(28 days)
Not Found
No
The description focuses on illumination and control features, with no mention of AI or ML. The "Hermes-Ready" feature describes voice and pendant control, which is not inherently AI/ML.
No
The device is an illuminator used to provide light during endoscopic surgical procedures. It does not actively treat a disease or condition.
No
Explanation: The device is an illuminator used to provide light during endoscopic surgical procedures. Its purpose is to illuminate body cavities, not to diagnose conditions.
No
The device description explicitly states it is a "300 Watt Xenon Illuminator," which is a hardware component. While it has a "Hermes-Ready™ feature" for control, the core device is a physical illuminator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing illumination during endoscopic surgical procedures to visualize internal body structures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description confirms it's a light source for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis, which are hallmarks of IVD devices.
Therefore, the Smith & Nephew Illuminators are surgical devices used for visualization during procedures, not IVDs.
N/A
Intended Use / Indications for Use
The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures to provide illumination of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated endoscope.
Product codes
GCJ
Device Description
The Smith & Nephew 300 XL Illuminator - HERMES Ready is a 300 Watt Xenon Illuminator indicated for use in endoscopic surgical procedures. The Hermes-Ready™ feature will enable voice and pendant control of light intensity, manual and automatic mode control and standby and activation mode control from a central location when used in conjunction with a Hermes™ Digital O.R. Control Center.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
articular cavities, body cavities, hollow organs and canals, thoracic cavity
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 verification and validation data demonstrates that the device is safe and effective and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith & Nephew 300XL Xenon Illuminator.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
K0326A0 1/2
Endoscopy Smith & Noonow In 150 Minuteman Road Andover MA 01810
72 749 1500 Far ww smith-nenhow com We are and in the
Exhibit F
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as
SEP 2 6 2003
required by the safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device
Date Prepared: August 28, 2003
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA
B. Company Contact:
Deborah Connors Regulatory Affairs Manager Phone: (978)749-1495 Fax: (978)749-1443
C. Device Name
Smith & Nephew 300XL Xenon Illuminator-HERMES Ready Trade Name: Common Name: Endoscopic Light Source Classification Name: General and Plastic Surgery
D. Predicate Devices
The Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device(s) in commercial distribution: Smith & Nephew 300XL Xenon Illuminator.
E. Description of Device
The Smith & Nephew 300 XL Illuminator - HERMES Ready is a 300 Watt Xenon Illuminator indicated for use in endoscopic surgical procedures. The Hermes-Ready™ feature will enable voice and pendant control of light intensity, manual and
Smith & Nephew, Inc 300XL Illuminator Hermes-Ready Page 105 of
1
automatic mode control and standby and activation mode control from a central
location when used in conjunction with a Hermes™ Digital O.R. Control Center.
Intended Use F.
The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures to provide illumination of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated endoscope.
G. Comparison of Technological Characteristics
The Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device has the same technological characteristics and intended use as the predicate device, Smith & Nephew 300XL Xenon Illuminator. The addition of the communication interface for voice activation with the Hermes™ control center offers the surgeon direct communication without changing the intended use or features of the Smith & Nephew 300XL Xenon Illuminator.
Smith & Nephew 300XL Xenon Illuminator-HERMES Ready device will be tested with the following domestic and international standards:
- . UL 2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
- . EN 60601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety + Amendments1 and 2
- . EN 60601-1-1: Medical Electrical Equipment General Requirements for Safety 1, Collateral Standard: Safety Requirements for Medical Electrical Systems
- EN 60601-1-2: Medical Electrical Equipment General Requirements for Safety2, Collateral Standard: Electromagnetic Compatibility- Requirements and Tests
H. Summary Performance Data
All verification and validation data demonstrates that the device is safe and effective and performs as intended.
Delilah Correa
Deborah Connors Regulatory Affairs Manager
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The bird symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Public Health Service
SEP 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Deborah Connors Regulatory Affairs Manager Smith & Nephew, Inc. 150 Minuteman Road Andover, Massachusetts 01810
Re: K032680
Trade/Device Name: Smith & Nephew 300XL Xenon Illuminator-HERMES Ready™ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 28, 2003 Received: August 29, 2003
Dear Ms. Connors:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Deborah Connors
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew 300XL Xenon Illuminator-HERMES Ready™
Indications For Use: The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures to provide illumination of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated endoscope.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
Miriam C. Provost
I, Restorative
510(k) Number K032680