(125 days)
ALM Prismatic®, model 7001 and 9001 series, AMSCO SQ240, Berchtold Chromophare®, model C-570, C-570/570 and C-570/570/570
Not Found
No
The device description focuses on optical and mechanical design principles for illumination, with no mention of AI or ML technologies.
No
This device is a surgical light, designed to illuminate surgical procedures. Its function is to provide visibility for medical practitioners, not to treat or cure a disease or condition.
No
This device is a surgical light designed to illuminate surgical fields. Its function is to provide light, not to diagnose medical conditions, process diagnostic data, or provide diagnostic information.
No
The device description clearly details physical components like lenses, bulbs, steel structures, and electrical controls, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "ILLUMINATE SURGICAL PROCEDURES WITH COLOR CORRECTED WHITE LIGHT AND HEAT FILTERING (IR)." This is a function performed on the patient during a surgical procedure, not on a sample taken from the patient.
- Device Description: The description details the mechanical and electrical aspects of a surgical light, focusing on features like shadow elimination, depth of field, heat elimination, and color rendition. These are all related to providing illumination for surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
In summary, the device is a surgical light, which is a medical device used in a surgical setting, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Getinge/Castle OptiView Surgical Lights are to be used in the same, (general type and configuration), surgical operatory theatres, and out-patient surgery centers that currently employ various models of the referenced predicate devices.
The Getinge/Castle OptiView® surgical lights are to be used for the same purposes and in the same manner as the predicate devices. The lights will be used as the primary and secondary methods of illuminating areas of the human body such that deep cavities can be penetrated and shadows eliminated during surgical procedures. Our intended customer base includes various health care professionals working in medium to large operatory settings.
THE PRODUCT WILL BE USED TO ILLUMINATE SURGICAL PROCEDURES WITH COLOR CORRECTED LITE LIGHT AND HEAT FILTERING (FF.). DESIGNED TO ELIMINATE SHADOWS AND 14 DEEP CAVITY SOUNDS WITH ADCGRATE VENEFRATE 61947 115 IS INTENDED TO BE USED 137 THE PRODUCT SURGEONS AND OTHER MEDICIN CARE PRACTICING OF THERE ARE NO IN A SURGICAL SETTING FOR USE. CONTRA-INDICATIONS
Product codes (comma separated list FDA assigned to the subject device)
FSY
Device Description
The Getinge/Castle OptiView® surgical lights are designed to provide the high quality light required in an operating room setting. There are four major considerations that the lights have been designed for:
- Shadow Elimination. 144 radial dioptric lenses, disposed equally on the lens glass, are used to broaden the light beam such that a 10 X 20 cm patch of light is produced on the surgical site from each lens. Should one or several of the lenses become obstructed by the surgeon or from equipment, a constant quantity of light is subtracted from each point of the light field. This virtually eliminates shadows and provides for optimum visibility.
- Optimal Depth of Field. A central toric lens and conic mirror is used to produce very broad beams whose intersection are not points but are volumes. In some cases the volume can measure up to 70 cm in height and 20 cm across the center. The design also allows the volume of light to be moved in the axis of the beam, this is called variable focusing.
- Heat Elimination and High Color Rendition. Through the use of a special type of glass, the emitted light is corrected for color (towards the model for broadband sunlight) and filtered for infrared. This eliminates the thermal effect of the beam and allows a color rendition index of Ra = 95 or greater.
- Electromagnetic and Bacteriologic Neutrality. The product have been designed and tested to comply with the strictest electromagnetic compatibility standards. Also, the sealed optical unit, the flat, smooth surfaces and sensitive touch-controls provide for an extremely aseptic environment.
The mechanical aspects of the lights are that they are constructed of specifically designed steel load-bearing drop tubes, yokes and suspension assemblies that are coated with a strong epoxy resin paint. These structures are mechanically connected at pivot points that incorporate counter-balances for ease of movement as well as specially designed wire-runs and fully pivoting electrical connectors. The electrical aspects of the lights are designed to comply with international safety standards such as: Low Voltage Directive (LVD) 72/23/CEE, Decree No. 95-1081 Directive (EMC) 6. Electromagnetic Compatibility 89/336/CEE, Decree No. 95-587 Device Directive (MDD) 93/42/CEE. Power 7. Medical Supply Units, NF EN 60-4391 (IEC 433-1), NF EN 60-439-Operating Theatre Lighting, NF EN 60-601-1 (IEC 601) 8. The design will also be examined to UL 544 and certified by either Underwriters Laboratory or Intertek Testing Services (ITS) which should result in the UL or ETL mark.
