(81 days)
No
The device description and intended use focus solely on the physical properties and function of a sterilization container system. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No.
The device is described as a sterilization container system, intended to enclose and maintain sterility of other medical devices, not to treat or therapeutically affect a patient.
No
The device is a sterilization container system, designed to enclose and facilitate sterilization of other medical devices. It does not diagnose any medical condition.
No
The device is a physical sterilization container system made of materials like aluminum and stainless steel, with physical components like bases, covers, filters, and trays. It is not software.
Based on the provided text, the Jewel Precision Reusable Rigid Sterilization Container System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "enclose another medical device that is to be sterilized by a healthcare provider." It facilitates the sterilization process and maintains the sterility of the enclosed device.
- Device Description: The description reinforces this by detailing how the container functions to allow sterilant gas ingress/egress and protect instruments during sterilization, transport, and storage.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or assays to detect specific substances.
The device's function is solely related to the sterilization and storage of other medical devices, which falls under the category of a sterilization accessory or medical device accessory, not an IVD.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization Efficacy: Pre-Vacuum Steam
Study Type: Performance Test.
Key Results: Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using biological (BI) overkill method.
Dry Time for Dynamic Air Removal (Pre-Vacuum Steam Modality)
Study Type: Performance Test.
Key Results: Testing demonstrated a validated method of drying by absence of visible moisture.
Biocompatibility Testing
Study Type: Biocompatibility.
Materials tested: 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).
Key Results: All materials passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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.
1
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,
Image /page/1/Picture/7 description: The image shows the name "Michael J. Ryan -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the name is presented in a straightforward manner.
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
K162600 510(k)
Summary
per 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Jewel Precision Sheet Metal and Machine, Inc. |
| Address | 200 Commerce Road |
| Cedar Grove, NJ 07009 | |
| Phone Number | 973-857-5545 |
| Fax Number | 973-857-5548 |
| Establishment Registration | |
| Number | 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 to | |
| which equivalence is claimed | Genesis Reusable Rigid Sterilization Container System |
| K142529 | |
| 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 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 basp and pin stude |
| 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. | |
4
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 Wet |
| Laid Non-Woven Fabric comprised of Natural | |
| Wood Pulp Fibers bonded with a Synthetic | |
| Resin Binder, having a Basis Weight of 52.2 | |
| g/m². Cleared by FDA for use as a | |
| Sterilization 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.
5
| Summary of the Technological Characteristics of the Device Compared to the Predicate Device | |||
|---|---|---|---|
| Characteristic | Predicate Device - K142529 | New Device | |
| Intended Use | The Genesis 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 | |||
| 180 days. | |||
| Containers are suitable for dynamic | |||
| air removal (pre-vacuum) steam | |||
| sterilization, immediate use pre- | |||
| vacuum steam sterilization and | |||
| 100% ethylene oxide sterilization | |||
| when used as described in the | |||
| instructions for use. | |||
| Reusable baskets and accessory | |||
| items (pins, dividers, mats, etc.) are | |||
| intended to organize and secure | |||
| enclosed medical devices during | |||
| sterilization and storage of the | |||
| container. | |||
| Data cards are used to record | |||
| information regarding a specific | |||
| sterilization process load. Filter | |||
| media allows ingress and egress of | |||
| sterilant while providing a microbial | |||
| barrier. Tamper evident arrows | |||
| provide a visual indication that the | |||
| container system has not been | |||
| inadvertently opened prior to use. | |||
| Each arrow contains a modality- | |||
| specific external process indicator | |||
| that serves as a visual indication that | |||
| the system has been exposed to a | |||
| specific sterilization cycle parameter. | 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 when used as described in | |||
| the instructions for use. | |||
| 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. | |||
| Data cards, filters and tamper | |||
| evident arrows are single use only. | |||
| Container | Anodized 5000 and 1100 series | ||
| aluminum; 300 series stainless steel | Same | ||
| Gasket | Closed cell silicone foam | USP Class VI silicone elastomer | |
| Filter | SMS polypropylene for all | ||
| sterilization modalities | Ahlstrom Reliance 335 WL11395D, a | ||
| Wet Laid Non-Woven Fabric comprised | |||
| of Natural Wood Pulp Fibers bonded with | |||
| a Synthetic Resin Binder, having a Basis | |||
| Weight of 52.2 g/m². Substantially | |||
| equivalent to Dextex II Grade 3592 | |||
| cleared by FDA for use as a Sterilization | |||
| Barrier System under 510(k) Number | |||
| K800123 for dynamic air removal (pre- | |||
| vacuum) steam sterilization. | |||
| Trays (Baskets) | 304 Stainless Steel, electropolished | 1100 and 5000 series anodized | |
| aluminum; nylon coated 1100 and 5000 | |||
| series aluminum | |||
| Dividers, Brackets | 5000 series aluminum | Nylon coated 1100 and 5000 series | |
| aluminum 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 and | |||
| thermosetting polymers designated | |||
| for constant use at temperatures | |||
| above 135°C | Intrinsically stable metals, thermoplastic | ||
| and thermosetting polymers designated | |||
| for constant use at temperatures above | |||
| 135°C | |||
| Volume to Vent Ratio | 24.0 to 182.3 in³ / in² | JP-24-6: 76.55 in³ / in² | |
| The volume to vent ratio of the new | |||
| device falls within the ratios cited for the | |||
| predicate device. | |||
| Container Dimensions | 9.5" x 12.4" x 3.8" to | ||
| 23.1" x 12.5" x 8.8" | 23" x 11.2" x 7" | ||
| Microbial Barrier Properties / | |||
| Shelf Life | Maintains sterility of the enclosed | ||
| medical device until used for a | |||
| maximum of 180 days. | Maintains sterility of the enclosed | ||
| medical device until used for a maximum | |||
| of 30 days. | |||
| Sterilization parameters for | |||
| Pre-Vacuum steam for Lumen | |||
| devices | Lumens: 2.68 mm (ID) x 450 mm (L) |
- Qty 16
Lumens: 1.37 mm (ID) x 242 mm (L) - Qty 10
Total:
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: | Quantity
3
1
1
1
1
1
1
1
1
1
1
1
6
6
1
1
28 |
| | | | |
| Characteristic | Standard / Test / FDA Guidance | Results Summary | |
| 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 | |
| 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 | |
| Biocompatibility Testing of
the following 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 | | |
| Filter Media | | Pass | |
| USP Class VI Silicone
Cover Gasket with UAP
Class VI Silicone Adhesive | | Pass | |
| Anodized 5052 H32
Aluminum (Container and
Cover) | | Pass | |
| USP Class VI Silicone Filter
Retainer Gasket with USP
Class VI Silicone Adhesive | | Pass | |
| Filter Retainer Cover, 304
Stainless Steel | | Pass | |
| Container Handle, 303
Stainless Steel | | Pass | |
| USP Class VI Silicone
Bracket Insert | | Pass | |
| USP Class VI Nylon
(Polyamide 11) Coated
Bracket | | Pass | |
| Anodized 5052 H32
Aluminum (Insert Tray) | | Pass | |
| Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and / or
Clinical Information | | | |
6
7
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.
8
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.