(183 days)
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No
The document does not mention AI, ML, or any related terms, nor does it describe functionalities typically associated with these technologies (like image processing for analysis or automated decision-making based on data).
No.
The device is a surgical light, used for illumination during procedures, not for treating any medical condition or directly interacting with the patient in a therapeutic manner.
No
Explanation: This device is described as "Stellar Series Surgical Lights," which are used for illumination during surgical procedures. There is no indication that it is used to diagnose diseases or conditions. Its purpose is to provide light for surgeons, not to provide diagnostic information.
No
The device description explicitly states "Stellar Series Surgical Lights with Hermes," indicating a hardware component (surgical lights) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center and lists various surgical procedures. This describes a device used during surgical procedures to provide illumination, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description simply states "Stellar Series Surgical Lights with Hermes," which aligns with a surgical lighting system.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Measuring analytes or biomarkers
The information provided strongly indicates that this is a surgical lighting system used in an operating room setting, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC).
A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery.
Product codes
FSY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Users of the Stellar Series Surgical Lights with Hermes ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists,
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
00 Corporate Boulevard ockville MD 20850
NOV 1 3 2002
Skytron, Division The KMW Group, Inc Larry Perez VP Technical Services P. O. Box 888615 Grand Rapids, Michigan 49588-8615
Re: K021585
Trade/Device Name: Stellar Series Surgical Lights with Hermes Regulation Number: 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: September 24, 2002 Received: September 25, 2002
Dear Mr. Perez:
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.
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Page 2 - Mr. Larry Perez
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 t proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Muriam 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
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Page 1 of 1
510(k) Number (if known):
TM Stellar Series Surgical Lights with Hermes Device Name:
Indications For Use:
The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC).
A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery.
Users of the Stellar Series Surgical Lights with Hermes ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists,
(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)
ાવ
Over-The-Counter Use__
Miriam C. Purret
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K033535
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