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The Autoject 2 is a hand held mechanical device intended for a self-administered automated subcutaneous injection of FDA approved drugs. The device is designed for use with a 1ml glass fixed needle syringe, for use in the home by the patient or care-giver to aid and support a recommended treatment regime.

The Autoject 2 O.T.C is a hand held non-sterile semi-automatic device using pre-filled 1ml glass syringes capable of a subcutaneous injection of FDA approved drugs. The devices are designed for re-usable use to aid and support patient/ care-giver use in the home with a treatment regime.

The provided text describes a medical device, the Autoject 2, and indicates that a 510(k) premarket notification was submitted and found substantially equivalent to a predicate device. However, the document does not contain details about specific acceptance criteria, comprehensive study designs, or detailed performance metrics that would typically be found in a robust study report proving a device meets acceptance criteria.

The information primarily focuses on the device's description, intended use, and a list of tests performed. It mentions "User Trials" but provides no specifics on their methodology or results beyond a general statement of "success."

Therefore, I cannot populate all the requested sections with specific, quantitative data. I will extract what is available and clearly state what information is not present in the provided text.

Here's an attempt to answer based solely on the provided text, highlighting the absence of detailed information:

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

Note: The document only lists tests and states "proving the correct action" or "clearly indicates the success." It does not provide specific acceptance criterion values (e.g., "Force to Fire

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A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable 1ml non-fixed needle syringe and to accommodate self use in the home by the patient in order to aid and support compliance with the recommended treatment regime.

A hand-held general purpose mechanical injection device for the sub-cutaneous injection of Insulin and other approved medicines.

The provided text describes a 510(k) submission for the "Autoject®2 Non-Fixed Needle type" syringe introducer. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a comprehensive study with defined performance metrics and ground truth.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable in the context of this 510(k) summary. The submission focuses on demonstrating equivalence to an existing device, the Autoject® 2 (Fixed Needle type), by highlighting similarities in design, intended use, and general performance.

Here's a breakdown of the information as it relates to the provided text:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" as would be set for a novel device proving its efficacy and safety are not explicitly stated within the provided text. The primary acceptance criterion for the FDA in this context is the demonstration of substantial equivalence to a predicate device.

The document states: "The Autoject® 2 (Non-fixed Needle type) is visually identical to and has the same area of intended use i.e. for the sub-cutaneous injection of medicament, as the current 510(K) approved Autoject® 2 (Fixed Needle type) device to which substantial equivalence is claimed."

The specific performance aspect mentioned is "dose accuracy."

Study Details

The document mentions "NON-CLINICAL TRIAL DATA" and references "the study carried out in Australia." However, the details of this study are very limited in the provided text.

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: A study was "carried out in Australia." It's not specified if it was retrospective or prospective.

2. 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. The provided text does not describe a study involving expert-established ground truth for a test set in the way you might find for a diagnostic or AI device. The study mentioned is for a mechanical injection device.

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

   • Not Applicable. No information on adjudication methods for a test set is provided as this is not a diagnostic device or a study requiring such an approach.

4. 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. This is a mechanical injection device. MRMC studies and AI assistance for human readers are entirely irrelevant to this device and its 510(k) submission.

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

   • No. This is a mechanical injection device. The concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not Applicable. The "ground truth" for a mechanical device like this would likely relate to objective physical measurements (e.g., dose delivered, injection depth, force required) rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in the typical sense. The text mentions "dose accuracy results," implying quantitative measurements.

7. The sample size for the training set

   • Not Applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.

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

   • Not Applicable. As above, no training set for an algorithm is involved.

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The device is for the subcuraneous injection of insulin.
The Unifine range of Syringes is designed for the subcutaneous injection of insulin.

The Unifica range if syringes are ldentical to that of the Orientan range of syringss manufactured by B Braun. The syringes are manufactured, packed and mentised by B Braun and supplied to Owen Mumford for sale or distribution. No re-packaging roworking or modifications are made to the systems or packaging by Owen Mumford, The are supplied in three sizes (0.3ml, 0.5ml) in boxes of 100. The individual syringes are supplied in peel pouches and are sterilised using Ethylone Oxide.

