(51 days)
The Scintillant light is intended to provide localized illumination of surgical sites.
The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.
The Scintillant Surgical Light is an untethered, self-contained medical lighting device that allows illumination inside the surgical field. The light can be hand-held and is provided with accessories which allow it to be attached to almost any surgical tool or instrument.
The light is provided sterile and is battery powered. The light consists of light-emitting diode (LED) mounted on the end of a flexible wand. A single button turns the light on and off. A battery and circuit board are contained in the device handle.
This is a 510(k) premarket notification for the Scintillant Surgical Light, a surgical lamp. The provided documents establish substantial equivalence to predicate devices, but do not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary (K071180) merely states that:
- The Scintillant Surgical Light is an untethered, self-contained medical lighting device for illumination inside the surgical field.
- It's hand-held, sterile, battery-powered, and uses an LED on a flexible wand.
- Its intended use is to provide localized illumination of surgical sites.
- It is technologically similar to predicate devices (AtriCure Dissector, Light Port Surgical Illuminator, VersaLight Multi-Function Surgical Illuminator, LightMat Surgical Illuminator), all being sterile, hand-held, battery-powered surgical field illuminating devices with the same overall intended use.
- The conclusion is that the device is as safe and effective as the predicate device and does not raise any new questions regarding safety and effectiveness.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies with defined acceptance criteria and performance metrics for all new devices.
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SECTION 5. 510(K) SUMMARY
TUN 2 0 2007
| SubmissionCorrespondent: | Keystone Regulatory Services, LLC342 E. Main StreetSuite 211Leola, PA 17557USA |
|---|---|
| Phone: 717-656-9656Fax: 717-656-3434Email: bill.mclain@keystoneregulatory.comContact: William G. McLainPresident and Principal Consultant | |
| Submission Sponsor: | Engineered Medical Solutions Co. LLC85 Industrial DrivePhillipsburgNJ, 08865USA |
| Phone: 908-329-9117Fax: 908-454-5394Email: pchurch@bihler.comContact: Phil ChurchQA 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 devicesto which the device issubstantially equivalent: | AtriCure Dissector, K041681Light Port Surgical Illuminator, K041621VersaLight Multi-Function Surgical Illuminator, Class ILightMat Surgical Illuminator, Class I |
| Description of the device: | The Scintillant Surgical Light is an untethered, self-contained medicallighting device that allows illumination inside the surgical field. The lightcan be hand-held and is provided with accessories which allow it to beattached to almost any surgical tool or instrument.The light is provided sterile and is battery powered. The light consists oflight-emitting diode (LED) mounted on the end of a flexible wand. A singlebutton turns the light on and off. A battery and circuit board are containedin the device handle. |
| Intended use of the device: | The Scintillant light is intended to provide localized illumination of surgicalsites. |
| Technologicalcharacteristics: | The technological characteristics between the predicate and proposeddevice are similar. Both are sterile, hand-held, battery powered surgicalfield illuminating devices and regarding the lighting function have the sameoverall intended use and indications for use. |
| Conclusions: | Other than the Atricure dissector being labeled as a cutting instrument,there are no significant differences between the Atricure Dissector and theScintillant Surgical Light. Therefore, the proposed device does not raiseany questions regarding safety and effectiveness.The Scintillant Surgical Light, as designed, is as safe and effective as thepredicate device. Comparisons have been made to a legally marketedpredicate device, and the device is determined to be substantiallyequivalent to the references predicate device currently on the market. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing health, human services, and the department's commitment to serving the nation. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
§ 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.