(185 days)
No
The description mentions standard image processing and correction, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on standard device functionality and safety, not AI/ML performance metrics.
No.
The device is described as a bronchoscope system used for observation and image processing within the airways and tracheobronchial tree. It facilitates visual inspection rather than providing a therapeutic effect like treatment or alleviation of a medical condition.
Yes
This device is a diagnostic device because it captures and processes images from within the body (airways and tracheobronchial tree) to allow trained physicians to observe and assess the internal structures. While it doesn't explicitly state it performs a diagnosis, the primary function of providing internal visual information to support a medical evaluation falls under the scope of diagnostics.
No
The device description clearly outlines both hardware components (flexible bronchoscope with camera and light source, video processor) and software components (image processing). It is a system that includes both hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for direct visualization within the airways and tracheobronchial tree using a bronchoscope. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The device is a bronchoscope system used for imaging the inside of the body. It involves inserting a flexible tube with a camera and light source into the airways.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any analysis on biological specimens.
The device is a medical imaging device used for direct visualization during a medical procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Veran SPIN VisionTM Single-Use Flexible Bronchoscope is intended to be used with the SPiN Vision™ Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Veran SPiN Vision™ Single-Use Flexible Bronchoscopes and SPiN Vision™ Video Processor are for use in hospitals, clinics, and/or urgent care centers by trained physicians.
Product codes
EOQ
Device Description
The Veran SPiN Vision™ Bronchoscope System consists of the Veran SPiN Vision™ Single-Use Flexible Video Bronchoscope accessories (Model Nos. INS-7100 and INS-7130) and the Veran SPiN Vision™ Video Processor (Model: SYS-5100) for clinical image processing. The Veran SPiN Vision™ Single-Use Flexible Bronchoscope is introduced within the airways or tracheobronchial tree during Bronchoscopy. The Veran SPiN Vision™ Video Processor provides power and processes the images for medical electronic endoscope.
The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope is a sterile, single use flexible bronchoscope. The Veran SPiN Vision™ Video Processor is a reusable device.
The light emitted by the LED cold light source of the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Veran SPiN Vision™ Video Processor via the encoding circuit. The Veran SPiN Vision™ Video Processor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.
The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope has the following physical and performance characteristics:
-
Maneuverable tip controlled by the user
-
. Flexible insertion cord
-
. Camera and LED light source at the distal tip
-
Working channel
-
. Sterilized by Ethylene Oxide
-
For single use .
The differences between the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope models are as follow: -
. Working channel diameters
-
. Insertion tube outer diameter
The Veran SPiN Vision™ Video Processor has the following physical and performance characteristics:
- . Provides images from the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope for observation
- . Can connect to an external monitor
- . Reusable device
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical imaging through CMOS
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, clinics, and/or urgent care centers by trained physicians.
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)
The following performance data are provided in support of the substantial equivalence determination:
- . Declaration of Conformity with the product specific standards ISO 8600-3, and ISO 8600-4
- Performance tests to test leaking, bending, articulating angle, endurance of the bending . section, radius of the bending section and irrigation tests were performed.
- . Packaging and labeling performance tests were performed
- . Biocompatibility Test
- . Aging Performance Test
- Sterile Packaging Integrity Test •
- Electrical Compatibility according to IEC 60601-1-2
- . Electrical Safety according to IEC 60601-1 and IEC 60601-2-18
- . Color Performance Testing and Image Intensity Uniformity (IIU) Testing
- . Software Verification and Validation Testing
Results: All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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.
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February 19, 2021
Veran Medical Technologies, Inc. B. Nathan Hunt Vice President, Quality Assurance and Regulatory Affairs 1908 Innerbelt Business Center Dr St. Louis, Missouri 63114
Re: K202346
Trade/Device Name: Veran SPiN Vision™ Bronchoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: January 15, 2021 Received: January 19, 2021
Dear B. Nathan Hunt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shu-Chen Peng, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202346
Device Name Veran SPiN VisionTM Bronchoscope System
Indications for Use (Describe)
The Veran SPIN VisionTM Single-Use Flexible Bronchoscope is intended to be used with the SPiN Vision™ Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Veran SPiN Vision™ Single-Use Flexible Bronchoscopes and SPiN Vision™ Video Processor are for use in hospitals, clinics, and/or urgent care centers by trained physicians.
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) | ☐ |
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Image /page/3/Picture/0 description: The image shows the logo for Veran Medical Technologies. The logo features a green and blue circular design on the left, followed by the word "VERAN" in large, bold, black letters. Below the word "VERAN" are the words "MEDICAL TECHNOLOGIES" in smaller, light blue letters.
1908 INNERBELT BUSINESS CENTER DRIVE ST. LOUIS, MISSOURI 63114 PHONE 314.659.8500 FAX 314.659.8560 www.veranmedical.com
510(k) Summary Veran Medical Technologies, Inc. SPiN Vision™ Bronchoscope System
In accordance with 21 CFR 807.92 the following summary of information is provided, on this date,
January 14th, 2021:
1. 510(k) SUBMITTER
Veran Medical Technologies 1908 Innerbelt Business Center Drive St. Louis, MO 63114 Tel: 314-659-8500 Fax: 314-659-8560
Contact Person:
B. Nathan Hunt Vice President, Quality Assurance and Requlatory Affairs Veran Medical technologies 1908 Innerbelt Business Center Drive St. Louis. MO 63114 Tel: 314-659-8500 Fax: 314-659-8560
Date Prepared:
January 14th, 2021
2. DEVICE
Trade Name of Device:
Veran SPiN Vision™ Bronchoscope System Models: SYS-5100, SPiN Vision™ Video Processor INS-7100, SPiN Vision™ Scope, 4.0mm OD, 2.0mm WC INS-7130, SPiN Vision™ Scope, 6.0mm OD, 3.0mm WC
Common or Usual Name:
Bronchoscope (flexible or rigid) and accessories
Classification Names:
Bronchoscope (flexible or rigid) and accessories (21 CFR 874.4680)
Regulation Class: II
Classification Code: EOQ
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Image /page/4/Picture/0 description: The image shows the logo for Veran Medical Technologies. The logo consists of a green and blue geometric shape resembling a stylized flower or starburst, followed by the word "VERAN" in a bold, black serif font. Below "VERAN" are the words "MEDICAL TECHNOLOGIES" in a smaller, light blue sans-serif font.
1908 INNERBELT BUSINESS CENTER DRIVE ST. LOUIS, MISSOURI 63114 PHONE 314.659.8500 FAX 314.659.8560 www.veranmedical.com
3. PREDICATE DEVICE
Predicate Device:
Trade Name: Vathin® Video Bronchoscope System
Common Name: Bronchoscope (flexible or rigid) and accessories
510(K) No.: K191828
Device Models:
Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope BCV1-01 BCV1-02 BCV1-C1 BCV1-C2 BCV1-H1 BCV1-K1 BCV1-K1 BCV1-K2 BCV1-M1 BCV1-M2 BCV1-01 BCV1-02 BCV1-S1 BCV1-S2 BCV1-U1 BCV1-U2 BCV1-W1 BCV1-W2 Vathin®VisionCenterTM I Digital Video Processor DVP-A1
Classification Name: Bronchoscope (flexible or rigid) and accessories (21 CFR 874.4680)
Product Code: EOQ
Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
4. DEVICE DESCRIPTION
The Veran SPiN Vision™ Bronchoscope System consists of the Veran SPiN Vision™ Single-Use Flexible Video Bronchoscope accessories (Model Nos. INS-7100 and INS-7130) and the Veran SPiN Vision™ Video Processor (Model: SYS-5100) for clinical image processing. The Veran SPiN Vision™ Single-Use Flexible Bronchoscope is introduced within the airways or tracheobronchial tree during Bronchoscopy. The Veran SPiN Vision™ Video Processor provides power and processes the images for medical electronic endoscope.
The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope is a sterile, single use flexible bronchoscope. The Veran SPiN Vision™ Video Processor is a reusable device.
The light emitted by the LED cold light source of the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Veran SPiN Vision™ Video Processor via the encoding circuit. The Veran SPiN Vision™ Video Processor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.
The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- . Flexible insertion cord
- . Camera and LED light source at the distal tip
- Working channel
- . Sterilized by Ethylene Oxide
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Image /page/5/Picture/0 description: The image shows the logo for Veran Medical Technologies. The logo features a green and blue circular design to the left of the company name. The company name is written in a bold, sans-serif font, with the word "VERAN" in black and "MEDICAL TECHNOLOGIES" in blue.
-
For single use .
The differences between the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope models are as follow: -
. Working channel diameters
-
. Insertion tube outer diameter
The Veran SPiN Vision™ Video Processor has the following physical and performance characteristics:
- . Provides images from the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope for observation
- . Can connect to an external monitor
- . Reusable device
5. INDICATION FOR USE
The Veran SPiN Vision™ Single-Use Flexible Bronchoscope is intended to be used with the SPiN Vision™ Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Veran SPiN Vision™ Single Bronchoscopes and SPiN Vision™ Video Processor are for use in hospitals, clinics, and/or urgent care centers by trained physicians.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Veran SPiN Vision™ Bronchoscope System has the same technological characteristics and fundamental design as the predicate device. The Veran SPiN Vision™ Bronchoscope System and the predicate device are designed to provide real-time images to the physician in order to facilitate diaqnostic and therapeutic procedures in the lung tract.
The differences between The Veran SPiN Vision™ Bronchoscope System and predicate device do not alter suitability of the proposed device for its intended use.
The Veran SPiN Vision™ Bronchoscope System is substantially equivalent to the cleared predicate device (K191828).
The Veran SPiN Vision™ Bronchoscope System has equivalent Indications for Use as the predicate device.
The subject and predicate device are similar in the following technological elements:
- . They are single-use devices delivered sterile.
- . They are flexible endoscopes with a maneuverable tip.
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Image /page/6/Picture/0 description: The image shows the logo for Veran Medical Technologies. The logo features a green and blue circular graphic on the left, followed by the word "VERAN" in large, black, serif font. Below "VERAN" are the words "MEDICAL TECHNOLOGIES" in a smaller, blue, sans-serif font.
- . They are video endoscopes with a camera located in the distal tip to provide an image on a separate monitor.
- . They use an LED-light source located in the distal tip.
- They have suction functionality.
- . They have a working channel for insertion of endoscopic accessories.
The following technological differences exist between the subject and predicate device:
- The proposed device has different physical specifications.
- . The conical lock/working channel port of the proposed device is compatible with existing biopsv valves.
- . The steering level of the proposed device includes a locking function.
- . The video processor of the proposed device has a different cable connector.
Non-clinical bench testing has been completed ensuring that the differences don't affect the safety and effectiveness of the proposed subject device.
7. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination:
- . Declaration of Conformity with the product specific standards ISO 8600-3, and ISO 8600-4
- Performance tests to test leaking, bending, articulating angle, endurance of the bending . section, radius of the bending section and irrigation tests were performed.
- . Packaging and labeling performance tests were performed
- . Biocompatibility Test
- . Aging Performance Test
- Sterile Packaging Integrity Test •
- Electrical Compatibility according to IEC 60601-1-2
- . Electrical Safety according to IEC 60601-1 and IEC 60601-2-18
- . Color Performance Testing and Image Intensity Uniformity (IIU) Testing
- . Software Verification and Validation Testing
Results: All tests passed.
8. CONCLUSION
The Veran SPiN Vision™ Video Bronchoscope System is substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe and as effective and performs as well as the legally marketed device.