(15 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 0.8 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).
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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and the comments of the country of the country
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KOGOIS9 FEB -6 2008
BB-62009
| 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: | January 21, 2009 |
| Trade Name: | INSORB™ Absorbable Staple |
| Classification | Class II, 21 CFR 8787.4750, Staple, Implantable |
| Product Code: | GDW |
| Predicate Deviceand 510(k) No. | INSORB™ Absorbable Staple K061784 |
| DeviceDescription: | INSORB™ Absorbable Staples are 5 mm in length, 0.8 mm thick, 3.5 mm wide overall, and have cleat tips that are 0.8 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). |
| 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 an optimization in the staple shape that allows the following specification changes:• Minimum "peak load" pull strength specification for the staple in its "dry" as packaged state is increased 25% to 1.500-lbs.• Minimum "peak load" pull strength specification for the staple following exposure to 37°C buffered saline for 1-day is increased 25% to 0.750-lbs• Minimum "peak load" pull strength specification for the staple following exposure to 37°C buffered saline for 7-days is increased 25% to 0.375-lbs. |
| Conclusion: | The modified INSORB Absorbable Staple described in this submission is substantially equivalent to the predicate device. |
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and the comments of the comments of
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle, with its wings spread, symbolizing protection and service.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 2009
Incisive Surgical, Inc. % Mr. James Peterson Vice President 14405 21st Avenue North, Suite 130 Plymouth, Minnesota 55447-2000
Re: K090159
Trade/Device Name: INSORB Absorbable Staples Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: January 21, 2009 Received: January 22, 2009
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. 1
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket.notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Mulkerson
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 Statement
510(k) Number (if known)
K090159
Device Name
INSORB™ Absorbable Staples
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.
Stapler is designed to aid in the prevention of accidental needle stick injuries.
Prescription Use Yes (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K090155
§ 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.