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510(k) Data Aggregation
(57 days)
MUI
Sterile and Non-Sterile Ultrasonic Coupling Agent are ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to cound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.
The subject device, Sterile and Non-Sterile Ultrasonic Coupling Agent, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. The Ultrasonic Coupling Agent is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the Ultrasonic Coupling Agent is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.
The document describes the premarket notification (510(k)) for a medical device called "Sterile and Non-Sterile Ultrasonic Coupling Agent." It provides information about its intended use, technical characteristics, and performance testing to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, formatted to answer your questions:
Acceptance Criteria and Study Proving Device Meets Criteria
The device under review is an "Ultrasonic Coupling Agent," which is a gel used to facilitate ultrasound imaging. The acceptance criteria for this type of device are primarily based on its physical and chemical properties, biocompatibility, and sterilization effectiveness (for sterile versions). The study proving the device meets these criteria is a series of non-clinical bench tests and compliance with recognized consensus standards, demonstrating substantial equivalence to a legally marketed predicate device. No clinical study was performed.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table summarizing performance testing (bench tests) for the subject device against specified acceptance criteria.
| Test Item & Acceptance Criteria (Requirement Specification) | Reported Device Performance (Test Results) | Meets Criteria? |
|---|---|---|
| Sound Velocity (Acoustic Velocity) | ||
| Measured at 35°C, 1520-1620 m/s | 1541.8 m/s ~ 1551.7 m/s | Pass |
| Acoustic Impedance | ||
| Measured at 35°C, 1.5x10^6 ~ 1.7x10^6 Pa·s/m | 1.58x10^6 Pa·s/m ~ 1.59x10^6 Pa·s/m | Pass |
| Sound Attenuation | ||
| Measured at 35°C, ≤0.1 dB/(cm·MHz) | 0.04 dB/(cm · MHz) ~ 0.07 dB/(cm · MHz) | Pass |
| Viscosity | ||
| Measured at 25°C, ≥15 Pa·s | 42 Pa·s ~ 50 Pa·s | Pass |
| Density | ||
| 987-1049 kg/m³ | 1024.5 kg/m³ ~ 1029.7 kg/m³ | Pass |
| pH | ||
| 5.5 ~ 8.0 | 6.62 ~ 6.86 | Pass |
| Microbial Limit (Non-sterile Ultrasonic Coupling Agent) | ||
| Total aerobic bacteria ≤10² cfu/g; Fungi and yeast ≤10¹ cfu/g; Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans cannot be detected. | Pass | Pass |
| Sterility (Sterile Ultrasonic Coupling Agent) | ||
| Sterile after confirmed gamma sterilization. | Pass | Pass |
| Appearance | ||
| 1) Generally colorless or light-colored transparent gel without insoluble foreign matters. |
- Free from stratification, mildew, and odor under normal storage conditions. | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of batches, number of samples per batch) used for each bench test. These are typically detailed in the full test reports, which are summarized here.
The data provenance is from non-clinical bench testing performed by the manufacturer, Anhui Deepblue Medical Technology Co., Ltd., located in Hefei, Anhui, PEOPLE'S REPUBLIC OF CHINA. The testing is retrospective in the sense that it was conducted as part of the product development and regulatory submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a premarket notification for an ultrasonic coupling agent, which is a physical material, not an AI/software device that generates diagnostic outputs requiring expert interpretation. Therefore, the concept of "ground truth established by experts" in the context of image interpretation (e.g., radiologists) does not apply to this submission. The "ground truth" for the performance tests (e.g., sound velocity, pH) is established by the validated measurement methods and equipment used in the laboratory.
4. Adjudication Method for the Test Set
As this is a submission for a physical medical product based on laboratory bench testing and not an AI or diagnostic imaging device requiring human expert consensus for "ground truth," an "adjudication method" involving multiple experts is not applicable. The results are determined by instrumental measurements and standardized material testing procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human readers interpret cases, and the AI's impact on their performance is evaluated. For an ultrasonic coupling gel, this type of study is not relevant or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the sense of an algorithm's performance without human interaction was not done. This device is a passive material, not an algorithm. Its "performance" is its physical and chemical properties and ability to conduct ultrasound waves.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective physical and chemical measurements obtained through validated laboratory testing methods (bench tests) and compliance with recognized standards. This includes:
- Physical properties (Sound Velocity, Acoustic Impedance, Sound Attenuation, Viscosity, Density, pH) measured by instruments.
