(180 days)
Not Found
No
The description focuses on the physical properties and function of a filter for sterilization containers, with no mention of AI or ML technologies.
No
The device is a filter for a sterilization container, designed to maintain a sterile barrier. It does not directly treat or diagnose a disease or condition in a patient.
No
This device is a filter used in a sterile container system for prevacuum steam sterilization. It is designed to maintain sterility by acting as a barrier against microbial contamination, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a PTFE filter, which is a physical component, not software.
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 filter is for use with a sterile container in prevacuum steam sterilization. This process is for sterilizing medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the filter's function in allowing sterilant penetration and evacuation while maintaining a microbial barrier. This is related to sterilization, not diagnostic testing.
- 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 used to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device's function is entirely separate from that.
N/A
Intended Use / Indications for Use
Aesculap's Reusable Sterile Container Filter is a PTFE (Polytetrafluoroethylene) filter that allows for thorough penetration and evacuation of the sterilant (steam), while maintaining an effective barrier against microbial contamination for a maximum of 2,200 uses. This filter is for use with the Aesculap SterilContainer in prevacuum steam sterilization.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
Aesculap's Reusable Sterile Container Filters allows for thorough penetration and evacuation of sterilants, while maintaining an effective barrier against microbial contamination. The Ulters are circular in shape and can be used for up to 2,200 washing and sterlilization cycles. Aesculages Reusable filters are to be used in conjunction with Aesculan's Sterilcontainer System (K792558).
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
Not Found
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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
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
DEC 1 3 2004
Image /page/0/Picture/3 description: The image shows a handwritten string of characters. The string appears to be "K041623". The characters are written in black ink on a white background. The handwriting is somewhat messy and the characters are not perfectly aligned.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
REUSABLE STERILECONTAINER FILTER
14 June 2004
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|---------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull
Requlatory Affairs Manager
800-258-1946 (phone) x5072
610-791-6882 (fax) |
| TRADE NAME: | Aesculap Reusable Sterilecontainer Filter |
| COMMON NAME: | Reusable Filter |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | FRG |
| CLASSIFICATION: | 880.6850 - Sterilization Wrap |
| REVIEW PANEL: | General Hospital and Personal Use Devices |
INTENDED USE
Aesculap's Reusable Sterile Container Filter is a PTFE (Polytetrafluoroethylene) filter that allows for thorough penetration and evacuation of the sterilant (steam), while maintaining an effective barrier against microbial contamination for a maximum of 2,200 uses. This filter is for use with the Aesculap SterilContainer in prevacuum steam sterilization.
DEVICE DESCRIPTION
Aesculap's Reusable Sterile Container Filters allows for thorough penetration and evacuation of sterilants, while maintaining an effective barrier against microbial contamination. The Ulters are circular in shape and can be used for up to 2,200 washing and sterlilization cycles. Aesculages Reusable filters are to be used in conjunction with Aesculan's Sterilcontainer System (K792558).
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
SUBSTANTIAL EQUIVALENCE
Aesculap believes that the Reusable Sterilcontainer Filter (when used in the Aesculap Stericontainer System) is substantially equivalent in its intended use, function, and basic operating principles to the following predicate devices:
- Aesulap's Sterilcontainer System (K792558) .
- Johnson & Johnson's Sterion container (K850289) .
- Medline's Steriset container (K010825) .
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2004
Mr. Matthew M. Hull Regulatory Affairs Manager Aesculap, Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K041623
Trade/Device Name: Reusable Sterilcontainer Filter Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 12, 2004 Received: November 15, 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.
2
Page 2 -- Mr. Hull
Please be advised that FDA's issuance of a substantial equivalence determination does not I tease to act rised that that your device complies with other requirements mount that I Drima may Federal statutes and regulations administered by other Federal agencies. or the Act of any I oderal bike Act's requirements, including, but not limited to: registration r ou interesting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 er read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) Frins fotor will and in JOThe Sognifial equivalence of your device of your device to a premaired news are 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), rl you donto 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,
Qur
Shia-Lien, Ph.D.
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
3
Reusable Sterilcontainer Filter
510(k) Premarkel Notification
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Reusable Sterilcontainer Filter
Indications for Use:
Indications for Use:
Aesculap's Reusable Steriloontainer Filter (JK090) is a PTFE (Polytetrafilurrethylene) filter Aesculap's Reusable Sterilon and evecuation of the steriliant (steriland (steam.
that allows for thorough penetration and evecuation of the sterilent (steam Assedaps steasure over against microbial contamination for a maximum of 2,200
that allows for thorough peneration for maximum of 2,200
maintaining an effective barins that alows for thereegy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - uses. This filter is for uses at 273° F.
sterilization cycle for 5 minutes at 273° F.
× Over-the-Counter Use or Prescription Use_
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED)
CONTINUE OF THE Office of Device Evaluation (ODE) (PLEASE DO NOT WRITE BECOW THIS LINE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Senette Michie ms.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
(Optional Formal 3-10-98)