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.

AI/ML Overview

The provided 510(k) premarket notification for the Invuity BriteField™ McCulloch Retractor System describes a surgical retractor system with an optional illumination feature. This device is classified as a Class II surgical lamp. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, function, and intended use, rather than presenting a performance study with acceptance criteria in the context of diagnostic accuracy or a new therapeutic claim.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device and submission.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) process for a device like this, which is seeking substantial equivalence to existing devices, typically relies on bench and animal/cadaver testing to demonstrate that the new device performs as intended and does not raise new safety or efficacy issues. The document does not specify quantitative acceptance criteria in the manner one would see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" can be inferred as the device successfully performing its intended function without failure during testing and demonstrating an equivalent profile to its predicates.

Criteria	Reported Device Performance	Comments
Functional Equivalence to Predicate Devices (Mechanical retraction and illumination delivery)	"The Invuity BriteField™ McCulloch Retractor System is similar in design and function to current existing McCulloch Retractor Systems... [with] optional accessory illumination devices (waveguides) that can be attached." "The BriteField McCulloch Waveguides are designed to deliver light from any hospital-provided ACMI compatible 300-watt surgical light source via fiber optic cables to a targeted output area in the surgical field." "Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy."	The acceptance here is implicit: the device must perform the core functions of retraction and light delivery as effectively and safely as its predicate devices. The document states this was achieved.
Material Compatibility & Biocompatibility (Implied for components in contact with tissue)	Reusable components (retractor components, fiber optic cables) and single-use sterile components (waveguides) are mentioned.	While not explicitly stated as "acceptance criteria," surgical devices must be biocompatible. The fact that the device was approved implies these aspects were covered in the "bench testing."
Sterility (for single-use waveguides)	"BriteField McCulloch Waveguides are single-use devices which are provided sterile."	The acceptance criterion is simply that these components are sterile as presented to the user. This would have been confirmed through sterilization validation studies, which are standard for sterile medical devices.
Durability / Reusability (for specified components)	"BriteField McCulloch Retractor components and fiber optic cables of the Invuity BriteField™ McCulloch Retractor System are reusable and supplied non-sterile."	The acceptance criterion is that these components withstand repeated use and reprocessing as specified by the manufacturer without degradation that impacts safety or performance. This would have been demonstrated via "bench testing."
Safety and Efficacy Equivalence (Overall absence of new safety/efficacy concerns)	"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." "Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy."	This is the overarching acceptance criterion for a 510(k): the device must be as safe and effective as its legally marketed predicate devices. The conducted testing aimed to prove this.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "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."

Test Set Sample Size: Not specified. "Bench testing" typically refers to laboratory tests on the device itself (e.g., light output, material strength, durability). "Cadaver testing" involves using human cadavers to simulate surgical use. The number of cadavers or specific tests performed are not detailed.
Data Provenance: The testing was conducted by Invuity, Inc. or its contracted labs. The data would be considered prospective in the sense that the tests were performed specifically for this 510(k) submission. The origin (e.g., country) is not specified but is implicitly tied to the manufacturer's location or their testing facilities. This is not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not Applicable. The device is a surgical tool, and the testing described (bench and cadaver) would involve engineers, technicians, and potentially surgeons for usability assessments in cadavers. There isn't a "ground truth" in the diagnostic sense that requires multiple expert readers/interpreters. The "truth" is whether the device performs its physical functions correctly and safely.

4. Adjudication Method for the Test Set

Not Applicable. As there is no diagnostic or interpretive ground truth established by experts, an adjudication method for conflicting expert opinions is not relevant. Results from bench and cadaver testing would be objectively measured and reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is typically conducted for diagnostic imaging devices to assess how AI affects human performance (e.g., radiologists interpreting images). The Invuity BriteField™ McCulloch Retractor System is a physical surgical tool with an illumination function, not an AI-powered diagnostic aide.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This refers to the performance of an AI algorithm on its own. The Invuity BriteField™ McCulloch Retractor System is a physical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements and observations from bench testing (e.g., light intensity output, mechanical stability, material properties, durability under stress, successful sterilization cycles) and functional assessment in cadavers (e.g., ease of use, adequate illumination of the surgical field, ability to retract tissue without issue). It is not dependent on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.

8. Sample Size for the Training Set

Not Applicable. This pertains to machine learning models. The Invuity BriteField™ McCulloch Retractor System is a physical medical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As above, this is for AI/ML models, not for physical medical devices.

Summary

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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

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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 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.

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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.

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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

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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

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
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.(b)
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.