(514 days)
The Synthes Reusable Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.
Synthes containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
Reusable lifting platforms are intended to hold enclosed medical devices above the filter areas of a perforated bottom container 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 (pre-vacuum steam) external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
The Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other Synthes medical devices and maintain sterility of these devices until used. The container system is comprised of a lid with gasket, base, filter, tamper evident arrows, and data cards.
The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container.
The document describes the Synthes Reusable Sterilization Container System and its substantial equivalence to a predicate device (Genesis Reusable Rigid Sterilization Container System K112535). The acceptance criteria and performance are based on non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Characteristic | Performance Requirement (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy (Pre-Vacuum Steam) | 12 log reduction and a sterility assurance level (SAL) of 10^-6 using biological overkill method and half-cycle validation. | Met: Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10^-6 using the biological (BI) overkill method and half-cycle validation. |
| Dry Time | Minimum dry time of 30 minutes for pre-vacuum steam sterilization modality. | Met: Dry time studies established a minimum dry time of 30 minutes for pre-vacuum steam sterilization modality. |
| 180 Day Event Related Shelf Life | Sterility maintenance for 180 days. | Met: 180 Day Event Related Shelf life studies demonstrated sterility maintenance for the recommended pre-vacuum steam sterilization modality. |
| Microbial Barrier (Whole Package Integrity) | 100% negative growth when subjected to an aerosol challenge of 1 x 10^6 Bacillus atrophaeus colony forming units (CFU). | Met: Whole package microbial challenge test, exposing a container to a minimum of 1 x 10^6 Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge demonstrating 100% negative growth. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test set, nor does it specify the country of origin or whether the data was retrospective or prospective. It mentions "all test samples" or "a container" without providing numerical details for the sample size. However, the data represents non-clinical testing performed to validate the device's efficacy and integrity.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device, a sterilization container, is established through standardized performance testing (e.g., microbial challenge, sterility assurance level determination) rather than expert consensus on interpretive data like medical images. The acceptance criteria are based on established scientific and regulatory standards (ANSI/AAMI ST77:2006, ANSI/AAMI ST79:2010).
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established via objective, standardized laboratory testing, not through expert adjudication of subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a sterilization container, and its effectiveness is determined through physical and microbiological tests, not through human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a passive sterilization container, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective, quantifiable results from non-clinical performance tests, specifically:
- Microbiological assays: Demonstrating a 12 log reduction and a 10^-6 sterility assurance level, and 100% negative growth in microbial challenge tests.
- Physical measurements/observations: Related to dry time and maintenance of sterility over a specified shelf life.
These align with established scientific and regulatory standards for sterilization efficacy and package integrity for medical devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as explained in point 8.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2014
Synthes USA Mr. Thomas Shea Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, PA 19380
Re: K130720
Trade/Device Name: Synthes Reusable Sterilization Container Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Container Regulatory Class: II Product Code: KCT Dated: July 16, 2014 Received: July 17, 2014
Dear Mr. Shea:
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.
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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a circular symbol with intersecting lines, followed by the company name in bold, dark blue letters. Below the company name, in smaller letters, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.
4.0 Indications for Use Statement
510(k): K130720
Device Name: Synthes Reusable Sterilization Container System
Indications for Use:
The Synthes Reusable Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.
Synthes containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
Reusable lifting platforms are intended to hold enclosed medical devices above the filter areas of a perforated bottom container 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 (pre-vacuum steam) external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
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Image /page/3/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interconnected circles in a gold color. To the right of the symbol is the company name, "DePuy Synthes," written in a bold, dark blue font. Below the company name, in smaller letters, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.
| Sterilization Method | Cycle Parameters | Total System Weight | Containers, Accessories & Validated Contents |
|---|---|---|---|
| Dynamic Air Removal(Pre-Vacuum) Steam | Exposure Temperature: 270°F(132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesDry Time Cycle: 30 MinutesMinimum Cool Time: 60 minutes (may vary according to load contents)Stacking Not Permitted | 25 lbs. | Solid Bottom Containers;Perforated BottomContainers; Lifting Platforms.Lumen (Cannulated) Devices.Devices or DeviceConfigurations withconjoined surfaces whichmeet, touch or unite. Matedsurfaces.Materials: Intrinsically stablemetals. Composites,thermoplastics andthermosetting polymers withconstant use temperaturesabove 135°C |
Examples of device types with conjoined or mated surfaces include: forceps, clamps, bending pliers, and cable or plate cutters. Lumen devices include: cannulated drill bits, guides, screwdrivers and cannulated screws.
Examples of intrinsically stable metals include stainless steel, titanium (CP and alloys) and aluminum. Examples of thermoplastic polymers are PEEK, PEKK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/Styrene) and POM (Polyoxymethylene). Examples of thermosetting polymers are Phenolic and Silicone.
Examples of composites include carbon fiber reinforced epoxy (CFRE).
