(340 days)
Not Found
No
The device description and performance studies focus on illumination and mechanical properties, with no mention of AI/ML, image processing, or data-driven algorithms.
No.
The device is used for illumination and visualization during surgery, not for treating a disease or condition.
No
The device is an illumination probe used to visualize and manipulate during cataract surgery, not to diagnose a condition. It provides light, which is an aid for a medical procedure, but it does not perform a diagnostic function itself.
No
The device description explicitly lists physical components (tube, handle, optical fiber, fiber cloth, and connector) and the performance studies include testing related to hardware (sterilization, biocompatibility, mechanical, benchtop performance).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The Nam illumination probe with chopper is used to illuminate the inside of the eye during surgery. It's a tool used to improve visualization within the body (in vivo) for a surgical procedure.
- Intended Use: The intended use clearly states it's for "illuminat[ing] with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery." This is a surgical aid, not a diagnostic test performed on a sample.
The information provided about the device's description, intended use, anatomical site, and performance studies all point to it being a surgical instrument used for illumination during an in-vivo procedure, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery.
Product codes
MPA
Device Description
This product transmits light through the optical fiber to the inside of the eye to illuminate the intraoperative field of the eyeball. It consists of tube, handle, optical fiber, fiber cloth, and connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraocular portion of the 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 following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing: EO sterilization validation in accordance with ISO 11135, Shelf-life testing in accordance with ASTM F1980-16, Sterility testing in accordance with USP, EO residual testing in accordance with ISO 10993-7, Endotoxin testing in accordance with USP.
Biocompatibility Testing: Cytotoxicity testing in accordance with ISO 10993-5, Skin Irritation testing in accordance with ISO 10993-10, Sensitization testing in accordance with ISO 10993-10, Acute systemic toxicity in accordance with ISO 10993-11, Endotoxin testing in accordance with USP, Material Mediated Pyrogenicity in accordance with USP.
Electrical safety and electromagnetic compatibility (EMC): Not Applicable - not a powered device.
Software Verification and Validation Testing: Not Applicable - device does not include software or firmware.
Mechanical and acoustic Testing: Performance testing in accordance with ISO 15004-1 & ISO 15752, Shipping validation in accordance with ASTM D4169-16.
Benchtop Performance Testing: Benchtop performance testing was performed in accordance with ISO 15752:2010 and ISO 15004-2:2007.
Animal Study: Animal performance testing was not required to demonstrate substantial equivalence of the device.
Human Clinical Performance Testing: Clinical testing was not required to demonstrate substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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August 20, 2021
Oculight Ltd. % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738
Re: K202670
Trade/Device Name: Nam illumination probe with chopper Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: MPA Dated: July 10, 2021 Received: July 12, 2021
Dear Robert Packard:
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. 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 located 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.
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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). 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-device-advice-comprehensive-regulatoryassistance/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.
J Angelo Green -S
for LCDR Charles Chiang 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
510(k) Number (if known) K202670
Device Name Nam illumination probe with chopper
Indications for Use (Describe)
The Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY - K202670
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| I. SUBMITTER | Oculight Co., Ltd. |
|---|---|
| Seongnamdaelo 1342, B111 | |
| Seongnam-si, Gyeonggi-do, 13120, Republic of Korea | |
| Tel: +82-031-8039-6177 | |
| Fax: N/A |
| Contact Person: | Robert Packard |
|---|---|
| Date Prepared: | August 19, 2021 |
| II. DEVICE | |
|---|---|
| Name of Device: | Nam illumination probe with chopper |
| Model 1: | 0.5mm, general Angle and 0.5mm, general Angle |
| Model 2: | 0.5mm Twisted and 0.64mm Twisted |
| Model 3: | 0.55mm Bend and 0.64mm, Bent |
| Classification Name: | Endoilluminator |
|---|---|
| Regulation: | 21 CFR §876.1500 |
| Regulatory Class: | Class II |
| Product Classification Code: | MPA |
III. PREDICATE DEVICE
| Predicate Manufacturer: | Syntec, Inc. |
|---|---|
| Predicate Trade Name: | Syntec, Inc. True Light Endoilluminator with Pick |
| Predicate 510(k): | K973290 |
There were two 510(k)-exempt reference devices used in this submission to support the "chopper" component of the device. Both reference devices are similarly designed cataract surgical instruments that are registered with the FDA:
- Katena Products, Inc. (FDA Establishment registration: 1934420)
- . Aesculap (FDA Establishment registration: 2916714)
An additional reference device (i.e. iVision Light Source) was used in this submission. The light source is a 510(k)-exempt device that was used for benchtop performance testing. This light source is registered with the FDA by Oculight Co., Ltd. (the submitter).
DEVICE DESCRIPTION IV.
This product transmits light through the optical fiber to the inside of the eye to illuminate the intraoperative field of the eyeball. It consists of tube, handle, optical fiber, fiber cloth, and connector.
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V. INDICATIONS FOR USE
The Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraccular portion of the eye for improved visualization and manipulation during cataract surgery.
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| Feature | Subject Device (Nam illumination probe with chopper) | Predicate Device (K973290) | Basis for determination of Substantial Equivalence |
|---|---|---|---|
| Indications for Use | The Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery. | The Syntec, Inc. Disposable Endoilluminator with Pick is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to manipulate tissue, during vitreo-retinal surgery. | Subject device's indications are limited to cataract surgery, but this limitation eliminates risks of vitreo-retinal surgery. |
| Materials | Stainless steel tubing | Stainless steel tubing | Same |
| Design | Fiberoptic delivery of light from lamp accessory; Chopper is integrated into tip of tubing | Fiberoptic delivery of light from lamp accessory; Pick is integrated into tip of tubing | Both devices deliver light in the same manner, but instruments of slightly different are integrated into the tip of the device. |
| Components | tube, handle, optical fiber, fiber cloth, and connector | handpiece tube, optical fiber, sheath, and connector | The subject device and the predicate both enclose the optical fibers in a stainless tube, but the predicate device is held by a handle and the predicate has a "handpiece tube". The predicate has a sheath around the optical fiber, while the subject device uses a fiber cloth for the same purpose. Both devices have a connector for the light source. |
| Energy Source | N/A – not powered | N/A – not powered | Same |
| Sterilization Method | EO Sterilization | EO Sterilization | Same |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE VI.
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
EO sterilization validation in accordance with ISO 11135 Shelf-life testing in accordance with ASTM F1980-16 Sterility testing in accordance with USP EO residual testing in accordance with ISO 10993-7 Endotoxin testing in accordance with USP
Biocompatibility Testing
Cytotoxicity testing in accordance with ISO 10993-5 Skin Irritation testing in accordance with ISO 10993-10 Sensitization testing in accordance with ISO 10993-10 Acute systemic toxicity in accordance with ISO 10993-11 Endotoxin testing in accordance with USP Material Mediated Pyrogenicity in accordance with USP
Electrical safety and electromagnetic compatibility (EMC)
Not Applicable - not a powered device
Software Verification and Validation Testing
Not Applicable - device does not include software or firmware
Mechanical and acoustic Testing
Performance testing in accordance with ISO 15004-1 & ISO 15752 Shipping validation in accordance with ASTM D4169-16
Benchtop Performance Testing
Benchtop performance testing was performed in accordance with ISO 15752:2010 and ISO 15004-2:2007.
Animal Study
Animal performance testing was not required to demonstrate substantial equivalence of the device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate substantial equivalence of the device.
VIII. CONCLUSIONS
The results of the testing performed demonstrate that the subject device is substantially equivalent when compared with the predicate device.