CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM

K120117 · Codman & Shurtleff, Inc. · KCT · Apr 16, 2012 · General Hospital

Device Facts

• Record ID: K120117
• Device Name: CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
• Applicant: Codman & Shurtleff, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Apr 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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. The system is not intended for the sterilization of endoscopes.

Device Story

Sterilization container system for surgical instruments; protects and organizes stainless steel, aluminum, titanium, plastic, and silicone instruments during prevacuum steam sterilization and storage. Components include aluminum container base, lid, safety cover, filters, and various internal accessories (baskets, dividers, clips). Used in hospitals and healthcare facilities; operated by sterile processing staff. System allows stacking up to three containers during sterilization. Validated for 132°C prevacuum steam sterilization (4 min exposure, 30 min dry). Maintains sterility for 180 days post-sterilization within facility. Benefits include organized instrument handling, protection of delicate instruments, and maintained sterility during storage/transport.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Aluminum (container base, lid, safety cover), stainless steel, plastic, silicone (accessories). Design: Modular container system with filter-based ventilation. Sterilization: Prevacuum steam (132°C). Connectivity: None. Software: None.

Indications for Use

Indicated for hospitals and health care facilities to organize, protect, and sterilize stainless steel, aluminum, titanium, plastic, and silicone surgical instruments via prevacuum steam sterilization. Maintains sterility for up to 180 days during internal facility transport. Not for endoscopes. Lumen constraints: 3mm+ diameter; length 400mm or less (medium/large) or 250mm or less (small). Max 4 lumen instruments per container. Max weight 25 lb (11.3 kg).

Regulatory Classification

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.

Predicate Devices

• Codman® Sterilization Container (K092437)

Submission Summary (Full Text)

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| 510(k) Summary<br>Codman® Quad-Lock™ Sterilization Container Systems | | | | | APR 16 2012 |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------|--|--|-------------|
| Date Prepared: | January 13, 2011 | | | | |
| Company Name: | Codman & Shurtleff, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 | | | | |
| Contact Person | Megan Herman<br>Regulatory Affairs Specialist<br>Telephone Number: [phone]<br>Fax Number: [phone] | | | | |
| 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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• 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<br>diameter | 3mm or larger |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Lumen length | 400mm or less (medium and<br>large size containers)<br>250mm or less (small size<br>containers) |
| Quantity | Up to 4 lumen instruments per<br>container |
| The system is not intended for the sterilization of<br>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 | 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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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:

K120117

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 inner<br>diameter | 3mm or larger |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Lumen length | 400mm or less (medium and<br>large size containers)<br>250mm or less (small size<br>containers) |
| Quantity | Up to 4 lumen instruments per<br>container |
| 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 1<br>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.

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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| Product<br>Code | 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:

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510(k) Premarket Notification

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ X (21 CFR 807 Subpart C)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)