(88 days)
No
The device description and performance studies focus on the physical components, light output, and biocompatibility of a surgical illuminator, with no mention of AI or ML.
No.
The device provides illumination during ophthalmic surgery, serving an assistive rather than therapeutic function.
No
Explanation: The device is described as an "ophthalmic illuminator" used for "wide angle illumination during ophthalmic surgery." Its purpose is to provide light for surgical procedures, not to diagnose a condition.
No
The device description explicitly details physical components made of PMMA, acetal, and PTFE, and mentions manufacturing processes and physical testing (bond strength, cannula & fiber inspection), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for wide angle illumination during ophthalmic surgery." This describes a surgical tool used during a procedure to provide light, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a fiber optic illuminator designed to be inserted into the eye during surgery. It focuses on its physical components, how it connects to other surgical equipment, and its function of providing light. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Reagents or assays
- Analysis of biological fluids or tissues
- Measurement of biomarkers or analytes
- Providing diagnostic results
The device is clearly intended for surgical illumination, which is an in vivo (within the body) application, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
Adjustable Chandelier Illuminator family of ophthalmic illuminators is for wide angle illumination during ophthalmic surgery.
Product codes
MPA
Device Description
The 23ga and 25ga Adjustable Chandelier Illuminators are made to work with the Bausch and Lomb surgical system and Bausch and Lomb Valved ESA (Entry Site Alignment) systems (K012435). These devices are to be manufactured with distally located "Infusion Cannulas" that adequately secure themselves within 23ga and 25ga Bausch and Lomb Valved ESA Systems. The 23ga and 25ga Adjustable Chandelier Illuminators consist of a PMMA (Polymethylm-ethacrylate with Flourinated Polymer Cladding) acrylic fiber (for light transmission), white acetal handle assembly with finger slide for adjustability, PTFE (Polytetrafluor-oethylene) jacket (for fiber) and Stellaris style light connector to fit into the Bausch and Lomb Stellaris PC Vision Enhancement System (K133486). The 23ga and 25ga Adjustable Chandelier Illuminators are to be provided sterile to the user, is a single-use device and is packaged in double Tyvek-to-poly pouches to facilitate introduction to the sterile environment. These provide illumination for eye surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ophthalmic
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)
To evaluate the performance of the Adjustable Chandelier Illuminator, the following tests were conducted: Sterility (ISO 11135-1), Shelf-life (ASTM F1980), Biocompatibility (ISO 10993-01), Light Output (Internal Test Method(ITP04-20)), Light Field (Internal Test Method (ITP04-30)), Thermal Inspection (Internal Test Method (ITP04-40)), Bond Strength (Internal Test Method (ITP03-75)), Cannula & Fiber Inspection (Internal Test Method (ITP52-00)). Biocompatibility and sterility testing has been conducted on the 25ga Adjustable Chandelier Illuminators as a "worst case device" and a family representative. All results were acceptable resulting in fully biocompatible device. The performance of the 23ga and 25ga Adjustable Chandelier Illuminators satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white 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 circumference. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble fabric or water.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2015
Peregrine Surgical Ltd. c/o Mr. Ryan O'Leary Product Development 51 Britain Dr. New Britain, PA 18901
Re: K151604
Trade Name: Peregrine 23 ga and 25 ga Adjustable Chandelier Illuminator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: MPA Dated: June 5, 2015 Received: June 15, 2015
Dear Mr. O'Leary:
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.
