Search Results

Date Cleared

2009-02-06

(15 days)

Product Code

Regulation Number

Type

Special

Panel

INSORB ABSORBABLE STAPLE, MODEL 1020

Reference & Predicate Devices

K061784

Predicate For

K120373,K131563

Intended Use

Device Description

INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have cleat tips that are 0.8 mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the INSORB™ Absorbable Staple. It outlines the device's characteristics, intended use, and a comparison to a predicate device. The core of the submission focuses on specific performance specifications related to staple pull strength.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Minimum "peak load" pull strength)	Reported Device Performance (Targeted for the modified device)
Staple in "dry" as packaged state: 1.500 lbs	Increased 25% to 1.500 lbs (from a previous value)
Staple after 1-day exposure to 37°C buffered saline: 0.750 lbs	Increased 25% to 0.750 lbs (from a previous value)
Staple after 7-days exposure to 37°C buffered saline: 0.375 lbs	Increased 25% to 0.375 lbs (from a previous value)

Note: The text indicates that these are minimum "peak load" pull strength specifications and that the modified staple's design allows for these 25% increases compared to the predicate device. This implies that the reported performance meets or exceeds these new, higher acceptance criteria.

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

The provided text does not specify a sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The information is presented as a statement of technological comparison and resulting specification changes, implying that internal testing was conducted to verify these new specifications.

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

This information is not applicable to this type of submission. The device is a physical medical staple, and its performance is measured by objective mechanical pull strength tests. There is no "ground truth" established by experts in the context of diagnosing or interpreting findings.

4. Adjudication Method for the Test Set

This is not applicable as the information pertains to objective mechanical testing rather than expert review or interpretation.

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. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists reading images) and comparing performance with and without AI assistance. The INSORB™ Absorbable Staple is a surgical fastener, and its effectiveness is determined by mechanical properties and clinical outcomes, not by human reader interpretation.

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

This is not applicable to the INSORB™ Absorbable Staple, as it is a physical medical device and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is the objective measurement of peak load pull strength under controlled laboratory conditions (dry and after specific durations in buffered saline at 37°C). This is a direct physical measurement, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. The INSORB™ Absorbable Staple is a physical device, not an AI or machine learning model that requires a training set. The "optimization in the staple shape" likely refers to engineering design and material science improvements, which are validated through physical testing, not a training set.

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

This is not applicable for the same reasons as point 8.

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K Number

K061784

Device Name

Manufacturer

Date Cleared

2006-07-26

(30 days)

Product Code

Regulation Number

Type

Special

Panel

INSORB ABSORBABLE STAPLE, MODEL SP-B20

Reference & Predicate Devices

K033602

Predicate For

K090159,K131563

Intended Use

Device Description

INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have cleat tips that are 0.7 mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).

AI/ML Overview

This 510(k) summary (K061784) describes a special 510(k) submission for the INSORB™ Absorbable Staple which primarily focuses on changes to the manufacturing process, sterilization, packaging, and shelf-life, rather than new performance studies with specific acceptance criteria related to a new-to-market device. Therefore, a direct comparison of the device's numerical performance against explicit acceptance criteria in a table format, as you might find for a diagnostic AI device, is not fully applicable here.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of substantial equivalence and identify the "studies" (or rather, validations/tests) that demonstrate these criteria were met for the modified device.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" and "study" within the context of a Special 510(k) for manufacturing changes:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Changes)	Reported Device Performance (Demonstrated by Validation)
Sterility Assurance Level (SAL): Achieves 10-6 SAL.	Sterilization Validation changed from VDmax to Method 1 to allow implementation of a 10-6 SAL validated gamma dose at less than 25kGy. This indicates successful validation of the new sterilization method to meet the required SAL.
Moisture Protection: Maintains device integrity and performance.	Packaging includes a desiccant, which indicates a measure to control moisture, implying successful packaging validation to ensure the device's stability.
Staple Strength (Post-Exposure): Increased by 50% compared to predicate.*	Strength specifications for the staple following exposure to 37°C buffered saline for 7 days and 21 days have been increased 50% to accommodate the STRONGER staple fabricated by the refinements in the micromolding process. This implies testing was done to verify the increased strength compared to the predicate, demonstrating this performance gain.
Shelf Life: Extended to 2 years.	Shelf Life extended to 2 years. This would have been supported by shelf-life testing (e.g., accelerated aging and real-time aging studies) to demonstrate that the device maintains its characteristics (including strength, sterility, and functionality) over the extended period under specified storage conditions, especially considering the packaging change with a desiccant and lower gamma dose. The document implicitly confirms successful completion of such studies to justify the extension.
Biocompatibility: Remains safe for intended use.	Although not explicitly stated as a change, as a Special 510(k) for a previously cleared device, it's assumed that the materials and their biocompatibility profile remain acceptable or were re-evaluated if material changes were implicit in the micromolding process. The overall conclusion of "substantial equivalence" implies continued biocompatibility.
Functionality/Performance (General): Performs as intended.	The changes (micromolding refinement, lower gamma dose, desiccant) are described as improvements leading to a "STRONGER staple." The substantial equivalence determination confirms that the modified device continues to meet the intended use and performs safely and effectively. This would typically be supported by functional testing.

Note: The 50% increase in strength is presented as an outcome of the combined changes rather than a pre-defined acceptance criterion in isolation. However, for a Special 510(k), demonstrating that changes lead to an improved or at least equivalent safety and effectiveness profile is key.

Details of the "Studies" (Validations/Tests) and Other Information:

Given that this is a Special 510(k) focused on manufacturing and packaging changes for an already cleared device, the information provided is less about clinical performance studies and more about engineering validations.

