(90 days)
The CODMAN QUAD-LOCK Sterilization Container System is indicated for use by hospitals and by health care facilities to:
- organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments that will be sterilized
- allow sterilization of the contained instruments by prevacuum steam sterilization (validated parameters shown in Table 1)
- maintain the sterility of the contents for up to 180 days during storage and transport within the health care facility, as long as the integrity of the container has not been compromised
The system has not been tested for maintenance of sterility after transportation outside the health care facility.
The system is intended for use with stainless steel, aluminum, titanium, plastic and silicone surgical instruments.
Lumen inner diameter: 3mm or larger
Lumen length: 400mm or less (medium and large size containers), 250mm or less (small size containers)
Quantity: Up to 4 lumen instruments per container
The system is not intended for the sterilization of endoscopes.
For effective sterilization and drying of any size CODMAN QUAD-LOCK Sterilization Container, the recommended maximum combined weight of the single container, lid, basket/tray and basket/tray contents is 25 lb. (11.3 kg).
Table 1 Sterilization Parameters
Cycle Type: Prevacuum
Temperature: 132°C
Exposure Time: 4 minutes
Dry Time: 30 minutes
The Codman® Quad-Lock™ Sterilization Container Systems can be stacked during sterilization with up to three containers.
The CODMAN QUAD-LOCK Sterilization Container System provides a means to organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments during sterilization and storage. The container lids, safety covers, and container bottoms are made from aluminum. The safety covers help ensure sterility during storage and protect the container lid when the containers are stacked. The Container System includes the container base, lid, safety cover, filters and other accessories.
Codman® Quad-Lock™ Sterilization Container Systems consists of a basket, container base, lids, filters, security seals, labels, ergonomic hand grips, wire base, protective mat, and accessories.
The Codman® Quad-Lock™ Sterilization Container Systems is a device intended for the organization and protection of surgical instruments during sterilization and storage. The 510(k) submission K120117 aims to expand the cleared Indications for Use of this device.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Indications for Use) | Reported Device Performance (from 510(k) Summary) |
|---|---|---|
| Sterilization Parameters | Cycle Type: Prevacuum | Achieved (supported by Non-Clinical Performance Testing) |
| Temperature | 132°C | Achieved (supported by Non-Clinical Performance Testing) |
| Exposure Time | 4 minutes | Achieved (supported by Non-Clinical Performance Testing) |
| Dry Time | 30 minutes | Achieved (supported by Non-Clinical Performance Testing) |
| Material Compatibility | Stainless steel, aluminum, titanium, plastic, and silicone surgical instruments | Achieved (supported by Non-Clinical Performance Testing) |
| Lumen Instruments (Min Diameter) | 3mm or larger | Achieved (supported by Non-Clinical Performance Testing) |
| Lumen Instruments (Max Length) | 400mm or less (medium and large containers), 250mm or less (small containers) | Achieved (supported by Non-Clinical Performance Testing) |
| Lumen Instruments (Max Quantity) | Up to 4 lumen instruments per container | Achieved (supported by Non-Clinical Performance Testing) |
| Sterility Maintenance | Up to 180 days during storage and transport within the health care facility, as long as integrity of container is not compromised | Achieved (supported by Non-Clinical Performance Testing) |
| Maximum Combined Weight | 25 lb. (11.3 kg) for single container, lid, basket/tray, and contents for effective sterilization and drying | Achieved (supported by Non-Clinical Performance Testing) |
| Stacking during Sterilization | Up to three containers | Achieved (supported by Non-Clinical Performance Testing) |
| Exclusion | Not intended for sterilization of endoscopes | Explicitly stated as not intended (compliance) |
| Sterility Maintenance (Exclusion) | Not tested for maintenance of sterility after transportation outside the health care facility | Explicitly stated as not tested (compliance) |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Testing has been completed and supports the safety and effectiveness of the proposed device for its proposed intended uses." However, specific sample sizes (e.g., number of containers, number of sterilization cycles) for the non-clinical performance testing are not explicitly provided in the summary.
