(232 days)
Not Found
No
The summary describes a mechanical and chemical cleaning and disinfection system with associated software for controlling the process. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an instrument cleaner and high-level disinfecor for flexible bronchoscopes, not a therapeutic device used for treatment or diagnosis on a patient.
No
The device is a system for cleaning and high-level disinfecting flexible bronchoscopes, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of hardware and software, and details the hardware components such as a stainless steel processing chamber, pump, and ozonator.
Based on the provided information, the Manzi Mach 1 Instrument Cleaner Processor System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to clean and high-level disinfect flexible bronchoscopes. This is a process performed on a medical device (the bronchoscope) to prepare it for reuse, not to perform a diagnostic test on a biological sample.
- Device Description: The device is described as a system of hardware and software designed to clean and disinfect instruments. It uses detergents and germicides to achieve this. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVD devices, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
- Performance Studies: The performance studies focus on the efficacy of the cleaning and disinfection process (microbial reduction, protein removal), not on the accuracy or reliability of diagnostic results.
- Predicate Devices: The predicate devices listed are also washer-disinfectors and sterilants, which are not IVD devices.
In summary, the Manzi Mach 1 Instrument Cleaner Processor System is a device used for reprocessing medical instruments, which falls under the category of sterilization and disinfection equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Manzi Mach 1 Instrument Cleaner Processor System is indicated for use with the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.
Product codes
FEB
Device Description
The Manzi Mach 1 Instrument Cleaner-Processor System consists of a Manzi Mach 1 Instrument Cleaner-Processor, a proprietary Manzi germicide, MS10; and a proprietary Manzi Detergent, MD10.
The Manzi Mach 1 Instrument Cleaner-Processor is a self-contained stand-alone system of hardware and software designed to clean and provide high level disinfection of bronchoscopes using the MD10 detergent, the MS10 germicide, 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, a push-pull agitation disinfection cycle that provides high level disinfection (spore log reduction of > 10 ° microorganisms with no CFUs) of the device, and a final rinse with an ozonated sanitized water rinse.
The hardware for the Manzi Mach 1 Instrument Cleaner-Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable bronchoscope trays, and printer paper.
The Manzi Mach 1 Instrument Cleaner-Processor is designed to: ( ) 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.
MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the Manzi Cleaner. MD10 is intended to be used with the Manzi Instrument Cleaner-Processor.
MS10 is a peracetic acid based liquid chemical germicide. MS10 is intended to be used with the Manzi Instrument Cleaner-Processor.
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
health care workers / health care settings
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
The Manzi Mach 1 Instrument Cleaner-Processor System was tested and found to conform with the requirements of the "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities", dated August, 1993". (Study type not specified, sample size not specified, AUC not specified, MRMC not specified, standalone performance not specified). Results: Process Parameter Tests: Passed, Simulated Use Tests: Passed, Cleaning Efficacy: Passed, Disinfection Efficacy: Passed, Rinsing Efficacy: Passed, Other Tests: Passed, Combined Process: Passed, In – Use Tests: Passed, Software Documentation: Passed, Toxicological Evaluation of Residues: Passed.
The Manzi Mach 1 Instrument Cleaner-Processor System 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. (Study type not specified, sample size not specified, AUC not specified, MRMC not specified, standalone performance not specified). Cleaning Efficacy - Scope Ninhydrin: Passed, Horse serum- prEN 15883-4 Annex B.1.1: Passed, Cleaning Efficacy - Surrogate Ninhydrin: Passed, Horse serum- prEN 15883-4 Annex B.1.1: Passed, Surrogate - prEN 15883-4: Passed, Disinfection Efficacy - Scope: Passed, Sheep blood - prEN 15883-4 Annex D: Passed, Disinfection Efficacy - Surrogate: Passed, Sheep blood - prEN 15883-4 Annex D: Passed.
The Manzi Mach 1 Instrument Cleaner-Processor System was also tested and found to conform to the LIC requirements. (Study type not specified, sample size not specified, AUC not specified, MRMC not specified, standalone performance not specified). Cleaning Efficacy: Reduction of protein loading of scopes contaminated with a Protein Laden Soil to Remaining Protein levels of 10^6 microbial loading of scopes with no colony forming units (CFUs): Passed, ≥ 6 spore log reduction with no CFUs. Microbiological Efficacy Tests for Simulated Use Test (15 min.) ISO 15883-4 Surrogates Sheep's blood soil with Test Organisms Bacillus subtilis, Mycobacterium terrae, Candida albicans, Enterococcus faecium, Styphlococcus aureus: > 6 spore log reduction; no Colony Forming Units (CFU). Simulated Use Test (15 min.) Olympus Bronchoscopes Sheep's blood soil with Test Organisms Bacillus subtilis: > 6 spore log reduction; no CFU. Simulated Use Test Ozonated Water System with Test Organisms Candida albicans, Staphylococcus aureus, Bacillus subtilis: > 6 spore log reduction; no CFU. Final Rinse System Efficacy: Reduction of ≥ 10^6 microbial loading of scopes with no colony forming units (CFUs): Passed, ≥ 6 spore log reduction with no CFUs.
