The Oricare L2700 Series Surgical Lamps provide illumination at varying illumination levels to the patient surgical area and provide video-visual procedural support for medical staff during surgical procedures.

Device Description

OL 2700 series Surgical Lamps are ceiling mounted Surgical Lamps, suitable for providing supplemental illumination, with reduced shadowing effects during surgical and non-surgical procedures. The lighting system utilizes LED's for illumination and is powered from a standard 115VAC voltage source. The head design is comprised of multiple LED's (Light Emitting Diodes). It provides a cool, color corrected light which is adjustable with 10 levels of intensity. The light path design provides an extended light depth so that the beam requires no manual focus. Light generated by the LEDs is focused by optical lens to achieve an ideal irradiance pattern. The OL 2700 series LED surgical light can be configured with one or two light heads, the primary light head is useful for major illumination while the secondary light head is for ancillary illumination. The lights can also provide low level background lighting for endoscopic surgery. Oricare L2700 series Operating Room Lamps can be easily used in conjunction with the optional SD or HD video systems, to document surgical procedures for training purposes, make use of live transmissions or consult with external surgeons during operations. The camera system is available in different versions and can be used with integrated OR systems. It delivers images in SD or HD quality straight to the TFT monitor.

AI/ML Overview

The provided document is a 510(k) summary for a surgical lamp (Oricare L2700 Series OR Surgical Luminaires), not a medical imaging or AI-enabled diagnostic device. Therefore, the detailed information requested in the prompt regarding acceptance criteria and a study proving a device meets them (especially concerning AI performance, ground truth, expert adjudication, MRMC studies, etc.) is not applicable to this submission.

The document describes the device's technological characteristics, intended use, and performance testing, primarily focusing on compliance with recognized industry standards for medical devices and establishing substantial equivalence to predicate devices.

Here's a breakdown of the relevant information provided, framed as closely as possible to your request, but acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for a diagnostic performance metric (like sensitivity or specificity) because it's a surgical light. Instead, it references compliance with various recognized industry standards. The reported "device performance" is implicitly that it meets these standards.

Acceptance Criteria (Standards Adhered To)	Reported Device Performance (Compliance)
IEC 60601-1:2005 (3rd edition)	Compliant
IEC 60601-1-2:2007	Compliant
IEC 60601-2-41:2009	Compliant
ISO 14971:2009	Compliant
IEC 60601-1-6	Compliant
FDA Software Guidance Document	Compliant (for "Minor Level of Concern" software)

The document states: "The combined testing and analysis of results provides assurance that the device meets the requirements for safety and essential performance and is effective for its intended use."

2. Sample Size Used for the Test Set and Data Provenance

This concept is not applicable. The device is a surgical lamp, not a diagnostic tool evaluated on patient data. Performance testing would involve engineering and electrical tests on the physical device itself, not a "test set" of patient cases.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for a surgical lighting system. Device performance (e.g., light intensity, color temperature, safety features) is typically established through engineering measurements and adherence to technical standards.

4. Adjudication Method for the Test Set

This is not applicable. No "test set" of patient cases or diagnostic results was used, so no adjudication method is relevant.

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

This is not applicable. The device is not an AI-assisted diagnostic tool, and no MRMC study was conducted. The document focuses on "Non-clinical Comparisons to Predicate Device" which are limited to "differences in design, material, and operational" aspects, and states these differences "do not raise any new issues of safety and efficacy."

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used

This is not applicable. The concept of "ground truth" (e.g., pathology, expert consensus) is for diagnostic accuracy studies, which are not relevant for a surgical lamp. The "truth" for this device lies in its physical performance characteristics meeting established engineering and safety standards.

8. The Sample Size for the Training Set

This is not applicable. The device is not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. No training set or associated ground truth was established for this device.

Summary

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ORICARE	DEC 18 2012	1900 AM DriveQuakertown, PA. 18951Phone: 215-538-2470Fax: +1-215-538-2578Website: www.oricaremed.com
510(k) Summary
Date Prepared:	September 11, 2012	K122875
Applicant:	Oricare, Inc.1900 AM DriveQuakertown, Pa 18951Registration Number: 3009129579
Contact Person:	Fred CowderyQA/RA ManagerPh 267-347-4544Fax 215-538-2578
Device Trade/Proprietary Name:	L2700 Series OR Surgical Luminaires
Device Name: Common / Usual:	Light, Surgical, Ceiling Mounted
Classification Name:	Surgical Lamp (21 CFR 878.4580, Product Code: FSY)
Predicate Devices:	Maquet PowerLED Surgical Lighting System (K070442)Steris Harmony LED-1 Surgical Lighting System (K072072)

Device Description / Technological Characteristics

ਦੇ ਪੈ

OL 2700 series Surgical Lamps are ceiling mounted Surgical Lamps, suitable for providing supplemental illumination, with reduced shadowing effects during surgical and non-surgical procedures.

