(259 days)
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.
SteriZign Signatur Device Protection System are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Protection System are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Protection System are not intended on their own to maintain sterility. The SteriZign Signatur Device Protection System have perforations and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap.
Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes
The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 lbs.
Validated sizes of stainless steel instrument lumens include:
1 each 1mm x 76 mm
1 each 1mm x 400 mm
1 each 2mm x 400 mm
1 each 3mm x 400 mm
1 each 5mm x 400 mm
SteriZign Signatur Device Protection System are cassettes/trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are different sizes of the same basic configuration: a rectangular base with a cover. The cassettes/trays have perforations to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassettes/trays.
Here's a breakdown of the acceptance criteria and study information for the SteriZign Signatur Device Protection System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantifiable, pass/fail format within the provided document. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K133015 Summit Medical, Instrument Protection System) by comparing various characteristics and performance data. The device performance listed below is what was reported and presumably met the internal criteria for substantial equivalence.
| Characteristic / Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (SteriZign Signatur Device Protection System) |
|---|---|---|
| Intended Use | To organize and protect medical devices intended for sterilization within a healthcare setting. Allows sterilization of enclosed medical devices during pre-vacuum steam sterilization cycles. Not intended to maintain sterility on its own. To be used with legally marketed, validated FDA cleared sterilization wrap. | Used to organize, transport, store, and protect surgical and other medical devices that are sterilized by a healthcare provider. Intended to allow sterilization of enclosed medical devices during pre-vacuum steam sterilization cycles. Not intended on its own to maintain sterility. Intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap. |
| Autoclave Sterilization Cycle | Pre-vacuum | Pre-vacuum |
| Temperature | 270°F (132°C) | 270°F (132°C) |
| Exposure Time | 4 minutes | 4 minutes |
| Dry Time | 30 minutes | 30 minutes |
| Max Weight of Tray (tray, insert, instruments) | 17 lbs (Predicate) | Never exceed 25 lbs |
| Validated Stainless Steel Instrument Lumen Sizes (ID x Length) | 1mm x 76mm, 1mm x 65mm, 1mm x 400mm, 2mm x 300mm, 3mm x 177mm, 3mm x 200mm, 3mm x 400mm, 5mm x 241mm (Predicate) | 1mm x 76mm, 1mm x 400mm, 2mm x 300mm, 3mm x 400mm, 5mm x 400mm |
| Material Composition | Anodized Aluminum lid and base, silicone brackets, Stainless Steel latch, Stainless Steel handles, Anodized aluminum bar holders, Polypropylene feet, Silicone dividers, Silicone mats, Stainless steel brackets, Locating post (High performance plastic), Accessory box (High performance plastic). | Base: Aluminum Anodized; Insert: Aluminum Anodized; Lid: Aluminum Anodized; Latch: 300 Series SS Passivated; Handle: 300 Series SS Passivated; Shelf Bracket: 300 Series SS Passivated; Mat(s): Silicone; Brackets: Polypropylene. |
| Microbial Barrier Properties | Intended to be used in conjunction with a legally marketed wrap. Not intended on its own to maintain sterility. | Intended to be used in conjunction with a legally marketed wrap. Not intended on its own to maintain sterility. |
| Sterilant Penetration Performance | Allows for sufficient sterilant penetration. | Verified that the system allows for sufficient sterilant penetration when exposed to a pre-vacuum steam 132°C two (2) minute sterilization, half cycle with no BI growth. |
| Toxicological Properties (Biocompatibility) | (Implied acceptable performance for predicate) | MEM Elution Cytotoxicity (ISO 10993-5): Test samples meet USP and ISO 10993-5 requirements. PASSED, considered NON-CYTOTOXIC. |
| Material Compatibility with Steam Sterilization | (Implied acceptable for predicate) | Materials of construction are compatible with steam sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document only explicitly mentions a "half cycle" sterilization test for sterilant penetration performance.
- Sample Size for Test Set: Specific sample sizes for each test (e.g., number of cassettes/trays, number of lumens tested) are not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It describes tests conducted for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. For a medical device like a sterilization container, the "ground truth" for sterilization effectiveness is typically determined by established biological indicator (BI) tests and physical/chemical indicator results, often interpreted by microbiologists and sterilization experts, but this is not detailed here.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned or performed. This type of study is typically relevant for interpretative diagnostic devices, not for a sterilization container.
6. Standalone (Algorithm Only) Performance
No standalone (algorithm only) performance was done. This concept is not applicable to a physical medical device like a sterilization container system, which does not employ algorithms or AI.
7. Type of Ground Truth Used
The ground truth for the device's performance is established based on:
- Sterilization Effectiveness: Demonstrated absence of biological indicator (BI) growth after sterilization cycles, which is a standard method for validating sterilization.