The data provenance is retrospective in the sense that the current submission builds upon previous clearance. The testing mentioned in this particular 510(k) is "Non-Clinical Performance Testing," presumably conducted during the development or re-evaluation of the device. The country of origin of the data is not specified, but the submission is from Codman & Shurtleff, Inc., a U.S.-based company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the testing performed was "Non-Clinical Performance Testing" and involved evaluating the physical and functional aspects of a sterilization container (e.g., ability to withstand sterilization cycles, maintain sterility, accommodate instruments), the concept of "experts establishing ground truth" in the diagnostic sense is not directly applicable here. The "ground truth" would be established by validated test methods and measurements, typically performed by laboratory technicians or engineers, showing compliance with predefined specifications and industry standards for sterilization efficacy and container functionality. The document does not specify the number or qualifications of experts involved in analyzing these non-clinical results.
4. Adjudication Method for the Test Set
As the evaluation primarily relies on objective non-clinical performance testing against predefined specifications (e.g., temperature, time, instrument dimensions, weight), an "adjudication method" in the context of expert review or consensus (like 2+1 or 3+1) is not applicable or described in the submission. The compliance is determined by the test results meeting the specified criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device. The device is a sterilization container system, not an AI or imaging diagnostic device where human reader performance would be a relevant metric. The submission explicitly states, "There were no Clinical Tests performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The device is a sterilization container system and does not involve an algorithm or AI. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth for this device is based on validated non-clinical test methods and predefined technical specifications related to sterilization parameters (temperature, exposure time, dry time), material compatibility, instrument dimensions, weight limits, and sterility maintenance duration. This is not "expert consensus," "pathology," or "outcomes data" in the typical medical imaging or diagnostic sense, but rather objective measurements and successful completion of sterilization cycle challenges.
8. The Sample Size for the Training Set
There is no training set as this device is a physical sterilization container system and does not employ machine learning or AI algorithms that require training data.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for this device, the concept of establishing ground truth for a training set does not apply.
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| 510(k) SummaryCodman® Quad-Lock™ Sterilization Container Systems | APR 16 2012 | ||||
|---|---|---|---|---|---|
| Date Prepared: | January 13, 2011 | ||||
| Company Name: | Codman & Shurtleff, Inc.325 Paramount DriveRaynham, MA 02767 | ||||
| Contact Person | Megan HermanRegulatory Affairs SpecialistTelephone Number: (508) 828-3571Fax Number: (508) 977-6428 | ||||
| Device Proprietary Name: | Codman® Quad-Lock™ Sterilization Container Systems | ||||
| Device Common Name: | Container Sterilization System | ||||
| Classification Name: | Container Sterilization System | ||||
| Device Classification: | Class II (21 CFR 880.6850) (KCT) | ||||
| Type of 510(k) Submission: | Traditional 510(k) | ||||
| Basis for Submission: | Expand Indications for Use | ||||
| Predicate Device(s): | K092437 | Codman® Sterilization Container |
Device Description
The CODMAN QUAD-LOCK Sterilization Container System provides a means to organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments during sterilization and storage. The container lids, safety covers, and container bottoms are made from aluminum. The safety covers help ensure sterility during storage and protect the container lid when the containers are stacked. The Container System includes the container base, lid, safety cover, filters and other accessories.
Indications for Use
The CODMAN QUAD-LOCK Sterilization Container System is indicated for use by hospitals and by health care facilities to:
- · organize and protect stainless steel, aluminum, plastic and silicone surgical instruments that will be sterilized
- · allow sterilization of the contained instruments by prevacuum steam sterilization (validated parameters shown in Table 1)
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స్థ
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• maintain the sterility of the contents for up to 180 days during storage and transport within the health care facility, as long as the integrity of the container has not been compromised
The system has not been tested for maintenance of sterility after transportation outside the health care facility.
