(233 days)
No
The 510(k) summary describes a reusable sterilization container system and its accessories. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The device's function is purely mechanical and related to sterilization and storage.
No.
The device is a sterilization container system used to enclose other medical devices for sterilization and maintain their sterility, not to treat a disease or condition itself.
No
The device is a sterilization container system used to hold other medical devices for sterilization and to maintain their sterility. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components made of anodized aluminum and stainless steel, indicating it is a hardware device, not software-only.
Based on the provided text, the Aesculap SterilContainer System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description focuses on the physical characteristics of the container system and its compatibility with different sterilization methods. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health
- Reagents or assays
The Aesculap SterilContainer System is a medical device used in the process of preparing other medical devices for use, specifically sterilization and storage. It does not perform any diagnostic function.
N/A
Intended Use / Indications for Use
The Aesculap SterilContainer System 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 for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
Product codes
KCT
Device Description
The Aesculap SterilContainer is designed as a container system that will allow for sterilization and storage of other medical devices. "This system consists of full, three-quarter, half, quarter, and extra long and wide body container system. They include mats, baskets, trays, holders, organizers, also available for this container system. This container is designed to be compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO. This system is manufactured primarily in anodized aluminum and has stainless steel handles on each end.
There are two types of lids for the container bottom. There are anodized aluminum lids that have removable retention plates to hold the filter in place and have a stainless steel latch on each end. There are also Prime Line lids available for use of the lid. These PrimeLine lids lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. There are also PrimeLine lids available for use of the lid lock the lid only to the container bottom. The PrimeLine lids have a reusable filter system. The reusable filter is also for use in Pre-vac steam and Immediate Use steam sterilization only.
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
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Aesculap SterilContainer was completed on this new three-quarter size 8" (187mm) for purposes of the worst case vent to volume ratio of the SterilContainer System making this container the most challenging container to achieve sterilization. The Aesculap SterilContainer was fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes. These validations were conducted in accordance with FDA and ETO/Ethylene Oxide AAMI standards by a qualified testing laboratory. This performance testing demonstrates substantial equivalence to the predicate devices.
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 Aesculap SterilContainer was completed on this new three-quarter size 8" (187mm) for purposes of the worst case vent to volume ratio of the SterilContainer System making this container the most challenging container to achieve sterilization. The Aesculap SterilContainer was fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes. These validations were conducted in accordance with FDA and ETO/Ethylene Oxide AAMI standards by a qualified testing laboratory. This performance testing demonstrates substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073168, K053389, K944864, K792558
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Page 1 of 4
510(k) SUMMARY (as required by 21 CFR 807.92) B.
MAY - 4 2012
Aesculap SterilContainer for PreVac Steam, Immediate Use Steam, and EtO Sterilization September 12, 2011
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Denise R. Adams
610-984-9076 (phone)
denise.adams@aesculap.com
610-791-6882 (fax) |
| TRADE NAME: | Aesculap SterilContainer |
| COMMON NAME: | Sterilization Container Wrap |
| CLASSIFICATION NAME: | Wrap, Sterilization |
| REGULATION NUMBER: | 880.6850 |
| PRODUCT CODE: | KCT |
SUBSTANTIAL EQUIVALENCE
Aesculap, Inc. believes that the SterilContainer is substantially equivalent to:
- Aesculap PrimeLine Container (K073168) .
- Aesculap SterilContainer System (Flash Indication) (K053389) �
- Aesculap PriMed Rigid Container System (K944864) .
- Aesculap Container System (K792558) .
DEVICE DESCRIPTION
The Aesculap SterilContainer is designed as a container system that will allow for sterilization The Aesculap StelliContainer is designed as a sommittee of full, three-quarter, half, quarter, and storage of other medical devices. "This cystem bolights. There are a variety of accessories extra long and wide body container system. They include mats, baskets, trays, holders, organizers, also available for this container byetem. This container is designed to be compatible for filiers, findcator Cards and tamper proof for the se steam and Ethylene Oxide (EO)
use in pre-vacuum steam, pre-vacuum immediate use steam and beso sta use in pre-vacuum steam, pre-vaoually in modiate as a sub-dized aluminum and has stainless steel handles on each end.
