(322 days)
Not Found
No
The device description and intended use clearly define the device as a physical container for sterilization, with no mention of software, data processing, or AI/ML capabilities.
No.
The device is described as a container for sterilizing and storing other medical devices, not a device that directly provides therapy to a patient.
No
The device described is a container for sterilizing and storing other medical devices, not a diagnostic device used to identify medical conditions or diseases.
No
The device description clearly states the devices are composed of anodized aluminum, indicating they are physical containers, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "containing other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers." This describes a sterilization container, not a device used to perform tests on samples from the human body.
- Device Description: The description focuses on the material (anodized aluminum) and the specific models and sizes of the containers. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health
- Using reagents or assays
The device's function is purely related to the sterilization and storage of other medical devices.
N/A
Intended Use / Indications for Use
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices (natural aluminum color containers and lids) subject to this submission are as follows:
Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W
(Full Size Max Load Wt. 24.75 Ibs including basket & instruments) Lumen Size min 1mm diameter X 300mm length
% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W
(1% Max Load Wt. 12.5 Ibs including basket & instruments) Lumen Size min 1mm diameter X 200mm length
(1/2 Size Max Load Wt. 9.25 Ibs including basket & instruments} Lumen size min 1mm diameter X 200mm length
Product codes
KCT
Device Description
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices subject to this submission are as follows:
Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W
% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W
The devices are composed of anodized aluminum (this does not include colored anodized lids).
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 healthcare 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 subject devices were subjected to sterility testing and performance testing. In conclusion we believe the devices are substantially equivalent to the predicate devices and do not introduce new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KII2090 510(k) Summary (as required by 21 CFR 807.92(c))
Manufacturer Name and Address
Bahadir USA Corp. 275 West Hoffman Avenue Lindenhurst, NY 11757 Contact: Ismail Kilic Tel: 631-608-8522
Submitter / Contact Person
Bahadir USA Corp. 275 West Hoffman Avenue Lindenhurst, NY 11757 Contact: Ismail Kilic Tel: 631-608-8522 Email: info@bahadirusa.com
Date Prepared
Revised July 8, 2011 Revised February 27, 2012 Revised April 2, 2012 Revised May 22, 2012
Name of Device
BAHADIR STERILIZATION TRAYS (INCLUDING WIDE BODY)
Classification Name
Sterilization Wraps, Trays, Containers Class 2 - KCT
Predicate Device
Bahadir — K102146
JUN - 7 2012
1
Description of the Device Intended Use
Intended for use in hosoitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices (natural aluminum color containers and lids) subject to this submission are as follows:
Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W
(Full Size Max Load Wt. 24.75 Ibs including basket & instruments) Lumen Size min 1mm diameter X 300mm length
% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W
1% Max Load Wt. 12.5 Ibs including basket & instruments) Lumen Size min 1mm diameter X 200mm length
(1/2 Size Max Load Wt. 9.25 Ibs including basket & instruments} Lumen size min 1mm diameter X 200mm length
2
DESCRIPTION
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices subject to this submission are as follows:
Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W
% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W
The devices are composed of anodized aluminum (this does not include colored anodized lids).
3
Comparison to Predicate Devices
The containers are the identical design, materials, sterilization cycle, and indications for use. The only difference is the dimensions (sizes).
