(76 days)
Amsco SQ240 Surgical Light, Hill-Rom BrightStar Surgical Light and Berchtold Chromophare D650 Surgical Lights
Not Found
No
The document describes a surgical lighting and media system with standard features like variable intensity, pattern control, and optional audio-visual components. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a surgical lighting and media system designed to illuminate the surgical field and provide audio-visual support, not to treat or diagnose a disease or condition.
No
The device is a surgical lighting and media system designed to provide illumination and audio-visual support, not to diagnose medical conditions.
No
The device description explicitly details hardware components such as lighthead suspension, horizontal arms, lighthead assemblies, electronic control system, fiber optic light, camera, monitors, and an audio-visual system. It also mentions a sterile disposable sheath. This is clearly a hardware-based medical device with integrated software for control and audio-visual support.
Based on the provided information, the Amsco Harmony Surgical Lighting and Media System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide visible illumination of the surgical field or the patient and audio-visual support for O.R. staff. This is a direct interaction with the patient or the surgical environment, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a surgical light system with optional features like cameras and monitors. These are tools for visualization and support during surgery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, urine, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The Amsco Harmony Surgical Lighting and Media System does not fit this definition.
N/A
Intended Use / Indications for Use
The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff.
Product codes (comma separated list FDA assigned to the subject device)
FTD
Device Description
The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed is provedural support for the O.R. staff. The field or the pattent and to provide accident of a system consists of a center-mounted Amsco Harmony Surgical Lighting and Media System consists and lighthe Amsco Harmony Surgical Lighting and Mood Cossible differing lengths and lighthead suspension, which supports horizontal arms of possible discussion for the system suspension, which supports nortzonal and or orcharder. Optional features for the HERM assemblies and operates via an elections voice control of the system via the HERMES include a fiber optic light for task lighting, voice control of the system via the HERMES include a fiber optic light for ask lighting, for vegrated in surgical lighthead, optional standard or flat screen monitor or a high end audio visual system. The systems standard of hat screen momor of a mga enous system configurations depending upon the components can be arrayed to produce various of calable System has a sterile needs of the user. The Amseo Transmy Start as needed and maintenance of the sterile disposable sheath for postdoming of the sterile sheath is latest free and is made of approved field during surgical procedures. The sterile sheath is blackting and Madia Sust tield during surgical procedures: The Jersen Surgical Lighting and Media System is medical grade material. The Amsco Harmony Surgical Lighting and Medical medical grade material. The Alliber Hith IEC 60601-2-41 (Ed.1.0 (2000-02) Medical designed to assure compilance with IDC 600 mirements for the Safety of Surgical Electrical Equipment - Fart 2-11-2 and Childers for Diagnosis, IEC 60601-1 (Electrical Station US, 260 Luminates and Lummanes for Diagnolo, I.S. To evice carries the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Surgical field or the patient
Indicated Patient Age Range
Not Found
Intended User / Care Setting
O.R. staff / Surgical setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Discussion of non-clinical tests: Like the predicate device(s), the Amso Harmony Surgical Lighting and Media System will utilize existing lighting technology to position the light of the consis control asepsis contro Extection the light the light to deliver illumination to the operations of disposable sterile optical characterisites, drift-free performance, and surgical asepsis control th optical characteristics, drift-free performance, and surgently and the prove substantial. covers are among the aspect that have been examied to compare to the prove substanti opires are among the aspects that have been examined to compare to the prediction in the province in and one been examined to equivalence. Dimensional specifications and/or t equivalence. Difficilisional specifican ensure the device meets human factors considerations.
Discussion of clinical tests: Directors of Harmony Surgical Lighting and Media System clinical testing was not performed; bench testing is and the contraction of the most of the davice For the Amseo Harmony Durgery and efficacy of the device.
