods for nonwovens – Part 10: Lint and other particles generation in the dry state – Linting/Cleanliness, ISO 9073-10 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure, ASTM D5733-99 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test), ASTM D5034-95 Test Method of Failure in Sewn Seams of Woven Fabrics, ASTM D1683/D1683M-11 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus, ASTM | The physical properties testing met the acceptance criteria and demonstrated passing results for the KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) Sterilization wrap:
Bacterial Filtration Efficiency (%) ASTM F2101:07 Flammability CPSC 1610.4 (16 CFR Part 1610) Hydrostatic Resistance (mbar) AATCC127-2008; WSP 80.6:2005 Basis Weight (osy) ASTM D3776-07 Mullen Burst (psi) ASTM D3786-06 Grab Tensile Strength (lbf) ASTM D5034-09 Trapezoid Tear Strength (lbf) ASTM D5733-99 Abrasion Resistance - Martindale ASTM D4966-98 (re-approved 2004) Air Permeability Test (cfm) ISO 9237:1995 E Tensile Strength and Elongation - Seam Test (gf) ASTM D1683-90a Gelbo Lint (particles > 10 microns) WSP 160-1:2005 | Similar |
| Technology/ Chemical composition | 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. [SAME] | Same |
| Single Use Device | Yes | Yes [SAME] | Same |
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19
20
| Table 1.7 Technological Characteristics Comparison Table | |||||
|---|---|---|---|---|---|
| Component | Subject | ||||
| Device, | |||||
| K181959 | Reference | ||||
| Device, K140963 | Comparison to the Reference | ||||
| 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. | Same | ||||
| Packaging | Bulk and Non-sterile | Bulk and Non-sterile | Same | ||
| Base Materials of Construction | Three-layer SMS (spunbond-meltblown-spunbond) | ||||
| fabric | Three-layer SMS (spunbond-meltblown- | ||||
| spunbond) fabric. | Same | ||||
| Design | Two pre-shaped sheets of KIMGUARD* | ||||
| Sterilization Wrap, which include reinforcement | |||||
| strips, and seamed on edges to allow convenient | |||||
| wrapping with two sheets simultaneously | Two pre-shaped sheets of KIMGUARD | ||||
| Sterilization Wrap, which include reinforcement | |||||
| strips, and seamed on edges to allow | |||||
| convenient wrapping with two sheets | |||||
| simultaneously. | Same | ||||
| Technology/ Chemical | |||||
| composition | 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 | ||||
| Use | Single Use | Single Use | Same |
Both the subject device and predicate device have similar in use statement, which is to enclose another medical device that is to be sterilized by a heathcare provider using Steris V-PRO Low sterilization system. The predicate 510(k) was cleared for use with Steris V-PRO 60 sterlizer under K142782. The remaining models, Steris V-PRO 1 Plus and Steris V-PRO 1 naX were cleared for use with KIMGUARD* One -Step sterilization by FDA under 510(k) submissions, K092167 and K112805.
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The subject device, under this submission, HALYARD SMART-FOLD* Sterilization Wrap is the reference devices which is cleared under K140963. Additionally, the HALYARD SMART-FOLD* Sterilization Wrap is comprised of the same material and composition as the base sheet of the Halyard ONE-STEP* sterilization wrap, which is the predicate device.
SUMMARY OF NONCLINICAL TESTS
Performance testing was conducted in accordance to the applicable requirements. Test results demonstrate that HALYARD SMART-FOLD* Sterilization Wrap (H450, H650), after steris V-PRO Low Temperature system (Models: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX2 and V-PRO 60) maintains sterility until used.
