(93 days)
Not Found
No
The summary describes a mechanical device for inserting intraocular lenses and performance studies focused on mechanical properties and clinical outcomes, with no mention of AI or ML.
No
The device is an IOL injector used for insertion of an intraocular lens, which is a surgical tool rather than a therapeutic device that directly treats a disease or condition. While used in a therapeutic procedure (cataract surgery), the device itself is an instrument for insertion.
No
The device is an insertion device for intraocular lenses, used for surgical implantation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the folding and insertion of an intraocular lens into the human eye through a surgical incision. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is described as an IOL injector device used to fold and insert intraocular lenses into the eye. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for a surgical procedure to implant a lens, which is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human 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)
Non-clinical performance testing included simulated surgical manipulation and recovery of properties including both pre- and post-injection evaluation of aged IOLs in accordance with ISO 11979-3:2012 in support of the proposed 1 year shelf-life. Specifically, mechanical dimensions and sagitta were verified following lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012. Optical properties including overall surface and bulk homogeneity were tested pre- and post-lens injection per ISO 11979-2:2014. Additionally, a particulate analysis was performed on aged product to demonstrate coating stability of the sterile insertion device coating following shelf-life aging.
To evaluate whether the RxSight insertion device (with associated insertion methods) presents a significant risk to the corneal endothelium, post-operative endothelial cell density (ECD) data was collected in a prospective clinical study. This study compared the ECD changes following cataract surgery between eyes implanted with the RxLAL using the RxSight insertion device and eyes implanted with a commercially available monofocal control IOL and associated insertion device. The analysis presented in the 510(k) shows similar rates of ECD loss in eyes implanted with either device, supporting the safety of insertion of the LAL with the RxSight Insertion device.
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
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
RxSight, Inc. Maureen O'Connell Vice President, Clinical/Regulatory Affairs 100 Columbia Aliso Viejo, California 92656
Re: K192926
Trade/Device Name: RxSight Insertion Device Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserved Product Code: MSS Dated: December 21, 2019 Received: December 23, 2019
Dear Ms. O'Connell:
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. You must comply with all the Act's
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) 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-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). 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,
for Tieuvi Nguyen, Ph.D. 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) K192926
Device Name RxSight Insertion Device
Indications for Use (Describe)
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
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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1.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).
| APPLICANT: | RxSight, Inc.
100 Columbia
Aliso Viejo, CA 92656 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Maureen O'Connell
Vice President Clinical and Regulatory Affairs
moconnell@rxsight.com
Tel: (978) 207-1245 |
| DATE SUMMARY
PREPARED: | January 10, 2020 |
| TRADE NAME: | RxSight Insertion Device |
| COMMON NAME: | IOL Injector |
| CLASSIFICATION NAME: | Folders and Injectors, Intraocular Lens (IOL) |
| DEVICE CLASSIFICATION: | Class I; 21 CFR 886.4300 |
| PRODUCT CODE: | MSS |
| PREDICATE DEVICE: | RxSight Insertion Device. K181401 |
1.1 DEVICE DESCRIPTION
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
1.2 INDICATIONS FOR USE
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
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1.3 TECHNOLOGICAL CHARACTERISTICS COMPARISON
The technical features of the RxSight Insertion Device, both predicate and proposed, are the same as no modifications to these features are proposed in this 510(k) Premarket Notification. A comparison of the technological characteristics of the proposed and predicate devices is provided in the table below.
| | RxSight Insertion Device
Proposed Device | RxSight Insertion Device
Predicate Device
(K181401) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MSS | MSS |
| Indications for Use | The RxSight Insertion Device is indicated
for the folding and insertion of a 3-piece
silicone, intraocular lens into the human eye
through a surgical incision. The RxSight
Insertion Device is intended for the
insertion of the RxSight Light Adjustable
Lens, the Bausch & Lomb LI61A0 IOL and
IOL models validated for use with this
device in IOL approved labeling. | The RxSight Insertion Device is indicated
for the folding and insertion of a 3-piece
silicone, intraocular lens into the human
eye through a surgical incision. The
RxSight Insertion Device is only for the
insertion of the Bausch & Lomb LI61A0
IOL and IOL models validated for use with
this device in IOL approved labeling |
| Operating Principle | An IOL is placed in a loading cartridge.
Cartridge snapped into the handpiece.
Screw plunger advances the IOL through
the cartridge which folds the IOL and
advances it into the eye. | An IOL is placed in a loading cartridge.
Cartridge snapped into the handpiece.
Screw plunger advances the IOL through
the cartridge which folds the IOL and
advances it into the eye. |
| Pre-loaded IOL | No | No |
| Material (Injector) | Titanium | Titanium |
| Material (cartridge) | Polypropylene | Polypropylene |
| Cartridge Coating | LubriMATRIX™ | LubriMATRIX™ |
| How Supplied
(Reusable/Single Use) | Handpiece - Reusable
Cartridge - Single Use, supplied sterile | Handpiece - Reusable
Cartridge - Single Use, supplied sterile |
| Method of
Sterilization | Handpiece - Autoclave
Cartridge - Ethylene Oxide to SAL 10-6 | Handpiece - Autoclave
Cartridge - Ethylene Oxide to SAL 10-6 |
1.4 SUMMARY OF PERFORMANCE TEST RESULTS
The descriptive characteristics are well-defined and adequate to ensure equivalence of the RxSight Insertion Device with the predicate device.
Non-clinical performance testing included simulated surgical manipulation and recovery of properties including both pre- and post-injection evaluation of aged IOLs in accordance with ISO 11979-3:2012 in support of the proposed 1 year shelf-life. Specifically, mechanical dimensions and sagitta were verified following lens delivery and compared to the measurements performed prior to the lens delivery per ISO 11979-3:2012. Optical properties including overall surface and bulk homogeneity were tested pre- and post-lens injection per ISO 11979-2:2014.
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Additionally, a particulate analysis was performed on aged product to demonstrate coating stability of the sterile insertion device coating following shelf-life aging.
Endothelial Cell Density Clinical Data
To evaluate whether the RxSight insertion device (with associated insertion methods) presents a significant risk to the corneal endothelium, post-operative endothelial cell density (ECD) data was collected in a prospective clinical study. This study compared the ECD changes following cataract surgery between eyes implanted with the RxLAL using the RxSight insertion device and eyes implanted with a commercially available monofocal control IOL and associated insertion device. The analysis presented in the 510(k) shows similar rates of ECD loss in eyes implanted with either device, supporting the safety of insertion of the LAL with the RxSight Insertion device.
Conclusion
The RxSight Insertion Device has the same intended use as the legally marketed predicate devices identified in this 510(k) premarket notification and other IOL injectors regulated under 21 CFR 886.4300. This device continues to meet all product design requirements and applicable standards and embodies technological characteristics similar to the predicate device. Performance data support the conclusion that the proposed RxSight Insertion Device is substantially equivalent to the predicate device.