(314 days)
The SubQ It!™ Bioabsorbable Skin Closure System is intended for use in humans for 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.
The SubQ It!" Bioabsorbable Skin Closure System comprises bioabsorbable fasteners made of 82/18 L-lactide/Glycolide copolymer, a well-established material for resorbable medical devices. The fasteners have two legs with barbed tips (4.3mm long, 0.88mm diameter and spaced 2.75mm center-to-center). The fasteners are inserted using the SubQ It!" Stapler.
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the typical format of a medical device submission. Instead, it describes an administrative change related to the reclassification of surgical staplers and provides a 510(k) summary for the "SubQ It!™ Bioabsorbable Skin Closure System."
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly detailing acceptance criteria for a new device and a study to prove conformance. Substantial equivalence means that the device is as safe and effective as a legally marketed device (predicate device).
However, I can extract the information provided that is most relevant to the requested categories.
Here's a breakdown based on the provided text, using the closest available information:
1. Table of acceptance criteria and the reported device performance:
The document doesn't provide a table of explicit acceptance criteria with numerical targets. Instead, the "performance" is demonstrated by showing "no significant differences" to the predicate device in a comparative animal study. The "criteria" are implicitly tied to the performance of the predicate device.
| Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance (SubQ It!™) |
|---|---|
| Biocompatibility | Met requirements of biocompatibility tests |
| Mechanical Performance | Shelf-life study of mechanical performance conducted |
| Safety & Effectiveness | Demonstrated through animal model, bench tests, shelf-life study, and packaging tests |
| Comparison to predicate device (INSORB™ Absorbable Staple) in vivo | Data show no significant differences in 7cm incisions in a GLP compliant porcine animal model for 90 days. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Animal Study): Not explicitly stated as a number of animals or incisions, but it refers to "7cm long incisions in a GLP compliant porcine animal model for 90 days." For "other information" (implied additional testing), it mentions "1 cm and 2 cm incisions in a GLP compliant porcine animal model."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were conducted in a "GLP compliant porcine animal model," implying an established research setting. The nature is prospective with controlled animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For animal studies, "ground truth" (e.g., wound healing assessment) would typically be established by veterinary pathologists or clinical researchers, but no details are given.
4. Adjudication method for the test set:
This information is not provided in the document.
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 surgical stapler, not an AI-based diagnostic or imaging device that would typically involve human readers. Therefore, an MRMC study and AI assistance effect size are irrelevant in this context.
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 surgical stapler, not an algorithm.
7. The type of ground truth used:
- Animal Model Outcomes: Observation of wound healing, tissue approximation, and potentially histological analysis in the porcine model over 90 days. The "not significant differences" suggest a comparison of these biological outcomes.
- Bench Test Results: Mechanical properties, integrity, etc.
8. The sample size for the training set:
This is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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On October 8, 2021, FDA issued a final order reclassifying surgical staplers intended for internal use (formerly regulated under the classification for "manual surgical instrument for general use") from class I (general controls) into class II (special controls) and subject to premarket review. See here:
As part of this reclassification, FDA also amended the existing classification for "manual surgical instrument for general use" to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use. Under the new regulation, 21 CFR 878.4740, surgical staplers for internal use are classified into class II with special controls, while surgical staplers for external use remain in in class I, exempt from premarket notification.
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June 07, 2022
Image /page/1/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Opus Ksd, Inc. Rosina Robinson, RN, MED, RAC Affiliate Principal Regulatory Consultant 62 Forest Street Suite 300 Marlborough, Massachusetts 01752
Re: K131563
Trade/Device Name: Subq It! Bioabsorbable Skin Closure System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, QQS
Dear Rosina Robinson, RN, MED, RAC:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 09, 2014. Specifically, FDA is updating this SE Letter to reflect an administrative change corresponding to the reclassification of certain surgical staplers, as detailed in the final order published on October 8, 2021 (see here for more information: https://www.federalregister.gov/documents/2021/10/08/2021-22041/general-and-plasticsurgery-devices-reclassification-of-certain-surgical-staplers). As part of this reclassification, FDA has amended the existing classification for "manual surgical instrument for general use" to remove staplers and to create a separate classification for surgical staplers that distinguishes between surgical staplers for internal use and external use. Under the new regulation, 21 CFR 878.4740, surgical staplers for internal use are classified into class II with special controls, while surgical staplers for external use remain in class I, exempt from premarket notification. As a result of the final order, FDA has created a new product code (OOS) to better categorize surgical staplers for external use.
