(30 days)
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 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).
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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Exhibit I
JUL 26 2006
510(k) Summary
| Submitter: | Incisive Surgical14405 21st Avenue North, Suite 130, Plymouth, MN 55447-2000 |
|---|---|
| Contact Person: | James Peterson, Vice President, Ph: (952) 591-2543 ext 14 |
| Date Prepared: | June 22, 2006 |
| Trade Name: | INSORB™ Absorbable Staple |
| Classification | Class II, 21 CFR 8787.4750, Staple, Implantable |
| Product Code: | GDW |
| Predicate Deviceand 510(k) No. | INSORB™ Absorbable StapleK033602 |
| DeviceDescription: | 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). |
| 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. |
| Statement ofTechnologicalComparison | The subject device and the predicate device are identical except for:1) Sterilization Validation changed from VDmax to Method 1 to allow implementation of a 10-6 SAL validated gamma dose at less than 25kGy.2) Packaging includes a desiccant.3) 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, the lower gamma dose possible under a Method 1 validation, and the storage benefits of including a desiccant within the packaging.4) Shelf Life extended to 2 years. |
| Conclusion: | The modified INSORB Absorbable Staple described in this submission is substantially equivalent to the predicate device. |
Incisive Surgical, Inc.
.
Special 510(k)
June 22, 2006
CONFIDENTIAL
Page Joof 308
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
Incisive Surgical, Inc. % Mr. James Peterson Vice President 14405 21st Avenue North, Suite 130 Plymouth, Minnesota 55447-2000
Re: K061784
Trade/Device Name: INSORB™ Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 22, 2006 Received: June 29, 2006
Dear Mr. Peterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2 - Mr. James Peterson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please contacthe regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
hulul Lunes us
/ Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
INSORB™ Absorbable Staple
Indications For 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ _______________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Huler Lemen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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Kob 1784 510(k) Number_
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.