This document is a 510(k) summary for the Unifine Insulin Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance as typically seen in AI/ML device submissions. Therefore, many of the requested categories about acceptance criteria, study details, ground truth, and expert involvement are not applicable or cannot be extracted from this specific filing.

Here's a breakdown of the available information:

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

The provided document does not contain a table of acceptance criteria or reported device performance in the context of a new study to demonstrate safety and effectiveness. Instead, it asserts substantial equivalence to a predicate device based on manufacturing identity.

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

Not applicable. No formal test set or corresponding study data is presented in this 510(k) summary to evaluate a new device's performance. The basis for clearance is substantial equivalence.

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. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable.

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 clearance for an insulin syringe, not an AI/ML product.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of Device and 510(k) Basis:

• Device Name: Unifine (Insulin syringes)
• Intended Use: Subcutaneous injection of insulin.
• Substantial Equivalence Claim: The Unifine syringes are stated to be identical to the Omnican Insulin Syringe manufactured and distributed by B. Braun (K962084). Owen Mumford Inc. sells and distributes these syringes without re-packaging, re-working, or modifications.
• Regulatory Conclusion: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This determination is based on the claim of product identity with a previously cleared device, not on new performance study data.

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The delivery of insulin products using a variable dose pen for insulin dependent diabetics. The Owen Mumford 3ml Autopen is a non-sterile automatic subcutaneous injection device which uses a replaceable 3ml insulin cartridge Suboutineous injoction in automatic drive system is used to displace the insulin from the cartridge through a sterile disposable needle.

Autopen® is cylindrical in shape, approximately 165mm x 15mm including cover. The Owen Mumford 3ml Autopen® is based upon a proven design marketed in both Europe since 1988 and the United Sates since 1989 when 510(k) approval was granted for the Owen Mumford 1.5ml Autopen® K895890. There has been no change at all to the design concept since then, and only minor design improvements otherwise in response to customer feedback and continuous improvement as required of a company with ISO 9001, FDA GMP and EN 46001 status. These changes are essentially cosmetic such as: A) A one piece cap instead of a three piece cap to facilitate assembly. B) The cartridge housing was modified to a one piece rather than a two piece to improve durability. C) The cartridge housing can now accommodate a 3.0ml cartridge as opposed to the 1.5ml and is made of one piece rather than 2 separate components in the Owen Mumford 1.5ml Autopen® K895890. D) The printing on the dose selector was changed to improve visibility. The Owen Mumford Autopen® 3ml is a non-sterile, automatic, subcutaneous injection device which uses a replaceable 3ml insulin cartridge (supplied by others) held within the body of the device. Maximum delivery is 42 units in 2 unit increments. An automatic drive system is used to displace the insulin from the cartridge through sterile disposable pen needles.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Owen Mumford Autopen 3ml:

Context: The provided text is a 510(k) submission summary for the Owen Mumford Autopen 3ml, which is a device for insulin delivery. The core of the document focuses on demonstrating substantial equivalence to a previously approved device (Autopen 1.5ml K895890).

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a numerical table format for a specific "study." Instead, it states that the device was tested to draft ISO/TC 84/WG3 standard "pen injectors of medical use" and that "As confirmed by ISO test results, Autopen® is safe and effective when used as intended."

This implies that the acceptance criteria are the requirements set forth in the mentioned ISO draft standard, and the device's performance met these criteria. However, no specific performance metrics or thresholds are provided in the text.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Study Details

Given the nature of the 510(k) submission, the "study" referred to is primarily a performance verification against a recognized standard rather than an independent clinical trial.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document only mentions "ISO test results" without detailing the number of devices tested.
   • Data Provenance: Not explicitly stated, but the testing would have been conducted by or for Owen Mumford. The location of the testing laboratory is not provided. It's an internal test to demonstrate compliance with a standard.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this was a performance test against an engineering standard, not a clinical study requiring expert ground truth for diagnostic purposes. The "ground truth" would be the objectively measured performance against the specifications defined by the ISO standard.

3. Adjudication method for the test set:

   • Not applicable. Performance testing against an engineering standard typically involves objective measurements and comparisons against established parameters, not adjudication in the clinical sense.