NOTE: The lights were previously CE marked, while marketed in Europe, by the original manufacturer: Scialityque Industrie. The lights are electrically controlled via pressure sensitive touch controls that may be located on the lights or at remote locations. The controls allow the lights to be energized, the light level to be adjusted and the focus mechanisms to be operated. The light beam is achieved through the use of one or two (dependent upon model) tungsten-halogen 24 VDC bulbs that are contained in a sealed optical unit. The emitted light is focused through a toroidial lens and is reflected off of a conic. polished aluminum reflector and through 144 radial dioptric lenses which allows for a radial-focused broad-beam light pattern on the surgical surface. This eliminates shadows while concurrently extending the true depth of field of the beam.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
various health care professionals working in medium to large operatory settings, surgical operatory theatres, out-patient surgery centers
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)
Not Found
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.
ALM Prismatic®, model 7001 and 9001 series, AMSCO SQ240, Berchtold Chromophare®, model C-570, C-570/570 and C-570/570/570
The OptiView® 500 series lights are identified as follows:
Model 500: ALM PRC 7001, Berchtold C-570/570
Model 525: ALM PRC 7001, Berchtold C-570/570
Model 550: ALM PRC 5501 DF, Berchtold C-570/570
Model 555: ALM PRC 5551, Berchtold C-570/570
Model 590: ALM PRC 7001, Berchtold C-570/570
The OptiView® 700 series lights are identified as follows:
Model 700: ALM PRC 9001, AMSCO SQ240, Berchtold C-570/570/570
Model 750: ALM PRC 9501 DF, AMSCO SQ240, Berchtold C-570/570/570
Model 755: ALM PRC 9551, AMSCO SQ240, Berchtold C-570/570/570
Predicate devices for the Optiview Series 200: Model ALM Illuminator Spotlight, Berchtold Chromophare C-300
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
FINGE Clastle
Getinge/Castle, Inc. 7371 Spartan Blvd., East North Charleston, SC 29418
ಳು
ﺎﺕ ﺍﻟﺘﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ
Tei 803.552.8652 Fax 803.552.8652
| (1) | Submitters Name | Getinge/Castle, Inc. |
|---|---|---|
| Submitters Address | 7371 Spartan Blvd., East | |
| North Charleston, SC 29418 | ||
| Submitters Telephone No. | (803) 552-8652 | |
| Contact Name | Trevor Williamson | |
| Summary Preparation Date | October 3, 1997 | |
| (2) | Device Name | Getinge/Castle OptiView® Surgical Light |
| Common or Usual Name | Surgical Light | |
| Classification Name | Surgical Lamp | |
| (3) | Predicate Device(s) | ALM Prismatic®, model 7001 and 9001 series |
| AMSCO SQ240 | ||
| Berchtold Chromophare®, model C-570, C-570/570 and C-570/570/570 | ||
| (4) | Device Description | The Getinge/Castle OptiView® surgical lights are designed to |
| provide the high quality light required in an operating room | ||
| setting. | ||
| There are four major considerations that the lights have been | ||
| designed for: |
- Shadow Elimination. 144 radial dioptric lenses, disposed
equally on the lens glass, are used to broaden the light
beam such that a 10 X 20 cm patch of light is produced on
the surgical site from each lens. Should one or several of
the lenses become obstructed by the surgeon or from
equipment, a constant quantity of light is subtracted from
each point of the light field. This virtually eliminates
shadows and provides for optimum visibility. - Optimal Depth of Field. A central toric lens and conic
mirror is used to produce very broad beams whose
intersection are not points but are volumes. In some cases
the volume can measure up to 70 cm in height and 20 cm
across the center. The design also allows the volume of
light to be moved in the axis of the beam, this is called
variable focusing.
