(27 days)
Not Found
No
The description focuses on the physical design and functionality of a surgical light, with no mention of AI or ML capabilities.
No
The device is a surgical light, providing illumination to the surgical site. It does not exert any therapeutic effect on the patient.
No
The device is described as a surgical light providing illumination, not as a tool for diagnosis or detection of medical conditions. Its function is to optimize visibility within the surgical site.
No
The device description explicitly states it is a sterile, single-use device utilizing an internal battery and dual light tips with flexible leads, indicating it is a hardware device.
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 localized illumination of surgical sites." This describes a device used during a surgical procedure to aid the surgeon's vision, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on providing light to the surgical site, its power source, and its physical design for positioning the light. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring specific substances (analytes) in these specimens.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Scintillant Surgical Lights are a surgical tool for illumination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.
Product codes (comma separated list FDA assigned to the subject device)
FDT
Device Description
The Scintillant Dual Tip Light is a sterile, single-use device designed to provide surgeons with localized brilliant white illumination of the surgical site. Utilizing an internal battery, the device is designed to stay operational for up to three hours of continuous use. Dual light tips in combination with flexible leads containing memory wire allows for the surgeon to direct light from multiple locations optimizing the illumination provided by the device and allowing for increased visibility within the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
- Non-Clinical Testing: Engineering Rationales were developed comparing the subject devices to the predicate surgical light. The Engineering Rationales theorized the reduction of the light source temperature posed no new risk to the patient and provided sufficient light for physicians performing surgical procedures for up to three hours. Confirmatory testing was performed and validated the Engineering Rationales.
- Conclusions: There are no significant differences to functionality or intended use of the proposed devices to the Scintillant Surgical Light. The proposed device operates at a lower temperature than the predicate Scintillant Surgical Light and thus does not pose any additional risk to patient safety. Therefore, the proposed device does not raise any new questions regarding safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Scintillant Dual Tip Surgical Light
Special 510(k)
510(k) Summary
| Submission Contact: | Ryan Savage |
|---|---|
| Project Manager | |
| Engineered Medical Solutions Co., LLC | |
| 85 Industrial Drive | |
| Phillipsburg, NJ 08865 | |
| Phone: (908) 213-9001 | |
| Fax: (908) 329-9111 | |
| E-Mail: rsavage@bihler.com |
DEC 05 2013
Scintillant Surgical Lights (Dual Bent Tip Surgical Light, Scintillant Dual Straight Device Trade Names: Tip Surgical Light)
Device Common Name: Surgical Light
Device Classification: FTD, 21 CFR Part 878.4580, Surgical Lamp.
ll Class:
Identification of Legally Marketed Devices: The fundamental scientific technology, design features and indications for use for the subject lights are identical to the predicate Scintillant Surgical Light K071180 (SE 06/20/07)
| Device Description: | The Scintillant Dual Tip Light is a sterile, single-use device designed to provide
surgeons with localized brilliant white illumination of the surgical site. Utilizing
an internal battery, the device is designed to stay operational for up to three
hours of continuous use. Dual light tips in combination with flexible leads
containing memory wire allows for the surgeon to direct light from multiple
locations optimizing the illumination provided by the device and allowing for
increased visibility within the surgical site. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Intended Use: | The Scintillant Surgical Lights are intended to provide localized illumination of
surgical sites. |
| Technological
Characteristics. | The technological characteristics between the predicate and proposed devices |
characteristics between the are similar. Both the predicate and proposed devices are sterile, hand-held, battery powered, surgical field illuminating devices and regarding the lighting function have the same overall intended use and indications for use. The proposed devices have a lower operating temperature than the predicate device which does not impact patient safety risk.
Discussion of
Engineered Medical Solutions Co., LLC
1
- Non-Clinical Testing: Engineering Rationales were developed comparing the subject devices to the predicate surgical light. The Engineering Rationales theorized the reduction of the light source temperature posed no new risk to the patient and provided sufficient light for physicians performing surgical procedures for up to three hours. Confirmatory testing was performed and validated the Engineering Rationales.
- Conclusions: There are no significant differences to functionality or intended use of the proposed devices to the Scintillant Surgical Light. The proposed device operates at a lower temperature than the predicate Scintillant Surgical Light and thus does not pose any additional risk to patient safety. Therefore, the proposed device does not raise any new questions regarding safety and effectiveness.
Given the similarities in design, materials used, power source and the identical indications, EMS concludes the Scintillant Dual Bent Tip Surgical Light and the Scintillant Dual Straight Tip Surgical Light are substantially equivalent to the predicate Scintillant Surgical Lamp cleared by the FDA in K071180 (SE 06/20/07).
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avente Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Engineered Medical Solutions Co., LLC Mr. Ryan Savage Project Manager 85 Industrial Drive. Building B Philipsburg, New Jersey 08865
December 5, 2013
Rc: K133425
Trade/Device Name: Scintillant Surgical Lights Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FDT Dated: November 4, 2013 Received: November 14, 2013
Dear Mr. Savage:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 for use stated in the encreative to regard cate of the Medical Device Amendments. or to commerce provide 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). and Cosmetic net () tel () that the nevice, subject to the general controls provisions of the Act. The rou may, merciore, manuse the Act include requirements for annual registration, listing of general controls provisions of ractice. Iabeling, and prohibitions against misbranding and adulteration. Please note: CDRI-does not evaluate information related to contract liability additeration. Tease note: U.S. Over er, that device labeling must be truthful and not misleading.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 cquivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a deceminations administered by other Federal agencies. You must of any Federal statures and regulations annound.org. but not limited to: registration and listing (21 Comply with an the Act 3 requirements (1); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Ryan Savage
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Scintillant Dual Tip Surgical Light
Special 510(k)
Indications for Use Statement
510(k) Number:_ K133425
Device Name:
Scintillant Surgical Lights
Indications for Use:
The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.
Prescription Use: _ X __ (Part 21 CFR 801 Subpart D) Over-the-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and/or
Page 1 of _
Long H. Chen -A
1-1-1 1 601 מחדרחמנים 011-12-05 15:18:03 45
for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number: K133425
Engineered Medical Solutions Co., LLC
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