4. 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 mechanical injection pen, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI-related effectiveness are irrelevant here.

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

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

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

   • The "ground truth" for this performance test would be objective engineering measurements (e.g., dose accuracy, force required for injection, mechanical reliability) as defined and specified by the draft ISO/TC 84/WG3 standard "pen injectors of medical use."

7. The sample size for the training set:

   • Not applicable. There is no AI component or machine learning "training set" involved with this mechanical device.

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

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Intended to achieve a penile erection for men suffering from erectile dysfunction.

The Rapport VTD is a vacuum therapy impotence management system providing a simple, non-surgical, non-invasive method of creating and maintaining an erection in men with erectile dysfunction. The product consists of a hand pump and penile tube, used to create a vacuum, and loading cones, constriction rings and transfer sleeve used to maintain the erection.

The Rapport V.T.D. is a vacuum therapy impotence management system. The provided information leverages a previous 510(k) clearance (K971443) for the same device, stating that no new clinical trial data was generated for this submission. Therefore, the information below refers to the study cited in K971443.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated, but the submission indicates "over 80% of the men used in study."
• Data Provenance: The original 510(k) (K971443) likely contained the details. This specific submission (K982275) states "No additional trial data has been generated... as data supplied in the original 510(k) K971443 is considered adequate." Therefore, the provenance details are not available in the provided text for K982275. Given the previous clearance, it implies the data was retrospective from a previous study. The country of origin for the data is not specified in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not provided in the given text.

4. Adjudication Method for the Test Set

• This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study in question evaluated the device's ability to help men achieve erections, not its performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This device is a physical medical device (vacuum therapy pump), not an AI algorithm. Therefore, a standalone performance study in the context of AI algorithms is not applicable. The study evaluated the standalone performance of the physical device.

7. The Type of Ground Truth Used

• The ground truth was based on the ability of the device to "provide an answer to the impotence problems," which implies successful creation and maintenance of an erection in men with erectile dysfunction. This would likely be assessed by patient self-report or clinical observation of erectile rigidity, although specifics are not provided.

8. The Sample Size for the Training Set

• Not applicable in the context of an AI training set, as this is a physical medical device. The "sample size" refers to the patient cohort used in the study, not a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not applicable as this is a physical medical device and not an AI algorithm requiring a training set. The ground truth for the study was established by observing the device's effectiveness in addressing impotence.

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The device is intended to treat women suffering from vaginismus and dyspareunia. VAGINISMUS is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. DYSPAREUNIA is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device comes in varying sizes, the most appropriate is then selected by the physician for use by the patient and the patient's partner as an assistant if appropriate. It is used as a tool to DILATE the vagina in controlled stages.

Four smooth, high polished finish, hollow, penile shaped cones which are graduated in size and length. Owen Mumfords Amielle is visually and mechanically similar to that of Young's Vaginal Dilator to which substantially equivalence is claimed.

The provided text is a 510(k) submission for the Amielle Vaginal Dilator, seeking substantial equivalence to Young's Vaginal Dilator. This document does not describe a study with acceptance criteria and reported device performance in the way typically seen for novel or higher-risk devices requiring extensive clinical trials. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device. The performance is reported in terms of its similarity to the predicate and anecdotal market acceptance, rather than quantitative metrics from a dedicated study.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. No formal "test set" was used in a clinical study for this 510(k) submission.
• Data Provenance: The submission mentions that Owen Mumford has been marketing Amielle throughout Europe for over 3 years without adverse customer reports. This suggests real-world usage data from Europe, but it's not structured as a controlled study. This would be considered retrospective market surveillance/anecdotal evidence rather than a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not applicable. There was no formal test set requiring experts to establish ground truth. The submission relies on the established safety and efficacy of the predicate device and the new device's substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. No formal test set or adjudication process was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence, not on comparing reader performance with or without AI assistance. The device is a physical medical device (dilator), not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• The "ground truth" implicitly assumed is the established safety and efficacy of the predicate device (Young's Vaginal Dilator) for treating Vaginismus and Dyspareunia. The submission argues that because Amielle is substantially equivalent in design, intended use, and performance, it will also be safe and effective. The "no adverse customer reports" in Europe serves as supplementary evidence of safety in a real-world setting.

