(248 days)
Not Found
Not Found
No
The device description and intended use clearly define a physical sterilization container system, with no mention of software, data processing, or any AI/ML related terms. The performance studies focus on sterilization efficacy and substantial equivalence to existing physical containers.
No.
This device is a sterilization container for other medical devices, not a device used to treat a medical condition in a patient.
No
The device is a sterilization container system, which is used to sterilize and maintain the sterility of other medical devices. It does not perform any diagnostic functions like detecting, monitoring, or predicting diseases or health conditions.
No
The device description clearly states it is a physical container system made from aluminum and polypropylene, designed to enclose other medical devices for sterilization and storage. It does not mention any software components.
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 a "reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider." This describes a device used in the process of sterilizing other medical devices, not a device used to perform tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the physical characteristics of the container and its compatibility with a sterilization process. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostics.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or assays
- Measurement of analytes
The device is a medical device used in the sterilization process within a healthcare setting.
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 Sterrad 1005.
Product codes (comma separated list FDA assigned to the subject device)
80 FRG
Device Description
The Sterrad Compatible Aesculap Sterilcontainer 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 Sterrad sterilization processes (100S). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.
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
healthcare provider
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)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Sterrad Compatible Aesculap Sterilcontainer was completed. Sterilization testing results demonstrate the Aesculap Sterilcontainer for Sterrad is substantially equivalent to other Sterilization Containers currently on the market.
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.
Not Found
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
DEC - 6 2004
Image /page/0/Picture/3 description: The image shows a handwritten string of characters. The string appears to be "K040866". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.
C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)
AESCULAP STERILCONTAINER FOR STERRAD
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull, RAC
800-258-1946 x 5072 (phone)
610-791-6882 (fax) |
| TRADE NAME: | Sterrad Compatible Aesculap Sterilcontainer |
| COMMON NAME: | Sterilization Container Wrap |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 80 FRG |
| CLASSIFICATION: | 880.6850 - Wrap, Sterilization |
| REVIEW PANEL: | General Hospital |
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 Sterrad 1005.
DEVICE DESCRIPTION
The Sterrad Compatible Aesculap Sterilcontainer 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 Sterrad sterilization processes (100S). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Sterrad Compatible Aesculap Sterilcontainer was completed. Sterilization testing results demonstrate the Aesculap Sterilcontainer for Sterrad is substantially equivalent to other Sterilization Containers currently on the market.
1
SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Sterrad Compatible Aesculap Sterilcontainer is Aesoulap ', inc. believes that the Stericontainers. Additionally we feel it Substantially oquivalent to the sterilization containers marketed by Allegiance Healthcare (Genesis) and Case Medical (SteriTite).
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 2004
Mr. Matthew M. Hull Regulatory Affairs Manager Aesculap, Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K040865
Trade/Device Name: Aesculap Sterrad 100S Compatible Sterilcontainer Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 11, 2004 Received: November 12, 2004
Dear Mr. Hull:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Hull
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. or the rever mply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ibuing (2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirents as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sina Qumpe
Chiu Lin, Ph.D. 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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Page 1 of 1
INDICATIONS FOR USE STATEMENT B.
510(k) Number: K040865/S2
Device Name: Aesculap Sterrad Compatible Sterilcontainer
Indication for Use:
The Aesculap Sterilcontainer is a reusable sterilization container system intended 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 Sterrad 100S.
| SterilContainer Sterrad 100S Compatible Containers | ||
|---|---|---|
| Description | Size (L"xW"xH") | Item # |
| Full Size Perforated Bottom | 23 x 11 x 4 | JM440 |
| Full Size Perforated Bottom | 23 x 11 x $5 \frac{1}{3}$ | JM441 |
| Full Size Perforated Bottom | 23 x 11 x 6 | JM442 |
| Full Size Perforated Bottom | 23 x 11 x 8 | JM444 |
| ¾ Size Perforated Bottom | $18 \frac{1}{4}$ x 11 x 4 | JM740 |
| ¾ Size Perforated Bottom | $18 \frac{1}{4}$ x 11 x $5 \frac{1}{3}$ | JM741 |
| ¾ Size Perforated Bottom | $18 \frac{1}{4}$ x 11 x 6 | JM742 |
| ½ Size Perforated Bottom | $11 \frac{1}{4}$ x 11 x 4 | JM340 |
| ½ Size Perforated Bottom | $11 \frac{1}{4}$ x 11 x $5 \frac{1}{3}$ | JM341 |
| ½ Size Perforated Bottom | $11 \frac{1}{4}$ x 11 x 6 | JM342 |
| ½ Size Perforated Bottom | $11 \frac{1}{4}$ x 11 x 8 | JM344 |
| ¼ Size Perforated Bottom with Lid | 12 x 7 x $2 \frac{1}{2}$ | JM094 |
| ¼ Size Perforated Bottom with Lid | 12 x 7 x 5 | JM096 |
| Full Size Lid | JM489 | |
| ¾ Size Lid | JM789 | |
| ½ Size Lid | JM389 | |
| ¼ Size Lid | See JM094 & JM096 |
Prescription Use or Over-the-Counter Use
X
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Smith M. Chan acting chief inc BR 12-03-04
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Den
510(k) Number: K040865