(120 days)
Not Found
No
The device is a sterilization pouch with a chemical indicator, a passive product for packaging medical devices. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is a sterilization pouch used to enclose medical devices for sterilization, not to treat a disease or condition itself.
No
The device is a sterilization pouch with a chemical indicator to confirm that a sterilization process has occurred, not to diagnose a medical condition.
No
The device is a physical sterilization pouch made of paper and plastic film with a chemical indicator, not a software application.
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 medical 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 using in vitro methods (testing samples like blood, urine, or tissue).
- Device Description: The device is a pouch made of paper and plastic film with a chemical indicator. This physical structure is designed for packaging and sterilization, not for performing diagnostic tests.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information. The chemical indicator simply confirms that a sterilization process has occurred.
Therefore, the PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP) are considered a medical device used in the sterilization process, but not an IVD.
N/A
Intended Use / Indications for Use
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied.
The recommended (and validated) sterilization cycle parameters are;
· For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes.
· For EO sterilization: 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours.
Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process.
After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.
Product codes
FRG, JOJ
Device Description
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the fourth side has a self-seal adhesive strip and left opened. This side is manually sealed by the user with the self-seal adhesive strip. Triple band seal provides three independent barriers to contamination, while reducing the risk of fibre tear. PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are presented as 60 gsm model.
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 workers / 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)
The document indicates that the device has undergone performance testing to demonstrate substantial equivalence to the predicate device. These tests include:
- Sterilant Penetration: "The sterilization (steam and EO) was validated to a sterility assurance level (SAL) of 10-6"
- Microbial Barrier Properties: "Sterility was maintained for at least 30 days after processing in Steam and EO sterilizer."
- Material Compability: "Suitability for use in Steam and EO sterilization processes and cycle parameters."
- Biocompatibility: "Not direct patient-contacting devices; Materials are non-toxic and meet ISO 10993-1 requirements."
- Package Integrity: "Porous material providing a microbial barrier."
The conclusion states that the subject device meets the requirements of ANSI/ AAMI/ ISO 11140-1:2005 and ANSI/ AAMI/ ISO 11607-1:2006.
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
January 15, 2016
PMS Tip Teknolojileri Sanavi Ve Ticaret Limited. STI Ms. Derya Dikici Business Development Manager Mersin Tarsus Organize Sanayi Bolgesi, 12 CAD, No. 2 Huzurkent, Mersin, TR 33020
Re: K152669
Trade/Device Name: PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) Regulation Number: 21 CFR 880.6850 Regulation Name: Wrap, Sterilization Regulatory Class: II Product Code: FRG; JOJ Dated: December 10, 2015 Received: December 16, 2015
Dear Ms. Dikici,
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.
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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152669
Device Name
PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)
Indications for Use (Describe)
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied.
The recommended (and validated) sterilization cycle parameters are;
· For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes.
· For EO sterilization: 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours.
Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process.
After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for PMS. The logo consists of a red and gray graphic on the left, followed by the letters "PMS" in gray. The graphic on the left is a combination of red and gray shapes, with the red shape on top and the gray shape on the bottom.
510 (k) Summary for PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)
1. Name, address and contact
| PMS Tıp Teknolojileri Sanayi ve Ticaret Limited Şirketi | ||
|---|---|---|
| Mersin Tarsus Organize Sanayi Bölgesi 12.Cad.No:2 | ||
| Huzurkent 33020 Mersin-TURKEY | ||
| Phone | : | 90 324 2387042 – 90 542 648 6312 |
| Fax | : | 90 324 2386549 |
| Prepared by | : | Taner Ersen |
| Quality Management Representative | ||
| Contact | : | Derya Dikici |
| Business Development Manager | ||
| Phone | : | 90 324 2387042- 90 542 648 6312 |
| Fax | : | 90 324 2386549 |
| E-mail : derya.dikici@pmsmedikal.com | ||
| Date Prepared: | December 07, 2015 |
2. Device Name
Trade Name: PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator
Common/Usual Name: Sterilization Pouch (Self Seal)
Device Classification Name: Wrap, Sterilization; Indicator, Physical/Chemical Sterilization Process
Product Code: 1) FRG 2) JOJ
Product Classification: Class II
21 CFR 880.6850, General Hospital (FRG) 21 CFR 880.2800(b), General Hospital (JOJ)
3. Predicate Device
K102158, SIGMA Sterilization Pouch and Roll
4. Indications for Use/Intended Use
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP) are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied.
The recommended (and validated) sterilization cycle parameters are:
- · For steam sterilization pre-vacuum cycle at 132 degrees □C for 4 minutes.
- · For EO sterilization; 100% ethylene oxide (EO) with a concentration of 725mg/l 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8hrs.
4
Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process. After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.