- Microbial limits and sterility confirmed by microbiological testing.
- Biocompatibility assessed against ISO 10993 standards.
- Packaging and shelf-life validated per ISO 11607-1, ASTM F88/F88M-15, ASTM D3078.
There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for a coupling agent's performance in the same way it would be for a diagnostic tool or treatment.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this submission. This device is a physical product (ultrasound gel), not an AI algorithm that undergoes training on a dataset. The formulation and manufacturing processes are developed and validated, but there isn't a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this physical device, this question is not applicable.
Ask a specific question about this device
(33 days)
MUI
The Non-sterile Ultrasound Transmission Gels are ultrasound couplants intended to be used on intact skin during non-invasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics.
The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.
The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.
The proposed device, Non-Sterile Ultrasound Transmission Gels, are non- irritating, non sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.
The subject device is available in the below sizes: 20g/bag,250ml/bottle, 1000ml/bottle,2000ml/bottle,5000ml/bottle,250g/bottle,1000g/bottle,2000 g/bottle,5000g/bottle.
This document is a 510(k) Premarket Notification for a non-sterile ultrasound transmission gel, not an AI/ML medical device. Therefore, the information requested in points 1-9 regarding acceptance criteria, study details, expert involvement, and ground truth establishment for AI/ML performance is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (EcoVue® Sterile and Non-Sterile Ultrasound Gels, K181363) through physical, chemical, and performance testing for the ultrasound gel itself.
Here's a breakdown of the relevant information present in the document that aligns with the spirit of your request regarding product validation, but adapted for a non-AI/ML medical device:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML context)
The document presents performance testing results for the Non-Sterile Ultrasound Transmission Gels. The "Acceptance Criteria" here are the specified ranges or conditions that the gel must meet for various physical and chemical properties.
| Test Item | Acceptance Criteria (Specification) | Reported Device Performance (Test Results) | Conclusion |
|---|---|---|---|
| Sound Velocity (Acoustic Velocity) | 1520-1620 m/s (at 35°C) | 1538.1 m/s ~ 1540.3 m/s | Pass |
| Acoustic Impedance | 1.5×10^6 ~ 1.7×10^6 Pa·s/m (at 35°C) | 1.59×10^6 Pa·s/m ~ 1.60×10^6 Pa·s/m | Pass |
| Sound Attenuation | ≤0.1 dB/(cm • MHz) (at 35°C) | 0.06~0.07 dB/(cm • MHz) | Pass |
| Viscosity | ≥ 15 Pa·s (at 25°C) | 101 Pa·s ~ 103 Pa·s | Pass |
| Density | 987-1049 kg/m³ | 1033.42 kg/m³ ~ 1038.46 kg/m³ | Pass |
| pH | 5.5~8.0 | 6.74~6.79 | Pass |
| Antimicrobial Effectiveness | Bacteria: ≥ 2.0 log reduction at 14 days, no increase from 14-day count at 28 days. Yeast and Molds: No increase from initial count at 14 and 28 days. | Pass | Pass |
| Appearance | Colorless or light-colored transparent gel, no insoluble foreign matter. No delamination, mildew, or odor under normal storage. | Pass | Pass |
2. Sample Size and Data Provenance (Non-AI/ML context)
- Sample Size: The document does not specify the exact number of samples used for each bench test. These are typical material property tests, and standard laboratory practices would involve a sufficient number of samples to ensure reproducibility and statistical significance, though the detailed protocol and exact sample counts are not included in this summary.
- Data Provenance: The tests were conducted internally by Hony Medical Co., Ltd. in China. The nature of the study is "bench testing" or "non-clinical testing," implying experimental evaluation in a laboratory setting rather than retrospective or prospective clinical data.
3. Number of Experts and Qualifications (Not Applicable for this type of device)
This concept is not relevant for the validation of an ultrasound transmission gel's physical and chemical properties. The "experts" would be the laboratory personnel conducting and analyzing the bench tests, qualified in chemical and physical analysis.
4. Adjudication Method (Not Applicable)
This is a concept for reconciling disagreements in human annotations for ground truth in AI/ML studies, which is not applicable to bench testing of a physical product.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study (Not Applicable)
This study type is used to assess the impact of AI on human reader performance, which is not relevant for an ultrasound transmission gel. The document explicitly states: "No clinical study is included in this submission."