There are two types of lids for the container bottom. There are anodized aluminum lids that There are two types of hids for the ochtainer becess steel latch on each end nave removable relemion plates to noid the mere as o Prime Line lids available for use of the lid lock the lid only the container bottom. There are that in the sommonly known
1
as Radel R. The PrimeLine lids have a reusable filter system. The reusable filter is ao Hadol Ri Pre-vac steam and Immediate Use steam sterilization only.
INDICATIONS FOR USE
The Aesculap SterilContainer System 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 for 360 days. The InterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
niters, indicator cards and tamper proch looks.
The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) r ho ooncalner oyoten of three-quarter size aluminum or PrimeLine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use differ (US751, US994), a single use polypropylene filter (MD344), and a reusable PTFE filter paper liker (UST) , USB 17) a cligidated for 2200 uses. There are a variety of accessories for use (ortood). The rousebile in Please refer to the chart on the next page for sterilization compatibility of the container system.
Validated Sterilization Cycle Parameters
AAMI and AORN guidances recommend maximum load weights of 25 pounds or less in the healthcare setting. testing has been conducted
| 360 days of event related shelf life testing has been conducted. | |||||
|---|---|---|---|---|---|
| Sterilization | |||||
| Cycle | |||||
| Parameters | PrimeLine Lid | ||||
| w/ JP050 filter | Aluminum Lid | Filter | Bottom | Max No. of Lumens/ | |
| Lumen Configuration | |||||
| Immediate Use | |||||
| (Non porous) | |||||
| 270°F Temp, | |||||
| 3 min. Exposure | |||||
| Stacking not | |||||
| recommended | JP011, JP012, | ||||
| JP013, JP014, | |||||
| JP015, JP016, | |||||
| JP017 | JK785, JK786, | ||||
| JK787, | |||||
| JK788,JK789 | US751 | ||||
| US994 | |||||
| MD344 | |||||
| JK090 | JK744 | ||||
| Immediate Use | |||||
| (Porous) | |||||
| 270°F Temp, | |||||
| 4 min. Exposure | |||||
| Stacking not | |||||
| recommended | JP011, JP012, | ||||
| JP013, JP014, | |||||
| JP015, JP016, | |||||
| JP017 | JK785, JK786, | ||||
| JK787, | |||||
| JK788,JK789 | US751 | ||||
| US994 | |||||
| MD344 | |||||
| JK090 | JK744 | 1 lumen with ≥ 3mm I.D. | |||
| x ≤ 400mm L and a | |||||
| second lumen ≥ 3.8mm | |||||
| I.D. x ≤ 370mm L | |||||
| Pre-vacuum | |||||
| 270°F Temp, | |||||
| 4min.Exposure, | |||||
| 30 min. Dry time | |||||
| Stacking should | |||||
| not exceed 18" in | |||||
| height | JP011, JP012, | ||||
| JP013, JP014, | |||||
| JP015, JP016, | |||||
| JP017 | JK785, JK786, | ||||
| JK787, | |||||
| JK788,JK789 | US751 | ||||
| US994 | |||||
| MD344 | |||||
| JK090 | JK744 | ||||
| JN744 | 1 lumen with ≥ 3mm I.D. | ||||
| x ≤ 400mm L and a | |||||
| second lumen ≥ 3.8mm | |||||
| I.D. x ≤ 370mm L | |||||
| Ethylene Oxide | |||||
| 130° F temp, | |||||
| 60 min exposure | |||||
| ≥ 50% Relative | |||||
| Humidity | |||||
| 725 mg/L gas | |||||
| pressure | |||||
| Stacking not | |||||
| recommended | JK785, JK786, | ||||
| JK787, | |||||
| JK788,JK789 | US751 | ||||
| US994 | JK744 | ||||
| JN744 | 1 lumen with ≥ 3mm I.D. | ||||
| x ≤ 400mm L and a | |||||
| second lumen ≥ 3.8mm | |||||
| I.D. x ≤ 370mm L |
2
| Accessories | Pre-vac
Steam | Immediate Use Steam | EtO |
|----------------------------------------------------------------------------------------------------------|------------------|---------------------|-----|
| Stainless Steel baskets, basket lids and
dividers | X | X | X |
| Instrument Organization System (Silicone
and Stainless Steel racks, brackets, holders,
and clamps) | X | X | X |
| Silicone mats | X | X | X |
| Stainless Steel racks, trays, holders, clamps,
brackets and platforms | X | X | X |
TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s))
The Aesculap SterilContainer is compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO. These SterilContainers are a similar shape and size as the immodiate devices. The material used is the same as that used to manufacture the predicate devices. The new three-quarter size eight inch (187mm) container is exactly the same as the dontainers that received clearance in K944864, K053389, and K073168 with the exception of its size. This container represents the worst case vent to volume ratio for the SterilContainer System.