- Material Compatibility: Laboratory testing (e.g., MEM Elution Cytotoxicity) proving the materials are non-cytotoxic and compatible with steam sterilization.
- Physical Properties: Verification of ability to hold instruments, meet weight limits, and allow sterilant penetration through perforations.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of medical device (physical sterilization container) as it does not involve machine learning or AI algorithms that require training data.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this physical device, this question is not applicable.
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February 7, 2018
SteriZign Precision Technologies, LLC % Robert Dean President Compliance Systems International, LLC 1083 Delaware Ave. Buffalo, New York 14209
Re: K171520
Trade/Device Name: SteriZign Signatur Device Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 8, 2018 Received: January 12, 2018
Dear Robert Dean:
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 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);
{1}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -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}------------------------------------------------
Indications for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: 0MB No. 0910-0120
Expiration Date:January 31, 2017
510(k) Number (if known) K171520
Device Name
SteriZign Signatur Device Protection System
Indications for Use (Describe)
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.
SteriZign Signatur Device Cassette and Trays are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Cassette and Trays are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Cassette and Trays are not intended on their own to maintain sterility. SteriZign Signatur Device Cassette and Trays have perforations and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap.
Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes
The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 Ibs.
Validated sizes of stainless steel instrument lumens include:
- 1 each 1mm x 76 mm 1 each 1mm x 400 mm
- 1 each 2mm x 400 mm
- 1 each 3mm x 400 mm
- 1 each 5mm x 400 mm
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) x |Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| I. Company: | SteriZign Precision Technologies, LLC74 Orion StreetBrunswick, ME 04011888-234-3074 |
|---|---|
| II. Contact: | Sonia LutarewychPresident(206) 510-3650 |
| Date : | January 31, 2018 |
| Device Name: | SteriZign Signatur Device Protection System |
| Common Name: | Sterilization cassette/trays |
| Classification: | Sterilization Wrap Containers, Cassettes/trays , Cassettes & Accessories.(21 CFR 880.6850) |
| Class: | II |
Product Code: KCT
III. Predicate Devices: Cassettes/trays - K133015 Summit Medical, Instrument Protection System.
-
IV. Description:
SteriZign Signatur Device Protection System are cassettes/trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are different sizes of the same basic configuration: a rectangular base with a cover. The cassettes/trays have perforations to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassettes/trays . -
V. Indications for Use:
ldentification: 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.
SteriZign Signatur Device Protection System are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Protection System are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Protection System are not intended on their own to maintain sterility. The SteriZign Signatur Device Protections and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap.
Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes
The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 lbs.
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Validated sizes of stainless steel instrument lumens include:
1 each 1mm x 76 mm 1 each 1mm x 400 mm 1 each 2mm x 400 mm 1 each 3mm x 400 mm 1 each 5mm x 400 mm
VI. Device List
| CATALOG PART NUMBER | Cassette - Tray Size | Vent toVolumeRatio |
|---|---|---|
| 102010-3 | 9.86"X20.46"X3.58" | 0.075 |
| 122010-3 | 10"X20"X3" | 0.231 |
| 121610-3 | 10"X16"X3" | 0.225 |
| 121410-3 | 10"X14"X3" | 0.232 |
| 120910-3 | 10"X9.3"X3" | 0.228 |
| 122010-4 | 10"X20"X4" | 0.197 |
| 121610-4 | 10"X16"X4" | 0.195 |
| 121410-4 | 10"X14"X4" | 0.203 |
| 120910-4 | 10"X9.3"X4" | 0.184 |
| 122010-5 | 10"X20"X5" | 0.173 |
| 121610-5 | 10"X16"X5" | 0.172 |