6. Standalone Performance (Non-AI/ML context)
The performance data provided in Table 1 ("Performance testing summary - Bench") represents the "standalone" performance of the Non-Sterile Ultrasound Transmission Gels as a product, independent of human interaction in an AI context. The device's performance is measured against its own specifications, not as an algorithm assisting a human.
7. Type of Ground Truth (Non-AI/ML context)
The "ground truth" for this device's performance is established by objective laboratory measurements of its physical and chemical properties, compared against predefined specifications based on industry standards (e.g., ASTM F1980 for shelf life, ISO 10993-1 for biocompatibility) and the requirements for effective ultrasound transmission.
8. Sample Size for Training Set (Not Applicable)
This device does not involve a "training set" in the context of machine learning.
9. How Ground Truth for Training Set was Established (Not Applicable)
As there is no training set for this traditional medical device, this question is not applicable.
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(85 days)
MUI
Sterile and Non-Sterile Ultrasound Gels is intended to be used on external, intact skin as a coupling contact medium for ultrasonic procedures. The sterile Ultrasound Gel is also used for intra operative, biopsy applications. The Ultrasound Gel can be used during the procedures that involved adults and pediatrics in professional healthcare facility by qualified and trained healthcare professional.
The proposed device, Sterile and Non-Sterile Ultrasound Gels, are non- irritating, nonsensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.
The provided text describes the 510(k) premarket notification for "Sterile and Non-Sterile Ultrasound Gels" by Jianerkang Medical Co., Ltd. This document is a regulatory submission for a medical device accessory, specifically an ultrasound coupling gel, not an AI software or a device that has complex diagnostic or interventional functions.
Therefore, many of the requested elements for AI/imaging device performance studies (like MRMC studies, effect size of human reader improvement with AI, ground truth establishment for training/test sets, number of experts for adjudication, etc.) are not applicable to this type of device and submission.
The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (HR Pharmaceuticals, Inc., EcoVue® Sterile and Non-Sterile Ultrasound Gels, K181363) through bench testing, biocompatibility testing, sterilization validation, and packaging/shelf-life validation. The "study that proves the device meets the acceptance criteria" refers to these non-clinical performance tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating performance similar to or within acceptable ranges compared to the predicate device, and compliance with recognized standards.
| Acceptance Criteria (Requirement Specification) | Reported Device Performance (Test Results) |
|---|---|
| Physical & Chemical Properties (Measured at 35°C): | |
| Sound Velocity (Acoustic Velocity): 1520 ~ 1620 m/s | 1569 m/s ~ 1570 m/s |
| Acoustic Impedance: $1.5 \times 10^6$ ~ $1.7 \times 10^6$ Pa·s/m | $1.593 \times 10^6$ Pa·s/m ~ $1.597 \times 10^6$ Pa·s/m |
| Sound Attenuation: ≤ 0.1 dB/(cm·MHz) | 0.042 dB/(cm·MHz) ~ 0.049 dB/(cm·MHz) |
| Physical Properties (Measured at 25°C): | |
| Viscosity: ≥ 4000 cP (1000 Cp = 1 Pa.s) | 8844 cP ~ 13720 cP |
| Density: 0.85 - 1.15 g/cm³ | 1.021 - 1.022 |
| pH: 5.5 ~ 8.0 | 6.68 ~ 6.73 |
| Compositional/Visual Inspection: | |
| Appearance: Colorless or light transparent gel, no or only a few bubbles, non-soluble foreign bodies | Pass |
| Microbiological Purity (Non-Sterile Gel): | |
| TAMC: ≤ 100 CFU/g |
Ask a specific question about this device
(54 days)
MUI
Ultrasound Transmission Gels are ultrasound couplants intended to be used on intact skin during non-invasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.
The Ultrasound Transmission Gels, which shall be colorless or light-colored transparent , are non-irritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. The Ultrasound Transmission Gels are composed of purified water, glycerin, polyethylene glycol, carbomer, sodium hydroxide and phenoxyethanol. It is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image. The subject device is available in the below sizes: 5q/baq, 10g/baq, 15q/baq, 16q/baq, 20g/bag, 22g/bag, 25g/bag, individual, single-use packet. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's Gamma sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
The provided document describes the regulatory submission for "Ultrasound Transmission Gels" and does not contain information about an AI-powered medical device. Therefore, it is not possible to answer the request with the provided information.