5. Device Description
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the fourth side has a self-seal adhesive strip and left opened. This side is manually sealed by the user with the self-seal adhesive strip. Triple band seal provides three independent barriers to contamination, while reducing the risk of fibre tear. PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are presented as 60 gsm model.
Representative Engineering Drawing: "PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)"
Image /page/4/Figure/4 description: The image shows a technical drawing of a part with several dimensions labeled. The overall height is labeled as 'B', and the overall width is labeled as 'A'. At the bottom, 'P=2' and 'L=10' are indicated, along with 'V=2' on the right side and 'K' indicating the height of a section. The top of the drawing has a feature labeled 'S'.
A: Total width
- B: Total height
- L: Seal width (mm)
- V: Single seal width (mm)
- P: Distance between 2 seals (mm)
- S: Diameter
- K: Strip width
6. Description of the Principle of Operation
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP) are used to enclose medical devices that are to be sterilized by health care provider via sterilization methods. Medical device to be sterilized is put into pouch and the open parts of the packages are manually closed with the self-seal adhesive strip. Sterilization packages then are subjected to sterilization operation in related sterilization devices (steam sterilizers, EO sterilization devices). Sterilant penetration is carried out through
5
the medical grade paper into the packages and microorganisms on the surface of the medical devices are destroyed with the effect of the sterilant vapors. Other parameters of the sterilization process are temperature, pressure; humidity and time are determined according to the sterilization type.
The process indicator on the pouches are intended to be used by a health care provider with sterilization pouches to distinguish between processed and unprocessed units by changing color. Chemical process indicators on the pouch indicate that the pouch has been exposed to sterilization process by changing color.
Chemical process indicators are printed on the pouch exterior (printed on medical grade paper component) changes color when exposed to sterilant vapor during processing. After the sterilization is completed, the sterility of the enclosed medical device is maintained for 30 days. Chemical indicator pars printed on to the medical grade paper component of the pouches are 100 mm- size, having dimensions of 5 mmx20 mm.
The indicators used on the pouches are classified as Class 1 type process indicator according to the ISO 11140-1 standard.
7. Comparison of Submission Device and Predicate Device and Substantial Equivalence:
Technological characteristics of the submission device and the comparison with predicate devices are given in Table 7.1. as a summary.
| TABLE 7.1. Comparison of Submission Device and Predicate Device |
|---|
| (Characteristics) |
| DEVICE NAME | SUBMISSION
DEVICE | PREDICATE DEVICE | SE |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| CHARACTERISTICS | PMSSteripack Self Seal
Sterilization Pouch with
Chemical Indicator
(KP) | SIGMA Sterilization Pouch and
Roll (K102158) | YES |
| DESIGN AND
CONSTRUCTION &
MATERIAL
COMPOSITION | Medical grade paper and heat
sealed laminated PET/PP
plastic film. Externally printed
Steam and EO process
indicator ink. Pouches are
manufactured from medical
grade paper/plastic film that
are heat sealed on 3 sides, the
fourth side is left opened and
has an adhesive strip which is
used to seal the pouch. | Medical Grade Paper and
heat
sealed plastic film. EO and Steam
Process Indicator Print ink. Pouches
are made from a medical grade
plastic film that is heat sealed on
three sides. The forth side is left
opened and is heat- sealed when
using. In gusseted pouches, plastic
film is folded on both longest sides.
Self seal pouch has an adhesive
strip that is used to seal the pouch.
Release paper used in the pouch is a
laminated sheet with composing
structure of FE/paper/PE. It is a strip
to cover the adhesive area and is
released befre seal the pouch. The
medical grade paper conforms to
recognized material standards and
can be sterilized by steam
or
ethylene oxide gas. | YES |
| INTENDED USE | Single use devices to enclose
other medical devices that are to
be sterilized by health care
provider via Steam and Ethylene
Oxide (EO) sterilization methods.
The recommended (and
validated) sterilization cycle
parameters are:
For Steam sterilization pre-
vacuum cycle at 132 °C for 4
minutes.
For EO sterilization; 100%
ethylene oxide with a
concentration of 725 mg/L, at 55
°C and 50-80% relative humidity
for 60 minutes. Aeration time is 8
hours.
Chemical process indicators on
the pouch indicate that the pouch
has been exposed to sterilization
process by changing color. After
the sterilization is completed, the
sterility of the enclosed medical
device is maintained for 30 days. | Single use devices, to enclose
another medical devices that is to
be sterilized by a health provider.
Sterilization pouch and roll 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 4 hours at 55
°C with a relative humidity
between 50%-85% and a sterilant
concentration of 600 mg/L.
Furthermore, the sterilization
pouch and roll maintains the
enclosed devices up until 3 years
post sterilization. | YES |
| STERILIZATION
PROPERTIES | The recommended (and
validated) sterilization cycle
parameters are:
For Steam sterilization pre-
vacuum cycle at 132 °C for 4
minutes.
