(100 days)
Not Found
No
The device description focuses on mechanical retraction and illumination via fiber optics, with no mention of AI/ML capabilities or data processing.
No.
The device's intended use is to illuminate the surgical site, and its function is to retract tissue and deliver light. It does not exert any direct therapeutic effect on the body to treat, cure, mitigate, or prevent disease.
No
The device is a surgical retractor system with optional illumination, designed to retract tissue and provide light to the surgical site. It does not perform any diagnostic functions like analyzing data or identifying medical conditions.
No
The device is a physical retractor system with optional illumination accessories (waveguides) that deliver light from a surgical light source via fiber optic cables. It is clearly described as hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide surgical site illumination from a high intensity light source." This describes a device used during a surgical procedure to aid the surgeon's visibility.
- Device Description: The description details a surgical retractor system with optional illumination. It's a physical tool used to manipulate tissue and provide light within the surgical field.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any such analysis or testing of biological samples.
The device is clearly intended for use in vivo (within the living body) during surgery, not in vitro (in glass or outside the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Invuity BriteField™ McCulloch Retractor System is intended to provide surgical site illumination from a high intensity light source.
Product codes
FST
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080962, K043602, K080367, K042034
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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