The system is intended for use with stainless steel, aluminum, titanium, plastic and silicone surgical instruments.
| Lumen innerdiameter | 3mm or larger |
|---|---|
| Lumen length | 400mm or less (medium andlarge size containers)250mm or less (small sizecontainers) |
| Quantity | Up to 4 lumen instruments percontainer |
| The system is not intended for the sterilization ofendoscopes. |
For effective sterilization and drying of any size CODMAN QUAD-LOCK Sterilization Container, the recommended maximum combined weight of the single container, lid, basket/tray and basket/tray contents is 25 lb. (11.3 kg).
| Table 1 | |||
|---|---|---|---|
| Sterilization Parameters | |||
| Cycle Type | Temperature | Exposure Time | Dry Time |
| Prevacuum | 132°C | 4 minutes | 30 minutes |
The Codman® Quad-Lock™ Sterilization Container Systems can be stacked during sterilization with up to three containers.
Technological Characteristics
The technological characteristics of this device, including design and materials, are identical to the predicate device, Codman® Sterilization Container (K092437).
Non-Clinical Performance Testing
Testing has been completed and supports the safety and effectiveness of the proposed device for its proposed intended uses.
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Clinical Performance Testing
The intention of this Traditional 510(k) is to expand the cleared Indications for Use for the Codman® Quad-Lock™ Sterilization Container Systems. The Codman Quad-Lock Sterilization Container Systems were originally cleared by the FDA on March 25, 2010 under 510(k) K092437. There were no Clinical Tests performed.
Statement of Substantial Equivalence
The Codman® Quad-Lock™ Sterilization Container Systems are substantially equivalent to the Codman® Sterilization Container (K092437) based on similarities in intended use, design, principles of operation, and performance specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a single horizontal bar. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Megan Herman Regulatory Affairs Specialist Codman & Shurtleff, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767-0350
APR. 6 2012
Re: K120117
Trade/Device Name: Codman® Quad-Lock™ Sterilization Container Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap. Regulatory Class: II Product Code: KCT Dated: March 21, 2012 Received: March 22, 2012
Dear Ms. Herman:
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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Page 2- Ms. Herman
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Codman® Quad-Lock™ Sterilization Container Systems
Indications for Use
510(k) Number:
Device Name: Codman® Quad-Lock™ Sterilization Container Systems
Indications For Use:
The CODMAN QUAD-LOCK Sterilization Container System is indicated for use by hospitals and by health care facilities to:
· organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments that will be sterilized
· allow sterilization of the contained instruments by prevacuum steam sterilization (validated parameters shown in Table 1)
• maintain the sterility of the contents for up to 180 days during storage and transport within the health care facility, as long as the integrity of the container has not been compromised
The system has not been tested for maintenance of sterility after transportation outside the health care facility.
The system is intended for use with stainless steel, aluminum, titanium, plastic and silicone surgical instruments.
| Lumen innerdiameter | 3mm or larger |
|---|---|
| Lumen length | 400mm or less (medium andlarge size containers)250mm or less (small sizecontainers) |
| Quantity | Up to 4 lumen instruments percontainer |
| The system is not intended for the sterilization of | endoscopes. |
For effective sterilization and drying of any size CODMAN QUAD-LOCK Sterlization Container, For enective stemization and crying of any of any of the single container, lid, basket/tray and basket/tray contents is 25 lb. (11.3 kg).
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| Table 1Sterilization Parameters | |||
|---|---|---|---|
| Cycle Type | Temperature | Exposure Time | Dry Time |
| Prevacuum | 132°C | 4 minutes | 30 minutes |
The Codman® Quad-Lock™ Sterilization Container Systems can be stacked during sterilization with up to three containers.
