SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM

{0}------------------------------------------------ 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: https://www.federalregister.gov/documents/2021/10/08/2021-22041/general-and-plastic-surgery-devices-reclassification-of-certainsurgical-staplers. 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure in profile, with three faces overlapping to suggest community and connection. The overall design is simple and professional, reflecting the department's role in public health and human services. 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ ## 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) {6}------------------------------------------------ ### 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. {7}------------------------------------------------ #### 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.