(265 days)
The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior seqment of the eye in order to visualize the internal structures of the eyes during ophthalmic surgery.
The Midfield Light Pipe will be offered in a 23 gauge (GA), 25GA and 27GA size. Each device consists of an ABS handpiece, 304 stainless steel illumination connector, LDPE EVA jacket material, PMMA illumination fiber, 304 stainless steel needle and a PMMA scleral depressor. The Midfield Light Pipe is an external communicating device, in contact with tissue/bone/dentin for a limited duration (<24 hours). The device will be identical to the existing Peregrine 23GA and 25GA Chandelier Illuminator (K151604), except the illumination fiber used in the Midfield will have a higher numerical aperture (NA). The higher NA of the fiber will allow for a wider light field for improved visibility for the surgeon, without compromising illumination intensity ("brightness").
Peregrine will also provide a scleral depressor for use with the Midfield Light Pipe. Transcleral illumination makes use of the scleral depressor for examination of the vitreous base by manipulating and indenting the sclera while illuminating through the sclera. The scleral depressor is only intended to contact the outer surface of the eye (sclera) for a limited duration (<24 hours).
The Midfield Light Pipes are comprised of common materials used in ophthalmic devices. The light pipe is mechanical and contains no electrical components. The Midfield Light Pipes 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.
I am sorry, but based on the provided text, there is no information about acceptance criteria and a study that proves a device meets these criteria in the context of AI/ML performance, human reader studies, or associated metrics like AUC, sensitivity, specificity, etc.
The document discusses a 510(k) premarket notification for a medical device called "Midfield Light Pipe." The performance testing described is related to the physical characteristics and safety of the device, such as light output, needle strength, phototoxicity, sterilization, shelf-life, packaging, and biocompatibility.
Therefore, I cannot provide the requested information.
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August 8, 2024
Peregrine Surgical Inc. Melissa Dehass QA/QC/RA Manager 51 Britain Drive New Britain, Pennsylvania 18901
Re: K233653
Trade/Device Name: Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: MPA Dated: June 17, 2024 Received: June 17, 2024
Dear Melissa Dehass:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
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Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alexander 2024.08.05
Beylin -S 14:24:57 -04'00'
for Elvin Ng
Assistant Director
DHT1A: Division of Ophthalmic Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
Indications for Use (Describe)
The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior seqment of the eye in order to visualize the internal structures of the eyes 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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510(k) SUMMARY
GENERAL INFORMATION 1.
1.1 Submitter and 510(k) Owner
Peregrine Surgical LLC 51 Britain Dr. New Britain, PA 18901
Official Correspondent 1.2
Melissa DeHass 2380 Admire Springs Drive Dover, PA 17315 Telephone: (717) 476-0702 Email:
1.3 Date of Preparation
June 17, 2024
NAME OF THE DEVICE 2.
2.1 Trade/Proprietary Name
Midfield Light Pipe, 23GA (Reference No. 3269.M04-00) Midfield Light Pipe, 25GA (Reference No. 3269.M05-00) Midfield Light Pipe, 27GA (Reference No. 3269.M06-00)
2.2 Common/Usual Name
Endoilluminator
2.3 Classification Information
| Classification Name: | Endoscope and accessories |
|---|---|
| Classification Regulation: | 21 CFR 876.1500 |
| Class: | 2 |
| Product Code: | MPA – Endoilluminator |
| Panel: | Ophthalmic |
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| Device Name | 510(k) | DeviceManufacturer | Predicate orReference | RegulationNumber |
|---|---|---|---|---|
| 23GA and 25GAPeregrineChandelierIlluminators | K151604 | Peregrine Surgical,LLC | Predicate | 876.1500 |
| PeregrineDiffusion LightPipe | K950529 | Peregrine Surgical,LLC | Reference | 886.1945 |
| EVA NEXUSSurgical System | K213467 | D.O.R.C DutchOphthalmicResearch Center(International)B.V. | Reference | 886.4670 |
PREDICATE AND REFERENCE DEVICES 3.
4. DESCRIPTION OF THE DEVICE
The Midfield Light Pipe will be offered in a 23 gauge (GA), 25GA and 27GA size. Each device consists of an ABS handpiece, 304 stainless steel illumination connector, LDPE EVA jacket material, PMMA illumination fiber, 304 stainless steel needle and a PMMA scleral depressor. The Midfield Light Pipe is an external communicating device, in contact with tissue/bone/dentin for a limited duration (<24 hours). The device will be identical to the existing Peregrine 23GA and 25GA Chandelier Illuminator (K151604), except the illumination fiber used in the Midfield will have a higher numerical aperture (NA). The higher NA of the fiber will allow for a wider light field for improved visibility for the surgeon, without compromising illumination intensity ("brightness").