| Device/
System | Aesculap
SterilContainer
w/ Aluminum
Lid and
*PrimeLine Lid | Aesculap
PrimeLine
Container | Aesculap
SterilContainer
(Flash) | Aesculap
PriMed
Rigid
Container
System | Aesculap
Container
System |
|------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------|----------------------------------------------------|---------------------------------------------------|
| 510(k) | K112671 | K073168 | K053389 | K944864 | K792558 |
| Sterilization
Processes | Pre-vac steam,
Immediate
Use Pre-vac
steam &
EtO | Pre-vac steam,
Immediate Use
Pre-vac steam | Immediate Use
steam | Gravity
steam,
High-
vacuum
steam, EtO | Pre-vac
steam, EtO |
| Material | Anodized
Aluminum/Radel
R | Anodized
Aluminum/Radel
R | Anodized
Aluminum | Anodized
Aluminum/
JADEX | Anodized
Aluminum |
| Worst case
Vent to
Volume
Ratio | .41 | .49 | .68 | .59 | Not
available |
| Filter | Single use
paper filter,
*single use
polypropylene
filter, *reusable
filter | Reusable filter | Single use
paper filter | Single use
paper filter | Single use
paper filter,
reusable
filter |
| Shelf-life/
Barrier | 360 days (event
related) | 360 days (event
related) | N/A | Not
defined | Not defined |
| Reuse
testing | 100 cycles
minimum | 100 cycles
minimum
(bottom)/ 2,200
cycles (lid) | 100 cycles
minimum | 100 cycles
minimum | 100 cycles
minimum |
| Max total
weight | 25 pounds | 35 pounds | 35 pounds | 25 pounds | 35 pounds |
*The PrimeLine lid, polypropylene fiter, and the reusable filter are not for use in EtO sterliization
3
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Aesculap SterilContainer was completed on this new three-quarter size 8" (187mm) for Acounty of the worst case vent to volume ratio of the SterilContainer System making this container the most challenging container to achieve sterilization. The Aesculap SterilContainer was fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes. These validations were conducted in accordance with FDA and Eto othillable AAMI standards by a qualified testing laboratory. This performance testing demonstrates substantial equivalence to the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring. MD 20993-0002
Ms. Denise Adams Regulatory Affairs Specialist Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
MAY - 4 2012
Re: K112671
. '
Trade/Device Name: Aesculap SterilContainer System Regulation Number: 21 CFR 880.6850 . Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 23, 2012 Received: April 25, 2012
Dear Ms. Adams:
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.
5
Page 2 - Ms. Adams
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,
Ph From
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
6
INDICATIONS FOR USE STATEMENT A.
510(k) Number:_ K112671
Device Name: Aesculap SterilContainer System
Indications for Use:
The Aesculap SterilContainer System is a reusable sterilization container system intended to be I he resource 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 for 360 days. The Interiable to allett stories accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) r he ountainer cyclem ocheles overter size aluminum or PrimeLine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use unner filter (US751, US994), a single use polypropylene filter (MD344), and a reusable PTFE filter (JK090). The reusable PTFE is validated for 2200 uses. There are a variety of accessories for use with the container system. Please refer to the chart on the next page for sterilization compatibility of the container system.
and/or Over-the-Counter Use __ × Prescription Use_ (per 21 CFR 801 Subpart C) (per 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Elishatt F. Clavine- Will
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: