CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant

Q: Who is the manufacturer of CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant?

Cs Medical, LLC filed the 510(k) submission for CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant (K160921).

Q: What is the FDA product code for CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant?

PSW. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K160921 · Cs Medical, LLC · PSW · Nov 3, 2016 · Radiology

Device Facts

Record ID	K160921
Device Name	CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
Applicant	Cs Medical, LLC
Product Code	PSW · Radiology
Decision Date	Nov 3, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2

Intended Use

The TD 100 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-50 or TD-80 disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system. TD-50 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100@ disinfector for high-level disinfection of TEE ultrasound probes. TD-50 high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its use. TD-50 disinfectant should be used with the following contact conditions in TD 1008 disinfector: High-Level Disinfectant TD-5® Time 5 minutes Temperature 38°C - 40°C Minimum Recommended Concentration 1.7% glutaraldehyde TD-80 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 1000 disinfector for high-level disinfection of TEE ultrasound probes. TD-8@ high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its usc. TD-80 disinfectant should be used with the following contact conditions in TD 1008 disinfector: High-Level Disinfectant TD-8® Time 5 minutes Temperature 38°C - 40°C Minimum Recommended Concentration 0.3% ortho-phthalaldehyde

Device Story

The TD-100 Disinfector is an automated system for high-level disinfection of TEE ultrasound probes. The device operates as a closed system using single-use bottles of TD-5 (glutaraldehyde) or TD-8 (ortho-phthalaldehyde) disinfectant. The process involves loading a fresh disinfectant bottle, heating the solution to 38°-40°C, soaking the probe for 5 minutes, and performing a thorough rinse. The device prints a verification report confirming cycle success, time, and temperature. It is operated by trained qualified individuals in clinical environments. By automating the disinfection cycle and using single-use chemistry, the device eliminates the need for potency monitoring or daily solution testing, ensuring consistent disinfection and reducing potential exposure to chemical vapors for the operator. The system benefits patients by providing validated, repeatable high-level disinfection of semi-critical TEE probes.

Clinical Evidence

Bench testing and clinical in-use testing were performed. Bench testing confirmed sporicidal, tuberculocidal, bactericidal, fungicidal, and virucidal efficacy against organisms including Bacillus subtilis, Mycobacterium terrae, Staphylococcus aureus, and Poliovirus. Clinical in-use testing on soiled TEE probes processed in the TD-100 with TD-8 disinfectant demonstrated a complete kill of microorganisms. Biocompatibility testing per ISO 10993-5 confirmed the disinfectant is non-cytotoxic, non-irritant, and non-sensitizing.

Technological Characteristics

Automated disinfector for TEE probes; uses single-use TD-5 (1.7% glutaraldehyde) or TD-8 (0.3% ortho-phthalaldehyde) chemistry. Operates at 38°-40°C for 5 minutes. Includes integrated heating, rinsing, and printing verification. Software-controlled cycle. Materials tested for compatibility with TD-8. No activation or dilution required.

Indications for Use

Indicated for high-level disinfection of transesophageal (TEE) ultrasound probes in qualified clinical settings. Contraindicated for use with probes not approved by manufacturers for this system.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

CS Medical TD 100 Transesophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305)
Rapicide OPA-28® (K120306)
Metricide OPA Plus (K070627 as Opaciden Solution)
Cidex OPA (K030004)

