(99 days)
Not Found
No
The device description and performance studies focus on mechanical function and compatibility, with no mention of AI/ML terms or capabilities.
No
The devices (suction and biopsy valves) are used to control functions of an endoscope and facilitate endoscopic procedures, not to directly treat a medical condition.
No
The device is used to control suction and provide access for endoscopic device passage during an endoscopic procedure, facilitating the procedure itself rather than diagnosing a condition.
No
The device description clearly indicates that the devices are physical valves (suction valve and biopsy valve) designed to be attached to a bronchoscope. The performance studies also describe bench testing of physical properties like suction flow, vacuum leak, and pressing force, which are characteristic of hardware devices, not software.
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 devices are used to control suction and cover the biopsy/suction channel during an endoscopic procedure. These are functional roles within a medical procedure, not diagnostic tests performed on samples outside the body.
- Device Description: The description reinforces the functional nature of the devices, explaining how they attach to the bronchoscope and facilitate procedures like aspiration and device passage.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on the functional aspects of the devices (compatibility, flow, leak tests, pressing force, fatigue), not on the accuracy or reliability of a diagnostic result.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ANDORATE® Suction Valve and Biopsy Valve do not fit this description. They are accessories used during a medical procedure.
N/A
Intended Use / Indications for Use
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.
The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.
Product codes (comma separated list FDA assigned to the subject device)
KTI
Device Description
The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and or clinics
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 bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed - endoscope compatibility test, suction flow, vacuum leak, water leak test, pressing force test and fatigue test for suction valve and endoscope compatibility, vacuum leak and squeegee leak test for biopsy valve. The performance data demonstrated that the subject devices met established specifications.
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.
Not Found
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
§ 874.4680 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
May 11, 2023
GA Health Company Limited Rainy Lam Assistant Regulatory Affairs Manager 2 On Yiu Street Unit 18, 21/F, Metropole Square Shatin Hong Kong
Re: K230280
Trade/Device Name: ANDORATE® Suction Valve and ANDORATE® Biopsy Valve Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: February 1, 2023 Received: April 12, 2023
Dear Rainy Lam:
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
1
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 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 (OS) 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,
Joyce C. Lin -S
for 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
Enclosure
2
Indications for Use
510(k) Number (if known) K230280
Device Name ANDORATE® Suction Valve ANDORATE® Biopsy Valve
Indications for Use (Describe)
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.
The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.
| 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
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. Submission Sponsor
Submitter's Name: Submitter's Address:
Establishment Reqistration No.:
2. Sponsor Contact
GA Health Company Limited Unit 18, 21/F, Metropole Square 2 On Yiu Street, Shatin, N.T, Hong Kong. CHINA 3014749926
Cindy Ye Chief Executive Officer Telephone: +852 2833 9010 Email: cindy.ye@gahealth.com
Lam Wing Yu Assistant Requlatory Affairs Manager Telephone: +852 2833 9010 Email: rainy.lam@gahealth.com
3. Date Prepared
9 May 2023
4. Device Identification
Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Regulation Class: Device Panel:
Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Regulation Class: Device Panel:
5. Predicate Device Identification
Predicate Device 510(k) No.: Predicate Device Trade Name: ANDORATE® Suction Valve Suction valve 21 CFR 874.4680 Bronchoscope (flexible or rigid) and accessories KTI Bronchoscope Accessory 2 Ear Nose & Throat
ANDORATE® Biopsy Valve Biopsy valve 21 CFR 874.4680 Bronchoscope (flexible or rigid) and accessories KTI Bronchoscope Accessory 2 Ear Nose & Throat
K061313 EVIS EXERA II 180 System
4
Predicate Device Product Code: EOQ - Bronchoscope (Flexible Or Rigid)
6. Device Description:
The subject devices are intended for single-use and are supplied sterile. Table 1 shows the components included in the submission.
| Components | Qty | Product Code | Regulation
Number | Regulatory
Classification |
|----------------------------|-----|---------------------------------|----------------------|------------------------------|
| ANDORATE® Suction
Valve | 1 | KTI – Bronchoscope
Accessory | 21 CFR 874.4680 | 2 |
| ANDORATE® Biopsy
Valve | 1 | KTI – Bronchoscope
Accessory | 21 CFR 874.4680 | 2 |
| Table 1 - Components included in the Submission | ||||
|---|---|---|---|---|
| ------------------------------------------------- | -- | -- | -- | -- |
The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.
7. Indications for Use:
The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure.
The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.
8. Technological Characteristics
Table 2 summarizes the suction valve and biopsy valve technological characteristics as compared to the predicate device.
Table 2 Summary of design, features and principles of operation and technological characteristics between the subject device and predicate device
| Specification | Predicate Device | Subject Device | Substantial
Equivalence |
|------------------------------|-------------------------------------|------------------------|----------------------------|
| Product code | EOQ | KTI | Substantial
Equivalent |
| Regulatory
Classification | 2 | 2 | Identical |
| Regulation No | 21 CFR 874.4680 | 21 CFR 874.4680 | Identical |
| Regulation
Description | Bronchoscope (Flexible Or
Rigid) | Bronchoscope Accessory | Identical |
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| Specification | Predicate Device | Subject Device | Substantial
Equivalence |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indications for
Use | The suction valve is depressed
to activate suction. The valve is
also used to remove any fluid or
debris adhering to the objective
lens.
The biopsy valve is attached to
the instrument channel port, and
an EndoTherapy accessory can
be inserted or a syringe can be
attached. | The single use ANDORATE®
Suction Valve is used to control
the suction function of an
endoscope during the
endoscopic procedure.
The single use ANDORATE®
Biopsy Valve is used to cover the
opening to the biopsy/suction
channel of endoscope. The
biopsy valve provides access for
endoscopic device passage and
exchange and minimizes leakage
of biomaterial from the biopsy
port through the endoscopic
procedure. | Substantial
Equivalent |
| Compatibility | Olympus® 180 Series
Bronchoscopes | Olympus® 160/180/190/260/290
Series Bronchoscopes | Substantial
Equivalent |
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use or
Reusable | Single Use | Single Use | Identical |
| Material | Silicone, Polypropylene,
Polyethylene | Polyvinyl Chloride, Acrylonitrile
Butadiene Styrene, Silicone
Rubber | Substantial
Equivalent |
| Manufacturing
method | Injection molding | Injection molding | Identical |
| Packaging | Packaged in a sealed pouch | Packaged in a sealed pouch | Substantial
Equivalent |
| Sterilization | Yes | Yes | Substantial
Equivalent |
| Shelf Life | 3 years | 3 years | Substantial
Equivalent |
9. Performance Test
The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed - endoscope compatibility test, suction flow, vacuum leak, water leak test, pressing force test and fatigue test for suction valve and endoscope compatibility, vacuum leak and squeegee leak test for biopsy valve. The performance data demonstrated that the subject devices met established specifications.
10. Sterilisation
All the subject devices are sold in a sterile package. The subject devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°. EO residuals on the components are below the maximum levels defined in
6
ANSI/AAMI/ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals.
11. Shelf Life
The subject devices have a three (3) years shelf life, based on the design and existing sterile barrier data from the existing packaging integrity test in accordance with ASTM F88/F 88M-15, Standard test method for seal strength of flexible barrier materials, ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by dve Penetration. ASTM D 3078-02. Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission, DIN 58953-6, Sterilization - Sterile Supply - Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which Are to be Sterilized and ISO11737-2, Sterilization of Medical Devices – Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process and performance test were conducted after accelerated aging test according to ASTM F 1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life.
12. Biocompatibility
The biocompatibility of the subject device was conducted in accordance with the FDA quideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing is conducted on subject device in accordance with the ISO 10993 standard. The suction valve is non-patient contacting device while the biopsy valve is classified as an indirect patient contacting device and surface device with mucosal membrane contact for a limited duration (not more than 24 hours). The biocompatibility test was performed in accordance with the following standards - ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Test results show that the subject device is biocompatible.
13. Conclusion
The subject devices have the same intended use as the predicate device. Based on comparison of technological characteristics and evaluation of the characteristics through performance testing, the subject devices do not raise different questions of safety and effectiveness compared to the predicate. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent.