(302 days)
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.
The SklarLite" Rigid Sterilization Container System consists of a family of rigid, re-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.
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. The containers are validated for sterilization of enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270°F for 4 minutes with 30 minutes (minimum) dry time.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization of instruments with lumens (Full-Size/Mid-Size containers): No smaller than 2.4 mm I.D. in diameter and no longer than 380 mm in length. | 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 Full-Size (580mm x 280mm) and Mid-Size (465mm x 280mm) containers. |
| Sterilization of instruments with lumens (Half-Size containers): No smaller than 1.0 mm I.D. in diameter and no longer than 250 mm in length. | Validated for sterilization of up to two instruments with lumens no smaller than 1.0 mm I.D. in diameter and no longer than 250 mm in length for Half-Size (285mm x 280mm) containers. |
| Combined maximum load: Not exceeding 25 lbs. | Validated for a combined maximum load of 25 lbs. for Full-Size, Mid-Size, and Half-Size containers. |
| Internal stacking: Up to two internal stacked baskets and up to two silicon mats (one mat per basket). | Validated for up to two internal stacked baskets and up to two silicon mats (one mat per basket) for Full-Size, Mid-Size, and Half-Size containers. |
| Container stacking during sterilization: Maximum of 3 containers high for both solid and perforated bottom containers, maximum depth 150mm each. | Both solid and perforated bottom containers, maximum depth 150mm/each, can be stacked a maximum of 3 containers high during sterilization. |
| Maintenance of sterility: Up to six (6) months for stored and transported sterilized devices. | The container is intended to maintain sterility of the contents for up to six (6) months. |
| Conformance to appropriate AAMI standards. | Conforms to AAMI/ANSI ST77:2006 standard. |
| Pre-vacuum steam sterilization. | Yes, pre-vacuum steam sterilization was evaluated. |
| Test organisms for inoculated lumens (Full-/Mid-Size). | Test Organisms: (2) 2.4mm I.D. x 380mm, metal. |
| Test organisms for inoculated lumens (Half-Size). | Test Organisms: (2) 1.0mm I.D. x 250mm, metal. |
| Test organisms for inoculated stainless steel medical devices. | Yes, inoculated stainless steel medical devices were used. |
Study Information
-
Sample size used for the test set and the data provenance:
- The document implies that the validation testing was conducted on samples of the SklarLite™ Rigid Sterilization Container System, applying various configurations (e.g., container sizes, lumen sizes, load weights, stacking configurations). Specific numeric sample sizes for each test are not provided.
- Data Provenance: The study was conducted by Sklar Instruments for a 510(k) pre-market notification to the FDA. This indicates the testing was performed specifically for regulatory submission, likely at the manufacturer's facilities or a contracted testing lab. The data is prospective as it was gathered to prove the device's performance prior to market availability. Country of origin is the United States (Sklar Instruments is in West Chester, PA, and the FDA is in Silver Spring, MD).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a performance validation study for a medical device (sterilization container), not a diagnostic algorithm or image analysis. Therefore, the concept of "experts establishing ground truth" in the context of human interpretation of data (e.g., radiologists for images) is not applicable.
- Instead, ground truth is established through validated scientific methods and instrumentation (e.g., biological indicators, sterility testing, physical measurements of lumens and load, specific cycle parameters of sterilizers). The "truth" is whether sterilization was achieved and maintained, which is objectively measurable using established microbiological and engineering standards. The expertise would lie with microbiologists, sterilization engineers, and quality assurance personnel conducting the tests and interpreting the results according to AAMI/ANSI standards.
-
Adjudication method for the test set:
- Not applicable in the conventional sense of adjudication for intellectual tasks. Device performance testing adheres to standardized protocols and acceptance criteria (e.g., AAMI/ANSI ST77:2006). Results are typically binary (pass/fail) based on objective measurements (e.g., growth or no growth of test organisms, maintenance of mechanical integrity). Any deviations would likely be handled through standard quality control and technical review processes, rather than a panel of adjudicators.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. The device is a physical sterilization container, not an AI or diagnostic tool that involves human readers interpreting output.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical product, not an algorithm. The "standalone performance" is its ability to meet the sterilization and sterility maintenance criteria independently.
