(90 days)
Not Found
No
The description focuses on illumination and video capture, with no mention of AI/ML for image analysis, decision support, or automated control. The software is classified as "Minor Level of Concern," which is less likely to involve complex AI/ML algorithms.
No
Explanation: A therapeutic device is one that treats or prevents a disease or condition. This device is a surgical lamp that provides illumination and video support during surgical procedures, which is not a therapeutic function.
No
The device is a surgical lamp providing illumination and video-visual support, not a diagnostic device that detects or determines the presence of a disease or condition.
No
The device description clearly states it is a ceiling-mounted surgical lamp utilizing LEDs for illumination and powered by a standard voltage source. It also mentions optical lenses and a camera system, indicating significant hardware components. While software is mentioned as being evaluated, the core device is a physical lighting system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Oricare L2700 Series Surgical Lamps provide illumination for surgical procedures and offer video support. They do not analyze any biological samples.
- Intended Use: The intended use is to illuminate the surgical area and provide visual support during surgery, not to perform diagnostic tests on patient samples.
The device is a surgical light with an optional video system, which falls under the category of surgical equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
FSY
Device Description
Oricare L2700 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical staff, surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Maquet PowerLED Surgical Lighting System (K070442), Steris Harmony LED-1 Surgical Lighting System (K072072)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| ORICARE | DEC 18 2012 | 1900 AM Drive
Quakertown, PA. 18951
Phone: 215-538-2470
Fax: +1-215-538-2578
Website: www.oricaremed.com |
|--------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | | |
| Date Prepared: | September 11, 2012 | K122875 |
| Applicant: | Oricare, Inc.
1900 AM Drive
Quakertown, Pa 18951
Registration Number: 3009129579 | |
| Contact Person: | Fred Cowdery
QA/RA Manager
Ph 267-347-4544
Fax 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.
1
Image /page/1/Picture/0 description: The image shows the word "ORICARE" in bold, black letters. The font is sans-serif and slightly slanted to the right. The letters are tightly spaced, creating a solid block of text.
. (
Table 1 below defines the available configurations of the L2700 Series Surgical Lamps.
| Table 1 | |
|---|---|
| Oricare Part | |
| Number | 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:
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.
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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Image /page/2/Picture/0 description: The image shows the word "ORICARE" in a bold, sans-serif font. The letters are all capitalized and appear to be black. The font has a slightly distressed or textured appearance, giving it a somewhat rough or worn look.
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
4
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
5
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:
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.
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