The lighting system utilizes LED's for illumination and is powered from a standard 115VAC voltage source. The head design is comprised of multiple LED's (Light Emitting Diodes). It provides a cool, color corrected light which is adjustable with 10 levels of intensity. The light path design provides an extended light depth so that the beam requires no manual focus. Light generated by the LEDs is focused by optical lens to achieve an ideal irradiance pattern.

The OL 2700 series LED surgical light can be configured with one or two light heads, the primary light head is useful for major illumination while the secondary light head is for ancillary illumination. The lights can also provide low level background lighting for endoscopic surgery.

Oricare L2700 series Operating Room Lamps can be easily used in conjunction with the optional SD or HD video systems, to document surgical procedures for training purposes, make use of live transmissions or consult with external surgeons during operations. The camera system is available in different versions and can be used with integrated OR systems. It delivers images in SD or HD quality straight to the TFT monitor.

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Table 1 below defines the available configurations of the L2700 Series Surgical Lamps.

Table 1
Oricare PartNumber	Model Number / Description
LA5003	L2770 Operating Room Lamp
LA5004	L2750 Operating Room Lamp
LA5005	L2770L2750 Operating Room Lamp
LA5006	L2770L2770 Operating Room Lamp
LA5007	L2750L2750 Operating Room Lamp
LA5012	L27702750 OR Lamp with SD Video and Display
LA5013	L27702750 OR Lamp with HD Video and Display

Table 1

Intended Use:

Performance Testing:

Comprehensive performance testing has been conducted on the L2700 Series Surgical Luminaires in accordance with various recognized industry standards by a recognized third party organization. Product compliance with the following standards included: IEC 60601-1:2005 30 edition, IEC 60601-1-2:2007, IEC 60601-2-41:2009, ISO 14971:2009, IEC 60601-1-6.

Software was evaluated in accordance with relevant FDA Software Guidance Document, per the requirements assigned for software classified as a "Minor Level of Concern".

The combined testing and analysis of results provides assurance that the device meets the requirements for safety and essential performance and is effective for its intended use.

Non-clinical Comparisons to Predicate Device:

The differences between the proposed and predicate devices are limited to differences in design, material, and operational. These differences do not raise any new issues of safety and efficacy.

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1900 AM Drive Quakertown, PA. 18951 Phone: 215-538-2470 Fax: +1-215-538-2578 Website: www.oricaremed.com

Substantial Equivalence:

The Oricare L2700 Surgical Luminaires are believed to be substantially equivalent to currently marketed Surgical Lamps with regards to intended use, safety and effectiveness, technology, and performance.

Similar to the predicate devices, the L2700 Surgical Luminaires provide a shadowless light source using LEDs as the main light source. The L2700 Surgical Luminaires provide a variable intensity light source designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

Conclusions:

Based upon the information provided herein this 510(k) Premarket Notification, we conclude that the L2700 Series Surgical Luminaires are substantially equivalent to the identified predicate devices and are safe and effective when used as intended.

RLC

Fred Cowdery Manager, Regulatory Affairs and Quality Assurance Oricare, Inc. 1900 AM Drive Quakertown, PA. 18951

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 18, 2012

Oricare, Inc. % Mr. Fred Cowdery QA/RA Manager 1900 AM Drive Quakertown, Pennsylvania 18951

Re: K122875

Trade/Device Name: L2700 Series OR Surgical Luminaires Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: September 12, 2012 Received: September 19, 2012

Dear Mr. Cowdery:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see 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 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

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Page 2 - Mr. Fred Cowdery

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ORICARE

1900 AM Drive Quakertown, PA. 18951 Phone: 267-347-4544 Fax: +1-215-538-2578 Website: www.oricaremed.com

Indications for Use Statement

510 (k) Number (if known)

Device Name: Oricare L2700 Series Surgical Lamp

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2012.12.18 08:48:17 -05'00' 11. 11.

(Division Sign-Off)

Division of Surgical Devices

510(k) Number __ K122875

Regulation Number and Section

§ 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.