Related Devices

K051305 — CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 · Cs Medical, LLC · Aug 18, 2005
K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant · Cs Medical, LLC · Apr 1, 2020
K182891 — TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants · Cs Medical, LLC · Apr 12, 2019
K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator · Cs Medical, LLC · Nov 21, 2023
K150504 — GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor · Pci Medical, Inc. · Nov 16, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 30, 2017 CS Medical LLC Mr. Kendall Ashe Vice President 2179 East Lyon Station Road Creedmoor, North Carolina 27522 Re: K160921 Trade/Device Name: CS Medical TD-100 Disinfector with TD-50 and TD-88 High Level Disinfectants Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: PSW Dated: October 3, 2016 Received: October 4, 2016 Dear Mr. Ashe: This letter corrects our substantially equivalent letter of November 3, 2016. 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}------------------------------------------------ Page 2 – Mr. Ashe 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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, Tina Kiang -s Tina Kiang, Ph.D. Acting 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) K 16092 I Device Name CS Medical TD-100® Disinfector with TD-5® and TD-88 High Level Disinfectant System ### Indications for Use (Describe) The TD 1000 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-50 or TD-80 disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system. TD-50 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100@ disinfector for high-level disinfection of TEE ultrasound probes. TD-50 high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its use. TD-50 disinfectant should be used with the following contact conditions in TD 1008 disinfector: | High-Level Disinfectant | Time | Temperature | Minimum Recommended Concentration | |-------------------------|-----------|-------------|-----------------------------------| | TD-5® | 5 minutes | 38°C - 40°C | 1.7% glutaraldehyde | TD-80 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 1000 disinfector for high-level disinfection of TEE ultrasound probes. TD-8@ high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its usc. TD-80 disinfectant should be used with the following contact conditions in TD 1008 disinfector: | High-Level Disinfectant | TD-8® | |-----------------------------------|---------------------------| | Time | 5 minutes | | Temperature | 38°C - 40°C | | Minimum Recommended Concentration | 0.3% ortho-phthalaldehyde | 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) | Prescription Use (Part 21 [X] **Over-The-Counter Use (21 CFR 801 Subpart C)** # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ ### 510(k) Summary - K160921 #### 510(k) Owner CS Medical, L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 Phone 919-255-9472 Fax 919-528-3400 ### Contact Person Kendall Ashe Vice President and General Manager, CS Medical, L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 Email kendallashe@csmedicalllc.com ### Submission Prepared November 3, 2016 | CS Medical Trade Name | Common Name | Classification Name | |-------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------| | TD 100® Disinfector with TD-5® and TD-8® High Level Disinfectants | TD 100 automated disinfector with TD-5 and TD-8 disinfectants | Diagnostic ultrasound transducer (21 CFR 892.1570, Primary Product Code ITX) | ### Legally Marketed Predicate Devices - 1. CS Medical TD 100 Transesophageal Probe Disinfector and TD-5 High-level Disinfectant (K051305) - Primary Predicate - 2. Rapicide OPA-28® (K120306) - 3. Metricide OPA Plus (K070627 as Opaciden Solution) - 4. Cidex OPA (K030004) {4}------------------------------------------------ # Description of the CS Medical TD 100 Disinfector with TD-5 and TD-80 High Level Disinfectants The TD 100® disinfector provides high level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-50 or TD-80 disinfectants. The TD 1000 disinfector is for use only with TD-50 or TD-8® disinfectants. The TD-5º and TD-8º disinfectants are for use only in the TD 100 disinfector. Thus, the TD 100® disinfector with TD-50 and TD-80 disinfectants represents a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 100 disinfector. A fresh, unopened bottle of TD-50 or TD-80 disinfectant is loaded into the TD 100% disinfector. The TD 100% disinfector heats the TD-5% or TD-8% disinfectant to 38°-40°C, soaks the TEE probe for at least five minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 