(116 days)
Not Found
No
The description focuses on the hardware components (xenon lamp, filter wheels, membrane switches) and its function as a light source. There is no mention of data processing, algorithms, or learning capabilities.
No
The device is used to illuminate the eye during surgery, which is a supportive function rather than a direct therapeutic action to treat a disease or condition.
No
The device is described as a light source for illuminating the eye during surgery, not for diagnostic purposes. Its function is to provide light, not to gather information for diagnosis.
No
The device description explicitly states it is a "table-top, xenon lamp lightsource" and describes physical components like channels, filter wheels, and membrane switches, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "illuminate the eye during anterior and posterior vitreoretinal surgery." This is a surgical device used in vivo (within a living organism) to aid in a medical procedure.
- Device Description: The description confirms it's a "table-top, xenon lamp lightsource used for intraocular illumination during vitreoretinal surgery." It provides light for the surgeon to see during the procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any tests on samples.
Therefore, based on the provided information, the PHOTON EX is a surgical illumination device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
MPA
Device Description
The PHOTON EX is a table-top, xenon lamp lightsource used for intraocular illumination during vitreoretinal surgery. The lightsource employs two channels from a single lamp. The channels terminate with entry ports on the unit's front panel. Each channel has a dedicated filter wheel; the filter wheels include the following band pass filters with an upper cut-off at 650 nm and lower cut-offs at 435nm, 475nm, 475nm, and 515nm respectively. The user inputs are controlled by membrane switches on the front panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The PHOTON EX has undergone testing and complies with the applicable requirements of safety standards. The subject device performed equivalently to the predicate device in a comparative bench test. Therefore, the subject device and the predicate device have similar safety, effectiveness, and performance profiles.
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.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2015
Synergetics™ Mr. Mark Job Reviewer Regulatory Technology Services 1394 25th Street NW Buffalo, MN 55313
Re: K143123
Trade/Device Name: PHOTON EXTM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: MPA Dated: February 5, 2015 Received: February 9, 2015
Dear Mr. Job:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Post market Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Kesia Y. Alexander -S
for Malvina B. Eydelman, MD Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for "Synergetics". The logo consists of a geometric shape on the left, resembling a diamond made up of smaller squares. To the right of the shape is the word "Synergetics" in a bold, sans-serif font. There is a superscript "TM" symbol next to the word.
Section 4 - Indications for Use
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Synergetics PHOTON EX |
| Indications for Use: | The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery. |
Prescription Use AND/OR (Part 21 CFR 801 Subpart D) C)
Over-The-Counter Use _ (21 CFR 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric logo that looks like a diamond made up of smaller squares and triangles. The letters are all black, and there is a small "TM" symbol in the upper right corner of the word.
Section 5 - 510(k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
I. SUBMITTER
| Applicant's Name | Synergetics |
|---|---|
| and Address: | 3845 Corporate Centre Drive |
| O'Fallon, MO 63368 |
Contact Person: Dan Regan, Regulatory Affairs Director
Date Prepared: September 16, 2014
II. DEVICE
Device Trade Name: PHOTON EX
- Common Name: Ophthalmic Light Source
Device Classification: Class II
Class Name: Endoscope and Accessories (21 CFR 876.1500)
Product Code: MPA
FDA Panel: Ophthalmic
III. PREDICATE DEVICE
Predicate Device: Synergetics Synerlight FiberOptic Lightsource, K032598
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Image /page/4/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric design composed of several squares arranged to form a larger diamond shape. To the right of the word, there is a superscript "TM" symbol, indicating a trademark.
Section 5 - 510(k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
IV. DEVICE DESCRIPTION
The PHOTON EX is a table-top, xenon lamp lightsource used for intraocular illumination during vitreoretinal surgery. The lightsource employs two channels from a single lamp. The channels terminate with entry ports on the unit's front panel. Each channel has a dedicated filter wheel; the filter wheels include the following band pass filters with an upper cut-off at 650 nm and lower cut-offs at 435nm, 475nm, 475nm, and 515nm respectively. The user inputs are controlled by membrane switches on the front panel.
V. INDICATIONS FOR USE
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.
| Subject Device | Predicate Device | |
|---|---|---|
| Element | PHOTON EX | Synerlight (PHOTON) |
| 510(k) Number | To be assigned | K032598 |
| Product Code | MPA | MPA, GEX |
| Lamp | 75 Watt Xenon | 75 Watt Xenon |
| Consumable | ||
| Connectors | Generic Multiport | |
| Tubing Cut-off | Generic Multiport | |
| Tubing Cut-off | ||
| Multiport Connector Location | Internal, Front Panel | External, Front & Side |
| Panel |
VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS WITH THE PREDICATE DEVICE:
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Image /page/5/Picture/0 description: The image contains the logo for "Synergetics™". To the left of the word Synergetics is a geometric shape that is made up of 4 squares. The letters of the word Synergetics are in bold font. The letters TM are in superscript.
Section 5 - 510(k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
VI. COMPARISION OF TEHCNOLOGICAL CHARACTERISITICS WITH THE PREDICATE DEVICE:
| Subject Device | Predicate Device | |
|---|---|---|
| Element | PHOTON EX | Synerlight (PHOTON) |
| Method of Control | Digital | Analog |
| User Interface | Membrane Switches on front | |
| panel | Analog dial adjacent to | |
| multiport connection | ||
| Filter Selection | Selectable filter wheel with | |
| 650nm upper cut off and | ||
| lower cut offs of 435nm, | ||
| 455nm, 475nm, and 515nm | Fixed filter wheel with | |
| 650nm upper cut off | ||
| and a lower cut-off of | ||
| 435nm | ||
| Unit Height x Width x Depth | 8.1" x 13.2" X 12.6" | 9" x 9.5"x 6.8" |
| Unit weight | 18.5 pounds | 13.28 pounds |
| Electrical power specifications | 100-120V | 100-120V |
| 220-240V | 220-240V | |
| 50/60 Hz | 50/60 Hz | |
| Consumables provided sterile | ||
| (sold independent of device) | Yes | Yes |
| Consumables method of | ||
| sterilization | ETO | ETO |
| Consumables Sterility | ||
| Assurance Level | $10^{-6}$ | $10^{-6}$ |
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Image /page/6/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric design made up of squares and lines. A superscripted "TM" appears to the right of the word, indicating a trademark.
Section 5 - 510(k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
VII. Summary of Non-clinical tests:
The PHOTON EX has undergone testing and complies with the applicable requirements of safety standards. The subject device performed equivalently to the predicate device in a comparative bench test. Therefore, the subject device and the predicate device have similar safety, effectiveness, and performance profiles.
VIII. Substantial Equivalence Basis:
The conclusions performed by independent laboratories and internal comparative bench testing provide objective evidence to substantiate the Synergetics PHOTON EX is as safe and effective as the predicate device, the Synergetics Synerlight.