(27 days)
The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.
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.
The provided text describes a Special 510(k) submission for the Scintillant Dual Tip Surgical Light. This type of submission is for modifications to a manufacturer's own legally marketed device, where the modifications do not significantly alter the device's fundamental scientific technology, design, or indications for use.
Crucially, this submission does not involve an AI device. It's a traditional medical device (a surgical light) and the "study" referred to is non-clinical engineering rationale and confirmatory testing, not a clinical trial or performance study against acceptance criteria in the way one would for an AI/ML device. Therefore, many of the requested categories are not applicable.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|
| Provide localized brilliant white illumination of the surgical site | Provide localized brilliant white illumination of the surgical site |
| Operational for up to three hours of continuous use | Operational for up to three hours of continuous use |
| Maintain patient safety risks at or below predicate device levels | Lower operating temperature than the predicate device, thus posing no additional risk to patient safety. |
| Functionality and intended use are not significantly different from the predicate device | Functionality and intended use are not significantly different from the predicate device |
Summary of Device Acceptance: The proposed device ("Scintillant Dual Tip Surgical Light") was deemed substantially equivalent to the predicate device ("Scintillant Surgical Light K071180") because its fundamental scientific technology, design features, and indications for use are identical. The proposed device's lower operating temperature was seen as an improvement, not a new risk.
The following information is NOT APPLICABLE as the device is a surgical light, not an AI/ML device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This was a non-clinical submission for a physical device. Testing involved engineering rationales and confirmatory tests, not a "test set" in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. No expert ground truth was established for a "test set" as this is not an AI/ML device. Engineering rationales and confirmatory tests would have been performed by qualified engineers/technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method for a "test set" was described for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is not an AI device, so no MRMC study involving AI assistance would have been conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. The "ground truth" for this device's performance was its ability to provide localized illumination, operate for a specified duration, and maintain safety, as demonstrated through engineering analysis and physical testing. This isn't a "ground truth" for a diagnostic or predictive algorithm.
8. The sample size for the training set
- N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- N/A. This is not an AI/ML device that requires a training set or associated ground truth.
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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 providesurgeons with localized brilliant white illumination of the surgical site. Utilizingan internal battery, the device is designed to stay operational for up to threehours of continuous use. Dual light tips in combination with flexible leadscontaining memory wire allows for the surgeon to direct light from multiplelocations optimizing the illumination provided by the device and allowing forincreased visibility within the surgical site. |
|---|---|
| Device Intended Use: | The Scintillant Surgical Lights are intended to provide localized illumination ofsurgical sites. |
| TechnologicalCharacteristics. | 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
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- 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).
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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
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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
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Long H. Chen -A
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for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number: K133425
Engineered Medical Solutions Co., LLC
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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.