100 disinfector prints a verification report indicating a successful disinfection cycle and the time and average temperature during the disinfection. The TEE probe is then removed from the TD 100® disinfector and dried according to the TEE probe manufacturer's instructions. The TD 100® disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 or TD-8 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution. # Indications for Use The TD 100 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) probes. The system can use TD-5% or TD-80 disinfectants. which are designed to be used only with the TD 100% disinfector. The disinfectant bottles cannot be reused in the system. TD-58 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100® disinfector for high-level disinfection of TEE ultrasound probes. TD-5% high level disinfectant and TD 100® disinfector system are intended for use by qualified individuals trained in its use. TD-5® disinfectant should be used with the following contact conditions in TD 100% disinfector: | High-level disinfectant | Time | Temperature | Minimum Recommended Concentration | |----------------------------|-----------|-------------|--------------------------------------| | TD-5® | 5 minutes | 38°-40°C | 1.7% glutaraldehyde | {5}------------------------------------------------ TD-8® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100® disinfector for high-level disinfection of TEE ultrasound probes. TD-8® high level disinfectant and TD 100® disinfector system are intended for use by qualified individuals trained in its use. TD-8® disinfectant should be used with the following contact conditions in TD 100® disinfector: | High-level disinfectant | Time | Temperature | Minimum Recommended Concentration | |----------------------------|-----------|-------------|--------------------------------------| | TD-8® | 5 minutes | 38°- 40°C | 0.3% ortho-phthalaldehyde | | Element | Proposed Device TD 100® Disinfector with TD-5® and TD-8® High Level Disinfectants | Predicate Device TD 100® Transesophageal Probe Disinfector and TD-5 High- level Disinfectant (K051305) | Predicate Device Rapicide OPA-28® (K120306) | Predicate Deice Metricide OPA Plus (K070627 As Opaciden) | Predicate Deice Cidex OPA (K030004) | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classifi- cation Name (CFR; Product code) | Diagnostic ultrasound transducer (21 CFR § 892.1570, Primary Product Code - ITX) | Diagnostic ultrasound transducer (21 CFR § 892.1570, Primary Product Code - ITX) | 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) | Liquid chemical germicide/high level disinfectant (21 CFR § 880.6885, Product Code MED) | | Indications For Use | The TD 100® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) probes. The system can use TD-5® or TD-8® disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system. TD-5® disinfectant is intended for use as single use high-level | The TD 100® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system uses the TD-5® disinfectant, which is designed to be used only with the TD 100. The disinfectant bottles cannot be reused in the system. TD- 5® is intended for | Rapicide OPA-28 is a high level disinfectant solution for reprocessing of heat sensitive semi critical medical devices for which sterilization is not suitable. Rapicide OPA-28 may be used at or above its minimum recommended concentration (MRC) of 0.35% OPA as determined by Rapicide OPA- 28 test strips in | Metricide OPA Plus (K070627 as Opaciden) Solution is a high level disinfectant for reprocessing heat- sensitive medical devices for which sterilization is not suitable, and when used according to the Directions for Use. Metricide OPA Plus (K070627 as Opaciden) may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as | CIDEX OPA Solution is intended for use as a high level disinfectant for reprocessing heat sensitive medical devices. CIDEX OPA Solution can be used in manual systems (trays and buckets) and automated endoscope reprocessors. | | Element | Proposed Device TD 100® Disinfector with TD-5® and TD-8® High Level Disinfectants | Predicate Device TD 100® Transesophageal Probe Disinfector and TD-5 High- level Disinfectant (K051305) | Predicate Device Rapicide OPA-28® (K120306) | Predicate Deice Metricide OPA Plus (K070627 As Opaciden) | Predicate Deice Cidex OPA (K030004) | | | disinfectant to be used exclusively in the TD 100® disinfector for high-level disinfection of TEE ultrasound probes. TD-5® high level disinfectant and TD 100® disinfector system are intended for use by qualified individuals trained in its use. TD-5® disinfectant