SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001

K071180 · Engineered Medical Solutions Co., LLC · FTD · Jun 20, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071180
• Device Name: SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
• Applicant: Engineered Medical Solutions Co., LLC
• Product Code: FTD · General, Plastic Surgery
• Decision Date: Jun 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Scintillant light is intended to provide localized illumination of surgical sites.

Device Story

Scintillant Surgical Light is an untethered, self-contained, battery-powered surgical illuminator. Device consists of an LED mounted on a flexible wand, with a battery and circuit board housed in the handle. Operated via a single on/off button. Designed for hand-held use or attachment to surgical instruments to provide localized illumination within the surgical field. Provided sterile. Used by clinicians in surgical settings to improve visibility of the surgical site, potentially aiding in surgical precision and procedural outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, hand-held, battery-powered surgical illuminator. Features an LED light source mounted on a flexible wand. Includes an integrated battery and circuit board for power management. Designed for attachment to surgical instruments.

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

• AtriCure Dissector (K041681)
• Light Port Surgical Illuminator (K041621)
• VersaLight Multi-Function Surgical Illuminator (Class I)
• LightMat Surgical Illuminator (Class I)

Submission Summary (Full Text)

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K071180

## SECTION 5. 510(K) SUMMARY

## TUN 2 0 2007

| Submission<br>Correspondent: | Keystone Regulatory Services, LLC<br>342 E. Main Street<br>Suite 211<br>Leola, PA 17557<br>USA |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: William G. McLain<br>President and Principal Consultant |
| Submission Sponsor: | Engineered Medical Solutions Co. LLC<br>85 Industrial Drive<br>Phillipsburg<br>NJ, 08865<br>USA |
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Phil Church<br>QA Manager |
| Date summary prepared: | March 3, 2007 |
| Device trade name: | Scintillant Surgical Light |
| Device common name: | Surgical light, Surgical illuminator |
| Device classification name: | FTD, 21 CFR Part 878.4580, Surgical Lamp. |
| Legally marketed devices<br>to which the device is<br>substantially equivalent: | AtriCure Dissector, K041681<br>Light Port Surgical Illuminator, K041621<br>VersaLight Multi-Function Surgical Illuminator, Class I<br>LightMat Surgical Illuminator, Class I |
| Description of the device: | The Scintillant Surgical Light is an untethered, self-contained medical<br>lighting device that allows illumination inside the surgical field. The light<br>can be hand-held and is provided with accessories which allow it to be<br>attached to almost any surgical tool or instrument.<br><br>The light is provided sterile and is battery powered. The light consists of<br>light-emitting diode (LED) mounted on the end of a flexible wand. A single<br>button turns the light on and off. A battery and circuit board are contained<br>in the device handle. |
| Intended use of the device: | The Scintillant light is intended to provide localized illumination of surgical<br>sites. |
| Technological<br>characteristics: | The technological characteristics between the predicate and proposed<br>device are similar. Both are sterile, hand-held, battery powered surgical<br>field illuminating devices and regarding the lighting function have the same<br>overall intended use and indications for use. |
| Conclusions: | Other than the Atricure dissector being labeled as a cutting instrument,<br>there are no significant differences between the Atricure Dissector and the<br>Scintillant Surgical Light. Therefore, the proposed device does not raise<br>any questions regarding safety and effectiveness.<br><br>The Scintillant Surgical Light, as designed, is as safe and effective as the<br>predicate device. Comparisons have been made to a legally marketed<br>predicate device, and the device is determined to be substantially<br>equivalent to the references predicate device currently on the market. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Engineered Medical Solutions Co. LLC c/o Patricia L. Murphy Kema Quality B.V. 4377 County Line Road Chalfont, PA 18914

Re: K071180

Trade/Device Name: Scintillant Surgical Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTD Dated: June 4, 2007 Received: June 5, 2007

JUN 2 0 2007

Dear Ms. Murphy:

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 - Patricia L. Murphy

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

6/20/07

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Scintillant Surgical Light

071180

Indications for Use:

The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use l (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Pulv
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number

601180

Engineered Medical Solutions Co., LLC