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The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

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I am sorry, but the provided FDA 510(k) Clearance Letter for the "Baby Nasal Aspirator" does not contain information about acceptance criteria and a study proving the device meets those criteria.

This document is a formal clearance letter issued by the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory aspects such as:

• Device Identification: Trade name, regulation number, product code, regulatory class.
• Substantial Equivalence Determination: The FDA's finding that the device is equivalent to existing legal devices.
• Regulatory Requirements: Information about general controls (registration, listing, GMP, labeling, misbranding, adulteration), additional controls for Class II/III devices, Quality System (QS) regulation, medical device reporting, Unique Device Identification (UDI) system, and contact information for regulatory advice.
• Indications for Use: The stated purpose and target user group for the device.

The letter explicitly states: "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..."

The letter does not include details on:

• Specific performance acceptance criteria for the device itself (e.g., suction pressure, battery life, noise levels).
• Any studies or test results demonstrating the device meets such criteria.
• Information about test set sample sizes, data provenance, expert ground truth establishment, or clinical study methodologies (like MRMC studies) as these are typically associated with performance data for more complex or AI/imaging devices, not simple mechanical devices like a nasal aspirator.

For a device like a baby nasal aspirator, the "acceptance criteria" and "proof of meeting them" would typically involve:

• Bench testing: Measuring suction pressure, flow rate, durability, material biocompatibility, and safety (e.g., absence of sharp edges, proper battery compartment sealing).
• Biocompatibility testing: To ensure materials are safe for contact with human tissue.
• Electrical safety testing: If powered, to ensure it meets relevant electrical safety standards.
• Usability testing: To ensure it can be safely and effectively used by the intended users (parents or caregivers).

However, none of these specific test results or their underlying methodologies are detailed in the provided FDA clearance letter. The letter signifies regulatory clearance based on a review of the submitted documentation, which would have included these types of test reports, but it does not reproduce them within the letter itself.

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The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.

Electric Nasal Aspirator consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. The Electric Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line.

The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.

The provided text is a 510(k) clearance letter and summary for an Electric Nasal Aspirator. It details the device's characteristics and its comparison to a predicate device, along with the performance data submitted to demonstrate substantial equivalence.

However, the nature of this medical device (a nasal aspirator, essentially a suction pump) means the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering performance parameters (e.g., vacuum pressure, flow rate, safety standards) rather than clinical efficacy studies with human subjects that measure the device's ability to diagnose or treat a condition, which is what is typically discussed in the context of "human-in-the-loop performance," "ground truth," "expert consensus," and "MRMC studies" for AI/software-as-a-medical-device (SaMD).

Therefore, the requested information elements related to AI/SaMD (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance, ground truth for image analysis) are not applicable to this specific device submission. The "study" here is a series of bench tests and electrical/biocompatibility assessments.

Below is a breakdown of the applicable acceptance criteria and the "study" (bench testing) as described in the provided text, while explicitly stating when an element is not applicable.

Acceptance Criteria and Device Performance for Electric Nasal Aspirator (K244033)

1. Table of Acceptance Criteria and Reported Device Performance

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The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is ued in a home environment.

The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. It consists of main unit, and suction working together as one unit. The Baby Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The recharged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and the user can control the vacuum pressure through the button.

The provided text is a 510(k) summary for a Baby Nasal Aspirator. It describes the device, its intended use, and a comparison with a predicate device to establish substantial equivalence. However, it does not include acceptance criteria, performance data in a table format, or details about a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device.

Here's an analysis based on the information provided, highlighting what's present and what's missing in relation to your request about acceptance criteria and a study:

1. A table of acceptance criteria and the reported device performance

• Missing. The document states: "In order to verify and assure the performance of the Baby Nasal Aspirator, we have conducted the product appearance test (color, dimension, weight, etc.), product performance test (vacuum pressure, noise level, flow rate, etc.), and verification on lithium battery power indication."
• It mentions "vacuum pressure (52 - 60 Kpa) is the same as the predicate device" but does not explicitly state this as an acceptance criterion with a numerical target and then present the measured performance in a table. It also refers to compliance with IEC 60601-1 and IEC 60601-1-2 which are standards for medical electrical equipment, indicating safety and essential performance criteria were met, but details are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Missing. This device is a physical medical device (a nasal aspirator), not an AI/ML or software device that processes data. Therefore, there is no "test set" in the context of data for an algorithm. The "tests" performed were physical product performance tests. The document does not specify the number of units tested for appearance, vacuum pressure, noise level, or flow rate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. As this is a physical device and not an AI/ML algorithm requiring expert opinion for ground truth, this information is not relevant or provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method is described as this is not a study assessing interpretations of data by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a standalone nasal aspirator, not an AI-assisted diagnostic or interpretive tool for "human readers." No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. For a physical device like a nasal aspirator, "ground truth" would relate to objective measurements against engineering specifications and safety standards (e.g., measured vacuum pressure against a specified range, noise levels against acceptable limits, compliance with electrical safety standards). These are typically verified through direct measurement and testing rather than expert-derived ground truth as in AI/ML applications.

8. The sample size for the training set

• Not applicable. This refers to AI/ML algorithms. There is no concept of a "training set" for a physical device like a nasal aspirator.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Summary based on the provided document:

The document describes the regulatory clearance for a physical medical device, a Baby Nasal Aspirator. The "study" mentioned for demonstrating substantial equivalence consisted of non-clinical performance tests.

• Acceptance Criteria (Implicit/Inferred from the text):

  • Vacuum pressure: 52 - 60 Kpa (same as predicate device).
  • Compliance with safety standards: IEC 60601-1 and IEC 60601-1-2.
  • Product appearance: Conformance to design (color, dimensions, weight).
  • Noise level: Within acceptable limits ( implied by "product performance test").
  • Flow rate: Conformance (implied by "product performance test").
  • Lithium battery power indication: Verification conducted.

• Reported Device Performance:

  • "The vacuum pressure (52 - 60 Kpa) is the same as the predicate device."
  • "The device complies with IEC 60601-1 and IEC 60601-1-2 requirements."
  • Other tests (appearance, noise level, flow rate, battery indication) were "conducted to verify and assure the performance" and "demonstrate substantial equivalence," implying they met their respective criteria, although specific numerical results are not detailed.

• Study Description:

  • Type of Study: Non-clinical bench testing.
  • Tests Performed: Product appearance test (color, dimension, weight), product performance test (vacuum pressure, noise level, flow rate), and verification on lithium battery power indication.
  • Sample Size: Not specified for any of the individual tests. This is common for bench testing of physical devices where a small representative sample is typically used to confirm design specifications.
  • Data Provenance: Not applicable in the sense of patient data. The testing was conducted on manufactured device units.
  • Ground Truth: Objective measurements against engineering specifications and recognized safety standards (IEC 60601-1, IEC 60601-1-2).
  • No clinical data: The document explicitly states, "Not applicable, there is no clinical data."

In conclusion, the request is largely framed for an AI/ML device or a diagnostic device involving human interpretation, which does not align with the nature of the Baby Nasal Aspirator described in the provided FDA 510(k) summary. The document confirms that the device underwent non-clinical performance testing to demonstrate substantial equivalence to a predicate device, meeting relevant safety and performance standards.

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The Hair Removal Devices (models IPL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

The Hair Removal Devices (Model:IPL-D26,IPL-D19) are pulsed light hair removal devices. The IPL-D26 and IPL-D19 models use the same components and have the same features except for their color. The IPL-D26 is white and IPLD19 is red. The device uses light pulses to produce hair removal, and the effect of the device is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The IPL-D26 and IPL-D19 devices are each composed of a hand held applicator and an external power supply. Each applicator contains a xenon lamp, a skin color sensor and a skin proximity sensor. The xenon lamp emits the pulsed light flashes to produce hair removal. The skin color sensor is to ensure that the light will be emitted only to skin color appropriate for the device. The contact sensor is to ensure that the light pulses will not be emitted unless the applicator in full contact with the skin. The spot size (treatment area) in the Hair Removal Device devices is 3 cm²

This document is a 510(k) summary for a hair removal device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment is not applicable.

The document describes the device, its intended use, a comparison to a predicate device, and various performance tests conducted to demonstrate safety and substantial equivalence for a non-AI medical device.

