OPA 30 SOLUTION

• K Number: K140703
• Device Name: OPA 30 SOLUTION
• Manufacturer: CIDEN TECHNOLOGIES LLC
• Date Cleared: 2014-08-19 ( 152 days)
• Product Code: MED
• Regulation Number: 880.6885

Intended Use

OPA 30 Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used of reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20°C (68°F), for a reuse period not to exceed 30 days. OPA 30 Solution may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25°C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25℃ (77ºF), for a reuse period not to exceed 14 days.

Device Description

The OPA 30 Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30° C (59-86° F) for its labeled shelf life of 24 months. OPA 30 Solution may be used or reused for manual (up to 30 days) or automated reprocessing (up to 14 days), according to the Directions for Use. OPA 30 Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.

Predicate Devices

K070627

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a chemical disinfectant solution and the summary contains no mention of AI or ML technology.

Therapeutic

No
The device is a high-level disinfectant used for reprocessing heat-sensitive semi-critical medical devices, not for treating any medical condition or directly interacting with the patient in a therapeutic manner.

Diagnostic

No

Explanation: The device is described as a high-level disinfectant for reprocessing medical devices, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a liquid chemical disinfectant, not a software-only medical device. The description details its chemical composition and intended use for reprocessing medical devices, with no mention of software components.

IVD (In Vitro Diagnostic)

Based on the provided text, the OPA 30 Solution itself is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for reprocessing heat-sensitive semi-critical medical devices. This is a process performed on medical devices, not on biological samples from a patient for diagnostic purposes.
• Device Description: The description details a chemical solution used for disinfection.
• 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.)
  • Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis.
  • Mentioning any analytical performance metrics relevant to IVDs (sensitivity, specificity, etc.).

However, the text does mention a related product that is likely an IVD:

• Opaciden OPA Reagent Strips: The text states that the Minimum Recommended Concentration (MRC) of the OPA 30 Solution is determined by "Opaciden OPA Reagent Strips". Reagent strips used to test the concentration of a chemical solution for disinfection purposes are typically considered IVDs because they are used to assess the efficacy of the disinfectant, which has implications for patient safety.

In summary:

• OPA 30 Solution: Not an IVD. It's a high-level disinfectant.
• Opaciden OPA Reagent Strips: Likely an IVD, as they are used to test the concentration of the disinfectant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

OPA 30 Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used of reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20°C (68°F), for a reuse period not to exceed 30 days. OPA 30 Solution may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25°C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25℃ (77ºF), for a reuse period not to exceed 14 days.

Product codes (comma separated list FDA assigned to the subject device)

MED

Device Description

The OPA 30 Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30° C (59-86° F) for its labeled shelf life of 24 months. OPA 30 Solution may be used or reused for manual (up to 30 days) or automated reprocessing (up to 14 days), according to the Directions for Use. OPA 30 Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.

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

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 OPA 30 Solution has been tested for stability, re-use for manual processing and material compatibility following: Guidance for Industry and FDA Reviewers: "Content and Format of Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/High Level Disinfectants" Section III. The required testing was previously submitted, reviewed and cleared in K070627. Results for the applicable tests were acceptable and demonstrated performance in accordance with the proposed OPA 30 Solution product labeling.

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.

K070627

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

Regulation Number and Section

§ 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.

Summary

0

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

August 19, 2014

CIDEN Technologies, LLC c/o Courtney Clark, CBA, RAC Regulatory Affairs Manager of Submissions Sybron Dental Specialties 1717 W. Collins Ave Orange, CA 92867

Re: K140703

Trade/Device Name: OPA 30 Solution Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid chemical sterilant/high level disinfectants Regulatory Class: II Product Code: MED Dated: July 22, 2014 Received: July 23, 2014

Dear Ms. Clark,

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.

1

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 [phone] or [phone] 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 [phone] or [phone] 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) K140703

Device Name OPA 30 Solution

Indications for Use (Describe)

OPA 30 Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used of reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20°C (68°F), for a reuse period not to exceed 30 days. OPA 30 Solution may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25°C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25℃ (77ºF), for a reuse period not to exceed 14 days.

