← Product Code [GDW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW) · K131637 # ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) (K131637) _Rotation Medical, Inc. · GDW · Jul 12, 2013 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K131637 ## Device Facts - **Applicant:** Rotation Medical, Inc. - **Product Code:** [GDW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW.md) - **Decision Date:** Jul 12, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4750 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The RMST Staple is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. ## Device Story RMST Staple is an absorbable polymer strap with cleat tips; composed of synthetic polyester derived from lactic acid and dyed with D&C Violet #2. Used in conjunction with a manual orthopedic staple driver (Class I exempt). Device functions by engaging soft tissue via barbed ends to secure prosthetic material. Used in minimally invasive and open surgical procedures by surgeons. Provides mechanical fixation for tendon injury management; benefits patient by securing prosthetic material to soft tissue to facilitate healing. ## Clinical Evidence Bench testing and in vitro/in vivo biocompatibility studies performed. Biocompatibility testing included cytotoxicity, sensitization, intercutaneous reactivity, acute systemic toxicity, pyrogenicity, muscle implantation, subchronic toxicity, and hemolysis. Physical property testing included size, surface area, weight, and strength retention. Animal efficacy study conducted. No human clinical trial data provided. ## Technological Characteristics Absorbable synthetic polyester polymer strap with cleat/barbed tips; dyed with D&C Violet #2. Mechanical fixation principle. Sterilized device. Complies with ISO 10993-1 and FDA Blue Book Memorandum G95-1 for biocompatibility. ## Regulatory Identification An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Predicate Devices - Ethicon Securestrap 5mm Absorbable Strap Fixation Device ([K093845](/device/K093845.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for "Rotation Medical". The logo consists of a semi-circle of black dots above the word "rotation" in a stylized font. Below "rotation" is the word "MEDICAL" in a smaller, sans-serif font. There is a line above the word "MEDICAL". K131637 page 1/2 # 510(k) Summary JUL 1 2 2013 ## Applicant Information Applicant Name: Applicant Address: Telephone: Fax: Contact Person: Rotation Medical, Inc. 15350 25th Avenue North, Suite 100 Plymouth, MN 55447 763-746-7521 763-746-7501 Gail Schroeder Director, Quality Assurance and Operations May 31, 2013 Date Prepared: ## Name of Device Device Common Name: Device Trade Name: Device Classification Name: Absorbable Soft Tissue Staple Rotation Medical Soft Tissue Staple (RMST Staple) Staple, Implantable 878.4750 Class II GDW Legally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s): Ethicon SecurestrapTM 5mm Absorbable Strap Fixation Device, K093845; Ethicon, Inc. ## Description of the Device RMST Staple is an absorbable polymer strap with cleat tips. RMST Staple is composed of absorbable synthetic polyester derived from lactic acid and dyed with D&C Violet #2. The RMST Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical. (Note: Rotation Medical's orthopedic manual staple driver is a Class I exempt device pursuant to 21 CFR 888.4540 and is not the subject of this submission). 15350 25th Avenue No · Suite 100 · Plymouth MN 55447 · 763.746.7500 RMST Staple 510(k) Application, page 14 {1}------------------------------------------------ K131637 page 2/2 Image /page/1/Picture/1 description: The image shows the logo for Rotation Medical. The logo consists of a semi-circle of dots above the word "rotation" in a bold, sans-serif font. Below "rotation" is the word "MEDICAL" in a smaller, sans-serif font. ## Intended Use The RMST Staple is intended for fixation of prosthetic material to soft tissues in various minimally rne Kins 1 Stapie is international such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. # Summary/Comparison of Technical Characteristics RMST Staple and the predicate device have similar indications for use, technological characteristics, and material composition. Both devices are comprised of a polymer strap with barbed ends which engage in soft tissue. RMST Staple and the currently marketed Ethicon Securestrap (predicate device) are both indicated for the fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures. Both devices are composed of similar absorbable synthetic polyester and contain the same D&C Violet #2 dye. RMST Staple has been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility, including: tensile strength, retention strength (pull-out), cytotoxicity, sensitization, intercutaneous reactivity, acute systemix toxicity, pyrogenicity, muscle implantation, subchronic toxicity, and hemolysis. RMST Staple and its predicate have been implantedially for general physical properties including size, surface area, weight, and strength retention to demonstrate substantial equivalence. #### Conclusion The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. The results of the in vitro product characterization studies, bench testing and in vitro and in vivo biocompatibility studies, as well as the animal efficacy study demonstrate that the RMST Staple is safe and substantially equivalent to the predicate devices. 15350 25th Avenue No ・ Suite 100 ・ Plymouth MN 55447 ・ 763.746.7500 RMST Staple 510(k) Application, page 15 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or flowing lines. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Rotation Medical, Inc. % Ms. Gail Schroeder Director, Quality Assurance and Operations 15350 25th Avenue North, Suite 100 Plymouth, Minnesota 55447 July 12, 2013 Re: K131637 Trade/Device Name: Rotation Medical Soft Tissue Staple (RMST Staple) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: May 31, 2013 Received: June 04, 2013 Dear Ms. Schroeder: 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 {3}------------------------------------------------ Page 2 - Ms. Gail Schroeder device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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. # Mark N. Melkerson -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Confidential Rotation Medical, Inc. # Indications for Use K131637 510(k) Number (if known): _ Rotation Medical Soft Tissue Staple (RMST Staple) Device Name: _ Indications for Use: The RMST Staple is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. 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) # David Krause -S (Division Sign-Off) Division of Surgical Devices 510(k) Number: K131637 Page 1 of _1 RMST Staple 510(k) Application, page 13 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K131637](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K131637) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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