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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "OPA 30 Solution," a liquid chemical sterilant/high-level disinfectant. The document focuses on demonstrating substantial equivalence to a predicate device (Opaciden® Solution, K070627). Crucially, this document is for a chemical disinfectant, not an AI/ML-driven device, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for training set" are not applicable in the context of an AI/ML device.

The closest analogous information for a chemical disinfectant would be:

1. A table of acceptance criteria and the reported device performance:

The document implicitly defines "acceptance criteria" through comparison to the predicate device and adherence to FDA guidance for liquid chemical sterilants/high-level disinfectants. The "reported device performance" is largely established by stating that the chemical formulation is identical to the predicate and that previous testing (for the predicate) demonstrated acceptable performance. The key performance outcome tested explicitly for the new device is extended reuse periods.

Acceptance Criteria (Implied by Predicate & Guidance)	Reported Device Performance (OPA 30 Solution)
Microbiological Efficacy:
- Vegetative organisms effectiveness	Effective against: Staphylococcus aureus, Salmonella choleraesuis, Pseudomonas aeruginosa, Mycobacterium bovis (Identical to predicate)
- Fungi effectiveness	Effective against: Trichophyton mentagrophytes (Identical to predicate)
- Viruses, non-enveloped effectiveness	Effective against: Poliovirus Type 1, Rhinovirus Type 42, Hepatitis A (AER) (Identical to predicate)
- Viruses, enveloped effectiveness	Effective against: Avian influenza, Hepatitis B, Influenza Type A (Hong Kong), HIV-1 (Identical to predicate)
- Spores effectiveness	Effective against: Herpes simplex Type 1, Clostridium sporogenes, Bacillus subtilis (Identical to predicate)
Chemical Composition:
- Active ingredient concentration	0.60% ortho-Phthalaldehyde (Identical to predicate)
- Inert ingredients percentage	99.40% (Identical to predicate)
- pH range	7.5 (Identical to predicate)
- Stability at specified temperature	Stable at 15-30°C (59-86°F) for labeled shelf life (Identical to predicate)
Minimum Effective Concentration (MEC):	0.3% (Identical to predicate)
Reuse Period:
- Manual reprocessing reuse period	30 Days Manual (Expanded from 14 days in predicate, confirmed by "re-use for manual processing" testing)
- Automated reprocessing reuse period	14 Days Automated (Identical to predicate)
Toxicity:	Positive for acute oral toxicity, moderate skin irritation. Negative for dermal and cytotoxicity. Probable eye irritant. (Identical to predicate)
Device Compatibility:	Olympus and Pentax endoscopes are compatible. (Identical to predicate)
- Material compatibility	Materials previously cleared in predicate and Acrylonitrile Butadiene Styrene (ABS) (Expanded from predicate, confirmed by "material compatibility" testing)
Shelf Life:	24 month shelf life for a closed container (Expanded from 15 months in predicate, confirmed by "stability" testing)
Chemical Indicator:	Opaciden OPA Reagent Strips (Identical to predicate)

2. Sample sized used for the test set and the data provenance:

This information is not provided in a way that defines "test set" as it would for an AI/ML device. The document states that performance testing was performed for "stability, re-use for manual processing and material compatibility." However, specific sample sizes (e.g., number of re-use cycles, number of material samples) and the provenance (country of origin, retrospective/prospective) are not detailed. The previous testing for microbiological efficacy was submitted and cleared as part of the predicate device (K070627). This previous testing would have been prospective studies following established disinfectant testing protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable to a chemical disinfectant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable to a chemical disinfectant.

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, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an AI/ML device. The "standalone" performance for a chemical disinfectant would be its efficacy in killing microorganisms under specific conditions, which was tested.

7. The type of ground truth used:

For a chemical disinfectant, "ground truth" would relate to the successful inactivation or killing of microorganisms. This is established through standardized laboratory testing (e.g., AOAC methods) where the presence or absence of viable microorganisms after exposure to the disinfectant is directly measured. This is akin to definitive pathology/microbiology laboratory results.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/ML device.

