(302 days)
Not Found
No
The device is a rigid sterilization container system, a physical container for sterilizing other medical devices. The description focuses on its physical characteristics, sterilization process validation, and comparison to a predicate device, with no mention of software, algorithms, or AI/ML capabilities.
No.
This device is a sterilization container system intended to hold other medical devices for sterilization, storage, and transport, not to provide therapeutic treatment itself.
No
This device is a sterilization container system designed to hold other medical devices for sterilization, storage, and transport, not to diagnose medical conditions or analyze patient data.
No
The device description clearly outlines physical components such as container bottoms, lids, baskets, labels, and disposable filters, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "containing other medical devices that are to be sterilized" and for "sterilization of the enclosed medical devices." It is a sterilization packaging system.
- Device Description: The description details the components of a rigid sterilization container system, including bottoms, lids, baskets, labels, and filters. These are all components related to the physical containment and sterilization of medical devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used on patient samples, not on other medical devices for sterilization.
The device's function is to facilitate the sterilization and storage of other medical devices, which falls under the category of a general medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The studies conducted on the SklarLite™ Rigid Sterilization Container System demonstrate that the device is substantially equivalent to the Miltex Rigid Sterilization Containers (K050570).
VALIDATION TESTING: Pre-vacuum steam - Yes; Load - Up to 25 lbs. for all container sizes.
TEST ORGANISMS: Inoculated Lumens - (2) 2.4mm I.D. x 380mm, metal for Full- and Mid-Size container models. (2) 1.0mm I.D. x 250mm, metal for Half-Size container models. Inoculated Stainless Steel Medical Devices - Yes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 containing | ||
| instruments to be sterilized in vacuum | ||
| 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 | ||
| entry of sterilant agents | Yes | Yes |
| Incorporates a filter system to prevent | ||
| microbial 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 AAMI | ||
| standards | Conforms to | |
| AAMI/ANSI | ||
| ST77:2006 standard | Conforms to | |
| AAMI/ANSI ST77 | ||
| Draft |
| VALIDATION TESTING | ||
|---|---|---|
| Pre-vacuum steam | Yes | Yes |
| Load | Up to 25 lbs. for all | |
| container 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. x | |
| 380mm, metal for | ||
| Full-and-Mid-Size | ||
| container models. | ||
| (2) 1.0mm I.D. x | ||
| 250mm, metal for | ||
| Half-Size container | ||
| models. | 3mm I.D. x 400mm, | |
| metal (large | ||
| containers) and 3mm | ||
| I.D. x 200mm, metal | ||
| (medium and small | ||
| containers) | ||
| Inoculated Stainless Steel Medical | ||
| 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).
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 Containers | |||
| Basic/Safe Models | Perforated Lid and | ||
| 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 | |||
| 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 | |||
| Basic/Safe Models | Perforated Lid and | ||
| 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 | |||
| 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 | |||
| Basic/Safe Models | Perforated Lid and | ||
| 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 | |||
| 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 |