The document details the technical characteristics and non-clinical testing of an ultrasound couplant (gel) to demonstrate its substantial equivalence to a predicate device. This involves material composition, sterilization, biocompatibility, and physical properties like sound velocity, acoustic impedance, and viscosity. There is no mention of algorithms, AI, machine learning, or any form of software that would involve diagnostic performance metrics, training sets, or expert adjudication.
Specifically, the document states:
- "No clinical study is included in this submission."
- The device is a physical product (gel) used to facilitate ultrasound imaging, not an image analysis software.
Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.
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(203 days)
MUI
Ultrast Gel is an in vivo biocompatible sterile sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications.
Ultrast Gel is used to couple sound waves between the patient and medical imaging electronic transducers during intracavitary medical diagnostic ultraging procedures, transcutaneous ultrasound image guided biopsy and aspiration, intracavity ultrasound imaging, and gel infusion sonography.
Ultrast Gel is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required.
ULTRAST Gel is available by prescription only for use by healthcare providers trained in performing the indicated procedure.
The Ultrast Gel device, manufactured for Ultrast, Inc. is a phase changing hydrogel ultrasound coupling agent comprised of hydroxy-propylcellulose, sodium chloride, sodium citrate, and water. HCl may be added to adjust pH if necessary. The gel is viscous at room temperature, but subsequently liquefies as its temperature rises and reaches body temperature. In addition to general lubricating/coupling properties, the gel may be instilled in the uterine cavity through a standard intrauterine insemination (IUI) catheter to provide excellent ultrasonographic visualizations, after which point it liquifies and passes out of the uterine cavity.
The gel is contained in a single use 5cc capped syringe enclosed in a peel pouch to maintain sterility.
The provided text is a 510(k) Premarket Notification summary for Ultrast Gel, a medical device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/human-in-the-loop study.
The "Performance Data" section primarily addresses biocompatibility testing, electrical safety/EMC (not applicable, as it's not a software/electrical device), software verification/validation (not applicable), and bench testing related to the physical properties of the gel (appearance, pH, viscosity, syringe force, acoustic properties, and package integrity). There is no mention of a study involving human readers, AI assistance, ground truth establishment by experts, or MRMC studies.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them in the context of AI/human-in-the-loop performance. The information required for your request (AI performance, human reader improvement, expert adjudication, ground truth type, sample sizes for training/test sets related to AI) is simply not present in this regulatory document, as the device is a physical gel, not an AI software.
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(211 days)
MUI
The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for noninterventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.
The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for noninterventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.
This is a 510(k) clearance letter for a sterile ultrasound gel. As such, the document primarily focuses on the regulatory review process and substantial equivalence to a predicate device. It does not contain the kind of performance study data and acceptance criteria typically found for AI/ML-powered diagnostic devices.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Details about expert readers or ground truth establishment.
- MRMC studies or standalone algorithm performance.
The product in question is a "Safergel Sterile Ultrasound Gel," which is a consumable medical device used to facilitate ultrasound imaging, not an AI/ML diagnostic software.
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(21 days)
MUI
Eco Vue® Sterile and Non-Sterile Ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.
The proposed device, EcoVue® Sterile and Non-Sterile Ultrasound Gels, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image.