Type of Use (Select one or both, as applicable)

• Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

SECTION 5. 510(k) SUMMARY for OPA 30 Solution (K140703)

• 1. Submitter Information: Ciden Technologies, LLC 360 Cold Spring Avenue West Springfield, MA 01089
     Contact Person: Courtney Clark Telephone Number: 714-516-7426 Fax Number: 714-516-7472

Date Prepared: 22 July 2014

2. Device Name:

Proprietary Name:	OPA 30 Solution
Classification Name:	Liquid chemical germicide/high level disinfectant
CFR Number:	21 CFR 880.6885
Device Class:	II
Product Code:	MED
FDA review panel code:	INCB

3. Predicate Device:

The legally marketed predicate device is Opaciden® Solution (K070627), Product Code MED, manufactured by Ciden Technologies LLC and determined to be substantially equivalent to a legally marketed device on August 2, 2007.

4. Description of Device:

The OPA 30 Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30° C (59-86° F) for its labeled shelf life of 24 OPA 30 Solution may be used or reused for manual (up to 30 days) or months. automated reprocessing (up to 14 days), according to the Directions for Use. OPA 30 Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.

• న. Statement of Intended Use:
  OPA 30 Solution is a high level disinfectant for reprocessing heat-sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20° C (68° F), for a reuse period not to exceed 30 days. OPA 30 Solution may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25℃), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an

4

immersion time of at least 5 minutes at a minimum of 25°C (7°P), for a reuse period not to exceed 14 days.

6. Description of Safety and Substantial Equivalence:

Technological Characteristics

The chemical formulation and technical characteristics of the proposed OPA 30 Solution are identical to those of the predicate Opaciden® Solution (K070627). The indications for use, material compatibility and shelf life have been expanded for the proposed OPA 30 Solution due to the results of additional performance testing. There are no substantial technical or functional differences between the proposed OPA 30 Solution and the predicate (K070627) device. Based on this information and the results of the performance testing, it is expected that the proposed OPA 30 Solution will be as safe and effective as the predicate Opaciden® Solution (K070627) when used as directed.

