(256 days)
No
The summary describes standard image processing and performance testing for an endoscope, with no mention of AI, ML, or related concepts.
No
The device is described as an endoscope intended for visualization and examination within the nasal lumens and upper airway anatomy, not for treating a condition.
No
The primary purpose of the device, as described in the "Intended Use / Indications for Use," is for visualization during endoscopic procedures within the nasal lumens and upper airway anatomy. It explicitly states, "The endoscope is intended to provide visualization via an Image Processor." There is no mention of the device analyzing or interpreting data to diagnose a condition, only to provide images for a healthcare professional to view.
No
The device description explicitly mentions both a "Single-Use Rhinolaryngoscope" (hardware) and an "Image Processor" (hardware), indicating it is not a software-only device.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states the device is an endoscope used for visualization within the nasal lumens and upper airway anatomy. It provides images for examination.
- No sample analysis: The device does not analyze any biological samples taken from the patient. It directly visualizes the internal anatomy.
Therefore, this device falls under the category of a medical device used for direct visualization and examination, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) to be introduced within the nasal lumens and upper airway anatomy and Image Processor (model: VLM-02) for clinical image processing. The Image Processor provides power and processes the images for medical electronic endoscope.
The Single-Use Rhinolaryngoscope is a sterile single used flexible Rhinolaryngoscope. The Image Processor is a reusable monitor.
The differences between the Single-use Rhinolaryngoscope models are as follow:
- Have or haven't working channel
- Working channel inner diameter
- Insertion tube outer diameter
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal lumens and upper airway anatomy.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospital environment.
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 were provided in support of the substantial equivalence determination.
Biocompatibility testing: Biocompatibility of the Single-Use Rhinolaryngoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were performed, as recommended:
- Cytotoxicity
- Sensitization
- Oral Mucosa Irritation
Sterilization and shelf life testing: The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Single-use Rhinolaryngoscope is validated.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Rhinolaryngoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.
Bench performance testing: The following bench tests were performed:
- Optical performance testing according to ISO 8600 series.
- Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity), SNR and dynamic range, image frame frequency and system delay test compared with the predicate device.
-
- Mechanical bending testing.
-
- Photobiological safety test verified compliance to IEC 62471:2006
- Thermal safety performance test verified compliance to Protection against excessive temperature and other safety hazards of IEC 60601-2-18:2009
Clinical study: No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
April 26, 2024
Shenzhen HugeMed Medical Technical Development Co., Ltd. % Yang Jie Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K232435
Trade/Device Name: Rhinolaryngoscope system Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: March 27, 2024 Received: March 27, 2024
Dear Yang Jie:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232435
Device Name Rhinolaryngoscope System
Indications for Use (Describe)
The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.
| 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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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
The assigned 510(k) number is K232435.
Prepared Date: 2024/04/25
1. Submission sponsor
Name: Shenzhen HugeMed Medical Technical Development Co., Ltd.
Address: 415, 416-1,516-1, Building 2, No. 1, Mawu Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen, Guangdong, 518115, China Contact person: Cathy Title: Regulatory engineer E-mail: cathy.shi@hugemed.cn Tel: +86-755-22275833
2. Submission correspondent
Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Yang Jie E-mail: yangjie@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Rhinolaryngoscope System |
|---|---|
| Model | Single-use Rhinolaryngoscope: RH-M58, RH-M52, RH-M50, |
| RH-M40, RH-M32, RH-M22 | |
| Image Processor: VLM-02 | |
| Common Name | Rhinolaryngoscope System |
| Regulatory Class | Class II |
| Classification | 21CFR 874.4760 / Nasopharyngoscope (flexible or rigid) and |
| accessories / EOB | |
| Submission type | Traditional 510(K) |
3. Subject Device Information
4. Predicate Device
-
- Predicate device 510(k) number: K191080 Product name: Ambu aScope 4 RhinoLaryngo Slim Submitter: Ambu Inc.
- Reference device 2) 510(k) number: K190972 Product name: Ambu AScope 4 RhinoLaryngo Intervention
4
Submitter: Ambu A/S
Reference device 3)
510(k) number: K221581 Product name: Single-Use Flexible Rhinolaryngoscope Submitter: Hunan Vathin Medical Instrument Co., Ltd.
ട. Device Description
The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) to be introduced within the nasal lumens and upper airway anatomy and Image Processor (model: VLM-02) for clinical image processing. The Image Processor provides power and processes the images for medical electronic endoscope.
| System name | Component name | Model |
|---|---|---|
| Rhinolaryngoscope | ||
| System | Single-Use | |
| Rhinolaryngoscope | RH-M58, RH-M52, RH-M50, RH- | |
| M40, RH-M32, RH-M22 | ||
| Image Processor | VLM-02 |
The Single-Use Rhinolaryngoscope is a sterile single used flexible Rhinolaryngoscope. The Image Processor is a reusable monitor.
The differences between the Single-use Rhinolaryngoscope models are as follow:
- Have or haven't working channel
- Working channel inner diameter
- Insertion tube outer diameter
6. Intended use & Indication for use
The endoscope is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor.
The endoscope is intended for use in a hospital environment. It is designed for use in adults.
7. Comparison to the Predicate Device
The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) and Image Processor (model: VLM-02). However, the Image Processor (model: VLM-02) has been cleared by K222910. The following lists the comparison with the predicate device for the Single-Use Rhinolaryngoscope.
| Features | Subject Device | Predicate
Device | Comparison |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K232435 | K191080 | / |
| Manufacturer | Shenzhen HugeMed
Medical Technical | Ambu Inc. | / |
| Features | Subject Device | Predicate Device | Comparison |
| | | | |
| Model | Development Co.,
Ltd. | Ambu aScope 4
RhinoLaryngo Slim | / |
| | Single-use
Rhinolaryngoscope:
RH-M58, RH-M52,
RH-M50, RH-M40,
RH-M32, RH-M22 | | |
| Product code
&
Classification | 21 CFR 874.4760,
EOB Class II | 21 CFR
874.4760,
EOB Class II | Same |
| Intended use | The endoscope is a
sterile, single-use,
flexible endoscope
intended for
endoscopic
procedures and
examination within
the nasal lumens and
upper airway
anatomy. The
endoscope is
intended to provide
visualization via an
Image Processor.
The endoscope is
intended for use in a
hospital
environment. It is
designed for use in
adults. | The endoscope is
a sterile, single-
use, flexible
endoscope
intended for
endoscopic
procedures and
examination
within the nasal
lumens and
upper airway
anatomy. The
endoscope is
intended to
provide
visualization via
Ambu displaying
unit.
The endoscope is
intended for use
in a hospital
environment. It
is designed for
use in adults. | Same |
| Scope type | Flexible | Flexible | Same |
| Field of view
(degree) | 120° | 85° | Similar
Although the field of view
is slightly different from the
predicate device, the area |
| Features | Subject Device | Predicate Device | Comparison |
| | | | within the view can be
adjusted by the advance or
retreat of the endoscope.
Therefore, the difference in
FOV does not affect the
safety and effectiveness of
the subject device. |
| Direction of
view
(degree) | 0° | 0° | Same |
| Depth of
Field | 3-50mm | 6-50mm | Similar
The subject device has a
wider range of depth of view
than the predicate device to
give physicians more
options for diagnosis and
treatment based on the
patient's condition.
Therefore, this difference
will not raise new question
on safety and effectiveness
of the proposed device. |
| Bending
angle
(degree) | 210° (up and down) | 130° (up and
down) | Different, but the K221581
reference device has the
same 210° (up and down)
Bending angle.
Because the Bending angle
is larger, it means more
flexibility in clinical use.
Therefore, this difference
will not raise new question
on safety and effectiveness
of the proposed device. |
| Maximum
insertion
portion
width(mm) | RH-M22:
2.2±10%mm
RH-M32:
3.2±10%mm
RH-M40:
4.4±10%mm | 3.5 mm | Similar, and the K190972
reference device also has a
similar 5.5 mm Maximum
insertion portion width.
The difference in Maximum
insertion portion width for |
| Features | Subject Device | Predicate Device | Comparison |
| | RH-M50:
$5.0\pm10%mm$ | | the subject device does not
alter or change the
indications for use or result
in a new intended use. |
| | RH-M52:
$5.2\pm10%mm$ | | |
| | RH-M58:
$5.8\pm10%mm$ | | |
| | | | |
| Minimum
insertion
channel
width(mm) | RH-M22: /
RH-M32: $1.2\pm10%$
mm
RH-M40: Φ≥1.1 mm
RH-M50: $2.8\pm10%$
mm
RH-M52: Φ≥2.1 mm
RH-M58: Φ≥2.50
mm | 3.0mm | Similar
The difference in Minimum
insertion channel width for
the subject device does not
alter or change the
indications for use or result
in a new intended use. |
| Working
length
(mm) | 350 mm | 300 mm | Similar, and the K190972
reference device has the
same 350 mm Working
length.
The length of 300mm meets
the needs of clinical use.
Therefore, this difference
will not raise new question
on safety and effectiveness
of the proposed device. |
| Illumination
Source | LED | LED | Same |
| LED Light
source | At distal tip | At distal tip | Same |
| Single-use | Yes | Yes | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Safety | IEC 60601-1
IEC 60601-2-18 | IEC 60601-1
IEC 60601-2-18 | Same |
| Bench test | ISO 8600-1
ISO 8600-3
ISO 8600-4 | ISO 8600-1
ISO 8600-3
ISO 8600-4 | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
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8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Single-Use Rhinolaryngoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were performed, as recommended:
- . Cytotoxicity
- . Sensitization
- Oral Mucosa Irritation
The Single-Use Rhinolaryngoscope is considered surface - mucosal membrane contacting for a duration of less than 24 hours.
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Single-use Rhinolaryngoscope is validated.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Rhinolaryngoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.
Bench performance testing
The following bench tests were performed:
-
Optical performance testing according to ISO 8600 series.
-
Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity), SNR and dynamic range, image frame frequency and system delay test compared with the predicate device.
-
- Mechanical bending testing.
-
- Photobiological safety test verified compliance to IEC 62471:2006
- Thermal safety performance test verified compliance to Protection against excessive temperature and other safety hazards of IEC 60601-2-18:2009
9. Clinical study
No clinical study is included in this submission
10. Conclusion
Substantial equivalence comparisons, performance testing and compliance with voluntary
9
standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.