Peregrine will also provide a scleral depressor for use with the Midfield Light Pipe. Transcleral illumination makes use of the scleral depressor for examination of the vitreous base by manipulating and indenting the sclera while illuminating through the sclera. The scleral depressor is only intended to contact the outer surface of the eye (sclera) for a limited duration (<24 hours).
The Midfield Light Pipes are comprised of common materials used in ophthalmic devices. The light pipe is mechanical and contains no electrical components. The Midfield Light Pipes 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.
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5. INDICATION FOR USE
The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior segment of the eye in order to visualize the internal structures of the eyes during ophthalmic surgery.
COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE 6.
The Midfield Light Pipe is intended for use as an endoillumination light guide. The Midfield Light Pipe has an equivalent intended use as the predicate device. Peregrine 23GA and 25GA Chandelier Illuminator (K151604).
7. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE
The Midfield Light Pipe is substantially equivalent to the predicate device regarding its similar intended use, function, design, materials, packaging and sterility.
The acrylic fiber utilized in the Midfield Light Pipes is comprised of the same materials, manufactured in the same manner and supplied by the same manufacturer as the fiber used in the predicate and reference devices. The only difference is the numerical aperture (NA). The Midfield Light Pipes utilize an illumination fiber with a higher numerical aperture (NA). This difference in NA is due to a difference in the formulation of the materials used in the fibers. No new materials are used, they are just used in different proportions. The higher NA of the fiber will allow for a wider light field for improved visibility for the surgeon, without compromising illumination intensity ("brightness").
The Midfield Light Pipe is packaged with a scleral depressor which serves as a protective cap.
Design verification and validation testing was conducted at t=0 and after accelerated aging to t=2 years to confirm that these changes do not raise issues of safety or effectiveness.
PERFORMANCE TESTING 8.
These 510(k) notifications provide performance data to establish the substantial equivalence of the Midfield Light Pipe to the predicate device.
- Functionality
- Light output O
- Needle strength o
- Phototoxicity (ISO 15004/ISO 15752) o
- · Sterilization (ISO 11607-1)
- · Shelf-life (ASTM F1980)
- · Packaging (ASTM D4169)
- · Biocompatibility
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| Component | Material | Contact Type | ContactDuration | Assessment | Standard |
|---|---|---|---|---|---|
| Light Fiber | PMMA | Tissue/bone/dentin | Limited(<24 hours) | CytotoxicityIrritation | ISO 10993-5ISO 10993-10 |
| Shaft | 304 StainlessSteel | Tissue/bone/dentin | Limited(<24 hours) | Sensitization | ISO 10993-10 |
| Adhesive | Loctite 4011 | Tissue/bone/dentin | Limited(<24 hours) | SubacuteToxicity | ISO 10993-11 |
| Material-MediatedPyrogenicity | ISO 10993-11 | ||||
| ScleralDepressor | PMMA | Surface - Mucosalmembrane | Limited(<24 hours) | Cytotoxicity | ISO 10993-5 |
| Irritation | ISO 10993-10 | ||||
| Sensitization | ISO 10993-10 |
Data from human clinical studies is not required to support the substantial equivalence of the Midfield Light Pipe.
9. CONCLUSIONS
The Midfield Light Pipes are intended to provide illumination for eye surgery. The Midfield Light Pipes have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate device, 23GA and 25GA Peregrine Chandelier Illuminator (K151604) and the reference device, Peregrine Diffusion Light Pipe (K950529). Physically, the Midfield Light Pipes share characteristics with both predicate and reference devices.
The EVA NEXUS Surgical System (K213467) was also selected as a reference device as it represents an operating system for which the Midfield Light Pipes are intended for use with. The Midfield Light Pipes, which are intended for use with the EVA NEXUS Surgical System, utilize the same biocompatible materials as the light pipes utilized with the EVA NEXUS Ophthalmic Surgical System (cleared under K213467). In addition, the EVA NEXUS Ophthalmic Surgical System and associated light pipes utilize a scleral depressor.
The information presented in this 510(k) submission demonstrates that the Midfield Light Pipe is substantially equivalent to the predicate device, Peregrine 23GA and 25GA Chandelier Illuminator (K151604).
§ 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.