MANZI CLEANER SYSTEM

K043314 · Langford IC Systems, Inc. · NVE · Jun 20, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043314
• Device Name: MANZI CLEANER SYSTEM
• Applicant: Langford IC Systems, Inc.
• Product Code: NVE · Gastroenterology, Urology
• Decision Date: Jun 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent MD10, is for the cleaning of bronchoscopes in a health care setting by health care workers.

Device Story

Manzi Cleaner System is a stand-alone device for cleaning bronchoscopes; utilizes proprietary MD10 anionic detergent and patented push-pull agitation system. Device consists of stainless steel processing chamber, agitation pump, and movable frame; accessories include disposable water filters and reusable trays. Scope placed in chamber; undergoes push-pull agitation cycle followed by two hot water rinses. System automatically dilutes MD10 detergent to 2.0% concentration. Operated by health care workers in clinical settings to facilitate compliance with reprocessing guidelines (SGNA, APIC, AORN, ASGE, CDC). Output is a cleaned bronchoscope; facilitates infection control by reducing microbial load and protein levels on instruments.

Clinical Evidence

Bench testing only. Performance validated against FDA Class II Special Controls Guidance (2002) and prEN ISO 15883-1/4 standards. Cleaning efficacy demonstrated via protein reduction (< 6.4 µg/cm² per AAMI TIR30:2003) and > 4-log reduction of Bacillus subtilis spores. Physical, simulated use, rinsing, electrical safety, and EMC tests passed.

Technological Characteristics

Stainless steel processing chamber; push-pull agitation pump; movable frame. Uses proprietary MD10 anionic detergent (2.0% dilution). Includes disposable water filters. Software-controlled cleaning cycle. Conforms to prEN ISO 15883-1:2003 and prEN ISO 15883-4:2001 requirements.

Indications for Use

Indicated for cleaning bronchoscopes in health care settings by health care workers.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• System 83 Plus™ Washer-Disinfector (K983017)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 13 2005

Mr. Terry Langford President & CEO Langford IC Systems, Incorporated 310 S. Williams Boulevard, Suite 270 Tucson, Arizona 85711

Re: K043314 Trade/Device Name: Manzi Cleaner System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and Accessories Regulatory Class: II Product Code: NVE Dated: June 2,2005 Received: June 2,2005

Dear Mr. Langford:

This letter corrects our substantially equivalent letter of June 20,2005, regarding the Product Code.

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 (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 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 announcementsconcerning your device in the Federal Register.

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Page 2 - Mr. Langford

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 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

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## JUN 2 0 2005 510(k) Summary - K043314, Manzi Cleaner System

## Applicant's Name, Address, Telephone, Fax, Contact Person

Langford IC Systems, Inc. 310 S. Williams Blvd, Suite 270 Tucson, Arizona 85711 Tel: [phone] Fax: E-mail: terrylangford(@licsystems.com

### Contact Person

Terry Langford President and CEO, Langford IC Systems, Inc. 520-745-6201 Tel: [phone] Fax: terrylangford(@licsystems.com E-mail:

### June 17, 2005

#### CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME 1.0

Classification Name: Pending - Currently Undefined, Class II Common / Usual Name: Medical Device Cleaner System Device Classification: 21 CFR § 876.1500. Endoscope and accessories Proprietary Name: Manzi Cleaner System

#### 2.0 PREDICATE DEVICE

System 83 Plus™ Washer-Disinfector, K983017

#### INDICATIONS FOR USE 3.0

The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent MD10. is for the cleaning of bronchoscopes in a health care setting by health care workers.

#### 4.0 DESCRIPTION OF THE DEVICE

The Manzi Cleaner System consists of a Manzi Cleaner and a proprietary Manzi Detergent, MD10.

The Manzi Cleaner is a self-contained stand-alone system of hardware and software designed to clean bronchoscopes using the MD10 detergent and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the bronchoscope without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle followed by two hot water rinses.

The hardware for the Manzi Cleaner consists of a stainless steel processing chamber, a push-pull agitation pump, and a variety of components that are mounted in a movable covered frame. The cleaner system utilizes accessories such as disposable water filters. reusable bronchoscope trays, and printer paper.