Conclusions drawn from the non-clinical and clinical tests: Doced on the non-clinical testing of the Amsco Harmony Surgical Lighting and Media System, there are no new questions of safety or efficacy that have been raised. The Amso Harmony Surgical Incl questions of safety or efficacy that have been raised. The Allaoo Hamber of the surgical field or the patient. meets its intended use of effectively providing visible illumin
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Amsco SQ240 Surgical Light, Hill-Rom BrightStar Surgical Light and Berchtold Chromophare D650 Surgical Lights
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY DEC 1 3 2001 Pertaining to the Safety and Effectiveness of the Amsco " Harmony™ Surgical Lighting and Media System
Submitter Information: STERIS Corporation
2720 Gunter Park Drive E. Montgomery, AL 36109 Tel: 334-213-3150 Fax: 334-271-3579 Robert H. McCall Sr. Regulatory Affairs Specialist
Date Summary Prepared: September 26, 2001
Name of the device:
Amsco® Harmony Surgical Lighting and Media System
Common or usual name of the device: Light, Surgical
Classification name of the device: Surgical Lamp
Predicate Devices:
Device Description:
Amsco SQ240 Surgical Light, Hill-Rom BrightStar Surgical Light and Berchtold Chromophare D650 Surgical Lights
The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern,
the surgical The Amsco Harmony Surgical Lighting and resident in the surgical in variable intensity surgical lights designer is provedural support for the O.R. staff. The field or the pattent and to provide accident of a system consists of a center-mounted
Amsco Harmony Surgical Lighting and Media System consists and lighthe Amsco Harmony Surgical Lighting and Mood Cossible differing lengths and lighthead
suspension, which supports horizontal arms of possible discussion for the system suspension, which supports nortzonal and or orcharder. Optional features for the HERM assemblies and operates via an elections voice control of the system via the HERMES
include a fiber optic light for task lighting, voice control of the system via the HERMES include a fiber optic light for ask lighting, for vegrated in surgical lighthead, optional standard or flat screen monitor or a high end audio visual system. The systems standard of hat screen momor of a mga enous system configurations depending upon the components can be arrayed to produce various of calable System has a sterile needs of the user. The Amseo Transmy Start as needed and maintenance of the sterile disposable sheath for postdoming of the sterile sheath is latest free and is made of approved
field during surgical procedures. The sterile sheath is blackting and Madia Sust tield during surgical procedures: The Jersen Surgical Lighting and Media System is
medical grade material. The Amsco Harmony Surgical Lighting and Medical medical grade material. The Alliber Hith IEC 60601-2-41 (Ed.1.0 (2000-02) Medical designed to assure compilance with IDC 600 mirements for the Safety of Surgical Electrical Equipment - Fart 2-11-2 and Childers for Diagnosis, IEC 60601-1 (Electrical Station US, 260 Luminates and Lummanes for Diagnolo, I.S. To evice carries the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings.
Intended Use:
The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, I he Amsed Harmony Surgical Lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The freld or the patient and to provide auction to the medical care practitioners in a surgical setting.
1
Substantial Equivalence: The Amso Harmony Surgical Lighting and Media System is substantialy guirvalent to
r Surgista Carl Chicked Light Hill Rom RrightStar Surgical Light Substantial Equivalenee: The Amso Surgical Lighting and Media System Sacommend the Amsco SQ240 Surgical Light, Hill-Kolli Brights and differences are listed below.
in function and intended use. Similarities and differences are listed below.