The Manzi MS10 germicide was tested to and met the requirements of the current edition of "Guidance for Industry and FDA Reviewers, Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants / High Level Disinfectants'?, doted January 3, 2000. (Study type not specified, sample size not specified, AUC not specified, MRMC not specified, standalone performance not specified). Potency Test: Passed, Simulated Use Tests: Passed, In-Use Tests: Passed, Biocompatibility: Passed. Microbiological Efficacy Summary Sporicidal Activity of Sterilants; AOAC Official Method 966.04 with Test Organisms Bacillus subtilis, Clostridium sporogenes: > 6 spore log reduction; No CFUs. Fungicidal Activity of Sterilants; AOAC Official Method 955.17 with Test Organisms Trichophyton mentagrophytes: MS10 is fungicidal. Use-Dilution Method; AOAC Official Method 955.14, 955.15, 964.02 with Test Organisms Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa: MS10 is bactericidal. Virucidal Testing with Test Organisms Poliovirus Type 1: MS10 is virucidal. Quantitative Tuberculocidal Test with Test Organisms Mycobacterium bovis: MS10 is tuberculocidal.
Overall Performance Conclusions: The studies demonstrate that the Manzi Mach 1 Instrument Cleaner-Processor System is safe and effective for the cleaning and high level disinfection of bronchoscopes within the stated indications for use for the Manzi Mach 1 Instrument Cleaner-Processor, the Manzi MS10 germicide, and the Manzi Detergent, MD10, and establishes substantial equivalence of the Manzi Mach 1 Instrument Cleaner Processor System to the predicate devices identified in Section 2.0 above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cleaning Efficacy: Reduction of protein loading of scopes contaminated with a Protein Laden Soil to Remaining Protein levels of 10^6 microbial loading of scopes with no colony forming units (CFUs). Results: ≥ 6 spore log reduction with no CFUs.
Simulated Use Test (15 min.) ISO 15883-4 Surrogates Sheep's blood soil with Test Organisms Bacillus subtilis, Mycobacterium terrae, Candida albicans, Enterococcus faecium, Styphlococcus aureus. Results: > 6 spore log reduction; no Colony Forming Units (CFU).
Simulated Use Test (15 min.) Olympus Bronchoscopes Sheep's blood soil with Test Organisms Bacillus subtilis. Results: > 6 spore log reduction; no CFU.
Simulated Use Test Ozonated Water System with Test Organisms Candida albicans, Staphylococcus aureus, Bacillus subtilis. Results: > 6 spore log reduction; no CFU.
Final Rinse System Efficacy: Reduction of ≥ 10^6 microbial loading of scopes with no colony forming units (CFUs). Results: ≥ 6 spore log reduction with no CFUs.
Sporicidal Activity of Sterilants; AOAC Official Method 966.04 with Test Organisms Bacillus subtilis, Clostridium sporogenes. Results: > 6 spore log reduction; No CFUs.
Fungicidal Activity of Sterilants; AOAC Official Method 955.17 with Test Organisms Trichophyton mentagrophytes. Results: MS10 is fungicidal.
Use-Dilution Method; AOAC Official Method 955.14, 955.15, 964.02 with Test Organisms Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa. Results: MS10 is bactericidal.
Virucidal Testing with Test Organisms Poliovirus Type 1. Results: MS10 is virucidal.
Quantitative Tuberculocidal Test with Test Organisms Mycobacterium bovis. Results: MS10 is tuberculocidal.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
Image /page/0/Picture/1 description: The image shows the letters "L/C" in a stylized font. The "/" is represented by a lightning bolt. The letters are black and white and have a textured appearance.