For EO Sterilization; 100%
ethylene oxide (EO) with a
concentration of 725 mg/L at 55
°C and 50-80% relative humidity
for 60 minutes. Aeration time is 8
hours. | The recommended steam
sterilization cycle parameters are
30 minutes at 121 °C.
The recommended EO sterilization
cycle is 4 hours at 55 °C with a
relative humidity between
50%/85% and a sterilant
concentration of 600 mg/L. | YES |
| PRINCIPLE OF
OPERATION | Medical device to be sterilized is
put into pouch and the open part
of the package is closed
manually with an adhesive strip.
Sterilization packages then are
subjected to validated sterilization
operation of steam & EO.
Sterilant penetration is carried out
through the medical grade paper
into the package and
microorganisms on the surface of
the medical device are destroyed
with the effect of the sterilant
vapors. Other parameters of the
sterilization process are
temperature, pressure, humidity,
time and are deteminded
according to the sterilization type.
Chemical process indicator is
printed exterior on the pouch
(printed on medical grade paper)
changes color when exposed to
sterilant vapor during processing.
After the sterilization is
completed, the sterility of the
enclosed medical device is
maintained for 30 days. | Medical device to be sterilized is
put into roll or pouch and the open
parts of the packages are closed
by self sealing. Sterilization
packages then are subjected to
sterilization operation in related
sterilization devices (steam
autoclaves, EO sterilization).
The process Indicators Ink printed
on the medical grade paper will
exhibit a color change after the
pouch is exposed to steam or
ethylene oxide gas.
The SIGMA sterilization pouch
and roll is offered in the following 5
types:
- Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted | YES |
| PRINCIPLES OF
OPERATION FOR
CHEMICAL
INDICATORS | The Process Indicator Ink printed
on the medical grade paper will
exhibit a color change after the
pouch is exposed to steam and
ethylene oxide gas. In steam
sterilization, printed indicator bar
changes from pink to brown
when exposed to steam. In EO
sterilization, printed indicator bar
changes from turquoise to yellow
when exposed to EO gas. | The Process Indicators Ink printed
on the medical grade paper will
exhibit a color change after the
pouch is exposed to steam or
ethylene oxide gas. | YES |
| SHELF LIFE | 5 years | 3 years | YES |
| CONFIGURATIONS&
DIMENSIONS | Various sizes (width and
height) | Various sizes (width, height
and gusset) | YES |
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TABLE 7.2. Comparison of Submission Device and Predicate Device (Performance)
| DEVICE
NAME | PROPOSED DEVICE | PREDICATE
DEVICE | SUBSTANTIALL
EQUIVALENCE |
|---------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------|
| PERFROMANCE | PMS Steripack Self Seal
Sterilization pouch with
Chemical Indicator | SIGMA sterilization
Pouch and Roll
(K102158) | YES |
| Sterilant
Penetration | The sterilization (steam and EO)
was validated to a sterility
assurance level (SAL) of 10-6 | Sterility assurance level
of 10-6 achieved. | YES |
| Microbial Barrier
Properties | Sterility was maintained for at least
30 days after processing in Steam
and EO sterilizer. | Meets
requirements | YES |
| Material
Compatibility | Suitability for use in Steam and EO Meets
sterilization processes and cycle
parameters. | requirements | YES |
| Biocompatibility | Not direct patient-contacting
devices; Materials are non-toxic
and meet ISO 10993-1
requirements. | Meets
requirements | YES |
| Package Integrity | Porous material providing a
microbial barrier. | Meets
requirements | YES |
8. Conclusion
PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) (subject device) and SIGMA Sterilization pouch and roll (predicate device) are both single use devices that are used to enclose another medical device to be sterilized in required sterilization methods.
PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and predicate device have many similar technological characteristics. SIGMA Sterilization pouch and rolls are made from medical grade paper and laminated plastic film by heat sealing. On the other hand, PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and SIGMA Sterilization pouch and roll have the same design features and they all have various size.
PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and predicate device have similar sterilization methods (Steam and EO).
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PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and predicate device have similar performance characteristics considering Sterilant Penetration, Drying Time, Aeration time, Package Integrity, Sterility Maintenance, Biocompatibility and Chemical Indicator Efficiency.
Both the subject device PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) and the predicate devices SIGMA Sterilization pouch and roll meet the requirements of ANSI/ AAMI/ ISO 11140-1:2005 and ANSI/ AAMI/ ISO 11607-1:2006.
In conclusion, the subject device PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) is substantially equivalent to predicate device K102158 SIGMA Sterilization Pouches and Rolls. Based on the intended use, technological characteristics, and performance data, the subject PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP) is substantially equivalent and is as safe and as effective as the legally marketed predicate device.