The Manzi Cleaner is designed to: (1) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations.

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## 510(k) Summary - K043314, Manzi Cleaner System

MD10 is a low foaming anionic chemical detergent packaged in custom containers for attachment to the Manzi Cleaner. The detergent is automatically diluted to a use dilution of 2.0% detergent concentration. MD10 is intended to be used exclusively with the Manzi Cleaner.

### SUMMARY OF NONCLINICAL TESTS 5.0

## 5.1 Qualification Testing - FDA Guidance

The Manzi Cleaner was tested and found to conform with the requirements of the current edition of Class II Special Controls Guidance Document: Medical Washers and Medical Washer - Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff, issued on February 7, 2002. The table below identifies the qualifications performed and the results obtained:

| 5. | Requirement | | Results |
|----|--------------------------------------|----------------------------------|----------------|
| | Performance Data | | |
| | 5.1 | Process Parameter Physical Tests | Passed |
| | 5.2 | Simulated Use Tests | Passed |
| | 5.3 | Cleaning Efficacy | Passed |
| | 5.4 | Disinfection Efficacy | Not Applicable |
| | 5.5 | Rinsing Efficacy | Passed |
| | 5.6 | Self Disinfection Efficacy | Not Applicable |
| | 5.7 | Other Tests | Passed |
| | 5.8 | In - Use Tests | Passed |
| 6. | Toxicological Evaluation of Residues | | Passed |
| 7. | Software Documentation | | Passed |
| 8. | Electrical Safety Documentation | | Passed |
| 9. | Electromagnetic Compatibility | | Passed |

### 5.2 Qualification Testing - EU Guidance

The Manzi Cleaner was also tested and found to conform with the requirements of the Draft prEN ISO 15883-1: 2003, Washer-disinfectors - Part 1: General Requirements, Definitions and Tests and Draft prEN ISO 15883-4: 2001, Washer-disinfectors - Part 4: Requirements and Tests for Washer-Disinfectors Employing Chemical Disinfection for Thermo-Labile Endoscopes as identified in the Table below.

| prEN ISO 15883-1: 2003 Requirement | Results | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------|--------|
| 6.10<br>Annex B | Cleaning Efficacy - Scope Ninhydrin<br>Horse serum- prEN 15883-4 Annex B.1.1 | Passed |
| Annex E | Cleaning Efficacy – Surrogate Ninhydrin<br>Horse serum- prEN 15883-4 Annex B.1.1<br>Surrogate - prEN 15883-4 | Passed |

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# 510(k) Summary - K043314, Manzi Cleaner System

## 5.3 Qualification Testing - Langford IC Systems (LIC) Requirements

The Manzi Cleaner was also tested and found to conform to the LIC requirement identified in the table below.

| LIC Requirement | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| A four spore log reduction of microbial load on scopes<br>contaminated with Birmingham soil mixture inoculated<br>with Bacillus subtilis spores at a concentration of > 107<br>spores/ml. | Passed<br>> 4 spore log<br>reduction |
| Cleaning Efficacy: Reduction of protein loading of scopes<br>contaminated with a Protein Laden Soil to Remaining<br>Protein levels of < 6.4 µg/cm² (Ref: AAMI TIR30:<br>2003, A Compendium of Processes, Materials, Test<br>Methods, and Acceptance Criteria for Cleaning Reusable<br>Medical Devices.). | Passed<br>Remaining<br>Protein levels<br>of < 6.4 µg/cm² |

### OVERALL PERFORMANCE CONCLUSIONS 6.0

The studies demonstrate that the Manzi Cleaner System is safe and effective for the cleaning of bronchoscopes within the stated indications for use for the Manzi Cleaner and the Manzi Detergent, MD10 and establishes substantial equivalence of the Manzi Cleaner System to the predicate device, the System 83 Plus™ Washer-Disinfector.

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# Indications for Use

510(k) Number (if known): K043314

Device Name: Manzi Cleaner System

Indications for Use: The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent MD10, is for the cleaning of bronchoscopes in a health care setting by health care workers.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shiela H. Murphy 10/17/05

(Division Sign-Off) (Division Sign-Old)
Division of Anesthesiology, General Hospital, Division of Antrol Dental Devices

510(k) Number: K04331

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