(63 days)
No
The device description explicitly states that the subject devices are identical to their predicate devices with the sole exception of adding epoxy to the suction nipple. There are no mentions of AI, ML, image processing, or any related technologies in the provided text.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices provide "therapeutic access" for various anatomical sites.
Yes
The device provides "optical visualization" and "ultrasonic visualization" of various anatomical structures within the pulmonary track, which are forms of imaging used for diagnostic purposes. It also states its use for observing "indications consistent with the requirement for procedure".
No
The device description clearly outlines physical components like an Insertion Portion, Control Body, PVE Connector, Light Guide Plug, and Ultrasound Umbilical Connector, and the performance studies focus on the physical suction nipple sub-assembly. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that these devices are used for optical visualization and ultrasonic visualization of internal anatomical structures (airways, tracheobronchial tree, nasal, pharyngeal, laryngeal, etc.). They are also used for therapeutic access to these areas.
- Method of Use: The devices are introduced directly into the body (per orally) to visualize and access internal structures. This is an in vivo procedure, not an in vitro test on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or performing any kind of laboratory test on bodily fluids or tissues.
The devices described are medical endoscopes used for direct visualization and intervention within the body, which falls under the category of medical devices but not specifically in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
- PENTAX Medical Video Bronchoscopes (EB Family): 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.
- PENTAX Medical Video Naso-Pharyngo-Laryngoscope (VNL-1570STK): The PENTAX Medical Video Naso-Pharyngo-Laryngoscope (VNL-1570STK) is designed to be used with a PENTAX Medical video processor, light source, documentation equipment, display monitor, endoscopic accessories, and other ancillary equipment and intended to provide optical visualization (via a video monitor) of, and therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.
- PENTAX Medical Ultrasound Video Bronchoscope, EB-1970UK: The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to the organs, tissues, and subsystems: Nasal Passage, Pharynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric populations.
Product codes
EOQ, EOB, ITX
Device Description
The PENTAX Medical Video Bronchoscopes, Video Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are identical to their respective predicate devices with the sole exception being that epoxy has been added to the suction nipple of the subject devices to prevent loosening of the suction nipple. There are no other changes to the design, specifications, or technological characteristics of the predicate devices as described in K131028 (EB family), K162151 (VNL-1570STK) and K081518 (EB-1970UK).
Both the Bronchoscopes and Naso-Pharyngo-Laryngoscope are composed of an Insertion Portion, Control Body, PVE Connector and Light Guide Plug. In addition to the parts above, the Ultrasound Video Bronchoscope has an Ultrasound Umbilical Connector.
All the Bronchoscopes, Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are reusable devices initially supplied non-sterile to the user and require the user to reprocess prior to initial use and between each use. All the Bronchoscopes, Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are used with compatible PENTAX Medical Video Processors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization, ultrasonic visualization
Anatomical Site
airways and tracheobronchial tree, nasal, pharyngeal, laryngeal and the upper airway anatomy, Pulmonary Track including but not restricted to the organs, tissues, and subsystems: Nasal Passage, Pharynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas.
Indicated Patient Age Range
adult and pediatric patient populations
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)
Performance testing of the suction nipple sub-assembly under stress conditions utilizing epoxy materials was conducted to determine the force (torque) required to loosen the subassembly. The results indicate that the subject epoxy has adequate adhesive strength to prevent looseness of the suction nipple under all stress conditions specified by the protocol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 19, 2018
PENTAX of America, Inc. James W. Monroe, Director RA PENTAX Medical 3 Paragon Drive Montvale, NJ 07645-1782
Re: K173554
Trade/Device Name: PENTAX Medical Video Bronchoscopes. PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasound Video Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ, EOB, ITX Dated: November 10, 2017 Received: November 17, 2017
Dear James Monroe:
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.
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
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known) K173554
Device Name PENTAX Medical Video Bronchoscopes (EB Family)
Indications for Use (Describe)
Device Name: PENTAX Medical Video Bronchoscopes (EB Family): 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
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."
FORM FDA 3881 (7/17)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Traditional 510(k) Premarket Notification - Suction Nipple Modification: PENTAX Medical Video Bronchoscopes (EB Family), Video Naso-Pharyngo-Laryngoscope (VNL-1570STK), and Ultrasound Video Bronchosope (EB-1970UK)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | | | |
| 510(k) Number ( if known ) | K173554 | | | |
| Device Name | PENTAX Medical Video Naso-Pharyngo-Laryngoscope | | | |
| Indications for Use ( Describe ) | The PENTAX Medical Video Naso-Pharyngo-Laryngoscope (VNL-1570STK) is designed to be used with a PENTAX Medical video processor, light source, documentation equipment, display monitor, endoscopic accessories, and other ancillary equipment and intended to provide optical visualization (via a video monitor) of, and therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy. | | | |
| 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 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | 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."
FORM FDA 3881 (7/17)
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173554
Device Name PENTAX Medical Ultrasound Video Bronchoscope
Indications for Use (Describe)
Device Name: PENTAX Medical Ultrasound Video Bronchoscopes, EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to the organs, tissues, and subsystems: Nasal Passage, Pharynx, Trachea Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Type of Use (Select one or both, as applicable)
X
Prescription Use (Part 21 CFR 801 Subpart D) | Subpart C)
Over-The-Counter Use (21 CFR 801
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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
5
510(k) Summary
I. SUBMITTER
PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 201-571-2318 Ext 2318 Fax: 201-571-2340
Contact: James W. Monroe Date Prepared: December 5, 2017
II. DEVICE
The purpose of this 510(k) is to obtain clearance for the addition of epoxy to the suction nipple of the PENTAX Medical Video Bronchoscopes (EB Family), PENTAX Medical Video Naso-Pharyngo-Laryngoscope (VNL-1570STK) and PENTAX Medical Ultrasound Video Brochoscope (EB-1970UK) to prevent loosening of the suction nipple. There are no changes to the intended use or indications for use of the EB scopes, VNL-1570STK or EB-1970UK.
Table 5.1: Regulatory Classification of PENTAX Medical Video Bronchoscopes, Naso-Pharyngo-Laryngoscope, and Ultrasound Video Bronchoscope
| Device Name | PENTAX Medical Video
Bronchoscopes | PENTAX Medical Video
Naso-Pharyngo-
Laryngoscope | PENTAX Medical
Ultrasound Video
Bronchoscope |
|------------------------|---------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Common Name | Bronchoscope | Nasopharyngoscope | Bronchoscope |
| Classification
Name | Bronchoscopes
(flexible or rigid) and
accessories | Nasopharyngoscop
e (flexible or rigid)
and accessories | Bronchoscope (flexible
or rigid) and accessories
Diagnostic Ultrasound
Transducer |
| Regulation No. | 874.4680 | 874.4760 | 874.4680, 892.1570 |
| Device Class | 2 | 2 | 2 |
| Product Code | EOQ | EOB | EOQ, ITX |
| Classification Panel | Ear, Nose, & Throat | Ear, Nose, & Throat | Radiology |
III. PREDICATE DEVICES
The predicate devices for this submission are also the subject devices of this submission (see
6
Traditional 510(k) Premarket Notification - Suction Nipple Modification: PENTAX Medical Video Bronchoscopes (EB Family), Video Naso-Pharyngo-Laryngoscope (VNL-1570STK), and Ultrasound Video Bronchosope (EB-1970UK)
Table 5.2). The predicate devices are identical to the devices subject to this 510(k) with the exception of the addition of epoxy to the suction nipple of the subject scopes.
