(167 days)
Not Found
No
The device description and intended use focus on a physical sterilization container system and its compatibility with sterilization systems. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is a sterilization container used to maintain the sterility of other medical devices, not to directly treat a medical condition.
No
This device is a sterilization container system used to hold other medical devices for sterilization and storage, not for diagnosing medical conditions.
No
The device description clearly states the device is a physical container system made from aluminum and polypropylene, indicating it is a hardware device, not software.
Based on the provided text, the Aesculap Sterilcontainer S is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider." It's about sterilizing and maintaining the sterility of other medical devices.
- Device Description: The description focuses on the physical container and its materials, designed for sterilization and storage.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide medical information. The Aesculap Sterilcontainer S's function is entirely related to the sterilization and storage of other medical instruments.
N/A
Intended Use / Indications for Use
The Aesculap Sterilcontainer is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the V-PRO 1 and V-PRO 1 Plus Systems. The Sterilcontainer S System includes accessories such as silicon mats, baskets, trays, and racks.
The Aesculap Sterilcontainer S is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the V-PRO 1 and V-PRO Plus Systems.
The Sterilcontainer S is recommended for surface and lumens:
≥ 1mm internal diameter and ≤ 125 mm in length > 2mm internal diameter and
§ 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
Aesculap Sterilcontainer S for PRO 1 & V-PRO Plus Systems
2093649/5001
Page 1 of 2
ﺎ
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
| | Aesculap Sterilcontainer S for
V-PRO 1 and V-PRO 1 Plus
November 24, 2009 | | MAY 11 2010 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|--|-------------|
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 | | |
| CONTACT: | Kathy A. Racosky
610-984-9291 (phone)
610-791-6882 (fax) | | |
| TRADE NAME: | Aesculap Sterilcontainer S | | |
| COMMON NAME: | Sterilization Container Wrap | | |
| CLASSIFICATION NAME: | Wrap, Sterilization | | |
| REGULATION NUMBER: | 880.6850 | | |
| PRODUCT CODE: | FRG | | |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the SterilContainer S is substantially equivalent to:
- . Aesculap STERRAD 100S Compatiable Sterilcontainer (K040865).
DEVICE DESCRIPTION
The Aesculap Sterilcontainer S is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with the V-PRO 1 and V-PRO 1 Plus sterilization systems. The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.
INDICATIONS FOR USE
The Aesculap Sterilcontainer is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the V-PRO 1 and V-PRO 1 Plus Systems. The Sterilcontainer S System includes accessories such as silicon mats, baskets, trays, and racks.
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TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s)}
The Aesculap Sterilcontainer S is compatible for use in V-PRO 1 and V-PRO 1 Plus Systems. The Sterilcontainer is offered in similar shapes and sizes as the predicate devices. The material used for the V-PRO 1 and V-PRO 1 Plus Compatible Aesculap Sterilcontainer S is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Aesculap Sterilcontainer S was completed. The Aesculap Steriicontainer S was fully validated for V-PRO 1 and V-PRO 1 Plus Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three wavy lines extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 1 2010
Ms. Kathy Racosky Regulatory Affairs Specialist Aesculap, ® Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K093649
Trade/Device Name: Aesculap Sterilcontantainer S Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: April 22, 2010 Received: April 23, 2010
Dear Ms. Kathy Racosky:
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. Kathy Racosky
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 vours.
Susan Ruaren
for
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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K0936049/s001
A. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: Aesculap Sterilcontainer S
Indication for Use:
The Aesculap Sterilcontainer S is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the V-PRO 1 and V-PRO Plus Systems.
The Sterilcontainer S is recommended for surface and lumens:
≥ 1mm internal diameter and ≤ 125 mm in length > 2mm internal diameter and