1
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 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" (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 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, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
23ga and 25ga Adjustable Chandelier Illuminator
Indications for Use (Describe)
Adjustable Chandelier Illuminator family of ophthalmic illuminators is for wide angle illumination during ophthalmic surgery.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
SECTION 5. 510(k) SUMMARY
510(k) SUMMARY for 23ga and 25ga Adjustable Chandelier Illuminator
-
- Submitter Information: Peregrine Surgical, Ltd. 51 Britain Drive New Britain, PA 18901
| Contact Person: | Ryan O'Leary |
|---|---|
| Telephone Number: | (215) 348-0456 |
| Fax Number: | (215) 348-5526 |
- Date Prepared: 05 June 2015
-
- Device Name:
| Proprietary Name: | 23ga and 25ga Adjustable Chandelier Illuminator |
|---|---|
| Classification Name: | Endoilluminator |
| CFR Number: | 876.1500 |
| Device Class: | II |
| Product Code: | MPA |
-
- Predicate Device:
Table 5.1 Predicate Devices
| Predicate Device
| Name | 510(k) | Product Code | Company Name |
|---|---|---|---|
| Peregrine Tapered | |||
| Diffusion Probe | K980025 | MPA | Peregrine Surgical, |
| Ltd. | |||
| 23 Gauge (ga) | |||
| Curved Illuminating | |||
| Laser Probe | K122997 | HQB, | |
| HQF, MPA | Peregrine Surgical, | ||
| Ltd. |
-
- Description of Device:
The 23ga and 25ga Adjustable Chandelier Illuminators are made to work with the Bausch and Lomb surgical system and Bausch and Lomb Valved ESA (Entry Site Alignment) systems (K012435). These devices are to be manufactured with distally located "Infusion Cannulas" that adequately secure themselves within 23ga and 25ga Bausch and Lomb Valved ESA Systems. The 23ga and 25ga Adjustable Chandelier Illuminators consist of a PMMA (Polymethylm-ethacrylate with Flourinated Polymer Cladding) acrylic fiber (for light transmission), white acetal handle assembly with finger slide for adjustability, PTFE (Polytetrafluor-oethylene) jacket (for fiber) and Stellaris style light connector to fit into the Bausch and Lomb Stellaris PC Vision Enhancement System (K133486).
- Description of Device:
4
The 23ga and 25ga Adjustable Chandelier Illuminators are to be provided sterile to the user, is a single-use device and is packaged in double Tyvek-to-poly pouches to facilitate introduction to the sterile environment. These provide illumination for eye surgery.
- ર. Indications for Use: Adjustable Chandelier Illuminator family of ophthalmic illuminators is for wide angle illumination during ophthalmic surgery.
-
- Substantial Equivalence: Technological Characteristics -
| Feature | Proposed Device
Adjustable Chandelier
Illuminator | | Predicate Device
Peregrine
Tapered
Diffusion Probe | Predicate Device
23 Ga Curved Illuminating Laser Probe |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 23 Ga | 25 Ga | | |
| | Image: Extended 25ga and Retracted 23ga | | Image: Peregrine Tapered Diffusion Probe | Image: 23 Ga Curved Illuminated Laser Probe |
| | Note: The above photo reflects the chandlier in
both the extended and retracted state. This
portion of both gauges is identical except for
the stainless infusion cannula which is slightly
smaller on the 25ga version. | | | |
| 510(k) | To be assigned | | K980025 | K122997 |
| Product Code | MPA | | MPA | HGB, MPA, HQF |
| Indications
for Use | Adjustable Chandelier Illuminator family of
ophthalmic illuminators is for wide angle
illumination during ophthalmic surgery. | | For wide angle
illumination of the
posterior segment during
ophthalmic surgery. | For photocoagulation and
illumination during
ophthalmic surgery. This
device delivers illumination
as well as laser energy to
target tissue, causing
coagulation. Spot size can
be varied by altering the
distance between the tissue
and probe tip. |
| Laser
Connection | No laser connecter | | No laser connecter | Ni/Cu Stainless Alloy
Connector |
| Handpiece
Construction | Acetal handpiece | | Acetal handpiece | Acetal handpiece |
Table 5.2 Technological Characteristics
5
| Optical fiber | No laser fiber | | No Laser Fiber | Glass-Silica core - .006"
(150 microns) |
|-----------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Jacket
Material | PTFE
(Polytetrafluoroethylene) | PTFE
(Polytetrafluoroethylene) | Polyethylene | Acrylated Olefin |
| Jacket Color | Black
Green | Black
Blue | Black | Orange |
| Inner
Diameter
(ID) | Black PTFE Jacket 0.022"
Green PTFE Jacket 0.052" | Black PTFE Jacket 0.022"
Blue PTFE Jacket 0.052" | 0.046" | 0.040" |
| Outer
Diameter
(OD) | Black PTFE Jacket 0.046"
Green PTFE Jacket 0.084" | Black PTFE Jacket 0.046"
Blue PTFE Jacket 0.084" | 0.062" | 0.070" |
| Length | 91" | 91" | 82" | 101" |
| Weight | 0.4198 oz. | 0.4198 oz. | 0.3704 oz | 0.9524 oz. |
| Gauge size | 23 ga | 25 ga | 20 ga | 23 ga |
| Illumination
Fiber - OD | 0.015" | 0.0150" | 0.030" | 0.015" |
| Illumination
Fiber
Material | PMMA
(Polymethylmethylacrylate
with Fluorinated Polymer
Cladding) | PMMA
(Polymethylmethylacrylate
with Fluorinated Polymer
Cladding) | PMMA
(Polymethylmethylacrylate
with Fluorinated Polymer
Cladding) | PMMA
(Polymethylmethylacrylate
with Fluorinated Polymer
Cladding) |
| Stretch
Capacity-
OD* | Not stretched | Not stretched | Not stretched | 0.0095" |
| Illumination
Connector | Acetal with Stainless
Tube | Acetal with Stainless
Tube | Aluminum | Acetal with Stainless Tube |
| Light Output | 3.7 lumen | 3.7 lumen | 7 lumen | 3.4 lumen |
| Tip
Angulation | Tapered | Tapered | Tapered | Straight |
| Needle
Material | 304 stainless (infusion
cannula) - OD .025" | 304 Stainless (infusion
cannula) - OD .021" | 304 stainless | 304 stainless |
The 23ga and 25ga Adjustable Chandelier Illuminators only transmit light energy, they do not control the intensity of the light output – this is controlled by the operating system to which it is attached. This is also true for both predicate devices.
