SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT

K133425 · Engineered Medical Solutions Co., LLC · FTD · Dec 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K133425
• Device Name: SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
• Applicant: Engineered Medical Solutions Co., LLC
• Product Code: FTD · General, Plastic Surgery
• Decision Date: Dec 5, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.

Device Story

The Scintillant Dual Tip Surgical Light is a sterile, single-use, battery-powered device providing localized white illumination of surgical sites. It features dual light tips on flexible leads containing memory wire, allowing surgeons to direct light from multiple angles to optimize visibility. The device operates for up to three hours on an internal battery. It is used by surgeons in clinical settings to improve visualization within the surgical field. The device is a modification of a predicate, featuring a lower operating temperature to enhance safety while maintaining identical functionality and intended use.

Clinical Evidence

No clinical data. Bench testing and engineering rationales were used to validate that the lower operating temperature of the subject device compared to the predicate does not impact safety or performance, confirming the device provides sufficient illumination for up to three hours.

Technological Characteristics

Sterile, hand-held, battery-powered surgical illumination device. Features dual light tips with flexible memory wire leads. Operates at a lower temperature than the predicate device. Single-use.

Indications for Use

Indicated for providing localized illumination of surgical sites during surgical procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Scintillant Surgical Light (K071180)

Submission Summary (Full Text)

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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: [phone] |
| | Fax: [phone] |
| | E-Mail: [e-mail] |

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<br>surgeons with localized brilliant white illumination of the surgical site. Utilizing<br>an internal battery, the device is designed to stay operational for up to three<br>hours of continuous use. Dual light tips in combination with flexible leads<br>containing memory wire allows for the surgeon to direct light from multiple<br>locations optimizing the illumination provided by the device and allowing for<br>increased visibility within the surgical site. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Intended Use: | The Scintillant Surgical Lights are intended to provide localized illumination of<br>surgical sites. |
| Technological<br>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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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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