(154 days)
Not Found
No
The device description and intended use focus on physical properties and chemical indicators for sterilization, with no mention of AI or ML.
No
The device is a self-sealing sterilization pouch, used to sterilize medical devices, not to treat a disease or condition.
No
This device is a sterilization pouch used to enclose medical devices for sterilization and maintain sterility. It is not designed to diagnose any condition or disease.
No
The device description clearly indicates it is a physical product (pouches made of paper and film) with physical components (adhesive strip, external indicators). It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose devices for sterilization and maintain their sterility. This is a function related to the processing and storage of medical devices, not the diagnosis of diseases or conditions.
- Device Description: The description focuses on the physical construction of the pouch and its features for sterilization and sterility maintenance.
- Performance Studies: The performance studies evaluate the pouch's ability to facilitate sterilization and maintain sterility, not its ability to detect or measure substances in biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 100 - 120 minutes at 50 °C with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
Product codes (comma separated list FDA assigned to the subject device)
KCT, JOJ
Device Description
The pouches are manufactured from a medical grade paper that is thermally sealed to a laminated film on the left, right, and bottom of pouch. The fourth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The pouches contain external indicators used to indicate the pouches were processed via steam or EO sterilization. See Section 7 for a detailed device description including shelf life, sterility achievement and compatibility with steam and EO sterilization processes.
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
health care workers
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)
Side by side testing was conducted on the The Medicom Self Sealing sterilization pouch and the Winner® Self Seal pouch to determine substantial equivalence. Sterilant Penetration, Drying Time, Aeration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy (recognized standard ISO 11140-1:2005) were the parameters used to determine substantial equivalence and validate the safety and efficacy of the device.
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
K070428
ary
510 (K) Summary
JUL 1 7 2007
| 5.1 Device Trade Name: | Medicom Self Sealing – Sterilization Pouch |
|---|---|
| 5.2 Named and Address of | |
| Manufacturer: | A.R. Medicom Inc. |
| 1200 55th Avenue, | |
| Lachine, Quebec | |
| H8T 3J8 Canada | |
| Establishment | |
| Registration Number: | 9680179 |
| Contact Person: | Jason Ludivg |
| Senior Quality & Regulatory Writer | |
| Tel: (514) 636-6262 x 2222 | |
| Fax: (514) 636-6267 | |
| E-mail: jludvig@medicom.ca | |
| 5.3 Device Classification | |
| Names: | 1) sterilization wrap containers, trays, cassettes & |
| accessories. |
- indicator, Physical/Chemical Sterilization
Process |
| Classification/Panel: | Class II, §880.6850 & 880.2800 |
| Classification Advisory
Committee: | General Hospital |
| Product Code: | 1) KCT 2) JOJ |
| Recognized Performance
Standard | ISO 11140-1:2005 (JOJ) |
| 5.4 Predicate Devices | Winner® Self Seal Sterilization pouch |
| 510(k) Number | K051242 |
| 5.5 Intended Use | The self-sealing sterilization pouches
are intended to provide health care workers with an
effective method to enclose devices intended for
sterilization in steam auto claves and via Ethylene
Oxide (EO). The recommended steam sterilization
cycle parameters are 30 minutes at 121°C. The
recommended EO sterilization cycle is 100 - 120
minutes at 50 °C with a relative humidity between
60 - 85% and a sterilant concentration of 600 mg/L.
Furthermore, the sterilization pouch maintains the
enclosed devices sterile up until one year post
sterilization. Lastly, the pouch's external chemical
ink indicators are designed to indicate to the user
that the pouch has undergone either a steam or EO
sterilization process. |
| 5.6 510(k) Statement | A 510(k) statement for the new device, as required
by 21 CFR 93, is replaced with this 510(k)
summary. |
| 5.7 Proposed Labeling | A comparison with the predicate labeling confirms
our claim of substantial equivalence with the
predicate. A draft copy of the proposed and
predicate device labeling may be found in Section
-
|
| 5.8 Device Description | The pouches are manufactured from a medical
grade paper that is thermally sealed to a laminated
film on the left, right, and bottom of pouch. The
fourth side has an adhesive strip that is used to seal
the paper to the film prior to sterilization of the
enclosed medical device. The pouches contain
external indicators used to indicate the pouches
were processed via steam or EO sterilization. See
Section 7 for a detailed device description including
shelf life, sterility achievement and compatibility
with steam and EO sterilization processes. |
| 5.9 Comparison Testing | Side by side testing was conducted on the The
Medicom Self Sealing sterilization pouch and the
Winner® Self Seal pouch to determine substantial
equivalence. Sterilant Penetration, Drying Time,
Aeration, Biocompatibility, Package Integrity. |
1
:
2
Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy (recognized standard ISO 11140-1:2005) were the parameters used to determine substantial equivalence and validate the safety and efficacy of the device. See sections 6 for the complete substantial equivalence comparison table.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2007
Mr. Jason Ludvig Senior Quality and Regulatory Writer A.R. Medicom, Incorporated 1200 55" Avenue Lachine, Quebec H8T 318 CANADA
Re: K070428
Trade/Device Name: Medicom Self Sealing Sterilization Pouch Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 19, 2007 Received: June 21, 2007
Dear Mr. Ludvig:
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.
4
Page 2 – Mr. Ludvig
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); 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.
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), please 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
5
510(k) Number: K070428
Device Name: Medicom Self Sealing Sterilization Pouch
Indications For Use:
The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121℃. The recommended EO sterilization cycle is 100 - 120 minutes at 50 ℃ with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
Prescription Use Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter
(2
(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)
Shula R. Murphy, MD
(Division Sign-Off)
livision of Anesthesiology, General Hospital Infection Control, Dental Devices
10(k) Number: K070428