← Product Code [FST](/submissions/SU/subpart-e%E2%80%94surgical-devices/FST) · K090070 # INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (K090070) _Invuity, Inc. · FST · Apr 22, 2009 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K090070 ## Device Facts - **Applicant:** Invuity, Inc. - **Product Code:** [FST](/submissions/SU/subpart-e%E2%80%94surgical-devices/FST.md) - **Decision Date:** Apr 22, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4580 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Invuity BriteField™ McCulloch Retractor System is intended to provide surgical site illumination from a high intensity light source. ## Device Story Blade-based surgical retraction system; provides tissue retraction via blades and hooks mounted on a retractor frame. Features optional accessory illumination devices (waveguides) attachable to blades/hooks. Waveguides deliver light from hospital-provided 300-watt ACMI-compatible surgical light source via fiber optic cables to surgical field. Used in surgical settings by surgeons. Retractor components and fiber optic cables are reusable; waveguides are single-use sterile devices. Enhances visualization of surgical site during procedures. ## Clinical Evidence Bench and cadaver testing conducted to support substantial equivalence. No clinical trial data provided. ## Technological Characteristics Blade-based retractor system with fiber optic waveguides. Components include retractor frame, blades, hooks, and fiber optic cables. Waveguides are single-use; retractor components and cables are reusable. Compatible with standard 300-watt ACMI surgical light sources. Non-sterile supply for reusable components; sterile supply for waveguides. ## Regulatory Identification A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient. ## Special Controls *Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. ## Predicate Devices - Thompson Lite Wand II ([K080962](/device/K080962.md)) - Medtronic MAST Quadrant Retractor System ([K043602](/device/K043602.md)) - Zimmer MIS Light ([K080367](/device/K080367.md)) - NuVasive MaXcess Light Guide ([K042034](/device/K042034.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}------------------------------------------------ k090070 Page 1 of 2 INVUITY, INC. INVUITY BRITEFIELD™ MCCULLOCH RETRACTOR SYSTEM 510(k) Premarket Notification ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ SECTION 5 510(k) Summary (Cont.) 510(k) Notification K GENERAL INFORMATION Applicant: Invuity, Inc. 39 Stillman Street San Francisco, CA 94107 USA Phone: 1-866-711-7768 FAX: (415) 778-0810 ### Contact Person: Kit Cariquitan Sr. Director, Regulatory and Clinical Affairs Experien Group, Inc. 155-A Moffett Park Dr., Suite 210 Sunnyvale, CA 94089 USA Phone: 408-400-0856 FAX: 408-400-0865 Date Prepared: January 9, 2009 #### DEVICE INFORMATION Classification: Surgical Lamp, 21 CFR \$878.4580, Class II ## Product Code: FST Trade Name: Invuity BriteField™ McCulloch Retractor System ## Generic/Common Name: Light, Surgical, Fiberoptic APR 2 2 2009 CONFIDENTIAL {1}------------------------------------------------ 090070 page 2 of 2 INVUITY, INC. ## INVUITY BRITEFIELD™ MCCULLOCH RETRACTOR SYSTEM 510(k) PREMARKET NOTIFICATION ## SECTION 5 510(k) SUMMARY (CONT.) ### PREDICATE DEVICE Invuity, Inc. believes that the Invuity BriteField™ McCulloch Retractor System is substantially equivalent to the following predicate devices: - Thompson Lite Wand II, K080962 t - . Medtronic MAST Quadrant Retractor System, K043602 - Zimmer MIS Light, K080367 . - NuVasive MaXcess Light Guide, K042034 . #### INTENDED USE The Invuity BriteField™ McCulloch Retractor System is intended to provide surgical site illumination from a high intensity light source. #### PRODUCT DESCRIPTION The Invuity BriteField™ McCulloch Retractor System is a blade-based retraction system designed to provide surgeons with the ability to retract tissue through any combination of blades and hooks, when these devices are assembled onto a retractor frame. The Invuity BriteField™ McCulloch Retractor System is similar in design and function to current existing McCulloch Retractor Systems (Class I Exempt) with the exception that it features optional accessory illumination devices (waveguides) that can be attached to the Invuity BriteField" McCulloch Retractor System's blades and hooks. The BriteField McCulloch Waveguides are designed to deliver light from any hospitalprovided ACMI compatible 300-watt surgical light source via fiber optic cables to a targeted output area in the surgical field. BriteField McCulloch Retractor components and fiber optic cables of the Invuity BriteField™ McCulloch Retractor System are. reusable and supplied non-sterile: BriteField McCulloch Waveguides are single-use devices which are provided sterile. #### SUBSTANTIAL EQUIVALENCE The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Invuity BriteField™ McCulloch Retractor System. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the Invuity BriteField™ McCulloch Retractor System is substantially equivalent to the predicate device. ## TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION All necessary bench and cadaver testing was conducted on the Invuity BriteField™ McCulloch Retractor System to support a determination of substantial equivalence to the predicate devices. #### SUMMARY The Invuity BriteField™ McCulloch Retractor System is substantially equivalent to the predicate devices. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA." Public Health Service APR 2 2 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Invuity, Inc % Experien Group, LLC Mr. Kit Cariquitan 155-A Moffet Park Drive, Suite 210 Sunnyvale, California 94089 Re: K090070 Trade/Device Name: Invuity BriteField™ McCulloch Retractor System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: April 8, 2009 Received: April 9, 2009 Dear Mr. Cariquitan: 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 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 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. {3}------------------------------------------------ Page 2 - Mr. Kit Cariquitan 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/. 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, For Nathan Du nr Mark N Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ INVUITY, INC. Kogo070. 1 of ## INVUITY BRITEFIELD™ MCCULLOCH RETRACTOR SYSTEM 510(k) PREMARKET NOTIFICATION SECTION 4 INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Device Name: Invuity BriteField™ McCulloch Retractor System ### Indications For Use: The Invuity BriteField™ McCulloch Retractor System is intended to provide surgical site illumination from a high intensity light source. Prescription Use X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) Nail Rp Ogden form km (Division Sign-Off) Division of General. Restorative, and Neurological Devices 510(k) Number K090070 #### CONFIDENTIAL 20 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K090070](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K090070) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com