The document describes the acceptance criteria and performance data for EcoVue® Sterile and Non-Sterile Ultrasound Gels, which are coupling media for diagnostic ultrasound.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (EcoVue® Sterile and Non-Sterile Ultrasound Gels) | Reported Device Performance (Predicate Device K130041) | Reported Device Performance (Predicate Device K112827) |
|---|---|---|---|
| Physical & Chemical Properties | |||
| Appearance | Clear to Hazy Color; free from foreign matter | Clear or Blue Color | Clear or Blue Color |
| Sound Velocity (Acoustic Velocity) | 1398-1750 m/s | 1591 m/s* | 1587 m/s* |
| Acoustic Impedance | 1.40-1.80 Mrayl | 1.63 Mrayl* | 1.63 Mrayl |
| Sound Attenuation (5 MHz) | 0.32-0.95 dB/cm | 0.82 dB/cm* | 0.90 dB/cm* |
| Sound Attenuation (7.5 MHz) | 0.65-1.10 dB/cm | 1.16 dB/cm* | 1.57 dB/cm* |
| Sound Attenuation (10 MHz) | 0.85-1.55 dB/cm | 1.46 dB/cm* | 2.19 dB/cm* |
| Viscosity | >35,000 cP | 96,700* | 93,700* |
| Density | 0.85-1.15 g/cm3 | 1.027 g/cm3* | 1.026 g/cm3* |
| pH | 5.5 – 7.8 | 6.7* | 6.7* |
| Biocompatibility | Meets ISO 10993-1:2009 requirements for irritation, sensitization, and cytotoxicity | Meets ISO 10993-1:2009 requirements for irritation/intracutaneous toxicity, sensitization, and cytotoxicity | Meets ISO 10993-1:2009 requirements for irritation/intracutaneous toxicity, sensitization, and cytotoxicity |
| Sterility | Sterility Assurance Level of 10⁻⁶ (for sterile gel) | - | - |
| Antimicrobial Effectiveness | Meets USP | - | - |
| Microbiological Growth | Meets USP | - | - |
| Shelf Life | 1 year | 3 years (for predicate K130041) | 5 years (for predicate K112827) |
* Note: These values for the predicate devices are reported in the comparison table, but the document states they were obtained from performance testing conducted per HR Pharmaceuticals' protocols, implying they are the subject device's performance measured against the predicate, rather than the predicate's reported performance from its own submission. The "Proposed Device" column directly lists the acceptance criteria for EcoVue®. While the table presents them side-by-side, the "Acceptance Criteria" for the subject device are explicitly listed in the first column, indicating what the new device must achieve.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for the performance bench testing (Sound Velocity, Acoustic Impedance, etc.), biocompatibility testing, sterilization validation, or packaging validation. It refers to these tests as "internal methods," "USP ," "USP ," "USP ," "ASTM D445-17a," and various ISO/AAMI/ASTM standards. These standards typically specify minimum sample sizes or allow for statistically sound justifications, but the specific numbers are not provided in this summary.
The data provenance is not specified regarding country of origin; the testing appears to be conducted by or for the device manufacturer, HR Pharmaceuticals, Inc., as indicated by "Values obtained from performance testing conducted per HR Pharmaceuticals' protocols" (Page 7). All testing described is prospective, as it was conducted to support the 510(k) submission for the EcoVue® gels.
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):
This information is not applicable to this type of device (ultrasound gel). The tests conducted are primarily physical, chemical, and biological characterizations according to established standards, not diagnostic performance evaluations requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for this type of device or study. Adjudication methods are typically used in clinical studies where multiple human readers assess data and discrepancies need to be resolved.
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:
This is not applicable. The device is a medical accessory (ultrasound coupling gel), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a physical product (ultrasound gel), not an algorithm or software. Therefore, standalone algorithm performance was not assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance data of the ultrasound gel is based on:
- Bench Test Standards: Industry-recognized physical and chemical measurement standards (e.g., ASTM D445 – 17a, USP , USP , USP ) and internal methods.
- Biocompatibility Standards: International standards for biological evaluation of medical devices (ISO 10993-1, 10993-5, 10993-10).
- Sterilization Standards: International standards for sterilization validation (ISO 11137 series, ISO 11737 series).
- Packaging Validation Standards: International and national standards for packaging of sterile medical devices and accelerated aging (ISO 11607-1, ASTM F88, ASTM F1886, ASTM F2096, ASTM F1980).
The "ground truth" is adherence to these established scientific and regulatory standards.
8. The sample size for the training set:
This is not applicable. There is no training set mentioned, as this device does not involve machine learning or AI models that require training data.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this device.
Ask a specific question about this device
(435 days)
MUI
UltraPhonic® Scanning Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.
Ultra/Phonic® Scanning Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 4L Cubitainers, 5L Cubitainers, and 250 mL bottles.