MANZI MACH 1 - INSTRUMENT CLEANER - PROCESSOR Pre-Market Notification 510(k) # K060458 Section II Tab 10 510(k) Summary
Applicant's Name, Address, Telephone, Fax, Contact Person
Langford IC Systems, Inc. 310 S. Williams Blvd. Suite 270 Tucson, Arizona 85711 Tel: 520-745-6201 Fax: 520-745-6286 E-mail: terrylangford(@)licsystems.com
Contact Person
Terry Langford President and CEO, Langford IC Systems, Inc. Tel: 520-745-6201 Fax: 520-745-6286 E-mail: terrylangford@licsystems.com
1.0 CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
- Classification Name: Pending Class II a) Common / Usual Name: Endoscope and accessories Device Classification: 21 CFR § 876.1500, -Endoscope and accessories Proprietary Name: Manzi Mach 1 Instrument Cleaner- Processor System with MS10 High Level Disinfector
- b) Classification Name: Pending - Class II Common / Usual Name: Endoscope and accessories Device Classification: 21 CFR & 876.1500. Proprietary Name: Manzi MS10
2.0 PREDICATE DEVICE
- a) System 83 Plus™ Washer-Disinfector, K983017 Manzi Cleaner System, K043314 (Washer)
- b) Steris 20 Sterilant, K875280
3.0 INDICATIONS FOR USE
The Manzi Mach 1 Instrument Cleaner Processor System is indicated for use with the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120% for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.
4.0 DESCRIPTION OF THE DEVICE
The Manzi Mach 1 Instrument Cleaner-Processor System consists of a Manzi Mach 1 Instrument Cleaner-Processor, a proprietary Manzi germicide, MS10; and a proprietary Manzi Detergent, MD10.
The Manzi Mach 1 Instrument Cleaner-Processor is a self-contained stand-alone system of hardware and software designed to clean and provide high level disinfection of bronchoscopes using the MD10 detergent, the MS10 germicide, 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
1
| Image: LIC logo with lightning bolt | |||
|---|---|---|---|
| LANGFORD IC SYSTEMS, INC. |
MANZI MACH 1 - INSTRUMENT CLEANER - PROCESSOR Pre-Market Notification 510(k) # K060458 Section II Tab 10 510(k) Summary
agitation cleaning cycle followed by two hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection (spore log reduction of > 10 ° microorganisms with no CFUs) of the device, and a final rinse with an ozonated sanitized water rinse.
The hardware for the Manzi Mach 1 Instrument Cleaner-Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable bronchoscope trays, and printer paper.
The Manzi Mach 1 Instrument Cleaner-Processor is designed to: ( ) 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.
MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the Manzi Cleaner. MD10 is intended to be used with the Manzi Instrument Cleaner-Processor.
MS10 is a peracetic acid based liquid chemical germicide. MS10 is intended to be used with the Manzi Instrument Cleaner-Processor.
5.0 SUMMARY OF NONCLINICAL TESTS for the MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR
5.1 Qualification Testing - FDA Guidance
The Manzi Mach 1 Instrument Cleaner-Processor System was tested and found to conform with the requirements of the "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities", dated August, 1993". The table below identifies the qualifications performed and the results obtained:
| Requirement | Results | |
|---|---|---|
| G. | Performance Data | |
| 1 Process Parameter Tests | Passed | |
| 2 Simulated Use Tests | Passed | |
| 2.c. Effectiveness Tests | ||
| 2.c.(1) Cleaning Efficacy | Passed | |
| 2.c.(2) Disinfection Efficacy | Passed | |
| 2.c.(3) Rinsing Efficacy | Passed | |
| 2.c.(4) Other Tests | Passed | |
| 2.c.(5) Combined Process | Passed | |
| 3. In – Use Tests | Passed | |
| H. | Software Documentation | Passed |
| I. | Toxicological Evaluation of Residues | Passed |
5.2 Qualification Testing - EU Guidance
10/12/06
2
The Manzi Mach 1 Instrument Cleaner-Processor System 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 | ||
| Annex B | ||
| Annex E | Cleaning Efficacy - Scope Ninhydrin | |
| Horse serum- prEN 15883-4 Annex B.1.1 | ||
| Cleaning Efficacy - Surrogate Ninhydrin | ||
| Horse serum- prEN 15883-4 Annex B.1.1 | ||
| Surrogate - prEN 15883-4 | Passed | |
| Passed | ||
| 6.11 | ||
| Annex D | Disinfection Efficacy - Scope | |
| Sheep blood - prEN 15883-4 Annex D | ||
| Disinfection Efficacy - Surrogate | ||
| Sheep blood - prEN 15883-4 Annex D | Passed | |
| Passed |
5.3 Qualification Testing - Langford IC Systems (LIC) Requirements
The Manzi Mach 1 Instrument Cleaner-Processor System was also tested and found to conform to the LIC requirements identified in the table below.