The light connector for the 23ga and 25ga Adjustable Chandelier Illuminators is the same light connector utilized in the 23ga Curved Illumination Laser Probe (K122997) and is designed to fit into the light sources of the Bausch and Lomb Stellaris PC Vision Enhancement System (K133486).
The materials used to fabricate the acrylic fiber, handpiece and illumination connector used in the 23ga and 25ga Adjustable Chandelier Illuminators are identical to that of the 23ga Curved Illuminating Laser Probe as it was approved in K122997 on June 26, 2013 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
6
The fiber used in the proposed device and both predicates is the exact same formulation (Polymethylmethacrylate (PMMA) with Flourinated Polymer Cladding) and is produced by the same supplier. The diameters of the fibers used in the 23ga and 25ga Adjustable Chandelier Illuminators and the 23ga Curved Illuminating Laser Probe are the same while the fiber used in the Tapered Diffusion is slightly bigger but still provides the same function.
The tapered fiber tip of the 23ga and 25ga Adjustable Chandelier Illuminators and the Tapered Diffusion Probe are manufactured in the same way and perform the same function.
4. Non-Clinical Performance Data
To evaluate the performance of the Adjustable Chandelier Illuminator, the following tests were conducted:
| Test | Test Method |
|---|---|
| Sterility | ISO 11135-1 |
| Shelf-life | ASTM F1980 |
| Biocompatibility | ISO 10993-01 |
| Light Output | Internal Test Method(ITP04-20) |
| Light Field | Internal Test Method (ITP04-30) |
| Thermal Inspection | Internal Test Method (ITP04-40) |
| Bond Strength | Internal Test Method (ITP03-75) |
| Cannula & Fiber Inspection | Internal Test Method (ITP52-00) |
Biocompatibility and sterility testing has been conducted on the 25ga Adjustable Chandelier Illuminators as a "worst case device" and a family representative. All results were acceptable resulting in fully biocompatible device. The 23ga and 25ga Adjustable Chandelier Illuminators are made of the same materials as the predicate devices, Tapered Diffusion Probe (K980025) and 23ga Curved Illumination Laser Probe (K122997). The performance of the 23ga and 25ga Adjustable Chandelier Illuminators satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
-
- Clinical Performance Data
No data from human clinical studies has been included to support the substantial equivalence of the 23ga and 25ga Adjustable Chandelier Illuminator.
- Clinical Performance Data
-
- Conclusion Regarding Substantial Equivalence
The 23ga and 25ga Adjustable Chandelier Illuminators are intended to provide illumination for eye surgery. The 23ga and 25g Adjustable Chandelier Illuminators have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate devices. Peregrine Tapered Diffusion Probe cleared under premarket notification K980025 and the 23ga Curved Illumination Laser Probe
- Conclusion Regarding Substantial Equivalence
7
cleared under K122997. Physically, the 23ga and 25ga Adjustable Chandelier Illuminators share characteristics with both predicate devices. The Tapered Diffusion Probe (K980025) was chosen as the primary predicate because the fiber is tapered in the exact same manner as the Chandelier and produces a very similar light output pattern. The 23ga Curved Illuminating Laser Probe (K122997) was chosen as a secondary predicate because it uses the same connects to the same light source as the Chandelier. Test data to verify the performance of the 23ga and 25ga Adjustable Chandelier Illuminators has been provided including sterility, shelf-life, biocompatibility and functionality. The results of this testing, combined with the design and intended use comparison with the predicate devices, support substantial equivalence.