| Predicate Device | Amsco Harmony | Amsco SQ240 | Hill-Rom BrightStar (Prima) | Berchtold Chromophare "D-series" |
|---|---|---|---|---|
| Items in BOLD are specifically requested in the Surgical Lamp Guidance Document | ||||
| Illumination Area | ||||
| Light beam diameter | large: 6-14" | |||
| medium: 5-12" | ||||
| small: 8" | 178mm - 216mm | |||
| (7-8.5") | 280mm (11") | 180mm - 280mm | ||
| (7.1-11") | ||||
| Illumination Area | ||||
| Light beam depth | 30" | 660mm (26") | 510mm (20") | 800mm (31.5") |
| Light focusing mechanism | Adjustable | Fixed | Adjustable | Fixed |
| Illumination @ 1m | ||||
| Foot-candles (Lux) | large: | |||
| 13,000 (140,000) | ||||
| medium: | ||||
| 12,000 (130,000) | ||||
| small: | ||||
| 6,000 (65,000) | 12,000 (130,000) | 12,000 (130,000) | 9,293 (100,000) | |
| Color Temperature (°K) | 4,400°K | 4,400°K | 4,200°K | 4,500°K |
| UV (≤400nm) | ||||
| Output (watts/cm²) | IV(I) plethated in substatially equivalent (for the referenced above and we have determined the actives is streted in in interstate commerce prior to | |||
| indications for use stated in the enclosure) to devices Amendments or to dev indications for use stated in the enclosures in actives institutions, or to devices that have May 28, 1976, the enactment date of the Wedren Device Andrialians, Crue, and Cosmetic Act | ||||
| been reclassified in accordance with the provisions of the Federal Food, Drug, been reclassified in accordance with the provisors of onlication (PMA). You may. | ||||
| (Act) that do not require approval of a premarket apprisions of the Act. The gen (Act) that do not require approval of a plenial controls provisions of the Act. The general | ||||
| therefore, market the device, subject to the general controls provisions of the e therefore, market the device, subject to the general registration, listing of devices, | ||||
| controls provisions of the Act include requirements for ammanshapping and adulteration. controls provisions of the Act include requirements for alliad. Februaries and adulteration. | ||||
| good manufacturing practice, labeling, and prohibitions against misbranding and a |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into entire) cass if epould oos affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controis. Extraig major regantes be found in the Code of Federal Regulations, Trile 24, This 24, 2017, 1991, 1991, 1991, 1991, 1991, 1991, 1991, 1991, 1991,
Please be advised that FDA issuance of a substantial equivalence determination does not mean
ts of the Actively of a start any device complies with other requirements of the Please be advised that FDA's issuance of a substance outbex with other requirements of the Act
that FDA has made a determination that your device onmplies with other require that FDA has made a determination inal your development Federal agencies. You must
or any Federal statutes and regulations administered by other to: registration and listi or any Federal statutes and regulations and united to: registration and listing (21
comply with all the Act's requirements, including, but limited to: requirements as set comply with all the Act s requirently, nicitating practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and if anylicable, the electron CFR Part 807); labeling (21 CFR Patl on ); good manates 200; and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050. forth in the quality systems (QS) regulation (21 OF R Parc 22) - 11:42 PM 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Laura Green
This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the submit and experiences and equivalence of your device to a legally This letter will allow you to begin marketing your device as useness are a regally
premarket notification. The FDA in a lassifises in your device and thus, permits your devi premarket notification. The FDA finding of substantial equivalite of 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 CPR Part 801 and If you desire specific advice for your devices devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vitte diagnostic devices, please contact the orde additionally 21 CFR Part 809.10 for mitto different on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the provincial of Compliance at (301) 594-4659. Additionally, Int questions on and the may of the mote the your device, please contact the Office of Conification" (21CFR Part Mr.97).
regulation entitled, «Misbranding by reference to premation notification» (1) var the regulation entitled, «Misbranding of responsibilities under the Act may be obtained from the Other general information on your responsional one Assistance at its tollars.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number Division of Small Mailtiractares, or at its Internet address
(800) 638-2041 or (301) 443-6597 or at its Internet address (800) 656-2014 gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walk, MP
Image /page/4/Picture/4 description: The image shows a black and white close-up of a signature. The signature appears to be stylized and abstract, with curved lines and a few sharp angles. The signature is positioned in the lower-left corner of the image, and the background is plain white.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Indications for Use Statement
| 510(k) Number | K013242 |
|---|---|
| (if known) | |
| Device Name | Amsco ® Harmony Surgical Lighting and Media System |
| Indications for Use | The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED
E
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Walk
Sign Off
(Division Sign-Off) (Division of G-eral, Restorative and Neurological Devices
510(k) Number K013242
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
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