(54 days)
Not Found
No
The description focuses on a mechanical device for folding and inserting lenses, with no mention of AI/ML terms or functions.
No.
The device is used for the mechanical insertion of an intraocular lens during surgery, not for treating a disease or condition itself.
No
The device is an insertion device for intraocular lenses, used during cataract surgery to fold and insert lenses into the eye. It is an surgical tool, not a diagnostic one.
No
The device description explicitly states it is a sterile, single-use device consisting of physical components (inserter, cartridge, haptic puller) used for a surgical procedure. There is no mention of software as the primary or sole component.
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's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as an IOL inserter and a haptic puller, used during cataract surgery. These are surgical tools.
- Lack of IVD Characteristics: There is no mention of the device being used to test a sample (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The RxSight® Insertion Device (Model 63002) 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 (Model 63002) is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, 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 (Model 63002) is a sterile, single-use device to be used to fold and insert intraocular lenses (IOL) into the eye through a small incision during cataract surgery. The RxSight Insertion Device (Model 63002) consists of:
- A single-use, disposable, sterile IOL inserter with a non-pyrogenic cartridge
- A single-use, disposable, sterile haptic puller.
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 the IOLs in accordance with ISO 11979-3:2012. 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. Additionally, optical properties and overall surface and bulk homogeneity were tested pre and post lens injection per ISO 11979-2:2014.
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.
0
August 15, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration".
RxSight, Inc. Maureen OConnell Senior Vice President, Clinical and Regulatory Affairs 100 Columbia Aliso Viejo, California 92656
Re: K231838
Trade/Device Name: RxSight® Insertion Device (63002) Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserved Product Code: MSS Dated: June 22, 2023 Received: June 22, 2023
Dear Ms. Maureen OConnell:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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-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,
Elvin Y. I
for Bennett Walker, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K231838
Device Name
RxSight® Insertion Device (63002)
Indications for Use (Describe)
The RxSight® Insertion Device (Model 63002) 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 (Model 63002) is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, 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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3
510(k) SUMMARY RxSight® Insertion Device (Model 63002)
This 510(k) summary 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
Sr. Vice President Clinical and Regulatory Affairs
moconnell@rxsight.com
Tel: (978) 207-1245 |
| DATE SUMMARY
PREPARED: | August 15, 2023 |
| TRADE NAME: | RxSight Insertion Device (Model 63002) |
| COMMON NAME: | IOL Injector |
| CLASSIFICATION NAME: | Intraocular Lens (IOL) Guide |
| DEVICE CLASSIFICATION: | Class I; 21 CFR 886.4300 |
| PRODUCT CODE: | MSS |
| PREDICATE DEVICE(S): | Primary: RxSight Insertion Device, K231466
Secondary: pioli IOL Delivery System, K172228 |
1.1 DEVICE DESCRIPTION
The RxSight Insertion Device (Model 63002) is a sterile, single-use device to be used to fold and insert intraocular lenses (IOL) into the eye through a small incision during cataract surgery. The RxSight Insertion Device (Model 63002) consists of:
- A single-use, disposable, sterile IOL inserter with a non-pyrogenic cartridge ●
- A single-use, disposable, sterile haptic puller. ●
1.2 INDICATIONS FOR USE
The RxSight® Insertion Device (Model 63002) is indicated for the folding and insertion of a 3piece 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®, RxSight
4
Light Adjustable Lens+, and IOL models validated for use with this device in IOL approved labeling.
1.3 TECHNOLOGICAL CHARACTERISTICS COMPARISON
RxSight believes that the RxSight Insertion Device (Model 63002) described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to legally marketed predicate devices that are Class I medical devices. The following table compares the RxSight Insertion Device (Model 63002) with the primary predicate device which is the RxSight Insertion Device (Model 63000/63001) cleared most recently in K231466 and the secondary predicate device, the AST Products pioli IOL Delivery System cleared in K172228.
| | Proposed Device | Primary Predicate
Device | Secondary Predicate
Device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | RxSight Insertion Device
(Model 63002) | RxSight Insertion Device
(Model 63000/63001) | AST Products
pioli IOL Delivery System |
| 510(k) Number | - | K231466 | K172228 |
| Product Code | MSS | MSS | MSS |
| Intended Use | Intraocular Lens Delivery | Intraocular Lens Delivery | Intraocular Lens Delivery |
| Indications for Use | The RxSight® Insertion
Device (Model 63002) 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
(Model 63002) is intended
for the insertion of the
RxSight Light Adjustable
Lens®, RxSight Light
Adjustable Lens+, 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 intended for the insertion
of the RxSight Light
Adjustable Lens®, the
RxSight Light Adjustable
Lens+, the Bausch & Lomb
LI61A0 IOL and IOL models
validated for use with this
device in IOL approved
labeling. | The pioli IOL Delivery system
is a single-use, sterile device
intended to insert a single-
piece foldable intraocular lens
(IOL) into the human eye
through a surgical procedure.
The system provides a tubular
pathway for lens implantation
through an incision. The pioli
IOL Delivery System is only
for the insertion of the Lenstec
Softec I IOL and IOL models
validated for use with this
device as indicated in the IOL
approved labeling. |
| Operating Principle | An IOL is placed in a loading
cartridge. 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. | Cartridge is back loaded into
the injection system with a
plunger that advances the IOL
through the cartridge and into
the eye |
| Pre-loaded IOL | No | No | No |
| Material (Injector) | Polycarbonate | Titanium | Polypropylene |
COMPARISON OF THE RXSIGHT INSERTION DEVICE (MODEL 63002) TO THE PREDICATE DEVICES
5
| | Proposed Device | Primary Predicate
Device | Secondary Predicate
Device |
|------------------------------------------|-------------------------------------------|---------------------------------------------------------------------|-------------------------------------------|
| | RxSight Insertion Device
(Model 63002) | RxSight Insertion Device
(Model 63000/63001) | AST Products
pioli IOL Delivery System |
| | Polybutylene terephthalate
polymer | | |
| Material (cartridge) | Polypropylene | Polypropylene | Polypropylene |
| Cartridge Coating | LubriMATRIX™ | LubriMATRIX™ | LubriMATRIX™ |
| How Supplied
(Reusable/Single
Use) | Single Use, supplied sterile | Handpiece - Reusable
Cartridge - Single Use,
supplied sterile | Single Use, supplied sterile |
| Method of
Sterilization | Ethylene Oxide to SAL 10-6 | Handpiece - Autoclave
Cartridge - Ethylene Oxide to
SAL 10-6 | 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 devices.
Non-clinical performance testing included simulated surgical manipulation and recovery of properties including both pre- and post-injection evaluation of the IOLs in accordance with ISO 11979-3:2012. 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. Additionally, optical properties and overall surface and bulk homogeneity were tested pre and post lens injection per ISO 11979-2:2014.
Conclusion
The RxSight Insertion Device (Model 63002) 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 meets all product design requirements and applicable standards and embodies technological characteristics similar to the predicate devices. Non-clinical data establish that the device is safe and effective in the delivery of the RxSight Light Adjustable Lens and Light Adjustable Lens+ and is shown to be substantially equivalent to the predicate devices.