(81 days)
The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days.
Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270°F (132°C) for 4 minutes with a drying time of 30 minutes.
Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.
Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only.
The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days.
The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used as described in the instructions for use.
Reusable trays and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.
The Jewel Precision Reusable Rigid Sterilization Container System comprises a sealed sterilization container consisting of a base, cover, filter retainers, single use replaceable paper filters, and accessories consisting of inner trays, and support brackets. Support brackets are configured to securely support container contents, and are secured to inner trays with stainless steel screws and cap nuts. The container is designed to allow efficient exposure of the tray's contents to sterilant gas during the sterilization process, and to contain and protect reusable surgical instruments during sterilization, transport, and storage. The cover incorporates a sealing gasket, and is secured to the base with latches which lock in place. The latching mechanism places a load on the gasket, which is held in compression against the top surface of the container base, maintaining sterile integrity and preventing unwanted separation. The cover also incorporates an alignment flange along its perimeter, which ensures correct alignment of the cover with the container bottom. Provisions are made on the external container surfaces for the use of user provided Sterilizer Load Data Cards and user provided Tamper Evident Locks, through the incorporation of stainless steel Load Data Card Holders and stainless steel hasp and pin studs are designed to fit standard autoclaves, and are manufactured of materials capable of withstanding repeated steam sterilization cycles. The containers and accessories are manufactured from materials which are suitable for use with Pulsed Pre-Vacuum Steam Sterilization methods.
Filter media is Ahlstrom Reliance 335 WL11359D paper, FDA cleared under K800123, which allows ingress and egress of sterilant gas while providing a microbial barrier. The Filter media is single use only.
The Jewel Precision Reusable Rigid Sterilization Container System is used to organize, protect, and transport surgical instruments during steam sterilization and subsequent storage. The Jewel Precision Reusable Rigid Sterilization Container System maintains sterility of enclosed instruments, having been validated for a period of 30 days post sterilization, using containers previously subjected to more than 100 sterilization usage cycles. The Jewel Precision Reusable Rigid Sterilization Container System is intended for sterilization of non-porous and porous items, e.g. scissors, hooks, probes, extractors, suction instruments, drivers, rasps, obturators, etc. The container does not come into direct patient contact while in use.
The provided document describes the Jewel Precision Reusable Rigid Sterilization Container System and its performance validation for sterilization efficacy, dry time, and biocompatibility, rather than an AI/ML medical device. Therefore, the information needed to answer many of the specific questions about AI/ML acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for AI/ML) is not present in this document.
However, I can extract the relevant acceptance criteria and reported performance for the described medical device.
1. A table of acceptance criteria and the reported device performance
Based on the "Performance Data" and "Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence" sections, the following acceptance criteria and device performance are reported:
| Acceptance Criteria / Characteristic | Standard / Test / FDA Guidance | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy: Pre-Vacuum Steam | ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10^-6 using biological (BI) overkill method. This indicates effective sterilization. |
| Dry Time for Dynamic Air Removal (Pre-Vacuum Steam Modality) | ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated a validated method of drying by absence of visible moisture. This confirms the device effectively dries contents after sterilization. |
| Biocompatibility Testing of various materials (after 100 cycles of cleaning and steam sterilization) | ISO 10993-5:2009/(R) 2014 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity | All tested materials (Filter Media, USP Class VI Silicone Cover Gasket with UAP Class VI Silicone Adhesive, Anodized 5052 H32 Aluminum (Container and Cover), USP Class VI Silicone Filter Retainer Gasket with USP Class VI Silicone Adhesive, Filter Retainer Cover (304 Stainless Steel), Container Handle (303 Stainless Steel), USP Class VI Silicone Bracket Insert, USP Class VI Nylon (Polyamide 11) Coated Bracket, Anodized 5052 H32 Aluminum (Insert Tray)) |
| Maintenance of Sterility (Shelf Life) | Not explicitly stated as a standard, but a core claim. | Maintains sterility of the enclosed medical device until used for a maximum of 30 days. Tested using containers previously subjected to more than 100 sterilization usage cycles. |
| Lumen Sterilization Parameters | Not explicitly stated as a specific standard, but a comparison to predicate. | New device accommodates a total of 28 lumens of varying sizes (e.g., 0.130" x 13 1/8", 0.048" x 6"). This is comparable to the predicate device's lumen capacity. |
| Volume to Vent Ratio | Not explicitly stated as a specific standard, but a comparison to predicate. | The volume to vent ratio of the new device (e.g., JP-24-6: 76.55 in³/in²) falls within the ratios cited for the predicate device (24.0 to 182.3 in³/in²). This ensures proper sterilant gas flow. |
| Material Compatibility | Not explicitly stated as a specific standard, but a characteristic. | Intrinsically stable metals, thermoplastic, and thermosetting polymers designated for constant use at temperatures above 135°C, ensuring durability and safety during sterilization. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide a specific sample size for "test sets" in the context of an AI/ML model. The testing performed is for a physical medical device (sterilization container). It mentions "containers previously subjected to more than 100 sterilization usage cycles" for the sterility maintenance claim, suggesting these cycles were part of the testing. No information on data provenance (country of origin, retrospective/prospective) is applicable or provided as it's not a data-driven AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the device is a physical sterilization container, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the device is a physical sterilization container, not an AI/ML algorithm requiring expert adjudication. The "ground truth" for this device's performance is established through standardized laboratory and engineering tests (e.g., sterility testing, drying tests, biocompatibility).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. No MRMC study was done, as this is a physical medical device and not an AI/ML diagnostic aid intended to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance relies on objective, quantitative measurements and laboratory tests based on recognized standards for sterilization (e.g., 12 log reduction for sterility assurance level), drying (absence of visible moisture), and biocompatibility (cytotoxicity testing). It is not based on expert consensus, pathology, or outcomes data in the sense of a diagnostic AI/ML system.