ELEMENT	PREDICATE DEVICE:	PROPOSED DEVICE:
	Opaciden® Solution
(K070627)	OPA 30 Solution
CLASSIFICATION NAME
(CFR; Product code)	Liquid chemical germicide/high
level disinfectant (21 CFR §
880.6885, Product Code MED)	Liquid chemical germicide/high
level disinfectant (21 CFR §
880.6885, Product Code MED)
INDICATIONS FOR USE	Opaciden® Solution (K070627)
is a high level disinfectant for
reprocessing heat-sensitive semi-
critical medical devices for
which sterilization is not suitable,
and when used according to the
Directions for Use. Opaciden®
Solution may be used or reused
at or above its Minimum
Recommended Concentration
(MRC) of 0.3%, as determined
by Opaciden OPA Reagent
Strips, in manual reprocessing
with an immersion time of at
least 12 minutes at a minimum of
20°C (68°F), for a reuse period
not to exceed 14 days.
Opaciden® Solution may also
be used or reused in a legally
marketed automatic endoscope
reprocessor (that can be set to a
minimum 25°C), at or above its
Minimum Recommended
Concentration (MRC), as
determined by Opaciden OPA
Reagent Strips, with an
immersion time of at least 5
minutes at a minimum of 25°C
(77°F), for a reuse period not to
exceed 14 days.	OPA 30 Solution is a high level
disinfectant for reprocessing
heat-sensitive semi-critical
medical devices for which
sterilization is not suitable, and
when used according to the
Directions for Use. OPA 30
Solution may be used or reused
at or above its Minimum
Recommended Concentration
(MRC) of 0.3%, as determined
by Opaciden OPA Reagent
Strips, in manual reprocessing
with an immersion time of at
least 12 minutes at a minimum of
20°C (68°F), for a reuse period
not to exceed 30 days. OPA 30
Solution may also be used or
reused in a legally marketed
automatic endoscope reprocessor
(that can be set to a minimum of
25°C), at or above its Minimum
Recommended Concentration
(MRC), as determined by
Opaciden OPA Reagent Strips,
with an immersion time of at
least 5 minutes at a minimum of
25°C (77°F), for a reuse period
not to exceed 14 days.
ACTIVE INGREDIENT	ortho-Phthalaldehyde 0.60%	ortho-Phthalaldehyde 0.60%
ELEMENT	PREDICATE DEVICE:
Opaciden® Solution
(K070627)	PROPOSED DEVICE:
OPA 30 Solution
INERT INGREDIENTS	99.40%	99.40%
PHYSICAL
PROPERTIES	Clear, pale blue liquid with a pH
of 7.5. Contains 0.60% OPA in
an aqueous base containing
buffers, chelating agents and a
corrosion inhibitor. It is stable at
15-30° C (59-86° F) for its
labeled shelf life.	Clear, pale blue liquid with a pH
of 7.5. Contains 0.60% OPA in
an aqueous base containing
buffers, chelating agents and a
corrosion inhibitor. It is stable at
15-30° C (59-86° F) for its
labeled shelf life.
MINIMUM EFFECTIVE
CONCENTRATION (MEC)	0.3%	0.3%
REUSE PERIOD	14 Days Manual, 14 days
automated	30 Days Manual, 14 days
automated
MICROBIOLOGY	Effective against:	Effective against:
Vegetative organisms	Staphylococcus aureus,
Salmonella choleraesuis,
Pseudomonas aeruginosa,
Mycobacterium bovis	Staphylococcus aureus,
Salmonella choleraesuis,
Pseudomonas aeruginosa,
Mycobacterium bovis
Fungi	Trichophyton mentagrophytes	Trichophyton mentagrophytes
Viruses, non-enveloped	Poliovirus Type 1
Rhinovirus Type 42
Hepatitis A (AER)	Poliovirus Type 1
Rhinovirus Type 42
Hepatitis A (AER)
Viruses, enveloped	Avian influenza
Hepatitis B
Influenza Type A (Hong Kong)
HIV-1	Avian influenza
Hepatitis B
Influenza Type A (Hong Kong)
HIV-1
Spores	Herpes simplex Type 1
Clostridium sporogenes
Bacillus subtilis	Herpes simplex Type 1
Clostridium sporogenes
Bacillus subtilis
TOXICITY	Positive for acute oral toxicity,
moderate skin irritation.
Negative for dermal and
cytotoxicity. Probable eye
irritant.	Positive for acute oral toxicity,
moderate skin irritation.
Negative for dermal and
cytotoxicity. Probable eye
irritant.
REUSABLE DEVICE
COMPATIBILITY	Olympus and Pentax endoscopes
are compatible	Olympus and Pentax endoscopes
are compatible
CHEMICAL INDICATOR	Opaciden OPA Reagent Strips	Opaciden OPA Reagent Strips
SHELF LIFE	15 month shelf life for a closed
container.	24 month shelf life for a closed
container.
MATERIAL
COMPATIBILITY	Materials previously cleared in
the predicate Opaciden®
Solution
(K070627)	Materials previously cleared in
the predicate Opaciden®
Solution
(K070627)
and
Acrylonitrile Butadiene
Styrene (ABS)

Device Comparison Table

5

6

Non-Clinical Performance Data

The OPA 30 Solution has been tested for stability, re-use for manual processing and material compatibility following:

• . Guidance for Industry and FDA Reviewers: "Content and Format of Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/High Level Disinfectants" Section III
  Due to the fact that the chemical formulation of the proposed OPA 30 Solution and the predicate Opaciden® Solution (K070627) is identical, additional testing requirements described in the FDA guidance "Content and Format of Premarket Notification [510(k)] Submission for Liquid Chemical Sterilants/High Level Disinfectants" have not been repeated. The required testing was previously submitted, reviewed and cleared in K070627. Results for the applicable tests were acceptable and demonstrated performance in accordance with the proposed OPA 30 Solution product labeling.

Clinical Performance Data

There is no clinical data included in this submission.

Conclusion as to Substantial Equivalence

The OPA 30 Solution is as safe, as effective, and performs as well as the predicate Opaciden® Solution (K070627), and is therefore determined to be substantially equivalent to Opaciden® Solution (K070627).