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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interconnected circles in a light brown color. To the right of the symbol is the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, in smaller letters, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.
| Synthes Reusable Sterilization Container and Accessory Configurations Supported byValidation Data | ||
|---|---|---|
| ModalityType of Container | Dynamic Air Removal (Pre-Vacuum) SteamContents / Configuration | Validation Details |
| Perforated BottomContainer and SolidBottom Container | Lifting Platform | Yes |
| Dead end lumen: Ø2.1mm x 330mm | Yes | |
| Open end lumens: Ø0.9mm x 278mm | Yes | |
| Open end lumens: Ø1.1mm x 285mm | Yes | |
| Open end lumens: Ø1.35mm x 278mm | Yes | |
| Open end lumens: Ø3.65mm x 465mm | Yes | |
| Open end lumens: Ø4.5mm x 438mm | Yes | |
| Mated Surfaces | Yes | |
| Materials: Intrinsically stable metals.Composites, thermoplastics andthermosetting polymers with constant usetemperatures above 135°C. | Yes | |
| Filter | NST Series | |
| Data Card | MD1-1 | |
| Tamper Evident Arrow | AS2-3 | |
| Maximum Total Weight(Container plus Contents) | 25 lbs. | |
| Stacking | Not permitted |
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Image /page/5/Picture/0 description: The image shows the logo for DePuy Synthes, a company that is part of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interlocking circles in a gold color. To the right of the symbol is the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, in smaller letters, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.
| Synthes PartNumber | Synthes PartDescription | Volume to VentRatio (in³/in²) | Weight(lbs.) | Outer Dimensions(L x W x H), in. | Inner Dimensions(L x W x H), in. |
|---|---|---|---|---|---|
| Perforated Bottom Containers | |||||
| 62.006.001 | Full-One Level,Perforated Base | 26 | 8.5 | 23.1 x 12.4 x 4.5 | 21.0 x 11.4 x 4.2 |
| 62.006.002 | Full-Two Level,Perforated Base | 31 | 8.8 | 23.1 x 12.4 x 5.3 | 21.0 x 11.4 x 5.1 |
| 62.006.003 | Full-Three Level,Perforated Base | 42 | 9.4 | 23.1 x 12.4 x 7.0 | 21.0 x 11.4 x 6.8 |
| 62.009.004 | Extended-Four Level,Perforated Base | 56 | 9.7 | 25.2 x 12.4 x 8.5 | 23.0 x 11.4 x 8.4 |
| 62.009.005 | Extended-Five Level,Perforated Base | 63 | 10.3 | 25.2 x 12.4 x 9.5 | 23.0 x 11.4 x 9.4 |
| Solid Bottom Containers | |||||
| 62.016.001 | Full-One Level, SolidBase | 52 | 7.8 | 23.1 x 12.4 x 4.5 | 21.0 x 11.4 x 4.2 |
| 62.016.002 | Full-Two Level, SolidBase | 62 | 7.9 | 23.1 x 12.4 x 5.3 | 21.0 x 11.4 x 5.1 |
| 62.016.003 | Full-Three Level, SolidBase | 83 | 8.5 | 23.1 x 12.4 x 7.0 | 21.0 x 11.4 x 6.8 |
| 62.019.004 | Extended-Four Level,Solid Base | 112 | 9.1 | 25.2 x 12.4 x 8.5 | 23.0 x 11.4 x 8.4 |
| 62.019.005 | Extended-Five Level,Solid Base | 126 | 10.0 | 25.2 x 12.4 x 9.5 | 23.0 x 11.4 x 9.4 |
| Lifting Platforms | |||||
| 62.006.010 | Lifting Platform forFull Container | Not Applicable | 2.6 | 20.5 x 10.6 x 1.3 | Not Applicable |
| 62.009.010 | Lifting Platform forExtended Container | Not Applicable | 2.9 | 22.5 x 10.6 x 1.3 | Not Applicable |
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Image /page/6/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol resembling interlocking circles in a gold color, followed by the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, the text "COMPANIES of Johnson & Johnson" is written, with "Johnson & Johnson" in a red script font.
| Additional Items in System | |
|---|---|
| Part Number | Description |
| Consumables | |
| DST-3 | Filters (1,000/Box) |
| AS2-3 | Tamper Evident Arrows (1,000/Box) |
| MD1-1 | Data Cards (500/Box) |
| Replacement Parts | |
| Lids | |
| 62.006.020 | Lid for Full Sterilization Container |
| 62.009.021 | Lid for Extended Sterilization Container |
| Bases | |
| 62.006.031 | Perforated Base for Full-One Level Container |
| 62.006.032 | Perforated Base for Full-Two Level Container |
| 62.006.033 | Perforated Base for Full-Three Level Container |
| 62.009.034 | Perforated Base for Extended-Four Level Container |
| 62.009.035 | Perforated Base for Extended-Five Level Container |
| 62.016.031 | Solid Base for Full-One Level Container |
| 62.016.032 | Solid Base for Full-Two Level Container |
| 62.016.033 | Solid Base for Full-Three Level Container |
| 62.019.034 | Solid Base for Extended-Four Level Container |
| 62.019.035 | Solid Base for Extended-Five Level Container |
| Filter Retention Plates | |
| 62.010.001 | Optional Protective Plate |
| 62.010.003 | Filter Retention Plate, Top |
| 62.010.006 | Filter Retention Plate, Bottom |
| Additional Parts | |
| 62.010.100 | Identification Tag |
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Image /page/7/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The DePuy Synthes logo is in blue and is oriented vertically. Below the logo is a circular design in gold. The Johnson & Johnson logo is in red and is oriented horizontally.