Here's a summary of the acceptance criteria and the study details for the Ultra/Phonic® Scanning Gel, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Ultra/Phonic® Scanning Gel Performance |
|---|---|
| Acoustic Properties: |
- Sound velocity
- Density
- Acoustic impedance
- Attenuation coefficient as a function of frequency | - Sound velocity: 1590 ms-1 at 22.5°C
- Density: 1035 kg/m3 at 22.5°C
- Acoustic impedance: 1.65 MRayls at 22.5°C
- Attenuation coefficient (a/f): 0.06 + 0.01116 f^1.3706
Conclusion: "Virtually identical to that of human skin" and "Similar to other coupling gels commonly used in the United States." Acoustic properties of the predicate gel (Sonishield™ 100) are also provided for comparison and are considered "virtually identical." |
| Antimicrobial Effectiveness (USP Category 2) | - Log reductions > 5 for bacterial counts (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa) at 14 and 28 days. - Yeasts and molds (Aspergillus brasiliensis, Candida albicans) did not increase, and "considerably decreased." |
| Biocompatibility (ISO 10993-10): - Skin Irritation
- Skin Sensitization | - Non-sensitizing
- Non-irritating |
| In Vitro Cytotoxicity (ISO 10993-5:2009) | - Meets the requirements of the test and is "not considered cytotoxic." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for each specific test (acoustic, antimicrobial, biocompatibility, cytotoxicity). It refers to "evaluations," "tests conducted," and "studies." The provenance of the data is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective, though performance testing is generally prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies performed are non-clinical (laboratory and animal) and do not involve human interpretation or subjective expert ground truth establishment in the traditional sense of diagnostic AI studies.
4. Adjudication Method for the Test Set
Not applicable, as this device does not involve subjective diagnostic interpretations requiring adjudication. The performance criteria are based on objective physical, chemical, and biological measurements.
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 is a medical device (ultrasound scanning gel) and not an AI-powered diagnostic tool. Therefore, an MRMC study and evaluation of human reader improvement with AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI model. Its performance is evaluated through direct physical, chemical, and biological testing, not through standalone algorithm performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by recognized scientific and regulatory standards and validated laboratory methods.
- Acoustic Properties: Comparative measurements against human skin properties and other commercially available gels.
- Antimicrobial Effectiveness: Defined log reduction criteria established by USP .
- Biocompatibility: Absence of irritation and sensitization as per ISO 10993-10.
- Cytotoxicity: Meeting negative control requirements and absence of cytotoxic effects as per ISO 10993-5:2009.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI model.
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(435 days)
MUI
Ultra Phonic® Free Conductivity Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.
Ultra/Phonic® Free Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals.
It is packaged in 5L Cubitainers and 250 mL bottles.
Major characteristics include:
- Non-sensitizing, non-irritating
- Water soluble, non-staining, and easily cleanable
- Does not contain oil or fatty matter
- Does not damage the probe
- pH level is 6.25 ± 0.25 @ 25°C
- Resists thinning and decomposition when exposed to perspiration and body heat
- Sheer thinning gel is easy to apply, but doesn't run or drip
- High viscosity allows for thick application, adapting to contours and hair to minimize interference
This document describes the premarket notification (510(k)) for the Ultra/Phonic® Free Conductivity Gel, a diagnostic ultrasonic transducer accessory. The focus of the provided text is on demonstrating the substantial equivalence of the new device to existing predicate devices, rather than a detailed algorithm performance study for an AI-powered device. Therefore, many of the requested elements for AI/algorithm performance (e.g., test set sample size, ground truth details, MRMC studies) are not applicable or not present in this document.
Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate and reference devices, as the goal is to demonstrate "substantial equivalence." The reported performance focuses on acoustic properties and biocompatibility.
