(363 days)
No
The document describes a standard video bronchoscope system and does not mention any AI or ML capabilities in the device description, intended use, or performance studies. The image processing described is basic conversion of raw image data to a displayable signal.
Yes
The device is described as being used with "endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery," indicating its role in therapeutic procedures beyond just diagnosis.
Yes
The device's intended use is to visualize the airways and tracheobronchial tree ("The PENTAX Video Bronchoscopes (EB Family) have been designed to be used... for endoscopy and endoscopic surgery within the airways and tracheobronchial tree."). This visualization enables the identification of abnormalities, which is a diagnostic function. While it also facilitates endoscopic surgery, the primary act of looking inside the body to observe conditions is diagnostic.
No
The device description clearly outlines physical hardware components such as an Insertion Portion, Control Body, PVE Connector, Objective Lens, Light Guide, Instrument Channel, CCD, and various mechanical controls. While it interacts with a video processor and displays images on a monitor, the core device itself is a physical bronchoscope with integrated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopy and endoscopic surgery within the airways and tracheobronchial tree." This describes a procedure performed directly on the patient's body for visualization and intervention.
- Device Description: The description details a bronchoscope, which is an instrument used to visualize the inside of the airways. It involves inserting a physical device into the body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any analysis on specimens in a laboratory setting.
- Focus on Visualization and Intervention: The device's function is to provide visual access to the airways and allow for the use of accessories like biopsy forceps for direct intervention.
Therefore, the PENTAX Video Bronchoscopes (EB Family) are considered medical devices used for diagnostic and therapeutic procedures in vivo (within the living body), not in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The PENTAX Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Product codes
EOQ, FOO
Device Description
The PENTAX Video Bronchoscopes (EB Family); Model Numbers: EB-1970TK, EB-1170K, EB-1570K, EB-1575K, EB-1970K, EB-1975K, EB-1990i are used with a Video Processor. The PENTAX Video Bronchoscopes (EB Family) are composed of the following main parts; an Insertion Portion, Control Body and PVE Connector.
The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument . Channel are located on the Distal End of the Insertion Portion.
The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever, Suction Cylinder, Suction nipple, Remote Button, and Instrument Channel Inlet. The Suction Control Valve is attached to the Suction Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Bending Section is bent by the Angulation Control lever to operate the endoscope angulation. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is . pushed, the fluid and air are suctioned. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel.
The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. The Light Guide of the Distal End is used to illuminate the body cavity by light which is carried through the Light Carrying Bundle. The Light Carrying Bundle quides the light Guide Plug which is connected to the Light Source. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.
The PENTAX Video Bronchoscopes are reusable semi-critical devices. Since they are · packaged non-sterile, they must be high-level disinfected or sterilized BEFORE initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification and Validation testing has been performed in accordance with Design control per 21 CFR Part 820.30. The performance of the EB Family Master Device (EB-1970TK) were evaluated using the appropriate methodology as specified in the following FDA recognized consensus standards in conjunction with our in-house test protocols and use of external testing laboratories:
-
- IEC 60601-1:1988+A1:1991+A2:1995 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-1:2000 requirements for safety- Collateral standard: Safety requirements for medical . electrical systems
-
- IEC 60601-1-2:2001+A1:2004 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in 5. vitro cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization
- IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular 7. requirements for the basic safety and essential performance of endoscopic equipment
-
- ISO 8600-1:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements
- ക. ISO 8600-3:1997+A1:2003 Optics and optical instruments -Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
-
- ISO 8600-4:1997 Optics and optical instruments -Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
- AAMITIR12:2010 Designing, testing, and labeling reusable medical devices for 11. reprocessing in health care facilities: A quide for device manufacturers
-
- AAMITIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
-
- ANSI/AAMI TIR79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
-
- IS013485:2003 Medical devices - Quality management systems - Requirements for requlatory purposes
-
- ISO 14971:2007 (corrected version): Medical devices -Application of risk management to medical devices
-
- IEC 60601-1-4:2000 Ed. 1.1 Medical electrical equipment- Part 1-4: General requirements for safety- Collateral Standard: Programmable electricalmedical svstems
-
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
- IEC 62366:2007 Medical devices -Application of usability engineering to medical devices
-
- IEC 62304:2006 Medical device software- Software life cycle processes
-
- IEC 604171SO 7000-DB-12M:2004 Graphical symbols for use on equipment-12-month subscription to online database comprising all graphical symbols published in IEC 60417 and ISO 7000
-
- ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
- IEC 60878:2003 Graphical symbols for electrical equipment in medical practice 22.