should be used with the following contact conditions in TD 100® disinfector: High-level disinfectant TD-5® Time 5 minutes Temperature 38° – 40°C Minimum Recommended Concentration 1.7% glutaraldehyde TD-8® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100® disinfector for high-level disinfection of TEE ultrasound probes. TD-8® high level disinfectant and TD 100® disinfector system are intended for use by qualified individuals trained in its use. | use as a single use high-level disinfectant to be used exclusively in the TD 100® for the high-level disinfection of TEE ultrasound probes. The TD-5® High Level Disinfectant and TD 100® disinfector system is intended for use by qualified individuals trained in its use. | manual device reprocessing with an immersion time of at least 10 minutes at a minimum temperature of 20°C for a reuse period not to exceed 28 days. Rapicide OPA-28® may also be used in compatible legally marketed automatic endoscope reprocessors at or above its MRC as determined by Rapicide OPA-28® test strips with an immersion time of at least 5 minutes at a minimum temperature of 25°C for a reuse period not to exceed 28 days. | Metricide OPA Plus (K070627 as 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. Metricide OPA Plus (K070627 as Opaciden) 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 Metricide OPA Plus (K070627 as 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. | | | Element | Proposed Device TD 100® Disinfector with TD-5® and TD-8® High Level Disinfectants | Predicate Device TD 100® Transesophageal Probe Disinfector and TD-5 High- level Disinfectant (K051305) | Predicate Device Rapicide OPA-28® (K120306) | Predicate Deice Metricide OPA Plus (K070627 As Opaciden) | Predicate Deice Cidex OPA (K030004) | | | TD-8® disinfectant should be used with the following contact conditions in TD 100® disinfector: High-level disinfectant TD-8® Time 5 minutes Temperature 38° – 40°C Minimum Recommended Concentration 0.3% ortho- phthalaldehyde | | | | | | Instrument ation For Automation | TD 100® with TD-5® and TD-8® disinfector is automated for single use with only TD-5® or TD-8® disinfectants. The user initiates automated cycle and receives disinfection verification ticket via touchpad. Software and user interface has been modified as compared to the predicate TD 100® (K051305) to facilitate choice of TD-5® or TD-8® disinfectants and minor updates. Other aspects of the instrumentation are identical to current TD 100® and TD-5® device. | TD 100® disinfector is automated for single use with only TD-5® disinfectant. The user initiates automated cycle and receives disinfection verification ticket via touchpad. | Rapicide OPA-28 is indicated for manual use and use with undesignated (legally marketed) automatic reprocessors that provide designated contact conditions. | Metricide OPA Plus (K070627 as Opaciden)is indicated for manual use and use with undesignated (legally marketed) automatic reprocessors that provide designated contact conditions. | Cidex OPA is indicated for manual use and use with undesignated (legally marketed) automatic reprocessors that provide designated contact conditions. | | Physical Properties | TD-8® | TD-5® | Rapicide OPA- 28 | Metricide OPA Plus (As Opaciden) | Cidex OPA | | 510(k) Number | K160921 | K051305 | K120306 | K070627 (As Opaciden) | K030004 | | Clearance Date | TBD | 8/18/05 | 9/27/12 | 8/2/2007 | 2/27/2003 | | Active Ingredients | Ortho- phthalaldehyde 0.59% | Glutaraldehyde 2.65% | Ortho- phthalaldehyde 0.575% | Ortho- phthalaldehyde 0.6% | Ortho- phthalaldehyde 0.55% | | Inert Ingredients | 99.41% | 97.35% | 99.425% | 99.4% | 99.45% | | Water-Based Liquid | Yes | Yes | Yes | Yes | Yes | | pH Value | 7.45 - 7.55 | 5.9 - 6.8 | 7.5-8.0 | 7.0-7.8 | 7.2-7.8 | | Buffer System | Phosphates | Phosphates | Not Published | Phosphates | Phosphates | | Minimum Recommended Concentration (MRC) | 0.3% | 1.7% | 0.35% | 0.3% | 0.3% (MEC) | | Dilution Required | No | No | No | No | No | | Activation Required | No | No | No | No | No | | High-Level Disinfection Claim | Yes | Yes | Yes | Yes | Yes | | Sterilization Claim | No | No | No | No | No | | Maximum Re-Use Period | Single Use | Single Use | 28 Days | 14 Days | 14 Days | | OPA Test Strip Available | No | No | Yes | Yes | Yes…

CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Related Devices

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CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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Special Control Matches

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