| Container | Lid | CompatibleGraphic CaseFootprint | Graphic CaseDimensions(L x W x H), in. | Contents | RequiredAccessories | Max.Weight(loaded) |
|---|---|---|---|---|---|---|
| ull-One Level,erforated or Solid Base | Full Size | Half length,1 high | 10.5 x 9.8 x 2.0 | Materials: Intrinsically stable metals. Composites,thermoplastics and thermosetting polymers with constant usetemperatures above 135°C.Devices: Graphic Cases, Orthopedic Surgical Instruments,Implants | 2 Filters (Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) |
| ull-Two Level,erforated or Solid Base | Full Size | 2/3 length,1 highFull length,1 high | 13.9 x 9.8 x 2.020.7 x 9.8 x 2.0 | Device Design Features: Mated Surfaces; Dead end lumen(Ø2.1mm x 330mm); Open end lumens ( $(Ø0.9mm x 278mm)$(Ø1.1mm x 285mm), (Ø1.35mm x 278mm), (Ø3.65mm x465mm), (Ø4.5mm x 438mm) | 2 Filters (Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) |
| ull-Two Level,erforated or Solid Base | Full Size | Half length,2 high2/3 length,2 highFull length,2 high | 10.5 x 9.8 x 3.413.9 x 9.8 x 3.420.7 x 9.8 x 3.4 | Materials: Intrinsically stable metals. Composites,thermoplastics and thermosetting polymers with constant usetemperatures above 135°C.Devices: Graphic Cases, Orthopedic Surgical Instruments,Implants | 2 Filters (Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) |
| ull-Three Level,erforated or Solid Base | Full Size | Half length,3 high2/3 length,3 highFull length,3 high | 10.5 x 9.8 x 4.913.9 x 9.8 x 4.920.7 x 9.8 x 4.9 | Device Design Features: Mated Surfaces; Dead end lumen(Ø2.1mm x 330mm); Open end lumens ((Ø0.9mm x 278mm)(Ø1.1mm x 285mm), (Ø1.35mm x 278mm), (Ø3.65mm x465mm), (Ø4.5mm x 438mm) | 2 Filters (Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) |
| Extended-Four Level,erforated or Solid Base | Extended | Half length,4 high | 10.5 x 9.8 x 6.3 | Materials: Intrinsically stable metals. Composites,thermoplastics and thermosetting polymers with constant use | 2 Filters (Solid Base)4 Filters (Perf. Base) | 25 lb.(11.3 kg) |
| es Reusable Sterilization Container Compatibility, Contents, Accessories and Maximum Allowable Wei | ||||||
| Container | Lid | Compatible Footprint | Graphic Case Dimensions (L x W x H), in | Contents | AccessoriesRequired | มอลิก |
| 2/3 length | 3.9 x 9.8 x 6.3 | eratures above 135°C. es: Graphic Cases, Orthopedic Surgical Instrmplants | amper EviderArrow | |||
| Full length 4 high | 20.7 x 9.8 x 6.3 | ce Design Features: Mated Surfaces; Dead end lumen Imm x 330mm); Open end lumens (Ø0.9mm x 278mm Imm x 285mm), (Ø1.35mm x 278mm), (Ø3.65mm x mm), (Ø4.5mm x 438mm) | ||||
| Half length 5 high | 10.5 x 9.8 x 7.8 | terials: Intrinsically stable metals. Composites, rmoplastics and thermosetting polymers with constant speratures above 135°C. wices: Graphic Cases, Orthopedic Surgical Instr | ||||
| tended-Five Level, rforated or Solid Bas | Extended | 2/3 length | 3 .9 x 9.8 x 7.8 | mplants | lters (Solid Base) | 25 lb. (11.3 kg) |
| Full length 5 high | 20.7 x 9.8 x 7.8 | ce Design Features: Mated Surfaces; Dead end lumen Imm x 330mm); Open end lumens (Ø0.9mm x 278mm Imm x 285mm); (Ø1.35mm x 278mm), (Ø3.65mm x mm), (Ø4.5mm x 438mm) | ||||
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Image /page/8/Picture/9 description: The image shows the logo for DePuy Synthes, a company that is part of Johnson & Johnson. The logo consists of the company name, "DePuy Synthes," written vertically in a dark blue sans-serif font. Below the name is a golden-colored abstract symbol. To the right of the name, the text "COMPANIES OF Johnson & Johnson" is written in a smaller, red font.
Prescription Use
(Per 21 CFR 801.109
lver-The-Counter Use AND/OR
X
21 CFR 807 Subpart
LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEL
ncurrence of CDRH, Office of Device Evaluation (OD)
720 – Synthes Reusable Sterilization Container Sys
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Image /page/9/Picture/0 description: The image is the logo for DePuy Synthes, a Johnson & Johnson company. The logo features a geometric symbol resembling interconnected circles in a tan color on the left. To the right of the symbol is the company name "DePuy Synthes" in a dark blue, sans-serif font. Below the company name, in smaller fonts, it says "COMPANIES of Johnson & Johnson" with "Johnson & Johnson" in a red script font.