Codman® Quad-Lock™ Sterilization Container Systems consists of a basket, container base, Oodman "Quad EUR" - Stonification Security lids, filters, security seals, labels, ergonomic hand wire bace, processories. The following tables give a complete list of available products:
FILTER BOTTOM Container Base
| Product Code | Height |
|---|---|
| Full Length | |
| 508726 | 100mm (4 inch) |
| 508727 | 135mm (5 inch) |
| 508728 | 150mm (6 inch) |
| 508729 | 200mm (8 inch) |
| 508730 | 260mm (10 inch) |
| Product Code | Height |
| Three Quarter Length | |
| 508736 | 100mm (4 inch) |
| 508737 | 135mm (5 inch) |
| 508738 | 150mm (6 inch) |
| Product Code | Height |
| Half Length | |
| 508731 | 100mm (4 inch) |
| 508732 | 135mm (5 inch) |
| 508733 | 150mm (6 inch) |
| 508734 | 200mm (8 inch) |
| 508735 | 260mm (10 inch) |
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SOLID BOTTOM Container Base
| Product Code | Height |
|---|---|
| Full Length | |
| 508739 | 100mm (4 inch) |
| 508740 | 135mm (5 inch) |
| 508741 | 150mm (6 inch) |
| 508742 | 200mm (8 inch) |
| 508743 | 260mm (10 inch) |
| Product Code | Height |
| Three-Quarter Length | |
| 508749 | 100mm (4 inch) |
| 508750 | 135mm (5 inch) |
| 508751 | 150mm (6 inch) |
| Product Code | Height |
| Half Length | |
| 508744 | 100mm (4 inch) |
| 508745 | 135mm (5 inch) |
| 508746 | 150mm (6 inch) |
| 508747 | 200 (8 inch) |
| 508748 | 260 (10 inch) |
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Filter Lids
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| Product Code | Color |
|---|---|
| Full Length | |
| 508944 | Grey |
| 508945 | Yellow |
| 508946 | Green |
| 508947 | Blue |
| 508948 | Red |
| 508949 | Black |
| Product Code | Color |
| Three-Quarter Length | |
| 508956 | Grey |
| 508957 | Yellow |
| 508958 | Green |
| 508959 | Blue |
| 508960 | Red |
| 508961 | Black |
| Product Code | Color |
| Half Length | |
| 508950 | Grey |
| 508951 | Yellow |
| 508952 | Green |
| 508953 | Blue |
| 508954 | Red |
| 508955 | Black |
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Security Lids
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| Product Code | Color |
|---|---|
| Full Length | |
| 508869 | Grey |
| 508870 | Yellow |
| 508871 | Green |
| 508872 | Blue |
| 508873 | Red |
| 508874 | Black |
| Product Code | Color |
| Three Quarter Length | |
| 508881 | Grey |
| 508882 | Yellow |
| 508883 | Green |
| 508884 | Blue |
| 508885 | Red |
| 508886 | Black |
| Product Code | Color |
| Half Length | |
| 508875 | Grey |
| 508876 | Yellow |
| 508877 | Green |
| 508878 | Blue |
| 508879 | Red |
| 508880 | Black |
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Basket Configurations
ﻣﮩﻤﺎﺭ
| Product Code | Height |
|---|---|
| Full Length | |
| 508500 | 30mm (1 inch) |
| 508501 | 50mm (2 inch) |
| 508502 | 70mm (3 inch) |
| 508503 | 100mm (4 inch) |
| Three Quarter Length | |
| 508508 | 30mm (1 inch) |
| 508509 | 50mm (2 inch) |
| 508510 | 70mm (3 inch) |
| 508511 | 100mm (4 inch) |
| Half Length | |
| 508504 | 30mm (1 inch) |
| 508505 | 50mm (2 inch) |
| 508506 | 70mm (3 inch) |
| 508507 | 100mm (4 inch) |
Wire Base Configurations
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| Product Code | Length | Height |
|---|---|---|
| 508512 | Half | 26mm (1 inch) |
| 508513 | Three-Quarter | 26mm (1 inch) |
| 508514 | Full | 26mm (1 inch) |