8. The Sample Size for the Training Set

• Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no training set.

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The Unifine Pentip are intended for the subcutaneous injection of drugs from prefilled cartridges used in conjunction with variable dose delivery systems such as Pen Injectors. Its intended use is substantially equivalent to that of the BD Microfine.

The Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges.

The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner.

One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.

The Owen Mumford Unifine Pentip is visually and mechanically extremely similar to the BD Microfine Pentip to which substantial equivalence is claimed.

I am sorry, but the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance.

The document is a 510(k) submission for the Unifine Pentip, claiming substantial equivalence to the Becton Dickinson Microfine Pentip. While it states that the performance is "substantially equivalent," it does not provide specific acceptance criteria, quantitative performance metrics, or details about a study conducted to demonstrate this equivalence.

Here's a breakdown of what cannot be extracted from the provided text:

• Acceptance Criteria Table: No specific criteria (e.g., success rate, accuracy, failure rate) are mentioned.
• Reported Device Performance: No quantitative performance data is provided for the Unifine Pentip.
• Sample size for the test set: Not mentioned.
• Data provenance (country, retrospective/prospective): Not mentioned.
• Number of experts used for ground truth: Not applicable, as no such study is described.
• Qualifications of experts: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not mentioned.
• Effect size of human reader improvement: Not applicable.
• Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable, as no study establishing ground truth is described.
• Sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm.
• How ground truth for training set was established: Not applicable.

The document focuses on regulatory approval based on substantial equivalence to an existing marketed device, citing similarity in design, intended use, and operational principles, and noting that the product has been marketed in Europe without adverse reports. It does not include a detailed clinical or performance study with quantified acceptance criteria as might be expected for an AI/algorithm-based device.

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Intended to achieve a penile erection for males suffering from erectile dysfunction.

The Rapport Vacuum Therapy Device is an impotence management system providing men with erectile dysfunction to create and maintain an erection. The device works on a vacuum principle, creating a negative pressure around the penis thus creating an erection. The device construction is detailed in the section on PRODUCT DESCRIPTION.

The provided text is a 510(k) submission for the Rapport V.T.D. (Vacuum Therapy Device), seeking substantial equivalence to the Osbon Erec-Aid. The document primarily focuses on the description and intended use of the device, and its operational similarity to the predicate device. Crucially, it does not include a dedicated study section with specific acceptance criteria or an analysis of performance against those criteria.

Instead, the submission states: "The vacuum performance of the Rapport VTD is similar to the Osbon Erec-Aid (as detailed in Section 6). The device is safe and effective when used as directed." This indicates that the "study" demonstrating performance was likely a comparison of vacuum characteristics between the Rapport VTD and the Osbon Erec-Aid, rather than a clinical trial with predefined acceptance criteria.

Given the limited information, I will infer the acceptance criteria and study details based on the statements provided and typical 510(k) submission practices for non-clinical performance.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative metrics for "vacuum performance" and the tolerance for "similar" are not provided in this summary. Section 6, mentioned in the document, would contain these details.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical test set or human subject data. The "study" appears to be a bench test comparison of the physical characteristics (vacuum performance) of the Rapport VTD against the Osbon Erec-Aid.

• Test Set Sample Size: Not applicable in the context of human subjects. For a bench test, it would refer to the number of Rapport VTD units and Osbon Erec-Aid units tested. This number is not specified in the provided text.
• Data Provenance: Not applicable in the context of human data. The data would be generated from laboratory measurements of the devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for a bench test comparison of vacuum performance would be the measured vacuum characteristics of the predicate device, the Osbon Erec-Aid, established through engineering specifications and calibration. No human experts are used to "establish ground truth" in this type of comparison beyond potentially calibrating equipment and interpreting technical specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC study is relevant for diagnostic imaging or subjective assessment tasks involving multiple human readers. This submission describes a physical device for erectile dysfunction and its performance relative to a predicate device, not a diagnostic or interpretive task.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for the performance comparison was the vacuum performance characteristics of the predicate device, the Osbon Erec-Aid, likely derived from its established specifications or direct measurement.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device's design would be based on engineering principles and the design of the predicate device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth in that context.

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