7
Table 5.2: Subject vs. Predicate Devices
| Subject
Device | PENTAX
Medical Video
Bronchoscopes | PENTAX Medical Video
Naso- Pharyngo-
Laryngoscope | PENTAX Medical
Ultrasound Video
Bronchoscope |
|---------------------|------------------------------------------|---------------------------------------------------------|----------------------------------------------------|
| Predicate
Device | PENTAX
Medical Video
Bronchoscopes | PENTAX Medical Video
Naso- Pharyngo-
Laryngoscope | PENTAX Medical
Ultrasound Video
Bronchoscope |
| Predicate
Device | K131028 | K162151 | K081518 |
IV. DEVICE DESCRIPTION
The PENTAX Medical Video Bronchoscopes, Video Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are identical to their respective predicate devices with the sole exception being that epoxy has been added to the suction nipple of the subject devices to prevent loosening of the suction nipple. There are no other changes to the design, specifications, or technological characteristics of the predicate devices as described in K131028 (EB family), K162151 (VNL-1570STK) and K081518 (EB-1970UK).
The model numbers for the PENTAX Medical Video Bronchoscopes, Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope that are applicable to this 510(k) are provided in Table 5.3.
Both the Bronchoscopes and Naso-Pharyngo-Laryngoscope are composed of an Insertion Portion, Control Body, PVE Connector and Light Guide Plug. In addition to the parts above, the Ultrasound Video Bronchoscope has an Ultrasound Umbilical Connector.
All the Bronchoscopes, Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are reusable devices initially supplied non-sterile to the user and require the user to reprocess prior to initial use and between each use. All the Bronchoscopes, Naso-Pharyngo-Laryngoscope and Ultrasound Video Bronchoscope are used with compatible PENTAX Medical Video Processors.
| Scope Family | Model Number |
|---|---|
| EB Family | EB-1170K EB-1570K EB-1970K |
| EB-1970TK | |
| VNL Family | VNL-1570STK |
Table 5.3: EB and VNL Model Numbers associated with addition of epoxy to suction nipple
8
V. INDICATIONS FOR USE
There are no changes to the Indications for Use for the subject devices. The sole purpose of this 510(k) is to obtain clearance for the addition of epoxy to the suction nipple of the scopes.
The PENTAX Medical Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Medical 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.
The PENTAX Medical Video Naso-Pharyngo-Laryngoscope (VNL-1570STK) is designed to be used with a PENTAX Medical video processor, light source, documentation equipment, display monitor, endoscopic accessories, and other ancillary equipment and intended to provide optical visualization (via a video monitor) of, and therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.
The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to the organs, tissues, and subsystems: Nasal Passage, Pharynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric populations.
VI. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE
The subject devices are identical to the predicate devices with the exception of the addition of epoxy to prevent loosening of the suction nipple of the subject devices. The subject devices have the same fundamental technology and operating principles as the predicate device, including the same intended use and technological characteristics, such as Insertion Portion, Control Body and fiberoptics illumination. There are no differences in specifications, including, but not limited to, depth of field, distal end width, insertion tube width, instrument channel width, and total length. The sole difference between the subject and predicate devices is the addition of epoxy to the suction nipple of the scopes. This modification does not impact the intended use and does not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
The addition of epoxy to the suction nipple of the EB, VNL and EB-1970UK scopes do not affect the biocompatibility, reprocessing, electrical safety, electromagnetic compatibility, or software
9
verification and validation.
Performance testing of the suction nipple sub-assembly under stress conditions utilizing epoxy materials was conducted to determine the force (torque) required to loosen the subassembly. The results indicate that the subject epoxy has adequate adhesive strength to prevent looseness of the suction nipple under all stress conditions specified by the protocol.
VIII. CONCLUSION
The subject and predicate devices are identical with the exception of the addition of epoxy to the suction nipple. The subject devices have the same intended use and technological characteristics as the predicate devices. There are no other changes to the design of the subject devices.
The performance data indicates that the subject devices with epoxy applied to the suction nipple have adequate adhesive strength to prevent looseness of the suction nipple under stress conditions. The data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.