SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM

K091720 · Sklar Corp. · KCT · Apr 9, 2010 · General Hospital

Device Facts

• Record ID: K091720
• Device Name: SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM
• Applicant: Sklar Corp.
• Product Code: KCT · General Hospital
• Decision Date: Apr 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The SklarLite™ Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. Containers allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270°F for 4 minutes with 30 minutes (minimum) dry time. The containers have been validated for sterilization of up to two instruments with lumens no smaller than 2.4 mm I.D. in diameter and no longer than 380 mm in length for the Full-Size (580mm x 280mm) and Mid-Size (465mm x 280mm) containers, and no smaller than 1.0 mm I.D. in diameter and no longer than 250 mm in length for the Half-Size (285mm x 280mm) containers have been validated for a combined maximum load of 25lbs. with up to two internal stacked baskets and up to two silicon mats (one mat per basket) for the Full-Size, Mid-Size and Half-Size containers. Both solid and perforated bottom containers, maximum depth 150mm/each, can be stacked a maximum of 3 containers high during sterilization. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the contents for up to six (6) months.

Device Story

SklarLite™ Rigid Sterilization Container System; reusable, stackable, sealed containers for medical device sterilization. Components: container bottoms (perforated/non-perforated), lids, baskets, labels, disposable filters, security seals. Used in hospitals/healthcare facilities; operated by sterile processing staff. Input: medical devices placed inside containers. Process: high vacuum steam sterilization (270°F); sterilant enters via perforated lids/bottoms; filters prevent microbial migration. Output: sterilized, protected instruments ready for storage/transport. Benefit: maintains sterility for up to 6 months; protects instruments during handling. Healthcare providers use containers to organize, sterilize, and store surgical instrumentation.

Clinical Evidence

Bench testing only. Validation included pre-vacuum steam sterilization cycles at 270°F. Testing confirmed sterility maintenance for 6 months and successful sterilization of inoculated stainless steel medical devices and lumens (2.4mm ID x 380mm and 1.0mm ID x 250mm). Conformance to AAMI/ANSI ST77:2006 standard demonstrated.

Technological Characteristics

Materials: Anodized aluminum alloy, stainless steel, silicon. Design: Rigid, stackable, closed container system with filter-based sterilant entry and microbial barrier. Dimensions: Various sizes (Full, Mid, Half). Sterilization: High vacuum steam. Connectivity: None. Software: None.

Indications for Use

Indicated for use in hospitals and health care facilities to contain medical devices during high vacuum steam sterilization (270°F, 4 min exposure, 30 min dry time). Validated for loads up to 25 lbs, including specific lumen constraints (2.4mm ID/380mm length for Full/Mid-size; 1.0mm ID/250mm length for Half-size).

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

• Miltex Rigid Sterilization Container System (K050570)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: This image shows the logo and contact information for Sklar Instruments. The logo features a stylized image to the left of the company name, "Sklar," written in a bold, serif font. Below the logo, it says "INSTRUMENTS" in smaller, capitalized letters. The address is listed as 889 South Matlack Street, West Chester, PA 19382, followed by the phone number 610-430-3200, toll-free number 800-221-2166, fax number 610-429-0500, and website www.sklarcorp.com.

Exhibit#6 FDA 510(k) Pre-Market Notification SklarLite™ Rigid Sterilization Container System

APR - 9 2010

Exhibit 1

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K091720.

### 1. Submitter's Identification:

Sklar Instruments 889 South Matlack Street West_Chester, PA_19382 800-221-2166 Tel:

Date Summary Prepared: April 2, 2010

- Name of the Device: SklarLite" Rigid Sterilization Container System 2. Class II, Product Code KCT
- Common or Usual Name: Closed Sterilization Container 3.
- 4. Predicate Device Information : Miltex Rigid Sterilization Container System, Miltex, Incorporated, K050570

### ર. Device Description :

Rigid Sterilization Container System consists of a family of rigid, re-The SklarLite" usable, stackable, sealed containers that provide an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. Containers can be fitted with safety lids, protecting filters during storage and/or transport. The system consists of the following components:

- Container bottoms (both perforated and non-perforated versions) .
- Container lids (both perforated and non-perforated_versions)_ .
- Container baskets .
- Container labels .
- Disposable filters .

The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated. Containers are offered in six colors. Filter media and sterilization indicator cards should be used in conjunction with the containers. Containers are protected by disposable plastic security seals.

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#### 6. Intended Use:

The SklarLite™ Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. Containers allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270°F for 4 minutes with 30 minutes (minimum) dry time.

The containers have been validated for sterilization of up to two instruments with lumens no smaller than 2.4 mm I.D. in diameter and no longer than 380 mm in length for the Full-Size (580mm x 280mm) and Mid-Size (465mm x 280mm) containers, and no smaller than 1.0 mm I.D. in diameter and no longer than 250 mm in length for the Half-Size (285mm x 280mm) containers have been validated for a combined maximum load of 25lbs. with up to two internal stacked baskets and up to two silicon mats (one mat per basket) for the Full-Size, Mid-Size and Half-Size containers. Both solid and perforated bottom containers, maximum depth 150mm/each, can be stacked a maximum of 3 containers high during sterilization.

Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the contents for up to six (6) months.