5.0 510(k) Summary – K130720
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| Sponsor Information | |
|---|---|
| Name | Synthes |
| Address | 1302 Wrights Lane East, West Chester, PA 19380 |
| Phone | 610-719-5679 |
| FAX | 484-356-9682 |
| Establishment Registration | 3008812563 |
| Contact Person | Thomas N. Shea |
| Date Prepared | August 1, 2014 |
| Device Information | |
| Proprietary Name | Synthes Reusable Sterilization Container System |
| Common Name | Sterilization Container |
| Device | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Regulation Description | Sterilization Wrap |
| Classification/Review Panel | 80 General Hospital |
| Product Code | KCT |
| Submission Type | Traditional 510(k) |
| Regulation | 880.6850 |
| Device Class | Class II |
| Predicate Device | Genesis Reusable Rigid Sterilization Container System (K112535) |
| Reason for Submission | Introduction of a Synthes sterilization container for use with Synthes orthopedic medical devices. |
| Device Description | The Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other Synthes medical devices and maintain sterility of these devices until used. The container system is comprised of a lid with gasket, base, filter, tamper evident arrows, and data cards.The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container. |
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Image /page/10/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol resembling interconnected circles in a gold color, followed by the company name "DePuy Synthes" in a dark blue sans-serif font. Below the company name, in smaller letters, it says "COMPANIES OF" followed by the Johnson & Johnson logo in red.
Device Models and Accessories:
| Container Descriptions and Dimensions | |||||
|---|---|---|---|---|---|
| Part Number | Description | Volume to Vent Ratio (in³/in²) | Weight (lbs.) | Outer Dimensions (L x W x H), in. | Inner Dimensions (L x W x H), in. |
| Perforated Bottom Containers | |||||
| 62.006.001 | Full-One Level, Perforated Base | 26 | 8.5 | 23.1 x 12.4 x 4.5 | 21.0 x 11.4 x 4.2 |
| 62.006.002 | Full-Two Level, Perforated Base | 31 | 8.8 | 23.1 x 12.4 x 5.3 | 21.0 x 11.4 x 5.1 |
| 62.006.003 | Full-Three Level, Perforated Base | 42 | 9.4 | 23.1 x 12.4 x 7.0 | 21.0 x 11.4 x 6.8 |
| 62.009.004 | Extended-Four Level, Perforated Base | 56 | 9.7 | 25.2 x 12.4 x 8.5 | 23.0 x 11.4 x 8.4 |
| 62.009.005 | Extended-Five Level, Perforated Base | 63 | 10.3 | 25.2 x 12.4 x 9.5 | 23.0 x 11.4 x 9.4 |
| Solid Bottom Containers | |||||
| 62.016.001 | Full-One Level, Solid Base | 52 | 7.8 | 23.1 x 12.4 x 4.5 | 21.0 x 11.4 x 4.2 |
| 62.016.002 | Full-Two Level, Solid Base | 62 | 7.9 | 23.1 x 12.4 x 5.3 | 21.0 x 11.4 x 5.1 |
| 62.016.003 | Full-Three Level, Solid Base | 83 | 8.5 | 23.1 x 12.4 x 7.0 | 21.0 x 11.4 x 6.8 |
| 62.019.004 | Extended-Four Level, Solid Base | 112 | 9.1 | 25.2 x 12.4 x 8.5 | 23.0 x 11.4 x 8.4 |
| 62.019.005 | Extended-Five Level, Solid Base | 126 | 10.0 | 25.2 x 12.4 x 9.5 | 23.0 x 11.4 x 9.4 |
| Lifting Platforms | |||||
| 62.006.010 | Lifting Platform for Full Container | N/A | 2.6 | 20.5 x 10.6 x 1.3 | N/A |
| 62.009.010 | Lifting Platform for Extended Container | N/A | 2.9 | 22.5 x 10.6 x 1.3 | N/A |
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Image /page/11/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interconnected circles in a gold color. To the right of the symbol is the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, in a smaller font, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red script.
| Additional Items in System | |
|---|---|
| Part Number | Description |
| Consumables | |
| DST-3 | Filters (1,000/Box) |
| AS2-3 | Tamper Evident Arrows (1,000/Box) |
| MD1-1 | Data Cards (500/Box) |
| Replacement Parts | |
| Lids | |
| 62.006.020 | Lid for Full Sterilization Container |
| 62.009.021 | Lid for Extended Sterilization Container |
| Bases | |
| 62.006.031 | Perforated Base for Full-One Level Container |
| 62.006.032 | Perforated Base for Full-Two Level Container |
| 62.006.033 | Perforated Base for Full-Three Level Container |
| 62.009.034 | Perforated Base for Extended-Four Level Container |
| 62.009.035 | Perforated Base for Extended-Five Level Container |
| 62.016.031 | Solid Base for Full-One Level Container |
| 62.016.032 | Solid Base for Full-Two Level Container |
| 62.016.033 | Solid Base for Full-Three Level Container |
| 62.019.034 | Solid Base for Extended-Four Level Container |
| 62.019.035 | Solid Base for Extended-Five Level Container |
| Filter Retention Plates | |
| 62.010.001 | Optional Protective Plate |
| 62.010.003 | Filter Retention Plate, Top |
| 62.010.006 | Filter Retention Plate, Bottom |
| Additional Parts | |
| 62.010.100 | Identification Tag |
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Image /page/12/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, followed by the company name in blue. Below the company name, the text "COMPANIES OF Johnson&Johnson" is written in a smaller font size, with "Johnson&Johnson" in red script.