true - Heat Elimination and High Color Rendition. Through the
use of a special type of glass, the emitted light is corrected
for color (towards the model for broadband sunlight) and
filtered for infrared. This eliminates the thermal effect of
the beam and allows a color rendition index of Ra = 95 or
greater. |
1
*GETINGE
Lancer
Getinge/Castle. Inc. 7371 Spartan Blvd.. East North Charleston, SC 29418 Tel 803.552.8652 Fax 803.552.8652
- Electromagnetic and Bacteriologic Neutrality. The product 4. Device Description (con't) (4) have been designed and tested to comply with the strictest electromagnetic compatibility standards. Also, the sealed optical unit, the flat, smooth surfaces and sensitive touch-controls orovide for an extremely aseptic environment. The mechanical aspects of the lights are that they are constructed of specifically designed steel load-bearing drop tubes, yokes and suspension assemblies that are coated with a strong epoxy resin paint. These structures are mechanically connected at pivot points that incorporate counter-balances for ease of movement as well as specially designed wire-runs and fully pivoting electrical connectors. The electrical aspects of the lights are designed* to comply with international safety standards such as: ഗ് Low Voltage Directive (LVD) 72/23/CEE, Decree No. 95-1081 Directive (EMC) 6. Electromagnetic Compatibility 89/336/CEE, Decree No. 95-587 Device Directive (MDD) 93/42/CEE. Power 7. Medical Supply Units, NF EN 60-4391 (IEC 433-1), NF EN 60-439-Operating Theatre Lighting, NF EN 60-601-1 (IEC 601) 8. The design will also be examined to UL 544 and certified by either Underwriters Laboratory or Intertek Testing Services (ITS) which should result in the UL or ETL mark. *NOTE: The lights were previously CE marked, while marketed in Europe, by the original manufacturer: Scialityque Industrie. The lights are electrically controlled via pressure sensitive touch controls that may be located on the lights or at remote locations. The controls allow the lights to be energized, the light level to be adjusted and the focus mechanisms to be operated. The light beam is achieved through the use of one or two (dependent upon model) tungsten-halogen 24 VDC bulbs that are contained in a sealed optical unit. The emitted light is focused through a toroidial lens and is reflected off of a conic. polished aluminum reflector and through 144 radial dioptric lenses which allows for a radial-focused broad-beam light pattern on the surgical surface. This eliminates shadows while concurrently extending the true depth of field of the beam.
2
*GETINGE asdc
Getinge/Castle, Inc. 7371 Spartan Blvd., East North Charleston, SC 29418
| (5) | Statement of Intended Use | The Getinge/Castle OptiView Surgical Lights are to be used
in the same, (general type and configuration), surgical
operatory theatres, and out-patient surgery centers that
currently employ various models of the referenced predicate
devices. |
|-----|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (6) | Summary of Similar Technology | See attached product comparison tables. The specific models
shown in the tables were chosen on the basis of the similarity
of the lamp head designs, illumination and other performance
data. |
The OptiView® 500 series lights are identified as follows:
| Model | Description | Predicate |
|---|---|---|
| 500 | Ceiling mount - one (1) 500 series lamp head | ALM PRC 7001, Berchtold C- |
| 570/570 | ||
| 525 | Ceiling mount - one (1) 200 series lamp head and one (1) | |
| 500 series lamp head | ALM PRC 7001, Berchtold C- | |
| 570/570 | ||
| 550 | Ceiling mount - two (2) 500 series lamp heads | ALM PRC 5501 DF, Berchtold |
| C-570/570 | ||
| 555 | Ceiling mount - three (3) 500 series lamp heads | ALM PRC 5551, Berchtold C- |
| 570/570 | ||
| 590 | Floor stand mount - one (1) 500 series lamp head | ALM PRC 7001, Berchtold C- |
| 570/570 |
The OptiView® 700 series lights are identified as follows:
| Model | Description | Predicate |
|---|---|---|
| 700 | Ceiling mount - one (1) 700 series lamp head | ALM PRC 9001, AMSCO |
| SQ240, Berchtold C- | ||
| 570/570/570 | ||
| 750 | Ceiling mount - one (1) 500 series lamp head and one (1) | |
| 700 series lamp head | ALM PRC 9501 DF, AMSCO | |
| SQ240, Berchtold C- | ||
| 570/570/570 | ||
| 755 | Ceiling mount - two (2) 500 series lamp heads and one | |
| (1) 700 series lamp head | ALM PRC 9551, AMSCO | |
| SQ240, Berchtold C- | ||
| 570/570/570 |
The basic assumptions that we are basing this pre-market notification on, and why we believe that the GetingelCastle OptiView® Surgical Light is substantially equivalent to the predicate devices, is that we believe that:
- We are not introducing new technology. The OptiView® lights and the predicate devices use very similar . technology to achieve the same basic goal; to illuminate the patient area and concentrate light at the surgical incision with deep cavity penetration. The use of the toric lens, conic reflector and radial dioptric lens in the 500 and 700 series has been standard practice for Scialytique (the original manufacturer) for over ten (10) years in Europe.
