(105 days)
Not Found
No
The summary describes a mechanical device that delivers controlled airflow and does not mention any AI/ML components or algorithms.
Yes
The device is indicated for the "treatment" of middle ear pressure, aiming to prevent fluid accumulation and hearing loss by equalizing pressure. This falls under the definition of a therapeutic device as it is intended to alleviate or cure a medical condition.
No
The device is indicated for the treatment of middle ear pressure by increasing air pressure in the eustachian tube to equalize pressure. It is not described as diagnosing any condition.
No
The device description explicitly states it is designed to "blow a controlled flow of air into the nose" and includes a "nosepiece." This indicates a physical hardware component that delivers air, not solely software. The performance studies also mention testing of physical attributes like pressure, flow rate, and drop testing, further confirming it is a hardware 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. They are used to diagnose, monitor, or screen for medical conditions.
- Device Function: The Ear Pressure Relief Device works by physically introducing air into the nasal cavity to equalize pressure in the middle ear. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is to treat negative middle ear pressure by a mechanical action (blowing air), not by analyzing a biological sample for diagnostic purposes.
Therefore, the device falls outside the scope of an In Vitro Diagnostic device. It is a therapeutic device that provides a physical intervention.
N/A
Intended Use / Indications for Use
The Ear Pressure Relief Device is indicated for the treatment of negative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Ear Pressure Relief Device provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
Product codes
MJV
Device Description
The Ear Pressure Relief Device is designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes.
For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Ear Pressure Relief Device is activated by pressing and holding the adjustment button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear.
Ear Pressure Relief Device is provided non-sterile, and is designed for reuse with a single patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Middle ear, Nose, Eustachian tube
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Performed at home by patient on their own or under adult supervision
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility (EMC):
- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012
(Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD); - IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests;
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Biocompatibility testing:
The biocompatibility evaluation for the Ear Pressure Relief Device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, 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. A series of tests include the following tests:
- ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10Third Edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.
Bench Testing:
Bench testing was conducted to validate intended performance of the Ear Pressure Relief Device:
- a. Dimensional verification
- b. Pressure value verification
- c. Flow rate verification
- d. Drop test verification
Software Verification and Validation Testing: This product does not include software.
Animal Study: Animal testing was not required for this submission.
Clinical Testing: Clinical testing was not required for this submission.
Key results: The biocompatibility, electrical safety, EMC, and bench testing conducted provide evidence that the proposed device performs comparable to the predicate device. The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 9, 2023
Ningbo Albert Novosino Co., Ltd. % Doris Dong General manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area, Shanghai, Shanghai 201613 China
Re: K230502
Trade/Device Name: Ear Pressure Relief Device (ER813B) Regulatory Class: Unclassified Product Code: MJV Dated: May 10, 2023 Received: May 12, 2023
Dear Doris Dong:
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
1
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 (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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Ear Pressure Relief Device
Indications for Use (Describe)
The Ear Pressure Relief Device is indicated for the treative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing loss. The Ear Pressure Reliever provides a method of ventilating the middle ear by momentarily increasing the air pressure in the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
| 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 [As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K230502 |
|---|---|
| Date: | June 8, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Owner: | Ningbo Albert Novosino Co.,Ltd. |
| No. 28 Yunshan Middle Road, Sanqishi town, Yuyao, Zhejiang 315412, China | |
| Contact person: Victor Zhou | |
| Tel: 86-574-87527882 | |
| Email: victor@albertnovosino.com | |
| Contact: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 602, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description
| Proprietary Name: | Ear Pressure Relief Device |
|---|---|
| Model: | ER813B |
| Common Name: | Middle Ear Inflation Device |
| Classification Name: | Device, Inflation, Middle Ear |
| Product Code: | MJV |
| Device Class: | Unclassified |
| Review Panel: | Ear Nose & Throat |
| Device Description: | The Ear Pressure Relief Device is designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes. |
| For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Ear Pressure Relief Device is activated by pressing and holding the adjustment button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear. | |
| Ear Pressure Relief Device is provided non-sterile, and is designed for reuse with a single patient. | |
| Indications for use: | The Ear Pressure Relief Device is indicated for the treatment of negative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Ear Pressure Relief Device provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss. |
4
3. Predicate Device Information
| Predicate 510(k) Number: | K203754 |
|---|---|
| Marketing clearance date: | 02/19/2021 |
| Product name: | Eustachi Ear Pressure Relief Device |