Comparison with Predicate Device:
| Element | K130720 - Subject Device | K112535 - Predicate |
|---|---|---|
| Synthes Reusable Sterilization Container System | Genesis Reusable Rigid Sterilization Container System | |
| Intended Use | The Synthes Reusable Sterilization Container System is adevice intended to be used to enclose other medical devicesto be sterilized by a healthcare provider. It allowssterilization of the enclosed medical devices and maintainssterility of the devices until used for a maximum of 180days.Synthes containers are suitable for dynamic air removal(pre-vacuum) steam sterilization when used according tothe instructions for use.Reusable lifting platforms are intended to hold enclosedmedical devices above the filter areas of a perforatedbottom container during sterilization and storage of thecontainer.Data cards are used to record information regarding aspecific sterilization process load. Filter media allowsingress and egress of sterilant while providing a microbialbarrier. Tamper evident arrows provide a visual indicationthat the container system has not been inadvertently openedprior to use. Each arrow contains a modality-specific (pre-vacuum steam) external process indicator that serves as avisual indication that the system has been exposed to aspecific sterilization cycle parameter. Data cards, filters andtamper evident arrows are single use only. | The Genesis Reusable Rigid Sterilization Container Systemis a device intended to be used to enclose another medicaldevice that is to be sterilized by a healthcare provider. Itallows sterilization of the enclosed medical device andmaintains sterility of the enclosed device until used for amaximum of 180 days.Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuumsteam sterilization and 100% ethylene oxide sterilizationwhen used as described in the instructions for use.Reusable baskets and accessory items (pins, dividers, mats,etc.) are intended to organize and secure enclosed medicaldevices during sterilization and storage of the container.Data cards are used to record information regarding aspecific sterilization process load. Filter media allowsingress and egress of sterilant while providing a microbialbarrier. Tamper evident arrows provide a visual indicationthat the container system has not been inadvertently openedprior to use. Each arrow contains a modality-specificexternal process indicator that serves as a visual indicationthat the system has been exposed to a specific sterilizationcycle parameter. Data cards, filters and tamper evidentarrows are single use only. |
| MaterialComposition | Stainless Steel, Aluminum, Silicone (Gasket), SMSPolypropylene (Filter). All components in the subjectsystem are identical in material composition to thepredicate. The subject system does not contain polymericcomponents to hold devices within the container. | Stainless Steel, Aluminum, Silicone (Gasket), SiliconeElastomer (Bars, Mats, Instrument Holders), SMSPolypropylene (Filter), Radel/Polyphenysulfone/Aluminum/Silicone Elastomer/Stainless (Laproscopic InstrumentRacks) |
| Element | K130720 - Subject DeviceSynthes Reusable Sterilization Container System | K112535 - PredicateGenesis Reusable Rigid Sterilization Container System |
| Physical Properties | Physical properties of the subject container system are identical to the predicated. The sole difference is the color of the lid and branding. The colorization is done according to the same process as the predicate device. | The predicate consists of an anodized aluminum container with a secure latching system that seals the lid to the base with a gasket running along the perimeter. Aluminum retention plates secure single use SMS Polypropylene filters in place over ventilation holes in the lid and/or base of the container. The materials of construction have been demonstrated to withstand repeated processing according to reuse and sterilization modality parameters described in the IFU. |
| ChemicalProperties | The material formulation, manufacturing process, chemical composition and steam sterilization modality for the proposed device is identical to the predicate device. The subject system does not include the polymeric components used to organize devices within the predicate container. | The predicate system is manufactured from aluminum, stainless steel, closed cell silicone foam, SMS polypropylene, and silicone polymeric components. |
| Configurations/Dimensions | Solid or perforated base with perforated lid. Container sizes range from 23.1 x 12.4 x 4.5 to 25.2 x 12.4 x 9.5, please see the table on the previous page for the dimensions of all subject container models offered. | Solid or perforated base with perforated lid. Container sizes cleared under K112535 range from 10.2 x 7.2 x 3.2 (smallest) to 28.1 x 11.2 x 6.4 (max length) 26.5 x 17.0 x 6.9 (max width) 19.2 x 12.5 x 9.4 (max depth). |
| Air Permeance | The subject container also has perforated lids and bottoms that feature the same size and amount of vent holes and makes use of the same filter as the predicate device (SMS Polypropylene) and will have the same permeability to allow ingress of sterilant. | The predicate container has perforated lids and bottoms and employs an SMS Polypropylene filter to allow ingress of sterilant. |
| Percent of SurfacePerforations | The volume to vent ratio (V:V, in3/in2) represents the total container volume divided by the total vent area. The V:V ratios for the proposed Synthes containers range from 26 – 126 in3/in2. All of the proposed containers fall within the range of volume to vent ratios for the predicate device. | The volume to vent ratio (V:V, in3/in2) represents the total container volume divided by the total vent area. The V:V ratios for the predicate containers (K120535) range from 24 – 182 in3/in2. |
| PerformanceSterilantPenetration | Lethality testing via over-challenge half-cycle lethality validation demonstrated all test samples were negative for growth following the seven (7) day incubation period | Lethality testing via over-challenge half-cycle lethality validation demonstrated all test samples were negative for growth following the seven (7) day incubation period |
| K130720 - Subject Device | K112535 - Predicate | |
| Element | Synthes Reusable Sterilization Container System | Genesis Reusable Rigid Sterilization Container System |
| identical to the predicate. | ||
| Microbial Barrier | Whole package integrity/microbial barrier aerosol challenge | Whole package integrity/microbial barrier aerosol challenge |
| Properties (Package | demonstrated all containers tested passed and were 100% | demonstrated all containers tested passed and were 100% |
| Integrity) | negative for growth when subjected to aerosol challengetesting. Identical to the predicate. | negative for growth when subjected to aerosol challengetesting. |
| Material | The subject container system is manufactured from the | The materials used in the construction of the containers do |
| Compatibility | same materials as the predicate device and it's compatibility | not degrade and have proven compatibility with the |
| with the sterilization process is identical to the predicate. | sterilization process and sterilants for which the system is | |
| indicated. | ||
| Toxicological | No patient contact, contact with devices that will have | No patient contact, contact with devices that will have |
| Properties | external communicating, tissue/bone/dentin contact (limited | external communicating, tissue/bone/dentin contact (limited |
| (Biocompatibility. | exposure). The subject Container System will include a | exposure). Primary dermal irritation testing was performed |
| including Sterilant | stainless steel lifting platform that represents the only | on polymeric components of the container system. All |
| Residue Limits) | internal component to hold devices within the container. | samples were subjected to ISO Skin Irritation Testing (2 |
| The lifting platform is manufactured from type 304 stainless | extracts - 0.9% Sodium Chloride and Sesame Oil Extracts) | |
| steel that conforms to ASTM Standard F899 and has an | in compliance with the requirements noted in ISO 10993- | |
| established biocompatibility profile. The system will not | 10. These polymeric components were evaluated for | |
| include the polymeric components, such as silicone bars or | biocompatibility and are considered to be toxicologically | |
| brackets that are included in the predicate system. The | acceptable for their intended use. | |
| proposed system is indicated for prevacuum steam | ||
| sterilization only therefore sterilant residues will not pose | ||
| any risk to the patient. The material formulation, | ||
| manufacturing process, chemical composition, body | ||
| contact, and steam sterilization modality of the proposed | ||
| device is equivalent to the predicate device. | ||
| Shelf Life | 180 Day shelf life identical to the predicate. | 180 Day shelf life demonstrated by real time event related |
| Shelf Life/Package Integrity testing. | ||
| Drying Time | 30 Minute Minimum Dry Time supported by validation | 30 Minute Minimum Dry Time supported by validation |
| study utilizing worst case device challenge identical to the | study utilizing worst case instrument challenge. | |
| predicate. | ||
| Aeration Time | N/A - System not indicated for EO Sterilization | 8 hours at 109.4°F (43°C) supported by 100% Ethylene |
| Oxide Aeration Residual validation study |
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Image /page/13/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo features a stylized graphic of interlocking circles in a gold color, followed by the company name "DePuy Synthes" in a dark blue, sans-serif font. Below the company name, the text "COMPANIES of Johnson & Johnson" is displayed, with "COMPANIES of" in gray and "Johnson & Johnson" in a red, script-like font.
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Image /page/14/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a circular graphic to the left of the company name, "DePuy Synthes," which is written in a dark blue, sans-serif font. Below the company name, in smaller letters, is the text "COMPANIES OF" in gray, followed by "Johnson & Johnson" in a red, cursive font.
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Image /page/15/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a geometric symbol on the left, resembling interconnected circles in a gold color. To the right of the symbol is the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, in smaller letters, it says "COMPANIES OF Johnson & Johnson", with "Johnson & Johnson" in a red script font.