| Property | Acceptance Criteria (Predicate/Reference) | Reported Performance (Ultra/Phonic® Free Conductivity Gel) | Met/Not Met |
|---|---|---|---|
| Acoustic Properties | Similar to Sonishield™ 100 & Ecogel 100 | Virtually identical to human skin; Similar to other coupling gels | Met |
| Sound velocity (m/sec) | Sonishield™ 100: 1497 ms-1 at 30°C | 1488 ms-1 at 22.5°C | Met (considered virtually identical despite temp diff) |
| Density (kg/m3) | Sonishield™ 100: 1023 kg/ m3 at 30°C | 1018 kg/ m3 at 22.5°C | Met (considered virtually identical despite temp diff) |
| Acoustic impedance (kg/m2 sec) | Sonishield™ 100: 1.53 MRayls at 30°C | 1.51 MRayls at 22.5°C | Met (considered virtually identical despite temp diff) |
| Attenuation coefficient (a/f) | Sonishield™ 100: 0.04 ± 0.0042 f | 0.0185 + 0.01335 $f^{1.0894}$ | Met (considered virtually identical) |
| Biocompatibility | Non-sensitizing, non-irritating | Non-sensitizing, non-irritating | Met |
| USP Antimicrobial Effectiveness Test | Log reductions > 5 for bacterial, no increase yeast/molds in 14/28 days | Log reductions > 5 for all 14 and 28 day bacterial counts; yeasts and molds decreased | Met |
| In Vitro Cytotoxicity (ISO 10993-5:2009) | Pass | Not met (considered cytotoxic) | Not Met (but mitigated by RIPT) |
| Human-Repeated-Insult-Patch-Test (RIPT) | No potential for dermal irritation/allergic sensitization | No potential for dermal irritation or allergic contact sensitization | Met (mitigated cytotoxicity concern) |
| Physical/Chemical Properties | (Based on comparison table with predicates) | (See detailed characteristics in comparison table) | Met |
| Ingredients (Salt free, Dye free, Alcohol free, Formaldehyde free, Perfume Free) | Similar to Sonishield™ 100 (Ecogel had green coloring) | All free | Met |
| pH | Sonishield™ 100: 4.5 – 6.5; Ecogel 100: 6.5 ± 0.75 | 6.25 ± 0.25 @ 25°C | Met |
| Viscosity (CPS) | Sonishield™ 100: 80,000 – 120,000; Ecogel 100: 35,000 - 40,000 | 600,000 ± 300,000 | Met (difference acknowledged, but deemed equivalent in function) |
| Boiling Point | Sonishield™ 100: > 200°C; Ecogel 100: 100°C | > 200°C | Met |
2. Sample size used for the test set and the data provenance:
- Acoustic performance: The document states that the acoustic properties of the gel were evaluated and compared to human skin and other coupling gels. No specific sample size (number of gels tested, or number of measurements) is provided for this evaluation. The data provenance is implied to be laboratory testing.
- Antimicrobial Effectiveness Test: The test followed USP (Category 2) standards, involving specific bacterial and fungal strains (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231). The sample size typically refers to the number of replicates per microbial challenge, which are standard for this test method.
- Biocompatibility (Skin Irritation, Skin Sensitization, Cytotoxicity): These refer to ISO 10993-10 and ISO 10993-5:2009 standards. These are in vitro or animal tests that follow specific protocols for sample sizes of cells or animals. The document does not specify the exact number of animals or cell cultures used but confirms that tests were conducted according to the stated ISO standards.
- Human-Repeated-Insult-Patch-Test (RIPT): This is a human clinical study. The document does not specify the number of human subjects used but indicates that such testing was performed. Data provenance is likely the testing laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a medical accessory (ultrasound gel), not an AI-powered diagnostic algorithm requiring expert "ground truth" for classification. The "truth" is established by physical/chemical measurements and biological assays.
4. Adjudication method for the test set:
Not applicable (refer to point 3).
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 is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used:
The "ground truth" for this device revolves around its physical, chemical, and biological properties:
- Acoustic Properties: Measured values (sound velocity, density, acoustic impedance, attenuation coefficient).
- Biocompatibility: Results of standardized in vitro and in vivo tests adhering to ISO 10993 guidelines, and the USP antimicrobial test.
- Functional Properties: pH, viscosity, ingredients, etc., measured via standard laboratory methods.
8. The sample size for the training set:
Not applicable. This is not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable (refer to point 8).
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(434 days)
MUI
Other-Sonic™ Transmission Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.
Other-Sonic™ Transmission Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 5L Cubitainers and 250 mL bottles.
The device under review is "Other-Sonic™ Transmission Gel," which is a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. The device is compared to a predicate device, "Sonishield™ 100 Antimicrobial Ultrasound Gel," and an additional reference device, "Ecogel 100 Ultrasound Gel."
Here's the breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance metric but rather presents a comparison of technological and non-clinical characteristics between the subject device and the predicate/reference devices to demonstrate substantial equivalence. The "performance" column below reflects the characteristics of the "Other-Sonic™ Transmission Gel" and the "Acceptance Criteria" column indicates that its performance should be substantially equivalent or similar to the predicate/reference devices for these characteristics.