| Manufacturer: | Exercore, LLC |
| Parameters | New Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) number | K230502 | K203754 | -- |
| Submitter | Ningbo Albert Novosino Co.,Ltd. | Exercore, LLC | -- |
| Device name | Ear Pressure Relief Device | Eustachi Ear Pressure Relief | |
| Device | -- | ||
| Model | ER813B | / | -- |
| Device class | Unclassified | Unclassified | Same |
| Product code | MJV | MJV | Same |
| Classification | |||
| name | Device, Inflation, Middle Ear | Device, Inflation, Middle Ear | Same |
| Indications for use | The Ear Pressure Relief Device is | ||
| indicated for the treatment of | |||
| negative middle ear pressure. | |||
| Negative middle ear pressure can | |||
| lead to fluid accumulation in the | |||
| middle ear, impaired hearing, and | |||
| hearing loss. The Ear Pressure | |||
| Relief Device provides a method | |||
| of ventilating the middle ear by | |||
| momentarily increasing the air | |||
| pressure in the nose and | |||
| the | |||
| eustachian tube. Equalizing the | |||
| pressure | |||
| can | |||
| prevent | |||
| the | |||
| accumulation of fluid and prevent | |||
| hearing loss. | The Eustachi is indicated for the | ||
| treatment of negative middle ear | |||
| pressure. Negative middle ear | |||
| pressure can lead to fluid | |||
| accumulation in the middle ear, | |||
| impaired hearing, and hearing | |||
| loss. The Eustachi provides a | |||
| method of ventilating the middle | |||
| ear by momentarily increasing the | |||
| air pressure in the nose and the | |||
| eustachian tube. Equalizing the | |||
| pressure can prevent the | |||
| accumulation of fluid and prevent | |||
| hearing loss. | Same | ||
| Type of Use | Over-the-Counter | Over-the-Counter | Same |
| Patient Use | Performed at home by patient on | ||
| their own or under adult | |||
| supervision | Performed at home by patient on | ||
| their own or under adult | |||
| supervision | Same | ||
| Intended | |||
| Use | |||
| Environment | Home Use | Home Use | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Product | 152.335.529.7mm | 1553045mm | Similar |
| Dimension(mm) | |||
| [HWD] | Note 1 | ||
| Product Weight | 105g | 116.4g | |
| Output Head | One output head | One output head | Similar |
| Diameter:16mm | Diameter:22mm | Note 3 | |
| Components | Handheld unit | Handheld unit | Same |
| Power Supply | Lithium battery | Alkaline Battery-powered (2 AA) | Similar |
| Note 2 | |||
| Mechanism of Action | Provides flow of air to open | ||
| eustachian tube | Provides flow of air to open | ||
| eustachian tube | Same | ||
| User Interface | Press on power button,then press | ||
| on working button | Single button press on handheld | ||
| unit | Similar | ||
| Note 1 | |||
| Air Pressure | 31 – 41 kPa (4.5 to 6 PSI) | 31 – 41 kPa (4.5 to 6 PSI) | Same |
| Air Flow Rate | 1.7 – 2.1 LPM | 1.7 – 2.1 LPM | Same |
| Patient Contact Type | Surface-contact device in contact | ||
| with mucosal tissue for limited | |||
| duration (less than 24 hours) | Surface-contact device in contact | ||
| with mucosal tissue for limited | |||
| duration (less than 24 hours) | Same | ||
| Materials | ABS plastic | ABS plastic | Same |
| Labeling | Meet FDA's requirement | Meet FDA's requirement | Same |
4. Comparison to predicate device
5
Differences between New device and Predicate Device:
Note 1:
The weight, dimensions and user Interface of the proposed device are a little different from the predicate device, this is a slightly different product design, but these differences are minor and do not affect device performance as compared to the predicate device.
Note 2:
The power supply of the proposed device are a little different from the predicate device,but these differences are insignificant in terms of safety or effectiveness.In addition, the proposed device has passed the electrical safety test and ,so these differences don't raise any new safety and effectiveness issues.
Note 3:
The predicate device requests that the user to press the nosepiece tightly against one nostril making an airtight seal and pinch other nostril tightly shut with other hand making an airtight seal. While the subject device requires the user to press the silicone heads tightly into both nostrils and ensure air tightness. The only difference is that instead of using hand to seal the other nostril, the new device uses its own silicon head. We have studied the diameter of nasal products on the market from 5 to 12 mm, and the diameter of the output head of both the new device and the predicate device can cover this range.In order to prove the same sealing effect, we did an additional air tightness test with the silicon head.
In addition, we have added in the instruction manual that users can use hand instead of silicone head to block the other nostril during treatment, depending on their personal habits. Therefore, we believe that this difference will not affect the device performance as compared to the predicate device.
5. Non-clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility (EMC):
- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012
(Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
- IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests;
6
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Biocompatibility testing:
The biocompatibility evaluation for the Ear Pressure Relief Device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, 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. A series of tests include the following tests:
-
ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
-
ISO 10993-10Third Edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-
ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.
Bench Testing:
Bench testing was conducted to validate intended performance of the Ear Pressure Relief Device:
- a. Dimensional verification
- b. Pressure value verification
- c. Flow rate verification
- d. Drop test verification
Software Verification and Validation Testing: This product does not include software.
6. Animal Study
Animal testing was not required for this submission.
7. Clinical Testing
Clinical testing was not required for this submission.
8. Conclusion
The biocompatibility, electrical safety, EMC, and bench testing conducted provide evidence that the proposed device performs comparable to the predicate device. The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as the predicate device.