| Summary of Technological Characteristics of the Subject Device | ||
|---|---|---|
| Characteristic | Proposed DeviceSynthes Reusable Sterilization Container | PredicateGenesis Reusable RigidSterilization Container System(K112535) |
| Container | Anodized Aluminum | Anodized Aluminum 5000 and1100 Series; Stainless Steel 300Series |
| Gasket | Closed Cell Silicone Foam | Closed Cell Silicone Foam |
| Filter Material | SMS Polypropylene for Pre-Vacuum Steam modality | SMS Polypropylene for allmodalities |
| LiftingPlatform/Basket | Lifting Platform 304 StainlessSteel Electropolished | Basket 304 Stainless SteelElectropolished |
| Dividers Brackets | N/A | Aluminum 5000 Series |
| Clips, Posts, Pins | N/A | 300 & 400 Series Stainless |
| Silicone Bars, Mats | N/A | Silicone Elastomer |
| Performance Data | ||
| Summary of Non-Clinical Testing Conducted for Determination of Substantial Equivalence | ||
| Performance Test Summary - Proposed Device | ||
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Sterilization Efficacy:Pre-Vacuum Steam | ANSI/AAMI ST77:2006Containment Devices forReusable Medical DeviceSterilization. | Testing demonstrated a 12 log reductionand a sterility assurance level (SAL) of 10-6using the biological (BI) overkill methodand half-cycle validation. |
| Dry Time | ANSI/AAMI ST77:2006Containment Devices forReusable Medical DeviceSterilization.ANSI/AAMI ST79:2010Comprehensive guide tosteam sterilization andsterility assurance inhealth care facilities. | Dry time studies establish minimum drytime of 30 minutes for pre-vacuum steamsterilization modality. |
| 180 Day Event RelatedShelf Life | ANSI/AAMI ST77:2006Containment Devices forReusable Medical DeviceSterilization. | 180 Day Event Related Shelf life studiesdemonstrated sterility maintenance for therecommended pre-vacuum steamsterilization modality. |
| Microbial Challenge | ANSI/AAMI ST77:2006Containment Devices forReusable Medical DeviceSterilization. | Whole package microbial challenge test,exposing a container to a minimum of 1 x106 Bacillus atrophaeus colony formingunits (CFU) via an aerosol challengedemonstrating 100% negative growth. |
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Image /page/16/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo features a geometric symbol resembling interconnected circles in a gold color. To the right of the symbol is the company name "DePuy Synthes" in a bold, dark blue font. Below the company name, in a smaller font, it says "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red.
Summary of Clinical Tests Conducted for Determination of Substantial Equivalence
N/A - No clinical tests were conducted for this submission.
Conclusion
Information presented supports substantial equivalence of the Synthes Reusable Sterilization Container System to the predicate device based on similarities in intended use, design, principles of operation, and performance specifications.
Sterilization Efficacy / Lethality testing was conducted on the proposed sterilization container system to support substantial equivalence to the predicate device and demonstrate effectiveness when used with Synthes orthopedic medical devices.
Filter material properties, package integrity testing and 180 day shelf life validation are exactly the same as the predicate device.
The performance testing data demonstrates that the Synthes Reusable Sterilization Container meet the same criteria as the predicate device is substantial equivalent.
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Image /page/17/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a circular graphic on the left, followed by the company name in bold, blue font. Below the company name, in smaller font, is the text "COMPANIES of Johnson & Johnson" with the Johnson & Johnson part in red.
| Sterilization Parameters for the Synthes Reusable Sterilization ContainerApplicable to both Solid Bottom and Perforated Bottom Containers with Lifting Platforms | |||
|---|---|---|---|
| SterilizationMethod | Cycle Parameters | TotalSystemWeight | Types of Medical Devices& Materials Validatedfor Use |
| Dynamic AirRemoval (Pre-Vacuum) Steam | Exposure Temperature:270°F (132°C)Pre-Conditioning Pulses: 3Exposure Time: 4 MinutesDry Time Cycle: 30MinutesMinimum Cool Time: 60minutes (may varyaccording to load contents)Stacking Not Permitted | 25 lbs.(Containerpluscontents) | Orthopedic MedicalDevices including Lumen(Cannulated) Devices.Devices or DeviceConfigurations withconjoined surfaces whichmeet, touch or unite.Mated Surfaces.Materials: Intrinsicallystable metals. Composites,thermoplastics andthermosetting polymerswith constant usetemperatures above 135°C. |
Examples of device types with conjoined or mated surfaces include: forceps, clamps, bending pliers, and cable or plate cutters. Lumen devices include: cannulated drill bits, guides, screwdrivers and cannulated screws.
Examples of intrinsically stable metals include stainless steel, titanium (CP and alloys) and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/Styrene) and POM (Polyoxymethylene).
Examples of thermosetting polymers are Phenolic and Silicone.
Examples of composites include carbon fiber reinforced epoxy (CFRE).
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Image /page/18/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a circular graphic on the left, followed by the company name in a bold, sans-serif font. Below the company name, in a smaller font, it says "COMPANIES of Johnson & Johnson".
| Synthes Reusable Sterilization Container System & Accessories | ||
|---|---|---|
| Supported by Validation Data | ||
| Modality | Dynamic Air Removal (Pre-Vacuum) Steam | |
| Type of Container | Contents / Configuration | Validation Details |
| Perforated BottomContainer and SolidBottom Container | Lifting Platform | Yes |
| Dead end lumen: Ø2.1mm x 330mm | Yes | |
| Open end lumens: Ø0.9mm x 278mm | Yes | |
| Open end lumens: Ø1.1mm x 285mm | Yes | |
| Open end lumens: Ø1.35mm x 278mm | Yes | |
| Open end lumens: Ø3.65mm x 465mm | Yes | |
| Open end lumens: Ø4.5mm x 438mm | Yes | |
| Mated Surfaces | Yes | |
| Materials: Intrinsically stable metals.Composites, thermoplastics andthermosetting polymers with constantuse temperatures above 135°C. | Yes | |
| Filter | NST Series(SMS Polypropylene) | |
| Data Card | MD1-1 | |
| Tamper Evident Arrow | AS2-3 | |
| Maximum Total Weight(Container plus Contents) | 25 lbs. | |
| Stacking | Not permitted |
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| Container Compatibility, Contents, Accessories, Maximum Allowable Weight | |||||||
|---|---|---|---|---|---|---|---|
| Container | Lid | CompatibleGraphic CaseFootprint | Graphic CaseDimensions(L x W x H), in. | Contents | RequiredAccessories | Max.Weight(loaded) | |
| Full-One Level.Perforated or Solid Base | Full Size | Half length,1 high | 10.5 x 9.8 x 2.0 | Materials: Intrinsically stable metals.Composites, thermoplastics and thermosettingpolymers with constant use temperaturesabove 135°C.Devices: Graphic Cases, Orthopedic SurgicalInstruments, ImplantsDevice Design Features: Mated Surfaces;Dead end lumen (Ø2.1mm x 330mm); Openend lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x285mm), (Ø1.35mm x 278mm), (Ø3.65mm x465mm), (Ø4.5mm x 438mm) | 2 Filters( Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) | |
| 2/3 length,1 high | 13.9 x 9.8 x 2.0 | ||||||
| Full length,1 high | 20.7 x 9.8 x 2.0 | ||||||
| Full-Two Level,Perforated or Solid Base | Full Size | Half length,2 high | 10.5 x 9.8 x 3.4 | Materials: Intrinsically stable metals.Composites, thermoplastics and thermosettingpolymers with constant use temperaturesabove 135°C.Devices: Graphic Cases, Orthopedic SurgicalInstruments, ImplantsDevice Design Features: Mated Surfaces;Dead end lumen (Ø2.1mm x 330mm); Openend lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x285mm), (Ø1.35mm x 278mm), (Ø3.65mm x465mm), (Ø4.5mm x 438mm) | 2 Filters( Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) | |
| 2/3 length,2 high | 13.9 x 9.8 x 3.4 | ||||||
| Full length.2 high | 20.7 x 9.8 x 3.4 | ||||||
| Full-Three Level,Perforated or Solid Base | Full Size | Half length,3 high | 10.5 x 9.8 x 4.9 | Materials: Intrinsically stable metals.Composites, thermoplastics and thermosettingpolymers with constant use temperatures | 2 Filters( Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) | |
| 2/3 length,3 high | 13.9 x 9.8 x 4.9 | above 135°C.Devices: Graphic Cases, Orthopedic SurgicalInstruments, Implants | |||||
| Full length,3 high | 20.7 x 9.8 x 4.9 | Device Design Features: Mated Surfaces;Dead end lumen (Ø2.1mm x 330mm); Openend lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x285mm), (Ø1.35mm x 278mm), (Ø3.65mm x465mm), (Ø4.5mm x 438mm) | |||||
| Container Compatibility, Contents, Accessories, Maximum Allowable Weight | |||||||
| Container | Lid | CompatibleGraphic CaseFootprint | Graphic CaseDimensions(L x W x H), in. | Contents | RequiredAccessories | Max.Weight(loaded) | |
| Extended-Four Level,Perforated or Solid Base | Extended | Half length,4 high | 10.5 x 9.8 x 6.3 | Materials: Intrinsically stable metals.Composites, thermoplastics and thermosettingpolymers with constant use temperatures | 2 Filters( Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) | |
| 2/3 length,4 high | 13.9 x 9.8 x 6.3 | above 135°C.Devices: Graphic Cases, Orthopedic SurgicalInstruments, Implants | |||||
| Full length,4 high | 20.7 x 9.8 x 6.3 | Device Design Features: Mated Surfaces;Dead end lumen (Ø2.1mm x 330mm); Openend lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x285mm), (Ø1.35mm x 278mm), (Ø3.65mm x465mm), (Ø4.5mm x 438mm) | |||||
| Extended-Five Level,Perforated or Solid Base | Extended | Half length,5 high | 10.5 x 9.8 x 7.8 | Materials: Intrinsically stable metals.Composites, thermoplastics and thermosettingpolymers with constant use temperatures | 2 Filters( Solid Base)4 Filters (Perf. Base)Lifting PlatformTamper EvidentArrow | 25 lb.(11.3 kg) | |
| 2/3 length,5 high | 13.9 x 9.8 x 7.8 | above 135°C.Devices: Graphic Cases, Orthopedic SurgicalInstruments, ImplantsDevice Design Features: Mated Surfaces; | |||||
| Full length,5 high | 20.7 x 9.8 x 7.8 | Dead end lumen (Ø2.1mm x 330mm); Openend lumens (Ø0.9mm x 2.78mm ) (Ø1.1mm x285mm), (Ø1.35mm x 278mm), (Ø3.65mm x465mm), (Ø4.5mm x 438mm) |
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Image /page/20/Picture/0 description: The image shows the logo for DePuy Synthes, a company of Johnson & Johnson. The logo consists of a symbol of two overlapping circles in gold, followed by the company name in blue. Below the company name, it says "COMPANIES OF" in gray, followed by "Johnson & Johnson" in red script.
§ 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).