(154 days)
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.
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.
The provided text describes the 510(k) summary for the Medicom Self Sealing – Sterilization Pouch. This device is a sterilization pouch with external chemical indicators, not an AI/ML-driven medical device for diagnosis or treatment. Therefore, the questions related to clinical studies, human readers, ground truth, and training sets for an AI/ML model are not applicable to this submission.
However, I can extract information related to the device's acceptance criteria and how its performance was evaluated for substantial equivalence.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Medicom Self Sealing Sterilization Pouch) |
|---|---|---|
| Material Compatibility | Equivalent to predicate (Winner® Self Seal pouch) | Demonstrated equivalence to predicate through side-by-side testing. |
| Sterility Maintenance | Maintains sterility up to one year post-sterilization. | Claimed to maintain sterility up to one year post-sterilization (based on the intended use statement). |
| Chemical Indicator Efficacy | Complies with ISO 11140-1:2005 for steam and EO indicators. | Demonstrated efficacy for indicating steam and EO sterilization processes. Substantial equivalence testing conducted against the predicate device. |
| Sterilant Penetration | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
| Drying Time | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
| Aeration | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
| Biocompatibility | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
| Package Integrity | Equivalent to predicate. | Demonstrated equivalence to predicate through side-by-side testing. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a "Comparison Testing" and "Substantial Equivalence" assessment against a legally marketed predicate device, the Winner® Self Seal Sterilization pouch (K051242), and relevant recognized standards, specifically ISO 11140-1:2005 for chemical indicators.
Non-Applicability for AI/ML Specific Questions:
The following questions are not applicable to this 510(k) submission as it concerns a physical medical device (sterilization pouch) and not an AI/ML diagnostic or therapeutic algorithm:
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" refers to physical samples of the device and predicate, not data for an AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, in the context of AI/ML ground truth. For this device, "ground truth" would be the verified performance of the predicate device and compliance with established ISO standards for physical characteristics and chemical indicator performance.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Device Evaluation Approach:
The evaluation of the Medicom Self Sealing Sterilization Pouch for 510(k) clearance relied on demonstrating substantial equivalence to a predicate device. This was achieved through:
- Side-by-side testing: Comparing the new device directly with the predicate (Winner® Self Seal pouch) across several key performance parameters including:
- Sterilant Penetration
- Drying Time
- Aeration
- Biocompatibility
- Package Integrity
- Compliance with recognized standards: Specifically, the chemical indicators were evaluated against ISO 11140-1:2005 for efficacy.
- Material Compatibility: Shown to be equivalent to the predicate.
- Sterility Maintenance: The intended use statement claims sterility maintenance for up to one year, which would typically be supported by accelerated or real-time aging studies and microbiological challenge tests, the specifics of which are not detailed in this summary but are implicit requirements for such a claim.
The 510(k) summary indicates that these comparisons and compliance demonstrations were sufficient for the FDA to determine substantial equivalence and allow the device to be marketed.
{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 ofManufacturer: | A.R. Medicom Inc.1200 55th Avenue,Lachine, QuebecH8T 3J8 Canada |
| EstablishmentRegistration Number: | 9680179 |
| Contact Person: | Jason LudivgSenior Quality & Regulatory Writer |
| Tel: (514) 636-6262 x 2222Fax: (514) 636-6267E-mail: jludvig@medicom.ca | |
| 5.3 Device ClassificationNames: | 1) sterilization wrap containers, trays, cassettes &accessories.2) indicator, Physical/Chemical SterilizationProcess |
| Classification/Panel: | Class II, §880.6850 & 880.2800 |
| Classification AdvisoryCommittee: | General Hospital |
| Product Code: | 1) KCT 2) JOJ |
| Recognized PerformanceStandard | 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 pouchesare intended to provide health care workers with aneffective method to enclose devices intended forsterilization in steam auto claves and via EthyleneOxide (EO). The recommended steam sterilizationcycle parameters are 30 minutes at 121°C. Therecommended EO sterilization cycle is 100 - 120minutes at 50 °C with a relative humidity between60 - 85% and a sterilant concentration of 600 mg/L.Furthermore, the sterilization pouch maintains theenclosed devices sterile up until one year poststerilization. Lastly, the pouch's external chemicalink indicators are designed to indicate to the userthat the pouch has undergone either a steam or EOsterilization process. |
| 5.6 510(k) Statement | A 510(k) statement for the new device, as requiredby 21 CFR 93, is replaced with this 510(k)summary. |
| 5.7 Proposed Labeling | A comparison with the predicate labeling confirmsour claim of substantial equivalence with thepredicate. A draft copy of the proposed andpredicate device labeling may be found in Section11. |
| 5.8 Device Description | The pouches are manufactured from a medicalgrade paper that is thermally sealed to a laminatedfilm on the left, right, and bottom of pouch. Thefourth side has an adhesive strip that is used to sealthe paper to the film prior to sterilization of theenclosed medical device. The pouches containexternal indicators used to indicate the poucheswere processed via steam or EO sterilization. SeeSection 7 for a detailed device description includingshelf life, sterility achievement and compatibilitywith steam and EO sterilization processes. |
| 5.9 Comparison Testing | Side by side testing was conducted on the TheMedicom Self Sealing sterilization pouch and theWinner® Self Seal pouch to determine substantialequivalence. 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
§ 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).