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

Sample Size for Test Set: Not explicitly stated in the provided text. For engineering and sterilization validations, sample sizes are typically determined statistically based on the type of test (e.g., destructive vs. non-destructive, variability of the parameter). These details would be in the full submission, not the summary.
Data Provenance: The studies are related to the manufacturing, sterilization, and packaging of the device by Incisive Surgical, located in Plymouth, MN, USA. Therefore, the data would originate from their internal testing and validation processes. It is retrospective in the sense that the testing was performed, and then the results were submitted.

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

This question is not applicable to this type of submission. The "ground truth" for manufacturing and sterilization validations is based on established engineering principles, international standards (e.g., for sterilization), and regulatory requirements, not human expert consensus on device performance in a diagnostic or clinical setting. Internal technical experts (e.g., engineers, microbiologists, quality assurance personnel) would design and oversee these validations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving interpretation of medical data (e.g., images) by multiple experts. For manufacturing validations, results are typically evaluated against pre-defined specifications and statistical criteria.

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

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of a diagnostic device (often AI-assisted) on human reader performance, which is not the subject of this 510(k).

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

No, a standalone performance study was not done. This device is a surgical staple, not an algorithm or a diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for these validations is engineering specifications, regulatory standards, and pre-defined performance targets. For example:
- Sterilization: Regulatory requirement for SAL (e.g., 10^-6).
- Strength: Mechanical specifications determined through product design and comparative testing to the predicate.
- Shelf-life: Stability parameters (e.g., physical integrity, sterility) maintained over time according to pre-established specifications.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this device.

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K Number

K033602

Device Name

Manufacturer

Date Cleared

2003-12-16

(32 days)

Product Code

Regulation Number

Type

Special

Panel

INSORB ABSORBABLE STAPLES, MODEL SP-B20

Reference & Predicate Devices

K024117

Predicate For

K061784,K131563

Intended Use

Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation. INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have barb tips that are 0.7 mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).

Device Description

INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have barb tips that are 0.7 mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).

AI/ML Overview

The provided K033602 510(k) summary does not contain the acceptance criteria or a study demonstrating that the device meets such criteria in the traditional sense of performance metrics against predefined thresholds.

This 510(k) submission is for a modified version of an already cleared device (K024117). The modification is solely related to the method of sterilization (Gamma Radiation). Therefore, the focus of this submission is on demonstrating that the new sterilization method does not alter the fundamental characteristics or safety and effectiveness of the device, rather than proving a new set of performance criteria for the device itself.

Based on the provided text, here's what can be inferred or stated about the study and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics. The underlying acceptance criterion for a 510(k) of this nature is substantial equivalence to the predicate device. This means demonstrating that the change in sterilization method does not introduce new questions of safety or effectiveness and that the device remains as safe and effective as the predicate.
Reported Device Performance: Not reported in terms of specific numerical performance data (e.g., tensile strength, absorption rates) in this document. The "performance" demonstrated is that the device, with the new sterilization method, is deemed substantially equivalent to the predicate.

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

Not Applicable / Not Provided: The summary does not describe a clinical or performance study with a "test set" as would be used for a new device's primary efficacy or safety claims. The focus is on the sterilization process. Information on the testing done for the sterilization validation itself (e.g., sterility testing, biocompatibility after sterilization) is not detailed in this 510(k) summary.

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

Not Applicable / Not Provided: There is no indication of experts establishing a "ground truth" for a test set. This type of evaluation is not relevant for a sterilization change submission.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided: No adjudication method is mentioned as there is no described test set requiring expert review or adjudication.

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

No: An MRMC study is typically used for diagnostic devices involving human interpretation of results. This device is a surgical staple, and such a study is not relevant.

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

No: This is not an AI/algorithm-based device.

7. Type of Ground Truth Used:

Not Applicable: For a sterilization change, the "ground truth" would relate to the validation of the sterilization process itself (e.g., demonstrating sterility assurance level, material compatibility post-sterilization), rather than expert consensus on clinical outcomes or pathology. This information is not detailed in the summary.

8. Sample Size for the Training Set:

Not Applicable / Not Provided: There is no "training set" as this is not a machine learning or diagnostic device that requires such data.

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

Not Applicable / Not Provided: Not relevant for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to its predicate device (K024117). The single key difference, as stated, is the method of sterilization (Gamma Radiation).

The implication is that Incisive Surgical provided data to the FDA to demonstrate:

Effectiveness of Gamma Sterilization: That the chosen Gamma radiation dose achieves the required sterility assurance level (SAL). This typically involves bioburden testing, dose mapping, and validation studies according to standards like ANSI/AAMI/ISO 11137.
Material Compatibility/Integrity: That the Gamma sterilization process does not adversely affect the physical properties, chemical composition, biocompatibility, or performance (e.g., strength, absorption profile) of the INSORB™ Absorbable Staple material. This would involve comparing pre- and post-sterilization testing of critical device characteristics.
Packaging Integrity: That the packaging maintains its integrity and barrier properties after exposure to Gamma radiation.

The acceptance criteria for this submission, though not explicitly listed as numerical targets, would have been that:

The device, post-Gamma sterilization, remains sterile (meeting SAL requirements).
The device's functional performance and safety characteristics remain unchanged compared to the predicate device.
The device continues to meet its intended use for subcuticular closure of skin.

The conclusion of the 510(k) summary explicitly states: "The modified INSORB Absorbable Staple described in this submission is substantially equivalent to the predicate device." This statement, along with the FDA's clearance letter ("We have reviewed your Section 510(k) premarket notification... and have determined that this device is substantially equivalent..."), confirms that Incisive Surgical successfully demonstrated these points to the FDA's satisfaction for the change in sterilization method.

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K Number

K024117

Device Name

Manufacturer

Date Cleared

2003-04-22

(130 days)

Product Code

Regulation Number

Type

Traditional

Panel