8. The sample size for the training set
This section is not applicable as there is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established
This section is not applicable as there is no AI/ML model or training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
Jewel Precision Sheet Metal and Machine, Inc. c/o Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K162600
Trade/Device Name: Jewel Precision Reusable Rigid Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: December 2, 2016 Received: December 5, 2016
Dear Mr. Job:
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 (reporting of medical devicerelated 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.
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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/MedicalDevices/ResourcesforYou/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 yours,
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for Tina Kiang, Ph.D.
Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162600
Device Name
Jewel Precision Reusable Rigid Sterilization Container System
Indications for Use (Describe)
The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days.
Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270°F (132°C) for 4 minutes with a drying time of 30 minutes.
Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.
Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only.
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)
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K162600 510(k)
Summary
per 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Jewel Precision Sheet Metal and Machine, Inc. |
| Address | 200 Commerce RoadCedar Grove, NJ 07009 |
| Phone Number | 973-857-5545 |
| Fax Number | 973-857-5548 |
| Establishment RegistrationNumber | 3004112448 |
| Name of Contact Person | Gary Schneberger, Manager Quality Assurance & Regulatory Affairs |
| Date Prepared | 9-December-2016 |
| Device Information | |
| Trade or Proprietary Name | Jewel Precision Reusable Rigid Sterilization Container System |
| Common or Usual Name | Sterilization Container |
| Classification Name | Sterilization Wrap, Containers, Trays, Cassettes, and Other Accessories |
| Classification Panel | 80 |
| Regulation | Class II per 21CFR 880.6850 |
| Product Code(s) | KCT |
| Legally Marketed Device towhich equivalence is claimed | Genesis Reusable Rigid Sterilization Container SystemK142529 |
| Reason for 510(k) submission | To obtain clearance to market for a new medical device |
| Device Description | The Jewel Precision Reusable Rigid Sterilization Container System is a deviceintended to be used to enclose another medical device that is to be sterilized bya healthcare provider. It allows sterilization of the enclosed medical device andmaintains sterility of the enclosed device until used, for a maximum of 30 days.The containers are suitable for dynamic air removal (pre-vacuum) steamsterilization when used as described in the instructions for use.Reusable trays and accessory items such as brackets of various configuration,dividers, caddies, and silicone nipple mats are intended to organize and securethe enclosed medical devices during sterilization and storage of the container.The Jewel Precision Reusable Rigid Sterilization Container System comprises asealed sterilization container consisting of a base, cover, filter retainers, singleuse replaceable paper filters, and accessories consisting of inner trays, andsupport brackets. Support brackets are configured to securely support containercontents, and are secured to inner trays with stainless steel screws and capnuts. The container is designed to allow efficient exposure of the tray's contentsto sterilant gas during the sterilization process, and to contain and protectreusable surgical instruments during sterilization, transport, and storage. Thecover incorporates a sealing gasket, and is secured to the base with latcheswhich lock in place. The latching mechanism places a load on the gasket, whichis held in compression against the top surface of the container base, maintainingsterile integrity and preventing unwanted separation. The cover alsoincorporates an alignment flange along its perimeter, which ensures correctalignment of the cover with the container bottom. Provisions are made on theexternal container surfaces for the use of user provided Sterilizer Load DataCards and user provided Tamper Evident Locks, through the incorporation ofstainless steel Load Data Card Holders and stainless steel basp and pin stude |
| are designed to fit standard autoclaves, and are manufactured of materialscapable of withstanding repeated steam sterilization cycles. The containers andaccessories are manufactured from materials which are suitable for use withPulsed Pre-Vacuum Steam Sterilization methods. | |