3
Image /page/3/Picture/0 description: The image shows the word "GETINGE" in bold, black letters next to a star-like symbol. To the right of "GETINGE" is another word that is difficult to read due to the image quality, but it appears to end in "...tic". The background is white behind "GETINGE" and the star, but it is black behind the other word. The overall impression is that this is a logo or brand name.
Getinge/Castle. Inc. 7371 Spartan Blvd., East North Charleston, SC 29418
Tel 803.552.8652 Fax 803.552.8652
- We are not introducing new or radical manufacturing methods. The Getinge/Castle OptiView® surgical lights . will be manufactured using production methods readly available to the general medical device industry. These practices are already in use for existing domestically marketed products and will be used for the manufacture of the OptiView® 500 and 700 series lights.
- We are not introducing any new indications for use. As stated earlier, the GetingelCastle OptiView® surgical . lights are to be used for the same purposes and in the same manner as the predicate devices. The lights will be used as the primary and secondary methods of illuminating areas of the human body such that deep cavities can be penetrated and shadows eliminated during surgical procedures. Our intended customer base includes various health care professionals working in medium to large operatory settings.
We consider the OptiView® lights to be a single product line and we intend to market them in that manner. We have included them together for this notification because we believe that, like the ALM Chromophare® product line, which incorporates several different lamp head configurations under the same FDA clearance number, the Optiview lights are contemporary and complimentary to each other. These lights will be used in different configurations as stand alone units but also will be combined together (i.e. the 500 series lamp paired with a 700 series lamp on the same suspension package) for total operatory coverage.
4
Getinge/Castle Getinge/Castle
Additional Information in Support of K974084
Part 2:
Predicate devices for the Optiview Series 200, with the requested specifications:
| Specification | Optiview 200 Series | Model
ALM Illuminator
Spotlight | Berchtold Chromophare
C-300 |
|------------------------------------------------------|-------------------------------|---------------------------------------|-----------------------------------------------|
| Diameter, cm (in) | | | |
| Lens | 230 (9.0) | Not specified | 365 (10.4) |
| Lighthead | 316 (12.4) | 330 (13) | 300 (11.8) |
| Weight, kg (lb.) | 2.5 (5.5) | Not specified | Not specified |
| Mounting Type | Wall, Ceiling, Floor
Stand | Wall, Ceiling, Floor
Stand | Wall, Ceiling, Floor
Stand |
| Supply Voltage, VAC | 120/230 | 120 | 110/220 |
| Power, W | 55 | 150 | 55 |
| Bulb, Type | Tungsten Halogen | Quartz Halogen | Halogen |
| Volts | 24 | Not specified | 24 |
| Life, hr | 500 | Not specified | Approx. 1000 |
| Number of Light Heads | 1 | 1 | 1 |
| Number of Bulbs | 1 | 1 | 1 |
| Color Temp. °K | 4300, Nominal | Not specified | 4500 |
| Field Size, cm (in) | | | |
| Diameter | 100-150 (3.9-5.9) | Not specified | 170 (6.7) |
| Depth | 400 (15.7) | Not specified | Not specified |
| Focal Length, cm (in) | 350 (13.8) | Not specified | Not specified |
| Illumination Level, ft-
candles (Lux) | 5,670 (61,000) at
4300°K | 3717 (40,000) | 3253 (35,000) |
| Controls | | | |
| Dimmer | Variable Intensity | Not specified | Not specified |
| Volts | 24 | Not specified | 24 |
| Focus | Adjustable | Not specified | Adjustable |
| Field Size | Adjustable | Not specified | Adjustable |
| Rotation, ° | 360 | Not specified | 360 |
| Vertical Adjustment
Range, cm (in) | 1792 (70.5) | Not specified | 1190 (46.9) |
| Heat Filtering, % | 99 | Not specified | Not specified |
| Filter Material | Glass | Not specified | Yes |
| Reflector Material | Polished Aluminum | Not specified | Not specified |
| Satellites | Optional | Optional | Not specified |
| Sterilizable Handle | Yes | Not specified | Not specified |
| Min. Ceiling Height,
cm (in) | 2591 (102) | Not specified | Not specified |
| Spec.
