(265 days)
No
The device description explicitly states that the device is mechanical and contains no electrical components, and it only transmits light energy. There is no mention of any computational or analytical capabilities that would suggest the use of AI/ML.
No
The device is used to visualize internal structures during ophthalmic surgery by conducting light, not to treat a disease or condition.
No
The device is described as a microsurgical instrument that conducts light to visualize internal structures during surgery. It is used to illuminate, not to diagnose or interpret medical conditions.
No
The device description explicitly details physical components such as an ABS handpiece, stainless steel parts, fiber, needle, and scleral depressor. It is a physical surgical instrument, not software.
Based on the provided information, the Midfield Light Pipe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is 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." This describes a surgical instrument used for visualization during a procedure on a living patient.
- Device Description: The description details a physical instrument with components like a handpiece, needle, fiber, and scleral depressor. It's designed for direct interaction with the eye during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Midfield Light Pipe does not perform any such analysis on specimens. It's a tool for direct visualization within the body.
Therefore, the Midfield Light Pipe is a surgical instrument, not an IVD.
N/A
Intended Use / Indications 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.
Product codes
MPA
Device Description
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 (
§ 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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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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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) | Device
Manufacturer | Predicate or
Reference | Regulation
Number |
|----------------------------------------------------------|---------|-----------------------------------------------------------------------|---------------------------|----------------------|
| 23GA and 25GA
Peregrine
Chandelier
Illuminators | K151604 | Peregrine Surgical,
LLC | Predicate | 876.1500 |
| Peregrine
Diffusion Light
Pipe | K950529 | Peregrine Surgical,
LLC | Reference | 886.1945 |
| EVA NEXUS
Surgical System | K213467 | D.O.R.C Dutch
Ophthalmic
Research 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 (