| Table 1.8: Sterilization Wrap Performance Tests | ||
|---|---|---|
| Study | Description | Results |
| Sterilant Penetration/Efficacy | The purpose of the sterilant penetration/Efficacy testing was to demonstrate sterilant | |
| penetration into instrument trays wrapped with Halyard SMART-FOLD* (H450, H650) | ||
| Sterilization Wrap. The testing was performed using end of shelf life sterilant to | ||
| demonstrate efficacy of the sterilant under half cycle condition in the V- PRO maX low | ||
| temperature sterilizer, worst case lumen cycle. | The Halyard SMART-FOLD* (H450, H650) Sterilization wrap | |
| demonstrated effective sterilant penetration into instrument trays | ||
| wrapped with Halyard Health SMART-FOLD* (H450, H650) | ||
| Sterilization Wrap after processing in the V-PRO maX low | ||
| temperature sterilizer under half cycle condition in the V- PRO | ||
| maX low temperature sterilizer, worst case lumen cycle. | ||
| Maintenance of 365-Day | ||
| Package Integrity | The purpose of the maintenance of Sterility testing was to demonstrate that the | |
| Halyard SMART-FOLD* (H450, H650) is an effective barrier for maintaining the | ||
| sterility of various sterilization load for 30, 180, 365 days after processing in the worst- | ||
| case V-Pro 60 Low Temperature Sterilizer Lumen cycle and followed by an event | ||
| related shelf life study. | The Halyard SMART-FOLD* (H450, H650) Sterilization wrap | |
| demonstrated effective barrier using the simulated test pack for | ||
| the best and worst-case weight wraps for maintaining the sterility | ||
| of their contents for 30, 180, 365 days after processing in the | ||
| worst-case V-PRO 60 Low Temperature Sterilizer Lumen cycle | ||
| and followed by an event related shelf life study. | ||
| Material Biocompatibility | The purpose of the biocompatibility testing was to demonstrate that the Halyard | |
| SMART-FOLD* (H450, H650) is non-irritating and non- cytotoxic in accordance to | ||
| Cytotoxicity, 10993-5, Biological Evaluation of medical devices - Tests for invitro | ||
| cytotoxicity and 10993 -10:2010, Biological Evaluation of medical devices - Tests for | ||
| Irritation and Sensitization. | The Halyard SMART-FOLD* (H450, H650) Sterilization wrap was | |
| found to be non-cytotoxic and non-irritant based on the conditions | ||
| of these tests. | ||
| Study | Description | Results |
| Physical properties | The purpose of the physical properties | |
| testing was to demonstrate passing | ||
| results for the following physical | ||
| properties for Halyard SMART-FOLD* | ||
| (H450, H650) wrap: | ||
| Bursting Properties of | ||
| Fabrics - Part 2 - Pneumatic | ||
| Method for Determination of | ||
| Bursting Strength and | ||
| Bursting Distension, ISO | ||
| 13828-2:1999 Determination of the permeability of fabrics (Air | ||
| Permeability), ISO 9237:1995 E Standard Test Method for Abrasion Resistance | ||
| of Textile Fabrics (Martindale Abrasion Tester | ||
| Method), | ||
| ASTM D4966-12 Standard Test Method for Mass Per Unit Area | ||
| (Weight) of Fabric, | ||
| ASTM D3776/D3776M-09a Flame resistance requirements for Class I | ||
| products of > 3.5 seconds | ||
| flame travel, CPSC 16 CFR 1610:2007 Water Resistance: Hydrostatic Pressure Test, | ||
| AATCC-127 Textiles - Test methods for nonwovens - Part | ||
| 10: Lint and | ||
| other particles generation in the dry state - | ||
| Linting/Cleanliness, ISO 9073-10 Standard Test Method for Tearing Strength of | ||
| Nonwoven Fabrics by the Trapezoid | ||
| Procedure, ASTM D5733-99 Standard Test Method for Breaking Strength | ||
| and Elongation of Textile Fabrics (Grab Test), | ||
| ASTM D5034-95 Test Method of Failure in Sewn Seams of | ||
| Woven Fabrics, ASTM D1683/D1683M-11 Standard Test Method for | ||
| Evaluating the Bacterial | ||
| Filtration Efficiency (BFE) of | The physical properties testing met the acceptance criteria | |
| and demonstrated passing results for the Halyard SMART- | ||
| FOLD* (H450, H650) Sterilization wrap. |
22
23
| Medical Face Mask
Materials, Using a Biological
Aerosol of Staphylococcus
| aureus, ASTM F2101 | |
|---|---|
In summary, testing was conducted to evaluate the performance of the HALYARD SMART-FOLD* when used with Steris Low temperature system, including chemical composition, physical propertation leficacy, maintenance of package integrity and biocompatibility tests that have passed and met the acceptance criteria. The passing results from above sterilant penetration, maintenance of package integrity, biocompatibility and the physical properties demonstrate that the acceptance criteria and the specification for the performance test for the subject device, HALYARD SMART-FOLD* when used with Steris V-PRO Low sterilization system (Models STERIS V-PRO maX, STERIS V-PRO maX 2, STERIS V-PRO 1, STERIS V-PRO 1 Plus).
Conclusion
Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is as safe, as effective, and performs as well as or better than the legally marketed prodicate device, K142782.