Model | OptiView®,
500 series | ALM, PRC 7001
series | Berchtold, C-570
series |
| Diameter, cm (in) | 44.3 (17.5) | 71.1 (28) | 50 (20) |
| Lens | 54.2 (21.3) | 71.1 (28) | 57 (22.5) |
| Lighthead | 12 (26.4) lamp
head only | 73.9 (163) lamp
head only | 63 (138) single,
95 (209) dual |
| Weight, kg (lb.) | Ceiling, wall,
floor stand | Ceiling | Ceiling, wall, floor
stand |
| Mounting Type | 120/230 | 120 | 120/230/240 |
| Supply Voltage,
VAC | 140 | 240 | 150 |
| Power, W | Tungsten
Halogen | Quartz Halogen | Xenon Halogen |
| Bulb, Type | 24 | 24 | 24 |
| Volts | 500 (min) | 1000 | 1000 |
| Life, hr | 1, 2 or 3 | 1 | 1,2 or 3 |
| Number of Light
heads | 1 or 2 | 2 | 1 main, 1 reserve |
| Number of Bulbs | 4,300 | 3,500 | 4,500 |
| Color Temp, °K | | | |
| Field Size, cm (in) | 10-15 (3.9-5.9) | 20.3 (8) | 18-28 (7-11) |
| Diameter | 40 (15.7) | 70 (27.6) | 80 (31) |
| Depth | 90-140 (35-55) | Not specified | 70-140 (27.5-55) |
| Focal Length, cm
(in) | 12,300 (130,000) | 9,300 (100,000) | 9,300 (100,000)
13,530 (145,000) |
| Illumination Level,
max ft-candles (lux) | | | |
| Controls | Variable intensity | Continuous | Continuous |
| Dimmer | 24 | 120 | 120 |
| Volts | Adjustable | Fixed | Adjustable |
| Focus | Adjustable | Fixed | Adjustable |
| Field Size | 360 | 360 | 360 |
| Rotation, ° | 122.6 (48.3) | 83.8 (33) | 115 (45) |
| Vert. Adjustment
Range, cm (in) | 99 | Not specified | 99 |
| Heat Filtering, % | Glass | Glass | Glass/film |
| Filter Material | Aluminum | N/A (refracted
through prisms) | Aluminum |
| Reflector Material | Optional | Optional | Optional |
| Satellites | Yes | Yes | Yes |
| Sterilizable Handle | 245 (100) | 264.2 (104) | 260 (102) |
| Min. Ceiling Height,
cm (in) | | | |
| Model
Spec. | OptiView®,
700 series | ALM, PRC 9001
series | AMSCO, SQ240 |
| Diameter, cm (in) | | | |
| Lens | 58.5 (23) | 91.4 (36) | 55.9 (22) |
| Lighthead | 75.6 (29.8) | 91.4 (36) | 60.9 (24) |
| Weight, kg (lb.) | 28 (61.6) | 21.8 (48) light unit
only | 67 (148) single,
113 (250) dual |
| Mounting Type | Ceiling | Ceiling | Single or dual arm,
track, optional AV arm |
| Supply Voltage,
VAC | 120/230 | 120 | 120 |
| Power, W | 140 | 120 | 220 |
| Bulb, Type | Tungsten Halogen | Quartz Halogen | Quartz Halogen |
| Volts | 24 | 24 | 22 |
| Life, hr | 500 (min) | 1000 | 1000 |
| Number of Light
heads | 1,2 or 3 | 1 | 1,2 or 3 |
| Number of Bulbs | 1 or 2 | 3 | 1 main, 1 reserve per
lighthead |
| Color Temp, °K | 4,300 | 3,500 | 4,200; 4,400 |
| Field Size, cm (in) | | | |
| Diameter | 17-24 (6.7-9.4) | 20.3 (8) | 16.5 (6.5); 17.8 - 21.6
(7-8.5) |
| Depth | 50 (19.7) | 70 (27.6) | 66 (26) |
| Focal Length, cm
(in) | 50 (19.7) | Not specified | 106.7 (42) |
| Illumination Level,
max ft-candles
(lux @ 1 m) | 11,200 (120,000) | 11,160 (120,000) | 10,000 (107,640)