| LIC Cleaning Requirement | Results |
|---|---|
| Cleaning Efficacy: Reduction of protein loading of scopes | |
| contaminated with a Protein Laden Soil to Remaining Protein | |
| levels of $10^6$ microbial | |
| loading of scopes with no colony forming units (CFUs) | Passed |
| ≥ 6 spore log reduction | |
| with no CFUs |
| LIC Microbiological Efficacy Tests | |||
|---|---|---|---|
| Test Method | Test Organisms | Results | |
| Simulated Use Test (15 | |||
| min.) | |||
| ISO 15883-4 Surrogates | |||
| Sheep's blood soil | Bacillus subtilis | ||
| Mycobacterium terrae | |||
| Candida albicans | |||
| Enterococcus faecium | |||
| Styphlococcus aureus | > 6 spore log reduction; | ||
| no Colony Forming | |||
| Units (CFU) | |||
| Simulated Use Test (15 | |||
| min.) | |||
| Olympus Bronchoscopes | |||
| Sheep's blood soil | Bacillus subtilis | > 6 spore log reduction; | |
| no CFU | |||
| Simulated Use Test | |||
| Ozonated Water System | Candida albicans, Staphylococcus | ||
| aureus, Bacillus subtilis | > 6 spore log reduction; | ||
| no CFU |
3
Image /page/3/Picture/0 description: The image shows the logo for Langford IC Systems. The logo consists of the text "LANCFORD IC SYST" in a stylized font. Above the text is a graphic element that appears to be a stylized checkmark or abstract design. The text and graphic are in black and white.
MANZI MACH 1 – INSTRUMENT CLEANER - PROCESSOR Pre-Market Notification 510(k) # K060458 Section II Tab 10 510(k) Summary
| LIC Sanitized Ozonated Water System Requirement | Results |
|---|---|
| Final Rinse System Efficacy: Reduction of ≥ 106 microbial | |
| loading of scopes with no colony forming units (CFUs) | Passed |
| ≥ 6 spore log reduction | |
| with no CFUs |
6.0 SUMMARY OF NONCLINICAL TESTS for the MANZI MS10
5.1 Qualification Testing - FDA Guidance
The Manzi MS10 germicide was tested to and met the requirements of the current edition of "Guidance for Industry and FDA Reviewers, Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants / High Level Disinfectants'?, doted January 3, 2000. The table below identifies the qualifications performed and the results obtained:
| Requirement | Results | |
|---|---|---|
| 5.4 | Potency Test | Passed |
| 5.5 | Simulated Use Tests | Passed |
| 5.6 | In-Use Tests | Passed |
| 6.0 | Biocompatibility | Passed |
| Microbiological Efficacy Summary | ||
|---|---|---|
| Test Method | Test Organisms | Results |
| Sporicidal Activity of Sterilants; | ||
| AOAC Official Method 966.04 | Bacillus subtilis | |
| Clostridium sporogenes | > 6 spore log reduction; | |
| No CFUs | ||
| Fungicidal Activity of Sterilants; | ||
| AOAC Official Method 955.17 | Trichophyton | |
| mentagrophytes | MS10 is fungicidal | |
| Use-Dilution Method; AOAC | ||
| Official Method 955.14, 955.15, | ||
| 964.02 | Salmonella choleraesuis | |
| Staphylococcus aureus | ||
| Pseudomonas aeruginosa | MS10 is bactericidal | |
| Virucidal Testing | Poliovirus Type 1 | MS10 is virucidal |
| Quantitative Tuberculocidal Test | Mycobacterium bovis | MS10 is tuberculocidal |
7.0 OVERALL PERFORMANCE CONCLUSIONS
The studies demonstrate that the Manzi Mach 1 Instrument Cleaner-Processor System is safe and effective for the cleaning and high level disinfection of bronchoscopes within the stated indications for use for the Manzi Mach 1 Instrument Cleaner-Processor, the Manzi MS10 germicide, and the Manzi Detergent, MD10, and establishes substantial equivalence of the Manzi Mach 1 Instrument Cleaner Processor System to the predicate devices identified in Section 2.0 above.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with three stripes forming its wing, symbolizing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2 2006
Langford IC Systems, Incorporated C/O Jimmie T. Johnston, Ph.D. Vice President of Regulatory and Clinical Affairs Proven Process Medical Devices 141 Washington Street East Walpole, Massachusetts 02032
Re: K060458
Trade/Device Name: Manzi Mach 1 Instrument Cleaner-Processor System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: September 19, 2006 Received: September 20, 2006
Dear Dr. Johnston:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
5
Page 2 -- Dr. Johnston
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 (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 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
6
Indications for Use
510(k) Number: K060458
Device.Name: Manzi Mach 1 Instrument Cleaner - Processor System with MS10 High Level Disinfector
Indications for Use:
The Manzi Mach 1 Instrument Cleaner Processor System is indicated for use with the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (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)
Clerz
on Sign-Off) ion of Anesthesiology, General Hospital. con Control, Dental Devices
) Number: K060458