| Acceptance Criteria (Compared to Predicate/Reference) | Reported Device Performance (Other-Sonic™ Transmission Gel) |
|---|---|
| Acoustic Performance: | |
| Sound velocity similar to predicate | 1601 ms-1 at 22.5°C (Predicate: 1497 ms-1 at 30°C) |
| Density similar to predicate | 1033 kg/ m3 at 22.5°C (Predicate: 1023 kg/ m3 at 30°C) |
| Acoustic impedance similar to predicate | 1.65 MRayls at 22.5°C (Predicate: 1.53 MRayls at 30°C) |
| Attenuation coefficient similar to predicate | 0.19 + 0.0000105 $f^{2.974}$ (Predicate: 0.04 ± 0.0042 $f$) |
| Antimicrobial Effectiveness: | |
| Pass USP (Category 2) log reductions | Passed with log reductions > 5 for bacteria, yeasts and molds decreased |
| Biocompatibility: | |
| Non-sensitizing | Non-sensitizing |
| Non-irritating | Non-irritating |
| In Vitro Cytotoxicity: | |
| Not considered cytotoxic (per ISO 10993-5:2009) | Not considered cytotoxic |
| Physical/Chemical Properties: | |
| Salt free | Salt free |
| Alcohol free | Alcohol free |
| Formaldehyde free | Formaldehyde free |
| pH range (comparable to predicate) | 6.80 ± 0.25 |
| Density (g/mL) (comparable to predicate) | 1.033 |
| Viscosity (comparable to predicate) | 966,000 ± 483,000 CPS |
| Boiling Point (comparable to predicate) | > 200° C |
| Water soluble high MW polymers | Water soluble high MW polymers |
| No irritation | No irritation |
| Other: | |
| External Use | External |
| Pediatric and adult Target Population | Pediatric and adult |
| Multiple Uses | Multiple uses |
| Hospital Environment of Use | Hospital |
2. Sample Size Used for the Test Set and Data Provenance:
- Acoustic Testing: The document does not specify a separate "test set" sample size for acoustic testing. The acoustic properties are reported as values for "Other-Sonic™ Transmission Gel" and "Sonishield™ 100 Antimicrobial Ultrasound Gel." It implicitly compares the characteristics of the gel rather than a study on a specific number of instances.
- Antimicrobial Effectiveness Testing: The sample size is not explicitly stated as a number of distinct gel samples. However, the test was performed according to USP (Category 2) using standard microbial challenges: Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Aspergillus brasiliensis ATCC 16404, and Candida albicans ATCC 10231. These represent specific strains used in lab testing.
- Biocompatibility (Skin Irritation and Sensitization): The document states "Animal tests" were conducted, referring to "Skin Irritation and Skin Sensitization." The number of animals or specific experimental setup (e.g., number of patches, individual subjects) is not provided.
- In Vitro Cytotoxicity: The test was conducted according to ISO 10993-5:2009. The sample size refers to the cell cultures used in the in vitro test, but specific numbers are not given.
- Data Provenance: The document does not specify the country of origin for the non-clinical test data. These tests are typically conducted in laboratory settings (i.e., in vitro or in vivo animal studies) rather than using retrospective or prospective human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable. The evaluations conducted for this device (acoustic properties, antimicrobial effectiveness, biocompatibility, cytotoxicity) are non-clinical laboratory tests. They do not involve expert interpretation of images or clinical data to establish a "ground truth" in the way a diagnostic algorithm might. The "ground truth" for these tests comes from established scientific methodologies and standards (e.g., USP , ISO 10993).
4. Adjudication Method for the Test Set:
This section is not applicable as the studies were non-clinical laboratory tests that do not involve human adjudication of results in the context of diagnostic interpretation.
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:
No MRMC comparative effectiveness study was done. This device is an ultrasound transmission gel, not an AI-powered diagnostic tool requiring human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No standalone (algorithm-only) performance was done because this is a physical medical device (ultrasound transmission gel), not an algorithm or AI software.
7. The Type of Ground Truth Used:
The "ground truth" for the performance claims comes from:
- Acoustic Properties: Direct physical measurements of the gel's sound velocity, density, acoustic impedance, and attenuation coefficient.
- Antimicrobial Effectiveness: Quantitative microbial count reductions as measured by standard microbiological assays (USP ).
- Biocompatibility: Results from standardized animal (in vivo) irritation and sensitization tests (ISO 10993-10).
- In Vitro Cytotoxicity: Results from standardized cell culture tests (ISO 10993-5:2009) to assess cell viability.
8. The Sample Size for the Training Set:
This section is not applicable. This device is a physical product (ultrasound transmission gel) and does not involve AI or machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable as there is no training set for this type of device.
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