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Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Deborah Fellhauer, OHT4: Office of Surgical and Infection Control Devices, 301-796-9570, Deborah.Fellhauer@fda.hhs.gov.
Sincerely,
Deborah A. Fellhauer -S
Deborah Fellhauer RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2014
Opus KSD Incorporated % Ms. Rosina Robinson, RN, Med, RAC Aptiv Solutions 62 Forest Street, Suite 300 Marlborough, Massachusetts 01752
Re: K131563
Trade/Device Name: SubQ It!" Bioabsorbable Skin Closure System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: February 20, 2014 Received: February 21, 2014
Dear Ms. Robinson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical 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: SubQ It!™ Bioabsorbable Skin Closure System
Indications for Use:
The SubQ It!™ Bioabsorbable Skin Closure System is intended for use in humans for 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summarv for the Opus KSD, Inc. SubQ It!™ Bioabsorbable Skin Closure System (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
Opus KSD, Inc. 210 Worcester Rd Peacham, VT 05862 Contact Person: Charles H. Rogers, C.E.O. Telephone: +1.781.929.7406
May 21, 2013 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | SubQ It!™ Bioabsorbable Skin Closure System |
|---|---|
| Common/Usual Name: | Skin staples and stapler |
| Classification Name: | Staple, implantable |
3. PREDICATE DEVICES
Incisive Surgical, INSORB™ Absorbable Staple (Multiple 510(k)'s e.g. K024117, K033602, K061784, K090159, K120373)
4. DEVICE DESCRIPTION
The SubQ It!" Bioabsorbable Skin Closure System comprises bioabsorbable fasteners made of 82/18 L-lactide/Glycolide copolymer, a well-established material for resorbable medical devices. The fasteners have two legs with barbed tips (4.3mm long, 0.88mm diameter and spaced 2.75mm center-to-center). The fasteners are inserted using the SubQ It!" Stapler.
5. INDICATION FOR USE/INTENDED USE
The SubQ It!™ Bioabsorbable Skin Closure System is intended for use in humans for 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.
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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE 6. PREDICATE DEVICE/S
The SubQ It!" Bioabsorbable Skin Closure System is substantially equivalent to the INSORB™ Absorbable Staple when used with the INSORB Subcuticular Skin Stapler manufactured by Incisive Surgical, Inc. The intended use is the same, the fasteners are similar in size and material, with similar strength and mass. Both the new device and the predicate are sterilized by gamma radiation and pre-loaded into a manual stapler, packaged for single patient use.
SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL 7. EQUIVALENCE
The SubQ It!" Bioabsorbable Skin Closure System was tested side-by-side with the INSORB™ device in 7cm long incisions in a GLP compliant porcine animal model for 90 days. Data show no significant differences between the SubO It!" and the predicate device.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Clinical testing has not been performed.
SUMMARY OF OTHER INFORMATION 9.
The SubQ It!™ Bioabsorbable Skin Closure System was also tested in 1 cm and 2 cm incisions in a GLP compliant porcine animal model, subjected to bench tests, shelflife study of mechanical performance, and packaging tests. These studies demonstrate the safety and effectiveness of the SubQ It!" Bioabsorbable Skin Closure System for its intended use. Additionally, the finished, sterilized product met requirements of biocompatibility tests.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on descriptive information and test results, Opus KSD, Inc. has determined that the SubQ It!" Bioabsorbable Skin Closure System is substantially equivalent to the INSORB™ Absorbable Staple manufactured by Incisive Surgical, Inc., that differences between the two products are minor, and raise no new issues of safety and effectiveness.
§ 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.