| 121410-5 | 10"X14"X5" | 0.172 |
| 120910-5 | 10"X9.3"X5" | 0.165 |
| 112410-3 | 10"X24"X3" | 0.158 |
| 112010-3 | 10"X20"X3" | 0.152 |
| 111610-3 | 10"X16"X3" | 0.152 |
| 111410-3 | 10"X14"X3" | 0.146 |
| 110910-3 | 10"X9.3"X3" | 0.139 |
| 112410-4 | 10"X24"X4" | 0.128 |
| 112010-4 | 10"X20"X4" | 0.123 |
| 111610-4 | 10"X16"X4" | 0.124 |
| 111410-4 | 10"X14"X4" | 0.121 |
| 110910-4 | 10"X9.3"X4" | 0.117 |
| 112410-5 | 10"X24"X5" | 0.11 |
| 112010-5 | 10"X20"X5" | 0.107 |
| 111610-5 | 10"X16"X5" | 0.105 |
| 111410-5 | 10"X14"X5" | 0.105 |
| 110910-5 | 10"X9.3"X5" | 0.103 |
| 202557-190 | 25"X5.75"X1.9" | 0.522 |
| 202535-190 | 25"X3.5"X1.9" | 0.561 |
| 202057-190 | 20"X5.75"X1.9" | 0.514 |
| 202035-190 | 20"X3.5"X1.9" | 0.563 |
| 201757-190 | 17.6"X5.75"X1.9" | 0.508 |
| 201757-190 | 17.6"X3.5"X1.9" | 0.543 |
| 201457-190 | 14"X5.75"X1.9" | 0.504 |
| 201435-190 | 14"X3.5""X1.9" | 0.548 |
| 201157-190 | 11"X5.75""X1.9" | 0.491 |
| 201135-190 | 11"X3.5""X1.9" | 0.543 |
| 301610-630 | 16"X10"X6.3" | 0.156 |
| 302210-630 | 22.6"X10"X6.3" | 0.131 |
| 302610-630 | 26"X10"X6.3" | 0.132 |
| 401510-166 | 15.61"X10.44"X1.66" | 0.428 |
| 401006-166 | 10.61"X6.44"X1.66" | 0.413 |
| 400606-166 | 6.61"X6.44"X1.66" | 0.423 |
| 400603-166 | 6.61"X3.44"X1.66" | 0.345 |
| ACCESSORIES | Inner Trays | |
| 902309-250 | 23.24"X9.4"2.5" | NA |
| 902309-200 | 23.24"X9.4"2.0" | NA |
| 902309-125 | 23.24"X9.4"1.25" | NA |
| 901909-250 | 19.24"X9.4"2.5" | NA |
| 901909-200 | 19.24"X9.4"2.0" | NA |
| 901909-125 | 19.24"X9.4"1.25" | NA |
| 901509-250 | 15.24"X9.4"2.5" | NA |
| 901509-200 | 15.24"X9.4"2.0" | NA |
| 901509-125 | 15.24"X9.4"1.25" | NA |
| 901309-250 | 13.24"X9.4"2.5" | NA |
| 901309-200 | 13.24"X9.4"2.0" | NA |
| 901309-125 | 13.24"X9.4"1.25" | NA |
| 900809-250 | 8.54"X9.4"2.5" | NA |
| 900909-200 | 8.54"X9.4"2.0" | NA |
| 900909-125 | 8.54"X9.4"1.25" | NA |
| 912309-250 | 23.24"X9.4"2.5" | NA |
| 912309-200 | 23.24"X9.4"2.0" | NA |
| 912309-125 | 23.24"X9.4"1.25" | NA |
| 911909-250 | 19.24"X9.4"2.5" | NA |
| 911909-200 | 19.24"X9.4"2.0" | NA |
| 911909-125 | 19.24"X9.4"1.25" | NA |
| 911509-250 | 15.24"X9.4"2.5" | NA |
| 911509-200 | 15.24"X9.4"2.0" | NA |
| 911509-125 | 15.24"X9.4"1.25" | NA |
| 911309-250 | 13.24"X9.4"2.5" | NA |
| 911309-200 | 13.24"X9.4"2.0" | NA |
| 911309-125 | 13.24"X9.4"1.25" | NA |
| 910909-250 | 8.54"X9.4"2.5" | NA |
| 910909-200 | 8.54"X9.4"2.0" | NA |
| 910909-125 | 8.54"X9.4"1.25" | NA |
{5}------------------------------------------------
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Comparative Chart VII
| Company | SteriZign | SubstantiallyEquivalent(Y/N) | Summit Medical Instru-Safe |
|---|---|---|---|
| Trade Name | SteriZign Signatur Device ProtectionSystem | Y | Instru-Safe® Instrument Protection System |
| FDA 510K # | K171520 | - | K133015 |
| Intended Use | Identification: A sterilization wrap (pack,sterilization wrapper, bag, or accessories, is adevice intended to be used to enclose anothermedical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization ofthe enclosed medical device and also to maintainsterility of the enclosed device until used.SteriZign Signatur Device Protection System areused to organize, transport, store and protectbetween uses of surgical and other medicaldevices that are sterilized by a healthcareprovider. SteriZign Signatur Device ProtectionSystem are intended to allow sterilization of theenclosed medical devices during a pre-vacuumsteam sterilization cycles. The SteriZign SignaturDevice Protection System are not intended ontheir own to maintain sterility. The SteriZignSignatur Device Protection System haveperforations and intended to be used inconjunction with legally marketed, validated FDAcleared sterilization wrap.Autoclave Sterilization Parameter Cycle:Pre-vacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesDry Time: 30 minutesThe total weight of a tray (e.g. tray, insert andinstruments) should never exceed 25 lbs.Validated sizes of stainless steel instrument lumensinclude:1 each 1mm x 76 mm1 each 1mm x 400 mm1 each 2mm x 400 mm1 each 3mm x 400 mm1 each 5mm x 400 mm | Y | Instru -Safe Instrument Protection System cassettes are usedto organize and protect other medical devices that aresterilized by a healthcare provider. Instru -Safe InstrumentProtection System cassettes are intend to allow sterilizationof the enclosed medical devices during a pre-vacuum steamsterilization cycles. Instru -Safe Instrument Protection Systemcassettes are intended to be used in conjunction with legallymarketed wrap or Aesculap rigid container. Instru -SafeInstrument Protection System cassettes are not intended ontheir own to maintain sterility.Autoclave Sterilization Parameter Cycle: Pre-VacuumTemperature: 270 degrees F (132 degrees C)Exposure Time: 4 minutes Minimum Dry Time: 30 minutes |