| Feature | Bahadir | Bahadir K102146 |
|---|---|---|
| Intended Use | Intended for use in | |
| hospitals and | ||
| healthcare 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 for 270 F | ||
| for 4 minutes with | ||
| 20 minutes | ||
| (minimum) dry time. | Intended for use in | |
| hospitals and | ||
| healthcare 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 for 270 F | ||
| for 4 minutes with | ||
| 20 minutes | ||
| (minimum) dry time. | ||
| Material | Aluminum Alloy, | |
| stainless steel | ||
| handles, silicone | ||
| seal, paper filter | Aluminum Alloy, | |
| stainless steel | ||
| handles, silicone | ||
| seal, paper filter | ||
| Filter | Paper Filter | Paper Filter |
| Sterilization Method | Steam | Steam |
| Configurations / | ||
| Dimensions | Includes: |
Full Size Y111.10W
(580x280x100mm)
Full Size Y111.13W
(580x280x135mm)
Full Size Y111.15W
(580x280x150mm)
Full Size Y111.20W
(580x280x200mm)
Full Size Y111.26W
(580x280x260mm) | Includes 1/2 size, 3/4
size, and full size
Full size
580mm x 280mm x
200mm
580mm x 280mm x
150mm
580mm x 280mm x
135mm
580mm x 280mm x
100mm |
4
| | Full Size Y110.62W
(600x400x120mm)
Full Size Y110.68W
(600x400x180mm)
Full Size Y111.62W
(600x400x120mm)
Full Size Y111.68W
(600x400x180mm)
3/4 Size Y211.10W
(465x280x100mm)
3/4 Size Y211.13W
(465x280x135mm)
3/4 Size Y211.15W
(465x280x150mm)
1/2 Size Y311.10W
(285x280x100mm)
1/2 Size Y311.13W
(285x280x135mm)
1/2 Size Y311.15W
(285x280x150mm)
1/2 Size Y311.20W
(285x280x200mm)
1/2 Size Y311.26W
(285x280x260mm) | 3/4 Size
465mm x 280mm x
150mm
465mm x 280mm x
135mm
465mm x 280mm x
100mm
1/2 size
285mm x 280mm x
200mm
285mm x 280mm x
150mm
285mm x 280mm x
135mm
285mm x 280mm x
100mm | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Perforation | The units included in
this submission
include perforated
lids and both non-
perforated and
perforated bottoms. | The units included in
this submission
include perforated
lids and non-
perforated bottoms. | | |
| Air Permeance | Permits entry of
sterilization agent
and prevents
microbial migration
during storage. | Permits entry of
sterilization agent
and prevents
microbial migration
during storage. | | |
| Intended to be re-
used | Yes | Yes | | |
| Sealed | Yes | Yes | | |
| Conformance to
AAMI ST 77 | Yes | Yes | | |
| Gasket | Silicone Based (gray
color) | Silicone Based (gray
color) | | |
| Handles | Wider handles with
silicone holder | Wider handles with
silicone holder | | |
| Cycle Parameters | 270 F at 4 minutes | 270 F at 4 minutes | | |
.
5
The differences are as follows:
- The only difference is the dimensions (wide body size). .
- Includes non-perforated and perforated bottom o
- Can be used with cannulized instruments o
Non-Clinical Tests Performed
The subject devices were subjected to sterility testing and performance testing.
Summary
In conclusion we believe the devices are substantially equivalent to the predicate devices and do not introduce new issues of safety or effectiveness.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Ismail Kilic President Bahadir USA Corporation 275 West Hoffman Avenue Lindenhurst, New York 11757
JUN - 7 2012
Re: K112090
Trade/Device Name: Bahadir USA Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: May 29, 2012 Received: May 31, 2012
Dear Mr. Kilic:
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.
7
Page 2 - Mr. Kilic
Enclosure
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 requirenients 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.goy/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,
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
8
Indications for Use
510(k) Number (if known): 11 2090
Device Name: Bahadir USA Sterilization Trays
· Indications For Use:
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilized devices may be stored and transferred in the container.
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices (natural aluminum color containers and lids) subject to this submission are as follows:
Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W
(Full Size Max Load Wt. 24.75 Ibs including basket & instruments) Lumen Size min 1mm diameter X 300mm length
% Size Y211.10W % Size Y211.13W % Size Y211.15W
(% Max Load Wt. 12.5 Ibs
including basket & instruments)
Lumen Size min 1mm diameter
½ Size Y311.26W
(½ Size Max Load Wt. 9.25 Ibs including basket & instruments) Lumen size min 1mm diameter X 200mm length
½ Size Y311.10W
½ Size Y311.13W
½ Size Y311.15W
1/2 Size Y311.20W
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
X 200mm length
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 |
| Page 1 of 1 |
|---|
| ------------- |
| 510(k) Number: | K112090 |
|---|---|
| ---------------- | --------- |