Key information provided in the document (and why it doesn't fit the AI/ML criteria):

• Device Type: The device described is a Hair Removal Device (models IPL-D26, IPL-D19) that uses pulsed light (IPL) technology. It is not an AI/ML powered device.
• Intended Use: The device is intended for permanent reduction in hair regrowth. This is a functional claim for a physical device, not an analytical claim for an AI algorithm.
• Performance Data: The performance data section ([7. PERFORMANCE DATA] on page 5) details:
  • Biocompatibility testing: Conducted according to ISO 10993-1. (Irrelevant for AI performance)
  • Electrical safety and electromagnetic compatibility: Compliance with IEC 60601-1 series and IEC 62471. (Irrelevant for AI performance)
  • Software Verification and Validation Testing: This is about the device's control software, not an AI algorithm for image analysis or diagnosis. The software was deemed "Moderate" level of concern, indicating basic safety V&V, not AI validation. (Irrelevant for AI performance criteria)
  • Usability: Compliance with IEC 60601-1-6. (Irrelevant for AI performance)

In summary, as this 510(k) submission pertains to a conventional medical device (IPL hair removal device) and not an AI/ML algorithm, the detailed acceptance criteria and study design elements relevant to AI/ML evaluation as requested are not present in this document.

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IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

The IPL sapphire cooling hair remove device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse.

This document describes the safety and performance testing for the "IPL sapphire cooling hair remove device" (Model: LB06) by Shenzhen Desida Technology Co., Ltd. for its 510(k) submission (K221635). The testing primarily focuses on safety rather than clinical efficacy for hair removal, as the device is determined to be substantially equivalent to previously cleared predicate devices for its intended use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Biocompatibility Safety:
   - ISO 10993-5 Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity	Passed
   - ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization	Passed
   Electrical Safety:
   - IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility	Passed
   - IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance	Passed
   - IEC 60601-1-11 Medical Electrical Equipment -Part 1: 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	Passed
   - IEC 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment	Passed
   Eye Safety:
   - IEC 62471 Photobiological safety of lamps and lamp systems	Passed
   Software Verification and Validation:	All software requirement specifications met; all software hazards mitigated to acceptable risk levels.

2. Sample Size Used for the Test Set and Data Provenance:
   The document does not explicitly state the sample size for any clinical test set, as the performance data provided focuses on laboratory and engineering safety tests (biocompatibility, electrical safety, eye safety, and software validation). No clinical study on human subjects is detailed for the subject device to prove its hair removal efficacy, likely due to substantial equivalence to predicate devices already cleared for that indication. The tests mentioned are likely conducted in a lab environment in China, given the manufacturer's location. The provenance is internal company testing to meet international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   Not applicable (N/A) for the types of tests described. These are standardized engineering and biological safety tests, typically evaluated against established international standards rather than expert consensus on a test set.

4. Adjudication Method for the Test Set:
   N/A. The evaluation methods for these standards are defined within the standards themselves, not through an adjudication process among experts in the context of this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
   No MRMC comparative effectiveness study was done or reported in this document. The submission relies on substantial equivalence to predicate devices for its intended use, rather than a direct clinical comparative effectiveness study against human readers or other devices for improved performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
   A standalone software validation was done, demonstrating that "all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This is a standalone assessment of the device's software function, not a standalone clinical performance study.

7. The Type of Ground Truth Used:
   For the safety tests (biocompatibility, electrical, eye), the "ground truth" is defined by the specific requirements and pass/fail criteria outlined in the referenced international standards (e.g., ISO 10993-5, ISO 10993-10, IEC 60601 series, IEC 62471). For software, the ground truth is the "software requirement specifications." There is no clinical "ground truth" (like pathology or outcomes data) mentioned for hair removal efficacy for this specific device in this document, as it relies on substantial equivalence for that claim.

8. The Sample Size for the Training Set:
   N/A. As this document describes evaluation for substantial equivalence through safety and engineering tests, there is no mention of a "training set" in the context of machine learning or AI models for clinical outcomes. The device is an IPL hair removal device, not an AI diagnostic tool.

9. How the Ground Truth for the Training Set Was Established:
   N/A for the same reasons as #8.

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