| Filter media is Ahlstrom Reliance 335 WL11359D paper, FDA cleared underK800123, which allows ingress and egress of sterilant gas while providing amicrobial barrier. The Filter media is single use only. | |
| The Jewel Precision Reusable Rigid Sterilization Container System is used toorganize, protect, and transport surgical instruments during steam sterilizationand subsequent storage. The Jewel Precision Reusable Rigid SterilizationContainer System maintains sterility of enclosed instruments, having beenvalidated for a period of 30 days post sterilization, using containers previouslysubjected to more than 100 sterilization usage cycles. The Jewel PrecisionReusable Rigid Sterilization Container System is intended for sterilization of non-porous and porous items, e.g. scissors, hooks, probes, extractors, suctioninstruments, drivers, rasps, obturators, etc. The container does not come intodirect patient contact while in use. |
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The containers, insert trays, covers, brackets, and filters are manufactured from the following materials:
| Material | Specification |
|---|---|
| Aluminum Sheet Metal | Alloy 5052 H32 |
| Aluminum Bar Stock | Alloy 6061 |
| Stainless Steel Sheet Metal | SAE 304 |
| Stainless Steel Rod Stock | AISI 303 |
| Nylon Powder Coating | USP Class VI Polyamide 11 |
| Silicone Elastomer | USP Class VI Vinyl Methyl Siloxane,Platinum Cured |
| Filter Paper | Ahlstrom Reliance 335 WL11395D, a WetLaid Non-Woven Fabric comprised of NaturalWood Pulp Fibers bonded with a SyntheticResin Binder, having a Basis Weight of 52.2g/m². Cleared by FDA for use as aSterilization Barrier System under 510(k)Number K800123. |
Indications For Use
The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days.
Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270 °F (132 °C) for 4 minutes with a drying time of 30 minutes.
Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddles, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.
Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only.
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| Summary of the Technological Characteristics of the Device Compared to the Predicate Device | |||
|---|---|---|---|
| Characteristic | Predicate Device - K142529 | New Device | |
| Intended Use | The Genesis Reusable RigidSterilization Container System is adevice intended to be used toenclose another medical device thatis to be sterilized by a healthcareprovider. It allows sterilization of theenclosed medical device andmaintains sterility of the encloseddevice until used for a maximum of180 days.Containers are suitable for dynamicair removal (pre-vacuum) steamsterilization, immediate use pre-vacuum steam sterilization and100% ethylene oxide sterilizationwhen used as described in theinstructions for use.Reusable baskets and accessoryitems (pins, dividers, mats, etc.) areintended to organize and secureenclosed medical devices duringsterilization and storage of thecontainer.Data cards are used to recordinformation regarding a specificsterilization process load. Filtermedia allows ingress and egress ofsterilant while providing a microbialbarrier. Tamper evident arrowsprovide a visual indication that thecontainer system has not beeninadvertently opened prior to use.Each arrow contains a modality-specific external process indicatorthat serves as a visual indication thatthe system has been exposed to aspecific sterilization cycle parameter. | The Jewel Precision Reusable RigidSterilization Container System is adevice intended to be used to encloseanother medical device that is to besterilized by a healthcare provider. Itallows sterilization of the enclosedmedical device and maintains sterility ofthe enclosed device until used, for amaximum of 30 days.Jewel Precision Reusable RigidSterilization Containers are suitable fordynamic air removal (pre-vacuum) steamsterilization when used as described inthe instructions for use.Reusable containers, covers, filterholders, insert trays, and accessoryitems such as brackets of variousconfiguration, dividers, caddies, andsilicone nipple mats are intended toorganize and secure the enclosedmedical devices during sterilization andstorage of the container.Filter media allows ingress and egress ofsterilant gas while providing a microbialbarrier. Filter media is single use only. | |
| Data cards, filters and tamperevident arrows are single use only. | |||
| Container | Anodized 5000 and 1100 seriesaluminum; 300 series stainless steel | Same | |
| Gasket | Closed cell silicone foam | USP Class VI silicone elastomer | |
| Filter | SMS polypropylene for allsterilization modalities | Ahlstrom Reliance 335 WL11395D, aWet Laid Non-Woven Fabric comprisedof Natural Wood Pulp Fibers bonded witha Synthetic Resin Binder, having a BasisWeight of 52.2 g/m². Substantiallyequivalent to Dextex II Grade 3592cleared by FDA for use as a SterilizationBarrier System under 510(k) NumberK800123 for dynamic air removal (pre-vacuum) steam sterilization. | |
| Trays (Baskets) | 304 Stainless Steel, electropolished | 1100 and 5000 series anodizedaluminum; nylon coated 1100 and 5000series aluminum | |
| Dividers, Brackets | 5000 series aluminum | Nylon coated 1100 and 5000 seriesaluminum with silicone elastomer inserts | |
| Clips, Posts, Pins | 300 and 400 series stainless steel | Same | |
| Silicone Bars, Mats | Silicone elastomer | Same | |
| Material Compatibility | Intrinsically stable metals,composites, thermoplastic andthermosetting polymers designatedfor constant use at temperaturesabove 135°C | Intrinsically stable metals, thermoplasticand thermosetting polymers designatedfor constant use at temperatures above135°C | |
| Volume to Vent Ratio | 24.0 to 182.3 in³ / in² | JP-24-6: 76.55 in³ / in²The volume to vent ratio of the newdevice falls within the ratios cited for thepredicate device. | |
| Container Dimensions | 9.5" x 12.4" x 3.8" to23.1" x 12.5" x 8.8" | 23" x 11.2" x 7" | |
| Microbial Barrier Properties /Shelf Life | Maintains sterility of the enclosedmedical device until used for amaximum of 180 days. | Maintains sterility of the enclosedmedical device until used for a maximumof 30 days. | |
| Sterilization parameters forPre-Vacuum steam for Lumendevices | Lumens: 2.68 mm (ID) x 450 mm (L)- Qty 16Lumens: 1.37 mm (ID) x 242 mm (L)- Qty 10Total:26 | Lumens:0.130" x 13 1/8"0.155" x 13 1/4"0.150" x 12 1/4"0.048" x 6"0.064" x 6"0.055" x 7 1/2"0.066" x 7 1/2"0.073" x 7 1/2"0.092" x 7 1/2"0.106" x 7 1/2"0.110" x 7 1/2"0.115" x 7 1/2"0.075" x 9 5/8"0.230" x 7 1/4"0.095" x 4"0.098" x 5 3/4"Total: | Quantity311111111111661128 |
| Characteristic | Standard / Test / FDA Guidance | Results Summary | |
| Sterilization Efficacy:Pre-Vacuum Steam | ST 77 2013 Containment Devices forReusable Medical Device Sterilization | Testing demonstrated a 12 log reductionand a sterility assurance level (SAL) of 10-6using biological (BI) overkill method | |
| Dry Time for Dynamic AirRemoval (Pre-VacuumSteam Modality) | ST 77 2013 Containment Devices forReusable Medical Device Sterilization | Testing demonstrated a validated methodof drying by absence of visible moisture | |
| Biocompatibility Testing ofthe following materials after100 cycles of cleaning andsteam sterilization: | ISO 10993-5:2009/(R) 2014 Biologicalevaluation of medical devices-Part 5:Tests for in vitro cytotoxicity | ||
| Filter Media | Pass | ||
| USP Class VI SiliconeCover Gasket with UAPClass VI Silicone Adhesive | Pass | ||
| Anodized 5052 H32Aluminum (Container andCover) | Pass | ||
| USP Class VI Silicone FilterRetainer Gasket with USPClass VI Silicone Adhesive | Pass | ||
| Filter Retainer Cover, 304Stainless Steel | Pass | ||
| Container Handle, 303Stainless Steel | Pass | ||
| USP Class VI SiliconeBracket Insert | Pass | ||
| USP Class VI Nylon(Polyamide 11) CoatedBracket | Pass | ||
| Anodized 5052 H32Aluminum (Insert Tray) | Pass | ||
| Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and / orClinical Information |
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While the indication statements for the Jewel Precision Reusable Rigid Sterilization Container System differ from those for the predicate device, the differences are not critical to the intended use of the device in that the subject device has been demonstrated both to perform as intended allowing sterilization of the enclosed medical device, and maintain sterility of the enclosed device until used, for a maximum of 30 days.
Performance Data
Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence
Performance Test Summary - New Device
Not Applicable - No clinical tests were conducted for this submission.
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Conclusions Drawn from Non-Clinical and Clinical Data
The Jewel Precision Reusable Rigid Sterilization Container System has been validated to meet the established performance criteria. The results of the verification studies demonstrate that the sterilization containers perform as intended, and based on the non-clinical tests performed the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K14529, Class II (21 CFR 880.6850), Product Code KCT, identified on page 1 of this section.
§ 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).