(559 days)
Not Found
No
The 510(k) summary describes a chemical disinfectant and its use in an automated system, with no mention of AI or ML technology.
No.
This device is a high-level disinfectant used for reprocessing medical instruments, not for diagnosing, treating, or preventing disease in a patient.
No
The device is a high-level disinfectant used for reprocessing medical instruments, not for diagnosing medical conditions.
No
The device is a chemical disinfectant (CIDEX® OPA Concentrate) intended for use in a specific hardware system (ASP EvoTech™ System). It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the high level disinfection of heat-sensitive semi-critical endoscopes. This is a process performed on medical devices to reduce the risk of infection transmission, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The description details the chemical composition and mechanism of action as a disinfectant, not a reagent or instrument used to analyze biological samples.
- Performance Studies: The performance studies focus on germicidal efficacy (killing microorganisms), which is relevant to disinfection, not diagnostic accuracy (like sensitivity, specificity, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, treatment, or prevention of disease based on in vitro analysis.
Therefore, CIDEX® OPA Concentrate is a disinfectant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CIDEX® OPA Concentrate is a high level disinfectant (HLD) at the minimum IN USE concentration of 0.055% with a contact time of 5 minutes at 50°C for reprocessing heat sensitive (6 Log10 reduction of Mycobacterium terrae when flexible endoscopes were contaminated with cells and artificial soil. The diluted CIDEX® OPA Concentrate at an MEC of 0.055% concentration at 50° C is effective against Mycobacterium terrae in artificial soil.
In-Use Testing: Endoscopes used in a clinical setting were subjected to high level disinfection without cleaning. Sterility testing showed no growth on all endoscope surfaces and channels after reprocessing in CIDEX OPA Concentrate In Use solution.
Biocompatibility: The active ingredient and the formulated product were subjected to a panel of toxicological tests including acute oral and dermal toxicity, skin sensitization, genetic toxicity, in vitro and in vivo systems, subchronic oral toxicity and developmental toxicity tests. All animal toxicity data indicate that the product is at least as safe for human use as the predicate device. Biocompatibility of product residues testing was conducted. Results indicate that CIDEX® OPA Concentrate In-Use solution residuals absorbed onto materials commonly used in reprocessed medical devices are at levels well below those, which cause toxic effects in animals.
Material compatibility: CIDEX® OPA Concentrate and the In-Use solution were evaluated for effects on materials commonly used to fabricate washer/disinfectors and medical devices. The results showed minimal effect on test articles and were similar to those seen with the predicate device.
Stability: CIDEX® OPA Concentrate was tested and found stable for 15 months at 15-30° C. The in machine use life is 80 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
6 Log10 reduction of Mycobacterium terrae
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
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
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APR - 4 2005
ု၊ နဲ့ နို
510(K) SUMMARY A.
1. 510(k) Summary of Safety and Effectiveness
| Contact | Neelu Medhekar R.A.C.,
Project Manager, Regulatory Affairs
Phone: 949 789 3838
Fax: 949 789 3900
Advanced Sterilization Products
Division of Ethicon Inc.
33 Technology Drive
Irvine, Ca 92618 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | September 22, 2003 |
| Device name | Classification: Liquid chemical germicide
Trade Name: CIDEX® OPA Concentrate
Proprietary Name: 5.75% nominal ortho-phthalaldehyde Solution |
| Legally marketed device | CIDEX® OPA Concentrate In-Use solution claims equivalence to the
following legally marketed medical devices: CIDEX® OPA Solution
(K991487) and Steris 20™ Sterilant/ Steris System 1™ (K875280) |
| Device description | CIDEX® OPA Concentrate is formulated to contain 5.75% w/v of
ortho-phthalaldehyde . The resultant solution contains a corrosion
inhibitor, a chelating agent, and a dye in a phosphate buffer.
ortho-Phthalaldehyde is chemically related to glutaraldehyde in that
they are both aldehydes. The mechanism of action of ortho-
phthalaldehyde is postulated to be similar to glutaraldehyde and is based
on powerful binding of the aldehyde to the outer cell wall of the
organism. |
1
CIDEX® OPA Concentrate is intended for use as a high level Intended use disinfectant for reprocessing heat sensitive (6 Log10 reduction of Mycobacterium terrae when flexible endoscopes were contaminated with cells and artificial soil. The diluted CIDEX® OPA Concentrate at an MEC of 0.055% concentration at 50° C is effective against Mycobacterium terrae in artificial soil. In-Use Testing: Endoscopes used in a clinical setting were subjected to high level disinfection without cleaning. Sterility testing showed no growth on all endoscope surfaces and channels after reprocessing in CIDEX OPA Concentrate In Use solution.
in vitro and in vivo
systems, subchronic oral toxicity and developmental toxicity tests. All
animal toxicity data indicate that the product is at least as safe for
human use as the predicate device. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility of product residues testing was conducted. Results
indicate that CIDEX® OPA Concentrate In-Use solution residuals
absorbed onto materials commonly used in reprocessed medical devices
are at levels well below those, which cause toxic effects in animals. |
| Material
compatibility | CIDEX® OPA Concentrate and the In-Use solution were evaluated for
effects on materials commonly used to fabricate washer/disinfectors and
medical devices. The results showed minimal effect on test articles and
were similar to those seen with the predicate device. |
| Stability | CIDEX® OPA Concentrate was tested and found stable for 15 months at
15-30° C. The in machine use life is 80 days. |
| Conclusion | The data presented and the equivalence demonstrated to the predicate
device support the claim of substantial equivalency for CIDEX® OPA
Solution. CIDEX® OPA Concentrate In Use solution is safe and
effective as a high level disinfectant when used as labeled for
reprocessing semi-critical medical devices. |
3
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized caduceus symbol, which is a staff with two snakes coiled around it.
APR - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Sterilization Products Ms. Neelu Medhekar Project Manager, Regulatory Affairs Ethicon, Incorporated 33 Technology Drive Irvine, California 92618
Re: K032959
Trade/Device Name: CIDEX OPA Concentrate Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 16, 2005 Received: March 17, 2005
Dear Ms. Medhekar:
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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 mr), it and 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 Eederal Register.
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Page 2 - Ms. Medhekar
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 and ilsuing (21 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 Iegally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), nlease 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suette M, chui Davis
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
Indications for Use
510(k) Number (if known): K032959
Device Name: CIDEX® OPA Concentrate
Indications For Use:
CIDEX® OPA Concentrate is a high level disinfectant (HLD) at the minimum IN USE concentration of 0.055% with a contact time of 5 minutes at 50°C for reprocessing heat sensitive (