The PENTAX Video Bronchoscope (EB Family) Master Device (EB-1790TK) test results satisfy the acceptance criteria specified by the above applicable standards.
Biocompatibility Test: Biocompatibility of direct and indirect contact materials were confirmed by testing the Cytotoxicity. Sensitization and Intracutaneous Reactivity for the surface device, mucosal membrane contact less than 24 hours duration device category in accordance with the ISO 10993-1. 5. and 10 Biological evaluation of medical devices standard and the FDA's guidance the Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'.
Reprocessing Validation: Simulated use conditioned test samples were used in the Cleaning validation and High Level Disinfection validation studies for validating the effectiveness of the reusable Bronchoscope Reprocessing procedures/methodology in accordance with the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: ' Validation Methods and Labeling distributed in May 2, 2011, AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, and AAMI TIR79:2010 Comprehensive quide to steam sterility assurance in health care facilities. All the study results satisfy the acceptance criteria specified by the above applicable standards.
In addition, the Reprocessing Instructions (Manual) were validated based on the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling distributed in May 2, 2011. The validation confirmed that the EB Family Bronchoscope Reprocessing Instructions are complete, understandable, and can reasonably be executed by the user. Also, the optional sterilization using the FDA cleared (K042116) STERRAD NX System for EB-1575K, EB-1975, and EB-1990i has been validated per the manufacturer's specification and in accordance with AAMI TIR79:2010 Comprehensive guide to steam sterility assurance in health care facilities.
EMC and Electrical Safety: The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the EB Family Master Device (EB-1790TK) were confirmed by testing in accordance with the IEC 60601-1: IEC 60601-1-2: IEC 60601-1-4: IEC 60601-1-6: Medical electrical equipment -Part 1: General requirements for basic safety and essential performance, Safety requirements for medical electrical systems. Electromagnetic compatibility - Requirements and tests: and IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OLYMPUS Bronchoscope BF Type 1T180 (K061313)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "K131028" at the top and the words "PENTAX MEDICAL" in bold, black letters below. The word "PENTAX" is on the top line, and the word "MEDICAL" is on the second line. There is a horizontal line separating the two lines of text. The number "K131028" is likely a serial or model number.
510(k) Summary
APR 1 0 2014
The following summary is provided in accordance with 21 CFR 807.92:
Date: 10 Apr 2014
.
| Submitter: | PENTAX Medical Company,
HOYA Corporation PENTAX Division
3 Paragon Drive
Montvale, New Jersey 07645-1782 | | | | | |
|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Contact: | Krishna Govindarajan
A
Regulatory Manager
PENTAX Medical Company.
3 Paragon Drive
Montvale, New Jersey 07645-1782
Phone: 800-431-5880 x 2125, 201-251-2300 x 2125
Fax: 201-799-4117
Email: Krishna.govindarajan@pentaxmedical.com | | | | | |
| Trade/Device Name: | PENTAX Video Bronchoscopes (EB Family) | | | | | |
| Model Numbers: | EB-1970TK, EB-1170K, EB-1570K, EB-1575K,
EB-1970K, EB-1975K, EB-1990i | | | | | |
| Common/Usual Name: | Bronchoscope | | | | | |
| Requlation Number:
Regulation Name: .
Regulatory Class:
Product Code: | 21 CFR Part 874.4680
Bronchoscopes (Flexible or rigid) and accessories
Class II
EOQ | | | | | |
| Predicate Device: | OLYMPUS Bronchoscope BF Type 1T180
(K061313; dated Aug 30 2006) | | | | | |
| Requlation Number:
Requlation Name:
Requlation Description:
Requlatory Class:
Product Code: | 21 CFR Part 874.4680
Bronchoscopes (Flexible or rigid) and accessories
Endoscope and accessories
Class II
FOO | | | | | |
1
Image /page/1/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, black letters on the top line. There is a horizontal line underneath the word "PENTAX". The word "MEDICAL" is in bold, black letters on the bottom line.
Device Description:
ﻴﻦ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ : - The PENTAX Video Bronchoscopes (EB Family); Model Numbers: EB-1970TK, EB-1170K, EB-1570K, EB-1575K, EB-1970K, EB-1975K, EB-1990i are used with a Video Processor. The PENTAX Video Bronchoscopes (EB Family) are composed of the following main parts; an Insertion Portion, Control Body and PVE Connector.
The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument . Channel are located on the Distal End of the Insertion Portion.