### Technological Characteristics as Compared to the Predicate Device: 8.

| | Sklar System | Miltex System |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------|
| PROPERTIES | | |
| Indicated for use containing<br>instruments to be sterilized in vacuum<br>steam sterilizers | Yes | Yes |
| Intended to be re-used | Yes | Yes |
| Closed System | Yes | Yes |
| Sealed | Yes | Yes |
| DESIGN | | |
| Incorporates a filter system to permit<br>entry of sterilant agents | Yes | Yes |
| Incorporates a filter system to prevent<br>microbial migration during transport | Yes | Yes |
| MATERIALS: | | |
| Container | Anodized Aluminum<br>-Alloy-stainless-steel-<br>& silicon | Aluminum alloy,<br>stainless-steel &-<br>silicon |
| Color | Silver, yellow, red,<br>blue, green and black | Silver |

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## 9. Performance Data as Compared to the Predicate Device:

| | Sklar System | Miltex System |
|----------------------------------------------|------------------------------------------------|----------------------------------------|
| PERFORMANCE DATA | | |
| Conformance to appropriate AAMI<br>standards | Conforms to<br>AAMI/ANSI<br>ST77:2006 standard | Conforms to<br>AAMI/ANSI ST77<br>Draft |

| VALIDATION TESTING | | |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Pre-vacuum steam | Yes | Yes |
| Load | Up to 25 lbs. for all<br>container sizes. | Up to 16 lbs. (small)<br>Up to 20 lbs. (med.)<br>Up to 25 lbs. (large) |
| TEST ORGANISMS | | |
| Inoculated Lumens | (2) 2.4mm I.D. x<br>380mm, metal for<br>Full-and-Mid-Size<br>container models.<br>(2) 1.0mm I.D. x<br>250mm, metal for<br>Half-Size container<br>models. | 3mm I.D. x 400mm,<br>metal (large<br>containers) and 3mm<br>I.D. x 200mm, metal<br>(medium and small<br>containers) |
| Inoculated Stainless Steel Medical<br>Devices | Yes | Yes |

## 10. Conclusions:

The studies conducted on the SklarLite™ Rigid Sterilization Container System demonstrate that the device is substantially equivalent to the Miltex Rigid Sterilization Containers (K050570).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Sklar Corporation C/O Ms. Natalya Valerio Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

APR - 9 2010

Re: K091720

Trade/Device Name: SklarLite™ Rigid Sterilization Container System Regulation Number: 21CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 2, 2010 Received: April 5, 2010

Dear Ms. Valerio:

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. Valerio

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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 yours.

Anthony D. Anton

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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# Indications for Use

Page _________ of ____________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name:_SklarLite™ Rigid Sterilization Container System

# Indications For Use:

The SklarLite™ Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. Containers allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270°F for 4 minutes with 30 minutes (minimum) dry time

The containers have been validated for sterilization of up to two instruments with lumens no smaller than 2.4 mm I.D. in diameter and no longer than 380 mm in length for the full-Size in (580mm x 280mm) and Mid-Size (465mm x 280mm) containers, and no smaller than 102c in diameter and no longer than 250 mm in length for the Half-Size (285mm x 280mm) container. Containers have been validated for a combined maximum load of 25lbs. with us to two internal stacked baskets and up to two silicon mats (one mat per basket) for the Full-Size, Mid-Size and Half-Size containers. Both solid and perforated bottom containers, maximum deeth 1500mmean, can be stacked a maximum of 3 containers high during sterilization.

Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the contents for up to six (6) months.

Prescription Use (Per 21 CFR 801 Subpart D)

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)

(Division Sign-Off)

Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: k091720

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Image /page/6/Picture/0 description: The image shows the logo for Sklar Instruments. The logo consists of a stylized graphic to the left of the word "Sklar" in a bold, serif typeface. Below the word "Sklar" is the word "INSTRUMENTS" in a smaller, sans-serif typeface. The logo is black and white.

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# Indications for Use

Page ___ 2____ of ____________________________________________________________________________________________________________________________________________________________

The sterilization containers which are the subject of this premarket notification are as follows:

| MODEL | Perforations | Dimensions | Load Limit |
|-------------------------------------------|---------------------------------------------|-----------------|-----------------|
| Full Size Containers<br>Basic/Safe Models | Perforated Lid and<br>Non Perforated Bottom | 580 x 280 x 100 | 25 lbs. |
| | | 580 x 280 x 135 | 25 lbs |
| | | 580 x 280 x 150 | 25 lbs |
| | | 580 x 280 x 200 | 25 lbs |
| | | 580 x 280 x 260 | 25 lbs |
| | Perforated Lid and<br>Perforated Bottom | 580 x 280 x 100 | 25 lbs |
| | | 580 x 280 x 135 | 25 lbs |
| | | 580 x 280 x 150 | 25 lbs |
| | | 580 x 280 x 200 | 25 lbs |
| | | 580 x 280 x 260 | 25 lbs |
| Mid Size Containers<br>Basic/Safe Models | Perforated Lid and<br>Non Perforated Bottom | 465 x 280 x 100 | 25 lbs |
| | | 465 x 280 x 135 | 25 lbs |
| | | 465 x 280 x 150 | 25 lbs |
| | Perforated Lid and<br>Perforated Bottom | 465 x 280 x 100 | 25 lbs |
| | | 465 x 280 x 135 | 25 lbs |
| | | 465 x 280 x 150 | 25 lbs |
| Half Size Containers<br>Basic/Safe Models | Perforated Lid and<br>Non Perforated Bottom | 285 x 280 x 100 | 25 lbs |
| | | | 285 x 280 x 135 |
| | | | 285 x 280 x 150 |
| | | 285 x 280 x 200 | 25 lbs |
| | | 285 x 280 x 260 | 25 lbs |
| | Perforated Lid and<br>Perforated Bottom | 285 x 280 x 100 | 25 lbs |
| | | | 285 x 280 x 135 |
| | | | 285 x 280 x 150 |
| | | | 285 x 280 x 200 |
| | | | 285 x 280 x 260 |
| | | 600 x 400 x 180 | 25 lbs |