Protective Mat Configurations
| Product Code | Length |
|---|---|
| 508550 | Half |
| 508551 | Three-Quarter |
| 508552 | Full |
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Accessories
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| ProductCode | Description |
|---|---|
| 509018 | Holding Pin for Divider - 1 Each (Use with 509026 to 509029) |
| 509019 | Holding Pin for Instruments 26mm (1 inch) (1 Each) |
| 509020 | Basket Handle Tag (1 Each) |
| 509021 | Spring Clip 7mm - 12mm ( $\frac{1}{4}$ inch - $\frac{1}{2}$ inch) |
| 509022 | Spring Clip 12mm - 16mm ( $\frac{1}{2}$ inch - $\frac{3}{4}$ inch) |
| 509023 | Spring Clip 16mm - 26mm ( $\frac{3}{4}$ inch - 1 inch) |
| 509024 | Spring Clip 26mm - 36mm (1 inch - 1 $\frac{1}{2}$ inch) |
| 509025 | Spring Clip 36mm - 45mm (1 $\frac{1}{2}$ inch - 1 $\frac{3}{4}$ inch) |
| 509026 | Divider 50mm x 20mm (2 inch x $\frac{3}{4}$ inch) (Use with two 509018) |
| 509027 | Divider 130mm x 20mm (5 inch x $\frac{3}{4}$ inch) (Use with two 509018) |
| 509028 | Divider 225mm x 20mm (9 inch x $\frac{3}{4}$ inch) (Use with two 509018) |
| 509029 | Divider 460mm x 20mm (18 inch x $\frac{3}{4}$ inch) (Use with two 509018) |
| 509030 | Polymer Spacer - 1 Each (Use with 509031 and 509032) |
| 509031 | Sliding Rail for Polymer Spacer 230mm (9 inch) (Use with 509030) |
| 509032 | Sliding Rail for Polymer Spacer 470mm (18 $\frac{1}{2}$ inch) (Use with 509030) |
| 509033 | Limiting Bar 230mm (9 inch) (Screws to Basket) |
| 509034 | Limiting Bar 470mm (18 $\frac{1}{2}$ inch) (Screws to Basket) |
| 509035 | Spiral Holding Device - Double 230mm (9 inch) (Screws to Basket) |
| 509036 | Spiral Holding Device - Single 130mm (5 inch) (Screws to Basket) |
| 509037 | Limiting Bar Right Angle 110mm (4 $\frac{1}{2}$ inch) (Screws to Basket) |
| 509038 | Limiting Bar Right Angle 170mm (6 $\frac{1}{2}$ inch) (Screws to Basket) |
| 509039 | Limiting Bar Right Angle 230mm (9 inch) (Screws to Basket) |
| 509040 | Limiting Bar Right Angle 470mm (18 $\frac{1}{2}$ inch) (Screws to Basket) |
| 509041 | Spiral Divider with Limiting Bar 130mm x 230mm (5 inch x 9 inch) |
| 509042 | Spiral Divider - Double 230mm (9 inch) (Use with 509018) |
| 509043 | Spiral Divider - Single 130mm (5 inch) (Use with 509018) |
| 509100 | Universal Rongeur Instrument Holder |
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Ergonomic Silicone Hand Grips (Pair)
| Product Code | Length |
|---|---|
| 509012 | Red |
| 509013 | Blue |
| 509014 | Green |
| 509015 | Yellow |
| 509016 | Grey |
| 509017 | Black |
Aluminum Name Plates (1 Each)
| Product Code | Length |
|---|---|
| 509000 | Red |
| 509001 | Blue |
| 509002 | Green |
| 509003 | Yellow |
| 509004 | Grey |
| 509005 | Black |
Single Use Products
| Product Code | Description | Quantity |
|---|---|---|
| 509006 | Paper Label with Indicator (small) | 250 |
| 509007 | Paper Label with Indicator (large) | 250 |
| 509008 | Security Seal Single-Use Only - Blue | 100 |
| 509010 | Filter - Single-Use Only | 1000 |
| 509044 | Filter Retention Disc | 1 |
Olahie langulur
(Division Sign-Off) 4/13/12
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K120117 510(k) Number:
{13}------------------------------------------------
510(k) Premarket Notification
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
.
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).