The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever, Suction Cylinder, Suction nipple, Remote Button, and Instrument Channel Inlet. The Suction Control Valve is attached to the Suction Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Bending Section is bent by the Angulation Control lever to operate the endoscope angulation. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is . pushed, the fluid and air are suctioned. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel.
The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. The Light Guide of the Distal End is used to illuminate the body cavity by light which is carried through the Light Carrying Bundle. The Light Carrying Bundle quides the light Guide Plug which is connected to the Light Source. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.
The PENTAX Video Bronchoscopes are reusable semi-critical devices. Since they are · packaged non-sterile, they must be high-level disinfected or sterilized BEFORE initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.
2
Image /page/2/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, black letters on the top line. There is a black line underneath the word "PENTAX", and the word "MEDICAL" is in large, bold, black letters on the bottom line.
The PENTAX Video Bronchoscopes (EB Family) Accessories and Component List:
.
·
.
.
·
· ,
r
. . . . .
.
| EB-1990 | N | > | |||||||
|---|---|---|---|---|---|---|---|---|---|
| EB-1975K | N | > | |||||||
| EB-1675K | x | ·N | ನ | ||||||
| Compatibles with | EB-1970K | N | k | > | > | ||||
| EB-1570K | A | N | λ | > | > | ||||
| EB-1170K | N | λ | λ | ||||||
| EB-1970TK : | N | > | |||||||
| nage/Pictur | ENTA | ||||||||
| E-BI5 | |||||||||
| APA | 10 118 0445 | ||||||||
| Descriptio | The brush cleans the instrument Chann | ||||||||
| Brush used for cleaning the endosco |
channels. | The brush cleans the Instrument Channell Channell
Brush used for cleaning the endosco
channels. | Instrument Channei | cyllinders. The brush is used to clean the Suction
Bruah used for cleaning the endosco
| It is used during reprocessing to seal the Control Suction Cyllinder located at the Control Body in order to fill the chemical solutio inside the channel. | The cap for communication the mornal insmall Baction Communication in Charlostraliano in China Bach Barning Commercial Charlos in Chamar Chailer and Chaines Friensiportation
endoscope. | During reprocessing, it prevents the chemical solution contacting the checking the checked Electrical Contacts by being sitteched the encloscope Electrical Contact. | |
| | Model nam | Cleaning Brush | Cleaning Brush | Clearing Brush
(Short) | Cleaning Bru | Cleaning Adapter | Vantilation Cap | Soaking Ca | |
| | Product No. | S6015ST | CS3010S | CS6002SN | CS-C3S | OF-B155 | OF-C5 | OE-Ca | |
| | Type | Accessory for | | | | | | | |
3
NOTE:
ssories and components listed above are included as part of this 5.00(k) wominstion
Cleaning, Disinfection, and Sterilization refer to Instructions for Use (Reprocessing), S
4
Image /page/4/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, sans-serif font on the top line. A horizontal line is directly underneath the word "PENTAX". The word "MEDICAL" is in a smaller, bold, sans-serif font on the bottom line.
Intended Use:
The PENTAX Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Summary of Technology Characteristics
The PENTAX Video Bronchoscope has the same fundamental technology and operating principles in comparison to those of the predicate device, including same intended use, design technological characteristics, such as Insertion Portion, Control Body and fiberoptics illumination. The minor differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device.
Safety and Performance Data (Non-clinical tests)
Design Verification and Validation testing has been performed in accordance with Design control per 21 CFR Part 820.30. The performance of the EB Family Master Device (EB-1970TK) were evaluated using the appropriate methodology as specified in the following FDA recognized consensus standards in conjunction with our in-house test protocols and use of external testing laboratories:
-
- IEC 60601-1:1988+A1:1991+A2:1995 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-1:2000 requirements for safety- Collateral standard: Safety requirements for medical . electrical systems
-
- IEC 60601-1-2:2001+A1:2004 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in 5. vitro cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization
- IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular 7. requirements for the basic safety and essential performance of endoscopic equipment
5
Image /page/5/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, sans-serif font on the top line. A horizontal line is directly underneath the word "PENTAX". The word "MEDICAL" is in a smaller, bold, sans-serif font on the bottom line.