12,000 (129,170 |
| Controls | | | |
| Dimmer | Variable intensity | Continuous | Variable intensity |
| Volts | 24 | 120 | 24 |
| Focus | Adjustable | Fixed | Fixed |
| Field Size | Adjustable | Fixed | Adjustable |
| Rotation, ° | 360 | 360 | 360 |
| Vert. Adjustment
Range, cm (in) | 122.6 (50) | 134.6 (53) | 74.9 - 200.1 (29.5 -
79) |
| Heat Filtering, % | 99 | Not specified | 98 |
| Filter Material | Glass | Glass | Cold/hot mirror; cold
mirror |
| Reflector Material | Aluminum | N/A (refracted through
prisms) | Plastic |
| Satellites | Optional | Optional | Optional |
| Sterilizable Handle | Yes | Yes | Yes |
| Min. Ceiling Height,
cm (in) | 245 (100) | 281.9 (111) | 257.8 (101.5) single
269.2 (106) dual |
5
Image /page/5/Picture/0 description: The image shows the logo for GETINGE, a company that provides equipment and systems for the healthcare and life sciences industries. To the left of the company name is a star-like symbol. To the right of the company name is the word "Castle" in a smaller font.
ﺎ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
OptiView® 500 series vs. Predicate Devices
6
Image /page/6/Picture/0 description: The image shows the logo for GETINGE and Listic. The GETINGE logo is a stylized asterisk followed by the word "GETINGE" in bold, sans-serif font. To the right of GETINGE is the word "Listic" in a smaller, less distinct font.
OptiView® 700 series vs. Predicate Devices
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human figures, possibly representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3
Mr. Peter L. Koste, Jr. benior Manager, Quality Assurance and Regulatory Affairs Getinge/Castle, Incorporated 7371 Spartan Boulevard, East (29418) P.O. Box 40488 North Charleston, South Carolina 29423-0488
Re: K974084 Getinge/Castle Optiview Series Surgical Trade Name: Light Regulatory Class: II Product Code: FSY January 27, 1998 Dated: Received: February 13, 1998
Dear Mr. Koste:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Koste
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fcella
coll
Celia M. Witten, Ph.D., M.D.
Director
Division of Coporal
and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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003
510(k) Number (if known): K979084 Device Name: Officient Sungican 61514
Indications For Use:
THE PRODUCT UNIL BE USED TO ILLUMNATE SURGICAL PROCEDURES WITH COLOR CORRECTED ITE LIGHT AND HEAT FILTERING (FF.). DESIGNED TO ELIMINATE SHADOWS AND 14 DEEP CALITY COUNDS WITH ADGRATE VENEFRATE 61947 115 IS INTENDED TO BE USED 137 THE PRODUCT SURGEONS AND OTHER MEDICIN CARE PRACTICING OF THERE ARE NO IN A SURGICAL SETTING FOR USE. CONTRA-INDICATIONS
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974084
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
D