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 (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) K140703

Device Name OPA 30 Solution

Indications for Use (Describe)

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

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/highlevel disinfectant (21 CFR §880.6885, Product Code MED)	Liquid chemical germicide/highlevel disinfectant (21 CFR §880.6885, Product Code MED)
INDICATIONS FOR USE	Opaciden® Solution (K070627)is a high level disinfectant forreprocessing heat-sensitive semi-critical medical devices forwhich sterilization is not suitable,and when used according to theDirections for Use. Opaciden®Solution may be used or reusedat or above its MinimumRecommended Concentration(MRC) of 0.3%, as determinedby Opaciden OPA ReagentStrips, in manual reprocessingwith an immersion time of atleast 12 minutes at a minimum of20°C (68°F), for a reuse periodnot to exceed 14 days.Opaciden® Solution may alsobe used or reused in a legallymarketed automatic endoscopereprocessor (that can be set to aminimum 25°C), at or above itsMinimum RecommendedConcentration (MRC), asdetermined by Opaciden OPAReagent Strips, with animmersion time of at least 5minutes at a minimum of 25°C(77°F), for a reuse period not toexceed 14 days.	OPA 30 Solution is a high leveldisinfectant for reprocessingheat-sensitive semi-criticalmedical devices for whichsterilization is not suitable, andwhen used according to theDirections for Use. OPA 30Solution may be used or reusedat or above its MinimumRecommended Concentration(MRC) of 0.3%, as determinedby Opaciden OPA ReagentStrips, in manual reprocessingwith an immersion time of atleast 12 minutes at a minimum of20°C (68°F), for a reuse periodnot to exceed 30 days. OPA 30Solution may also be used orreused in a legally marketedautomatic endoscope reprocessor(that can be set to a minimum of25°C), at or above its MinimumRecommended Concentration(MRC), as determined byOpaciden OPA Reagent Strips,with an immersion time of atleast 5 minutes at a minimum of25°C (77°F), for a reuse periodnot 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%
PHYSICALPROPERTIES	Clear, pale blue liquid with a pHof 7.5. Contains 0.60% OPA inan aqueous base containingbuffers, chelating agents and acorrosion inhibitor. It is stable at15-30° C (59-86° F) for itslabeled shelf life.	Clear, pale blue liquid with a pHof 7.5. Contains 0.60% OPA inan aqueous base containingbuffers, chelating agents and acorrosion inhibitor. It is stable at15-30° C (59-86° F) for itslabeled shelf life.
MINIMUM EFFECTIVECONCENTRATION (MEC)	0.3%	0.3%
REUSE PERIOD	14 Days Manual, 14 daysautomated	30 Days Manual, 14 daysautomated
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 1Rhinovirus Type 42Hepatitis A (AER)	Poliovirus Type 1Rhinovirus Type 42Hepatitis A (AER)
Viruses, enveloped	Avian influenzaHepatitis BInfluenza Type A (Hong Kong)HIV-1	Avian influenzaHepatitis BInfluenza Type A (Hong Kong)HIV-1
Spores	Herpes simplex Type 1Clostridium sporogenesBacillus subtilis	Herpes simplex Type 1Clostridium sporogenesBacillus subtilis
TOXICITY	Positive for acute oral toxicity,moderate skin irritation.Negative for dermal andcytotoxicity. Probable eyeirritant.	Positive for acute oral toxicity,moderate skin irritation.Negative for dermal andcytotoxicity. Probable eyeirritant.
REUSABLE DEVICECOMPATIBILITY	Olympus and Pentax endoscopesare compatible	Olympus and Pentax endoscopesare compatible
CHEMICAL INDICATOR	Opaciden OPA Reagent Strips	Opaciden OPA Reagent Strips
SHELF LIFE	15 month shelf life for a closedcontainer.	24 month shelf life for a closedcontainer.
MATERIALCOMPATIBILITY	Materials previously cleared inthe predicate Opaciden®Solution(K070627)	Materials previously cleared inthe predicate Opaciden®Solution(K070627)andAcrylonitrile ButadieneStyrene (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).

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.