-
- ISO 8600-1:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements
- ക. ISO 8600-3:1997+A1:2003 Optics and optical instruments -Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
-
- ISO 8600-4:1997 Optics and optical instruments -Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
- AAMITIR12:2010 Designing, testing, and labeling reusable medical devices for 11. reprocessing in health care facilities: A quide for device manufacturers
-
- AAMITIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
-
- ANSI/AAMI TIR79:2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
-
- IS013485:2003 Medical devices - Quality management systems - Requirements for requlatory purposes
-
- ISO 14971:2007 (corrected version): Medical devices -Application of risk management to medical devices
-
- IEC 60601-1-4:2000 Ed. 1.1 Medical electrical equipment- Part 1-4: General requirements for safety- Collateral Standard: Programmable electricalmedical svstems
-
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
- IEC 62366:2007 Medical devices -Application of usability engineering to medical devices
-
- IEC 62304:2006 Medical device software- Software life cycle processes
-
- IEC 604171SO 7000-DB-12M:2004 Graphical symbols for use on equipment-12-month subscription to online database comprising all graphical symbols published in IEC 60417 and ISO 7000
-
- ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
- IEC 60878:2003 Graphical symbols for electrical equipment in medical practice 22.
The PENTAX Video Bronchoscope (EB Family) Master Device (EB-1790TK) test results satisfy the acceptance criteria specified by the above applicable standards.
Biocompatibility Test
Biocompatibility of direct and indirect contact materials were confirmed by testing the Cytotoxicity. Sensitization and Intracutaneous Reactivity for the surface device, mucosal membrane contact less than 24 hours duration device category in accordance with the ISO 10993-1. 5. and 10 Biological evaluation of medical devices standard and the FDA's guidance the Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'.
Reprocessing Validation
6
Image /page/6/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, sans-serif font on the top line. There is a horizontal line below "PENTAX", and the word "MEDICAL" is in a similar font on the bottom line.
Simulated use conditioned test samples were used in the Cleaning validation and High Level Disinfection validation studies for validating the effectiveness of the reusable Bronchoscope Reprocessing procedures/methodology in accordance with the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: ' Validation Methods and Labeling distributed in May 2, 2011, AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, and AAMI TIR79:2010 Comprehensive quide to steam sterility assurance in health care facilities. All the study results satisfy the acceptance criteria specified by the above applicable standards.
In addition, the Reprocessing Instructions (Manual) were validated based on the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling distributed in May 2, 2011. The validation confirmed that the EB Family Bronchoscope Reprocessing Instructions are complete, understandable, and can reasonably be executed by the user. Also, the optional sterilization using the FDA cleared (K042116) STERRAD NX System for EB-1575K, EB-1975, and EB-1990i has been validated per the manufacturer's specification and in accordance with AAMI TIR79:2010 Comprehensive guide to steam sterility assurance in health care facilities.
EMC and Electrical Safety
The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the EB Family Master Device (EB-1790TK) were confirmed by testing in accordance with the IEC 60601-1: IEC 60601-1-2: IEC 60601-1-4: IEC 60601-1-6: Medical electrical equipment -Part 1: General requirements for basic safety and essential performance, Safety requirements for medical electrical systems. Electromagnetic compatibility - Requirements and tests: and IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
Substantial Equivalence discussion:
The PENTAX Video Bronchoscope has the same intended use, fundamental technology and operating principles including design technological characteristics, such as Insertion Portion, Control Body and fiberoptics illumination in comparison to those of the predicate device. The minor dimensional differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device.
Conclusion:
7
Image /page/7/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, sans-serif font on the top line. A horizontal line is underneath the word "PENTAX", and the word "MEDICAL" is in a smaller, bold, sans-serif font on the bottom line.
The PENTAX Medical Company believes that the PENTAX EB Family of Scopes as indicated in this special 510(k) premarket notification submission is to be as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system.
.
8
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. To the left of the bird-like figure is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2014
PENTAX Medical Company Mr. Krishna Govindarajan Regulatory Manager 3 Paragon Drive Montvale, NJ 07645-1782
Re: K131028
Trade/Device Name: PENTAX Video Bronchoscopes (EB Family) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscopes (Flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: March 7, 2014 Received: March 10, 2014
Dear Mr. Govindaraian:
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.
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Page 2 – Mr. Krishna Govindarajan
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,
Deborah L. Falls -S
for Malvina B. Eydelman, M.D. Director
· Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131028
Device Name: PENTAX Video Bronchoscopes (EB Family) Model Numbers: EB-1970TK, EB-1170K, EB-1570K, EB-1575K, EB-1970K, EB-1975K, EB-1990i
Indications for Use:
The PENTAX Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
... .
Sunny Park
2014.04.10-14.4.03 -04'00'
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