-
The type of ground truth used:
- Scientific and Objective Measurements: The ground truth for this device is based on objective, measurable scientific criteria for sterilization effectiveness and sterility maintenance. This includes:
- Biological Indicators: Confirmation of complete kill of highly-resistant microorganisms (e.g., Geobacillus stearothermophilus spores) within the most challenging locations (lumens, inside containers).
- Physical and Chemical Indicators: Monitoring of steam penetration, temperature, and duration during sterilization cycles.
- Microbiological Barrier Integrity Testing: Demonstrating that the container prevents microbial ingress over the stated sterility maintenance period.
- Mechanical Integrity Testing: Ensuring the container and its components withstand repeated sterilization cycles and handling.
- Dimensional Measurements: Verifying lumen internal diameters and lengths as well as container dimensions.
- Weight Measurements: Verifying load limits.
- Scientific and Objective Measurements: The ground truth for this device is based on objective, measurable scientific criteria for sterilization effectiveness and sterility maintenance. This includes:
-
The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device that requires a training set. The development of the container would involve design, prototyping, and iterative testing, but not in the sense of a data "training set" for an algorithm.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The design and engineering of the sterilization container would rely on established principles of sterile processing, material science, and manufacturing standards.
{0}------------------------------------------------
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.
-
- 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.
{1}------------------------------------------------
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 containinginstruments to be sterilized in vacuumsteam sterilizers | Yes | Yes |
| Intended to be re-used | Yes | Yes |
| Closed System | Yes | Yes |
| Sealed | Yes | Yes |
| DESIGN | ||
| Incorporates a filter system to permitentry of sterilant agents | Yes | Yes |
| Incorporates a filter system to preventmicrobial migration during transport | Yes | Yes |
| MATERIALS: | ||
| Container | Anodized Aluminum-Alloy-stainless-steel-& silicon | Aluminum alloy,stainless-steel &-silicon |
| Color | Silver, yellow, red,blue, green and black | Silver |
{2}------------------------------------------------
9. Performance Data as Compared to the Predicate Device:
| Sklar System | Miltex System | |
|---|---|---|
| PERFORMANCE DATA | ||
| Conformance to appropriate AAMIstandards | Conforms toAAMI/ANSIST77:2006 standard | Conforms toAAMI/ANSI ST77Draft |
| VALIDATION TESTING | ||
|---|---|---|
| Pre-vacuum steam | Yes | Yes |
| Load | Up to 25 lbs. for allcontainer sizes. | Up to 16 lbs. (small)Up to 20 lbs. (med.)Up to 25 lbs. (large) |
| TEST ORGANISMS | ||
| Inoculated Lumens | (2) 2.4mm I.D. x380mm, metal forFull-and-Mid-Sizecontainer models.(2) 1.0mm I.D. x250mm, metal forHalf-Size containermodels. | 3mm I.D. x 400mm,metal (largecontainers) and 3mmI.D. x 200mm, metal(medium and smallcontainers) |
| Inoculated Stainless Steel MedicalDevices | 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).
{3}------------------------------------------------
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.
{4}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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
{5}------------------------------------------------
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
{6}------------------------------------------------
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.
.
:
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 ContainersBasic/Safe Models | Perforated Lid andNon 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 andPerforated 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 ContainersBasic/Safe Models | Perforated Lid andNon 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 andPerforated Bottom | 465 x 280 x 100 | 25 lbs | |
| 465 x 280 x 135 | 25 lbs | ||
| 465 x 280 x 150 | 25 lbs | ||
| Half Size ContainersBasic/Safe Models | Perforated Lid andNon 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 andPerforated 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 |
§ 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).