| Lumen Claims | Lumen Inner Diameter (ID) x Length1 mm 76 mm1 mm 400 mm2 mm 300 mm3 mm 400 mm5 mm 400 mm | Y | Lumen Inner Diameter (ID) x Length1 mm x 76 mm1mm x 65mm1 mm x 400 mm2 mm x 300 mm3 mm x 177 mm3 mm x 200mm3 mm x 400 mm5 mm x 241 mm |
| Max Weight | The total weight of the container system (e.g. container,tray and instrument load) must not exceed 25 lbs. | Y | 17 lbs. |
| ClassificationMonograph | Y | ||
| RegulationName | Sterilization Wrap | Y | Sterilization Wrap |
| Class | 2 | Y | 2 |
| Class Code | KCT | Y | KCT |
| Predicate 510K | Summit K133015 | N/A | Not Indicated in 510k Statement |
| Description | SteriZign Signatur Device Protection System arecassettes/ trays used to enclose and hold surgicalinstruments and accessories in an organized mannerduring the sterilization process and subsequentstorage and transportation. The cassettes / trays bythemselves do not maintain sterility | Y | Instru-Safe Instrument Protection System cassettes include- perforated base- perforated cover- silicone inserts (hold-it / hold down)- handles-latches- feet- posts (optional)- divider (optional)- Shelf (optional) |
| MaterialComposition | Base: Aluminum AnodizedInsert: Aluminum AnodizedLid: Aluminum AnodizedLatch: 300 Series SS PassivatedHandle: 300 Series SS PassivatedShelf Bracket: 300 Series SS PassivatedMat(s): SiliconeBrackets: Polypropylene | Y | Anodized Aluminum lid and basesilicone bracketsStainless Steel latchStainless Steel handlesAnodized aluminum bar holdersPolypropylene feetSilicone dividersSilicone matsStainless steel bracketsLocating post - High performance plastic (Radel orDelrin)Accessory box- High performance plastic Delrin orRadel |
| Sterilizationparameters | Sterilant (steam) penetration through perforations in trayPreVacuum, 132 degrees C/270 Degrees F, 4 minute cyclewith 30 dry time | Y | From Summit Medical 510K 133015"*Validated by Summit Medical for use in steam prevacuumsterilizers ONLY operating at 270°F (132°C) for 4 minutesexposure time. Consult container instructions to ensure thatcontents do not exceed the sterilization containers loadclaims." |
| MicrobialBarrierProperties | SteriZign Signatur Device Protection System isintended to be used in conjunction with a legallymarketed wrap. The SteriZign Signatur DeviceProtection System are not intended on their own tomaintain sterility | Y | The Instru-Safe Instrument Protection System cassettes areintended to be used in conjunction with a legally marketedwrap. The Instru-Safe Instrument Protection System cassettesare not intended on their own tomaintain sterility. |
| Air Permeance | Yes | N/A | Not Indicated |
| MaterialCompatibility | Materials of construction are compatible with steamsterilization. | Y | Not Indicated |
| SteriZign Precision Technologies, LLC | |||
| ToxicologicalProperties(Biocompatibility includingsterilantresidual limits | MEM Elution Cytotoxicity (ISO 10993-5) The test samplesmeet the USP and ISO 10993-5 requirements for this test.All controls were acceptable and the test considered valid.The test samples PASSED and are considered NON-CYTOTOXIC under the test conditions employed. | ||
| Aeration Time | N/A | - | Not Indicated |
| TechnicalCharacteristics | The technological characteristics of the subject devices areequivalent to the predicate devices. The cassettes / traysare made of standard medical grade materials and do notincorporate any new technological characteristics. | Y | Not Indicated |
| SterilantPenetrationPerformanceData | The purpose of this study was to verify that theSteriZign Signatur Device Protection Systemallows for sufficient sterilant penetration whenexposed to a pre-vacuum steam 132°C two (2)minute sterilization, half cycle with no BI growth. | Y | Not Indicated |
| Drying Time | 30 minutes | Y | 30 minutes |
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510(k) Summary K171520 ・・・ icion 1 .
VIII. Conclusion
The subject device is substantially equivalent to the legally marketed predicate device.
§ 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).